Trial Outcomes & Findings for Visionaire™ Versus Standard Instrumentation Safety and Efficacy in Total Knee Arthroplasty (TKA) (NCT NCT01084772)
NCT ID: NCT01084772
Last Updated: 2020-04-03
Results Overview
The KSS was used to rate both the prosthesis function and the patient's functional abilities after TKA. The KSS Total Score (0-100 points) included a combined evaluation of joint motion (0-25 points), instability (0-25 points), alignment (0-25 points), and symptoms (0-25 points). A higher score indicated a better outcome for subjects.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
134 participants
Primary outcome timeframe
2 years postoperatively
Results posted on
2020-04-03
Participant Flow
The study was planned to enroll 196 subjects; 134 subjects were recruited to the study prior to its termination due to insufficient total enrollment. Subjects were enrolled from 21 June 2012 to 15 April 2014. Early termination was approved May 2014 and sites were officially notified of study termination in September 2015.
Participant milestones
| Measure |
VISIONAIRE Instrumentation
TKA with VISIONAIRE instrumentation
Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
|
Standard Instrumentation
TKA with standard instrumentation
Total Knee Arthroplasty was performed using conventional instrumentation.
|
|---|---|---|
|
Baseline
STARTED
|
68
|
66
|
|
Baseline
COMPLETED
|
61
|
60
|
|
Baseline
NOT COMPLETED
|
7
|
6
|
|
3 Months
STARTED
|
61
|
60
|
|
3 Months
COMPLETED
|
58
|
58
|
|
3 Months
NOT COMPLETED
|
3
|
2
|
|
1 Year
STARTED
|
58
|
58
|
|
1 Year
COMPLETED
|
55
|
50
|
|
1 Year
NOT COMPLETED
|
3
|
8
|
|
2 Years
STARTED
|
55
|
50
|
|
2 Years
COMPLETED
|
46
|
46
|
|
2 Years
NOT COMPLETED
|
9
|
4
|
Reasons for withdrawal
| Measure |
VISIONAIRE Instrumentation
TKA with VISIONAIRE instrumentation
Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
|
Standard Instrumentation
TKA with standard instrumentation
Total Knee Arthroplasty was performed using conventional instrumentation.
|
|---|---|---|
|
Baseline
Withdrawal by Subject
|
7
|
6
|
|
3 Months
Death
|
1
|
0
|
|
3 Months
Study Termination
|
2
|
2
|
|
1 Year
Withdrawal by Subject
|
0
|
1
|
|
1 Year
Lost to Follow-up
|
3
|
0
|
|
1 Year
Study Termination
|
0
|
7
|
|
2 Years
Withdrawal by Subject
|
1
|
0
|
|
2 Years
Lost to Follow-up
|
5
|
2
|
|
2 Years
Study Termination
|
3
|
2
|
Baseline Characteristics
Visionaire™ Versus Standard Instrumentation Safety and Efficacy in Total Knee Arthroplasty (TKA)
Baseline characteristics by cohort
| Measure |
VISIONAIRE Instrumentation
n=68 Participants
TKA with VISIONAIRE instrumentation
Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
|
Standard Instrumentation
n=65 Participants
TKA with standard instrumentation
Total Knee Arthroplasty was performed using conventional instrumentation.
|
Total
n=133 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.7 years
STANDARD_DEVIATION 8.71 • n=5 Participants
|
67.5 years
STANDARD_DEVIATION 7.70 • n=7 Participants
|
68.9 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, Not Hispanic
|
52 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, Not Hispanic
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Aus-Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Aus-Caucasian
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Height
|
168.0 cm
STANDARD_DEVIATION 9.84 • n=5 Participants
|
168.0 cm
STANDARD_DEVIATION 10.12 • n=7 Participants
|
168.0 cm
STANDARD_DEVIATION 9.94 • n=5 Participants
|
|
Weight
|
88.3 kg
STANDARD_DEVIATION 17.80 • n=5 Participants
|
83.7 kg
STANDARD_DEVIATION 17.77 • n=7 Participants
|
86.1 kg
STANDARD_DEVIATION 17.86 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2 years postoperativelyPopulation: The Knee Society Clinical Score was not completed for all enrolled subjects. Data was only available for 83 subjects.
The KSS was used to rate both the prosthesis function and the patient's functional abilities after TKA. The KSS Total Score (0-100 points) included a combined evaluation of joint motion (0-25 points), instability (0-25 points), alignment (0-25 points), and symptoms (0-25 points). A higher score indicated a better outcome for subjects.
Outcome measures
| Measure |
VISIONAIRE Instrumentation
n=42 Participants
TKA with VISIONAIRE instrumentation
Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
|
Standard Instrumentation
n=41 Participants
TKA with standard instrumentation
Total Knee Arthroplasty was performed using conventional instrumentation.
|
|---|---|---|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Total Score
|
91.4 score on a scale
Standard Deviation 13.7
|
94.3 score on a scale
Standard Deviation 8.9
|
PRIMARY outcome
Timeframe: 2 years postoperativelyThe KSS was used to rate both the prosthesis function and the patient's functional abilities after TKA. The KSS clinical evaluation included a questionnaire completed by the investigators to assess for pain, stability, flexion contracture, extension lag, and alignment and evaluated based on number of subjects experiencing any of these issues at the 2-year postoperative visit.
Outcome measures
| Measure |
VISIONAIRE Instrumentation
n=46 Participants
TKA with VISIONAIRE instrumentation
Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
|
Standard Instrumentation
n=46 Participants
TKA with standard instrumentation
Total Knee Arthroplasty was performed using conventional instrumentation.
|
|---|---|---|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Alignment - 0 or 15 degrees valgus
|
1 Participants
|
0 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Alignment - varus or > 15 degrees valgus
|
0 Participants
|
0 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Pain - none
|
26 Participants
|
27 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Pain - mild or occasional
|
12 Participants
|
14 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Pain - stairs only
|
1 Participants
|
1 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Pain - walking & stairs
|
1 Participants
|
1 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Pain - moderate occasional
|
2 Participants
|
1 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Pain - moderate continuous
|
3 Participants
|
1 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Pain - severe
|
1 Participants
|
0 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Pain - missing response
|
0 Participants
|
1 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
AP Stability - <5 mm
|
43 Participants
|
43 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Alignment - missing response
|
3 Participants
|
2 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
AP Stability - 5-10 mm
|
1 Participants
|
1 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
AP Stability - >10 mm
|
0 Participants
|
1 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
AP Stability - missing response
|
2 Participants
|
1 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Medio-lateral Stability - <6 degrees
|
44 Participants
|
44 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Medio-lateral Stability - 6-9 degrees
|
0 Participants
|
0 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Medio-lateral Stability - 10-14 degrees
|
0 Participants
|
0 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Medio-lateral Stability - >14 degrees
|
0 Participants
|
1 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Medio-lateral Stability - missing response
|
2 Participants
|
1 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Flexion Contracture - 0-4 degrees
|
42 Participants
|
42 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Flexion Contracture - 5-10 degrees
|
2 Participants
|
2 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Flexion Contracture - 11-15 degrees
|
0 Participants
|
0 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Flexion Contracture - 16-20 degrees
|
0 Participants
|
0 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Flexion Contracture - > 20 degrees
|
0 Participants
|
0 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Flexion Contracture - missing response
|
2 Participants
|
2 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Extension Lag - 0 degrees
|
43 Participants
|
44 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Extension Lag - < 10 degrees
|
1 Participants
|
0 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Extension Lag - 11-20 degrees
|
0 Participants
|
0 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Extension Lag - > 20 degrees
|
0 Participants
|
1 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Extension Lag - missing response
|
2 Participants
|
1 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Alignment - 5 or 10 degrees valgus (normal)
|
40 Participants
|
41 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Alignment - 4 or 11 degrees valgus
|
1 Participants
|
1 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Alignment - 3 or 12 degrees valgus
|
1 Participants
|
1 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Alignment - 2 or 13 degrees valgus
|
0 Participants
|
0 Participants
|
|
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Alignment - 1 or 14 degrees valgus
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 months postoperativePopulation: Evaluation of Mechanical Alignment 3 Months Postoperatively was not completed for all enrolled subjects. Only data for 88 participants was available.
Long radiographic anterior-posterior (AP) (full-leg standing x-rays) of the entire limb are superior for measuring alignment of the knee as the limb mechanical axes may be more precisely computed. For full-leg x-rays, 2 lines were drawn on the radiograph. First, a line was drawn from the center of the femoral head to the center of the femoral intercondylar notch and the line was extended through to the ankle. Second, a line was drawn from the center of the tibial spine to the center of the ankle talus. The angle between the first and second line was measured to determine mechanical alignment and assessed as either neutral (0 degrees) or a number of degrees of varus or valgus.
Outcome measures
| Measure |
VISIONAIRE Instrumentation
n=44 Participants
TKA with VISIONAIRE instrumentation
Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
|
Standard Instrumentation
n=44 Participants
TKA with standard instrumentation
Total Knee Arthroplasty was performed using conventional instrumentation.
|
|---|---|---|
|
Evaluation of Mechanical Alignment Assessed as Either Neutral or Varus/Valgus 3 Months Postoperatively Using a Full Leg X-ray
Alignment - Neutral
|
19 Participants
|
10 Participants
|
|
Evaluation of Mechanical Alignment Assessed as Either Neutral or Varus/Valgus 3 Months Postoperatively Using a Full Leg X-ray
Varus
|
11 Participants
|
28 Participants
|
|
Evaluation of Mechanical Alignment Assessed as Either Neutral or Varus/Valgus 3 Months Postoperatively Using a Full Leg X-ray
Valgus
|
14 Participants
|
6 Participants
|
|
Evaluation of Mechanical Alignment Assessed as Either Neutral or Varus/Valgus 3 Months Postoperatively Using a Full Leg X-ray
Missing
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (preoperative), 3 months, 1 year, and 2 years postoperativelyPopulation: Not all enrolled subjects completed the KOOS questionnaire at each time point.
Evaluation of KOOS questionnaire total scores including categories for symptoms, pain, function of daily living, function of sports and recreational activities, and quality of life. KOOS total scores ranged from 0 to 100, with 0 indicating worst (no function) and 100 indicating no symptoms at all.
Outcome measures
| Measure |
VISIONAIRE Instrumentation
n=62 Participants
TKA with VISIONAIRE instrumentation
Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
|
Standard Instrumentation
n=60 Participants
TKA with standard instrumentation
Total Knee Arthroplasty was performed using conventional instrumentation.
|
|---|---|---|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively
Pain - preoperative
|
40.9 score on a scale
Standard Deviation 17.0
|
43.9 score on a scale
Standard Deviation 16.6
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively
Pain - 3 months postoperative
|
73.7 score on a scale
Standard Deviation 15.5
|
76.3 score on a scale
Standard Deviation 16.1
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively
Pain - 1 year postoperative
|
85.4 score on a scale
Standard Deviation 16.7
|
88.5 score on a scale
Standard Deviation 16.7
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively
Pain - 2 years postoperative
|
89.4 score on a scale
Standard Deviation 13.2
|
92.3 score on a scale
Standard Deviation 10.2
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively
Symptoms - preoperative
|
46.6 score on a scale
Standard Deviation 21.2
|
49.9 score on a scale
Standard Deviation 17.7
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively
Symptoms - 3 months postoperative
|
66.4 score on a scale
Standard Deviation 17.5
|
73.1 score on a scale
Standard Deviation 13.6
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively
Symptoms - 1 year postoperative
|
81.6 score on a scale
Standard Deviation 17.2
|
82.5 score on a scale
Standard Deviation 16.4
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively
Symptoms - 2 years postoperative
|
85.7 score on a scale
Standard Deviation 10.9
|
88.2 score on a scale
Standard Deviation 9.4
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively
Activities of Daily Living (ADLs) - preoperative
|
46.5 score on a scale
Standard Deviation 18.9
|
51.4 score on a scale
Standard Deviation 18.8
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively
ADLs - 3 months postoperative
|
78.8 score on a scale
Standard Deviation 14.6
|
84.1 score on a scale
Standard Deviation 13.8
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively
ADLs - 1 year postoperative
|
86.8 score on a scale
Standard Deviation 14.9
|
89.5 score on a scale
Standard Deviation 12.4
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively
ADLs - 2 years postoperative
|
89.3 score on a scale
Standard Deviation 14.6
|
92.3 score on a scale
Standard Deviation 10.4
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively
Sports/Rec - preoperative
|
19.0 score on a scale
Standard Deviation 19.0
|
23.1 score on a scale
Standard Deviation 22.8
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively
Sports/Rec - 3 months postoperative
|
42.4 score on a scale
Standard Deviation 29.6
|
48.2 score on a scale
Standard Deviation 31.3
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively
Sports/Rec - 1 year postoperative
|
62.0 score on a scale
Standard Deviation 32.0
|
62.5 score on a scale
Standard Deviation 32.6
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively
Sports/Rec - 2 years postoperative
|
74.9 score on a scale
Standard Deviation 26.6
|
74.4 score on a scale
Standard Deviation 25.6
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively
Quality of Life (QoL) - preoperative
|
21.0 score on a scale
Standard Deviation 17.2
|
22.5 score on a scale
Standard Deviation 17.2
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively
QoL - 3 months postoperative
|
58.6 score on a scale
Standard Deviation 21.7
|
64.1 score on a scale
Standard Deviation 19.9
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively
QoL - 1 year postoperative
|
68.1 score on a scale
Standard Deviation 26.2
|
72.9 score on a scale
Standard Deviation 23.7
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively
QoL - 2 years postoperative
|
75.1 score on a scale
Standard Deviation 23.2
|
78.0 score on a scale
Standard Deviation 18.3
|
SECONDARY outcome
Timeframe: 1 year postoperativelyPopulation: Not all subjects completed the serial radiographic evaluations at the specified time points.
X-ray evaluations performed to assess for evidence of implant loosening by radiolucencies (\> 2 mm). Anterior-posterior (AP) and lateral serial x-ray evaluations were performed. The span of the bone-prosthesis interface, for each component, was broken down into zone systems. The scoring system for each of the 3 components was determined by measuring the radiolucent lines (mm) for each of these zones.
Outcome measures
| Measure |
VISIONAIRE Instrumentation
n=54 Participants
TKA with VISIONAIRE instrumentation
Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
|
Standard Instrumentation
n=50 Participants
TKA with standard instrumentation
Total Knee Arthroplasty was performed using conventional instrumentation.
|
|---|---|---|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 1 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone B (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone 1 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone 2 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 6 (≤ 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 1 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 1 (≤ 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 1 (> 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 2 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 2 (≤ 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 2 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 2 (> 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 3 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 3 (≤ 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 3 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 3 (> 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 4 (≤ 2 mm)
|
1 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 4 (≤ 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 4 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 4 (> 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 5 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 5 (≤ 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 5 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 5 (> 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 6 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 6 (≤ 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 6 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 6 (> 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 7 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 7 (≤ 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 7 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - femoral zone 7 (> 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 1 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 1 (≤ 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 1 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 1 (> 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 2 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 2 (≤ 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 2 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 2 (> 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 3 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 3 (≤ 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 3 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 3 (> 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 4 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 4 (≤ 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 4 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 4 (> 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 5 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 5 (≤ 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 5 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 5 (> 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 6 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 6 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 6 (> 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 7 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 7 (≤ 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 7 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - patellar zone 7 (> 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 1 (≤ 2 mm)
|
3 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 1 (≤ 2 mm and progressive
|
0 participants
|
1 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 1 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 1 (> 2 mm and progressive
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 2 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 2 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 2 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 2 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 3 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 3 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 3 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 3 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 4 (≤ 2 mm)
|
2 participants
|
1 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 4 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 4 (> 2 mm)
|
0 participants
|
1 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 4 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 5 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 5 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 5 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 5 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 6 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 6 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 6 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 6 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 7 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 7 (≤2 mm and progressive)
|
1 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 7 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 7 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 8 (≤ 2 mm)
|
1 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 8 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 8 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 8 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 9 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 9 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 9 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone 9 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone A (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone A (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone A (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone A (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone B (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone B (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial AP zone B (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone 1 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone 1 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone 1 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone 2 (≤ 2 mm)
|
1 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone 2 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone 2 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone 3 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone 3 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone 3 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone 3 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone 4 (≤ 2 mm)
|
1 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone 4 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone 4 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone 4 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone 5 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone 5 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone 5 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone 5 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone A (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone A (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone A (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone A (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone B (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone B (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone B (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Lucency - tibial ML zone B (>2 mm and progressive)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 1 year postoperativelyPopulation: Not all subjects completed the serial radiographic evaluations at the specified time points.
X-ray evaluations performed to assess for evidence of implant loosening by lack of evidence of surface wear or particulate debris generation, indications of early osteolysis, implant migration, and/or other clinical or radiographic abnormalities. Anterior-posterior (AP) and lateral serial x-ray evaluations were performed.
Outcome measures
| Measure |
VISIONAIRE Instrumentation
n=54 Participants
TKA with VISIONAIRE instrumentation
Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
|
Standard Instrumentation
n=50 Participants
TKA with standard instrumentation
Total Knee Arthroplasty was performed using conventional instrumentation.
|
|---|---|---|
|
Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively
Patella tracking - normal
|
53 participants
|
49 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively
Patella tracking - lateralized
|
1 participants
|
0 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively
Patella tracking - subluxation
|
0 participants
|
1 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively
Patella tracking - dislocation
|
0 participants
|
0 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively
Fixation - Ingrowth
|
35 participants
|
32 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively
Fixation - x-ray unclear
|
0 participants
|
1 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively
Fixation - indifferent, bone unchanged
|
34 participants
|
29 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively
Fixation - increased osseointegration
|
1 participants
|
2 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively
Fixation - bone loss
|
0 participants
|
0 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively
Fixation - implant at risk
|
0 participants
|
0 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively
Fixation - implant loosening
|
0 participants
|
0 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively
Fixation - revision indication
|
0 participants
|
0 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively
Observations - periosteal hypertrophy
|
0 participants
|
0 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively
Observations - osteolysis
|
0 participants
|
0 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively
Observations - subsidence
|
0 participants
|
0 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively
Observations - other
|
0 participants
|
0 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively
Evidence of deformity - no
|
54 participants
|
50 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively
Evidence of deformity - yes
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 2 years postoperativelyPopulation: Not all subjects completed the serial radiographic evaluations at the specified time points.
X-ray evaluations performed to assess for evidence of implant loosening by radiolucencies (\> 2 mm), lack of evidence of surface wear or particulate debris generation, indications of early osteolysis, implant migration, and/or other clinical or radiographic abnormalities. Anterior-posterior (AP) and lateral serial x-ray evaluations were performed. The span of the bone-prosthesis interface, for each component, was broken down into zone systems. The scoring system for each of the 3 components was determined by measuring the radiolucent lines (mm) for each of these zones.
Outcome measures
| Measure |
VISIONAIRE Instrumentation
n=45 Participants
TKA with VISIONAIRE instrumentation
Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
|
Standard Instrumentation
n=43 Participants
TKA with standard instrumentation
Total Knee Arthroplasty was performed using conventional instrumentation.
|
|---|---|---|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 4 (≤ 2 mm)
|
0 participants
|
1 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone B (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone 2 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 5 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 6 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 1 (≤ 2 mm)
|
1 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 1 (≤ 2 mm and progressive)
|
1 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 1 (> 2 mm)
|
1 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 1 (> 2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 2 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 2 (≤2 mm and progressive)
|
1 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 2 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 2 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 3 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 3 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 3 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 3 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 4 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 4 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 4 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femor0al zone 4 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 5 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 5 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 5 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 6 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 6 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 6 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 7 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 7 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 7 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - femoral zone 7 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 1 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 1 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 1 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 1 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 2 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 2 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 2 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 2 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 3 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 3 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 3 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 3 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 4 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 4 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 4 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 4 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 5 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 5 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 5 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 5 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 6 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 6 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 6 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 6 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 7 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 7 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 7 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - patella zone 7 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 1 (≤ 2 mm)
|
2 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 1 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 1 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 1 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 2 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 2 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 2 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 2 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 3 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 3 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 3 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 3 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 4 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 4 (> 2 mm)
|
0 participants
|
1 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 4 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 5 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 5 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 5 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 5 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 6 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 6 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 6 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 6 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 7 (≤ 2 mm)
|
0 participants
|
1 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 7 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 7 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 7 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 8 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 8 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 8 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 8 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 9 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 9 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 9 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone 9 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone A (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone A (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone A (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone A (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone B (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone B (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone B (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial AP zone B (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone 1 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone 1 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone 1 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone 1 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone 2 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone 2 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone 2 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone 3 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone 3 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone 3 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone 3 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone 4 (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone 4 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone 4 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone 4 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone 5 (≤ 2 mm)
|
0 participants
|
1 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone 5 (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone 5 (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone 5 (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone A (≤ 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone A (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone A (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone A (>2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone B (≤2 mm and progressive)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone B (> 2 mm)
|
0 participants
|
0 participants
|
|
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Lucency - tibial ML zone B (>2 mm and progressive)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 2 years postoperativelyPopulation: Not all subjects completed the serial radiographic evaluations at the specified time points.
X-ray evaluations performed to assess for evidence of implant loosening by lack of evidence of surface wear or particulate debris generation, indications of early osteolysis, implant migration, and/or other clinical or radiographic abnormalities. Anterior-posterior (AP) and lateral serial x-ray evaluations were performed.
Outcome measures
| Measure |
VISIONAIRE Instrumentation
n=45 Participants
TKA with VISIONAIRE instrumentation
Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
|
Standard Instrumentation
n=43 Participants
TKA with standard instrumentation
Total Knee Arthroplasty was performed using conventional instrumentation.
|
|---|---|---|
|
Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively
Patella tracking - normal
|
42 participants
|
43 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively
Patella tracking - lateralized
|
2 participants
|
0 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively
Patella tracking - subluxation
|
0 participants
|
0 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively
Patella tracking - dislocation
|
0 participants
|
0 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively
Patella tracking - missing
|
1 participants
|
0 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively
Fixation - fixation/ingrowth
|
28 participants
|
24 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively
Fixation - x-ray unclear
|
0 participants
|
0 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively
Fixation - indifferent, bone unchanged
|
27 participants
|
24 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively
Fixation - increased osseointegration
|
0 participants
|
0 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively
Fixation - bone loss
|
0 participants
|
0 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively
Fixation - implant at risk
|
1 participants
|
0 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively
Fixation - implant loosening
|
0 participants
|
0 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively
Fixation - revision indication
|
0 participants
|
0 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively
Observations - periosteal hypertrophy
|
0 participants
|
0 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively
Observations - osteolysis
|
0 participants
|
0 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively
Observations - subsidence
|
0 participants
|
0 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively
Observations - other
|
1 participants
|
0 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively
Evidence of deformity - no
|
45 participants
|
43 participants
|
|
Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively
Evidence of deformity - yes
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: During and immediately following surgeryPopulation: Not all analysis values were available for all enrolled subjects.
Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used.
Outcome measures
| Measure |
VISIONAIRE Instrumentation
n=62 Participants
TKA with VISIONAIRE instrumentation
Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
|
Standard Instrumentation
n=60 Participants
TKA with standard instrumentation
Total Knee Arthroplasty was performed using conventional instrumentation.
|
|---|---|---|
|
Evaluation of Health Economic Criteria - Surgical Time Details
Anesthesia time
|
128.8 minutes
Standard Deviation 37.2
|
126.5 minutes
Standard Deviation 32.8
|
|
Evaluation of Health Economic Criteria - Surgical Time Details
Skin to skin time
|
74.9 minutes
Standard Deviation 23.5
|
75.4 minutes
Standard Deviation 23.6
|
|
Evaluation of Health Economic Criteria - Surgical Time Details
Tray setup time
|
16.5 minutes
Standard Deviation 13.9
|
19.7 minutes
Standard Deviation 11.7
|
|
Evaluation of Health Economic Criteria - Surgical Time Details
Duration of operation
|
110.6 minutes
Standard Deviation 29.5
|
110.9 minutes
Standard Deviation 26.8
|
SECONDARY outcome
Timeframe: During and immediately following surgeryPopulation: Not all analysis values were available for all enrolled subjects.
Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used.
Outcome measures
| Measure |
VISIONAIRE Instrumentation
n=62 Participants
TKA with VISIONAIRE instrumentation
Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
|
Standard Instrumentation
n=60 Participants
TKA with standard instrumentation
Total Knee Arthroplasty was performed using conventional instrumentation.
|
|---|---|---|
|
Evaluation of Health Economic Criteria - Blood Loss
|
105.2 mL
Standard Deviation 85.1
|
93.8 mL
Standard Deviation 39.0
|
SECONDARY outcome
Timeframe: During and immediately following surgeryPopulation: Not all analysis values were available for all enrolled subjects.
Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used.
Outcome measures
| Measure |
VISIONAIRE Instrumentation
n=61 Participants
TKA with VISIONAIRE instrumentation
Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
|
Standard Instrumentation
n=59 Participants
TKA with standard instrumentation
Total Knee Arthroplasty was performed using conventional instrumentation.
|
|---|---|---|
|
Evaluation of Health Economic Criteria - Incision Length
|
153.6 mm
Standard Deviation 21.2
|
156.8 mm
Standard Deviation 18.4
|
SECONDARY outcome
Timeframe: During and immediately following surgeryPopulation: Not all analysis values were available for all enrolled subjects.
Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used.
Outcome measures
| Measure |
VISIONAIRE Instrumentation
n=60 Participants
TKA with VISIONAIRE instrumentation
Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
|
Standard Instrumentation
n=59 Participants
TKA with standard instrumentation
Total Knee Arthroplasty was performed using conventional instrumentation.
|
|---|---|---|
|
Evaluation of Health Economic Criteria - Instrument Tray Use
Instrument trays used in setup
|
5.3 number of trays
Standard Deviation 4.2
|
8.2 number of trays
Standard Deviation 2.6
|
|
Evaluation of Health Economic Criteria - Instrument Tray Use
Instrument trays used
|
5.1 number of trays
Standard Deviation 3.8
|
8.0 number of trays
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: During and immediately following surgeryAnalysis of health data captured during and immediately following surgery: surgical approach, cut order, final status of posterior cruciate ligament (PCL), and need for perioperative prophylaxis antibiotics.
Outcome measures
| Measure |
VISIONAIRE Instrumentation
n=62 Participants
TKA with VISIONAIRE instrumentation
Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
|
Standard Instrumentation
n=60 Participants
TKA with standard instrumentation
Total Knee Arthroplasty was performed using conventional instrumentation.
|
|---|---|---|
|
Evaluation of Health Economic Surgical Criteria
Surgical approach - medial parapatellar
|
58 participants
|
56 participants
|
|
Evaluation of Health Economic Surgical Criteria
Surgical approach - subvastus
|
0 participants
|
0 participants
|
|
Evaluation of Health Economic Surgical Criteria
Surgical approach - midvastus
|
4 participants
|
2 participants
|
|
Evaluation of Health Economic Surgical Criteria
Surgical approach - lateral parapatellar
|
0 participants
|
1 participants
|
|
Evaluation of Health Economic Surgical Criteria
Surgical approach - other
|
0 participants
|
1 participants
|
|
Evaluation of Health Economic Surgical Criteria
Surgical approach - missing
|
0 participants
|
0 participants
|
|
Evaluation of Health Economic Surgical Criteria
Cut order - distal cut first
|
57 participants
|
46 participants
|
|
Evaluation of Health Economic Surgical Criteria
Cut order - anterior cut first
|
5 participants
|
13 participants
|
|
Evaluation of Health Economic Surgical Criteria
Cut order - tibial cut first
|
0 participants
|
1 participants
|
|
Evaluation of Health Economic Surgical Criteria
Cut order - missing
|
0 participants
|
0 participants
|
|
Evaluation of Health Economic Surgical Criteria
Final status of PCL - excised
|
29 participants
|
27 participants
|
|
Evaluation of Health Economic Surgical Criteria
Final status of PCL - released
|
2 participants
|
3 participants
|
|
Evaluation of Health Economic Surgical Criteria
Final status of PCL - intact
|
13 participants
|
15 participants
|
|
Evaluation of Health Economic Surgical Criteria
Final status of PCL - N/A (PS component used)
|
18 participants
|
15 participants
|
|
Evaluation of Health Economic Surgical Criteria
Final status of PCL - missing
|
0 participants
|
0 participants
|
|
Evaluation of Health Economic Surgical Criteria
Perioperative prophylaxis antibiotics - no
|
0 participants
|
0 participants
|
|
Evaluation of Health Economic Surgical Criteria
Perioperative prophylaxis antibiotics - yes
|
62 participants
|
60 participants
|
Adverse Events
VISIONAIRE Instrumentation
Serious events: 0 serious events
Other events: 43 other events
Deaths: 1 deaths
Standard Instrumentation
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
VISIONAIRE Instrumentation
n=68 participants at risk
TKA with VISIONAIRE instrumentation
Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
|
Standard Instrumentation
n=66 participants at risk
TKA with standard instrumentation
Total Knee Arthroplasty was performed using conventional instrumentation.
|
|---|---|---|
|
Cardiac disorders
Chest pain
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 2 • The time of operation through 2 years postoperatively.
|
|
General disorders
Confusion
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Blood and lymphatic system disorders
Anemia
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Painful, hot, stiff knee post-op
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Stiff knee requiring manipulation under anesthesia
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
3.0%
2/66 • Number of events 2 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Contralateral TKR
|
2.9%
2/68 • Number of events 2 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Metabolism and nutrition disorders
Weight gain
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Endocrine disorders
Diabetes
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Knee pes tendonitis
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Blood and lymphatic system disorders
Vascular calcification, right leg popliteal artery
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Decreased ROM left knee secondary to post-op chest infection, unable to do PT
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Infections and infestations
Suspected chest infection 1 week post-op
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Infections and infestations
Superficial wound infection
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Skin and subcutaneous tissue disorders
Post-op wound inflammation, question of stitch reaction
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer of prostate
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Injury, poisoning and procedural complications
Fall on operated knee resulting in pain
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Injury, poisoning and procedural complications
Fall - painful knee and wrist
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Injury, poisoning and procedural complications
Right hip fracture
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
Planned left THA
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Left IT band tendonitis
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Left knee slight clicking sensation
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Injury, poisoning and procedural complications
Wound dehiscence/extruded stitches
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
Left knee arthroscopy
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Blood and lymphatic system disorders
Bilateral DVT
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Blood and lymphatic system disorders
Pulmonary embolism
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Injury, poisoning and procedural complications
Patient fell on buttock, increased left knee discomfort
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
Right total knee arthroplasty
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
6.1%
4/66 • Number of events 4 • The time of operation through 2 years postoperatively.
|
|
Cardiac disorders
Arterial blood clots due to mitral valve disease; had a TEE
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 2 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Medial joint line tenderness with certain twisting maneuvers
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Cervical stenosis with cervical DJD
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Gastrointestinal disorders
Nausea postoperatively during hospitalization
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
Left total knee arthroplasty
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
4.5%
3/66 • Number of events 3 • The time of operation through 2 years postoperatively.
|
|
Injury, poisoning and procedural complications
Patient fell and had minor bruising to study knee
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Mild lateral pain by insertion of ITB left study knee
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Bilateral thigh pain, left worse than right
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Bilateral trochanteric bursitis - hips
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain tumor
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
Left total shoulder replacement
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Painful left knee
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
Lumbar laminectomy, fusion of L3-5 and iliac crest bone graft
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
Heart surgery, insertion of mechanical valve in aorta
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
Surgery for bladder prolapse, mesh removal
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
Ascending aortic dissection repair
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
Chest pain, dx stenosis; catheterization and stent placement
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
Hernia repair
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
L5-S1 lumbar epidural steroid injection
|
1.5%
1/68 • Number of events 7 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
Back surgery for back pain
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
Removal of prosthesis, left unicompartmental knee arthroplasty revision
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Gastrointestinal disorders
Bright red blood from rectum and constipation while in hospital
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Left knee instability
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
Appendectomy
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Infections and infestations
Septic knee
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Gastrointestinal disorders
Re-hospitalization for GI bleed and anemia
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Skin and subcutaneous tissue disorders
Wound dehiscence requiring sutures
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
Arthroscopic shoulder debridement and biceps tenolysis
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
Cervical fusion
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic cancer
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
Whipple procedure
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
Right carpal tunnel release
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Skin and subcutaneous tissue disorders
Moderate effusion requiring aspiration
|
4.4%
3/68 • Number of events 4 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Skin and subcutaneous tissue disorders
Moderate effusion
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Blood and lymphatic system disorders
Thrombophlebitis
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Skin and subcutaneous tissue disorders
Effusion
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Injury, poisoning and procedural complications
Right distal radius fracture
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Injury, poisoning and procedural complications
Left distal radius fracture
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Nervous system disorders
Carpal tunnel pain with injection
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
Right A1 pulley ganglion cyst aspiration
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
Cervical disc decompression and fusion
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
Left knee injection for osteoarthritis
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Low back/hip pain
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Blood and lymphatic system disorders
DVT secondary to Factor V
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Persistent knee pain after kneeling on study knee
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
Mild effusion, aspiration performed
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Pain and discomfort in left knee due to osteoarthritis
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Skin and subcutaneous tissue disorders
Right knee effusion
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Skin and subcutaneous tissue disorders
Left knee effusion
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Blood and lymphatic system disorders
Peroneal and gastrocnemius vein clot at mid-calf
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
Repair of left rotator cuff tear
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
Right knee aspiration due to effusion
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Right mid-foot pain requiring cortisone injection
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Gastrointestinal disorders
Constipation
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Skin and subcutaneous tissue disorders
Knee swollen with no erythema
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
General disorders
Patient reported felt feverish post-op
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Poor ROM
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Pain in left knee
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Blood and lymphatic system disorders
Sed rate of 27; reference range 0-15
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Skin and subcutaneous tissue disorders
Skin and tissues around knee seem thick and woody
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Follow up for poor ROM
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Injury, poisoning and procedural complications
Fell post-op x2 at home after standing and getting dizzy
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 2 • The time of operation through 2 years postoperatively.
|
|
Injury, poisoning and procedural complications
Patellar dislocation
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Degenerative arthritis, right knee
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Cardiac disorders
Atrial fibrillation after elective right TKA
|
1.5%
1/68 • Number of events 3 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Cardiac disorders
Hypotension
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Cardiac disorders
Pericardial effusion
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis right shoulder
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Ischial bursitis on left
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
General disorders
Syncope
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Blood and lymphatic system disorders
Follow up for anemia
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Skin and subcutaneous tissue disorders
Swelling post-op right leg
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Left knee osteoarthritis
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Gastrointestinal disorders
Ileus
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Poor ROM right knee
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Right knee pain
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 2 • The time of operation through 2 years postoperatively.
|
|
Skin and subcutaneous tissue disorders
Erythema of wound
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Joint pain left knee
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Skin and subcutaneous tissue disorders
Right TKA incision tenderness
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Knee arthrofibrosis s/p TKA, treated with manipulation
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 2 • The time of operation through 2 years postoperatively.
|
|
Gastrointestinal disorders
Gastritis, with gallballder polys, had cholecystectomy
|
1.5%
1/68 • Number of events 2 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
Colonoscopy
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Respiratory, thoracic and mediastinal disorders
Cough x2 days
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Bilateral leg and foot pain; lumbar degenerative disc disease
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Surgical and medical procedures
TKA on contralateral leg
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
|
Blood and lymphatic system disorders
Acute blood loss anemia s/p surgery, transfusion not required
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Gastrointestinal disorders
Blood in stool, suspected hemorrhoid
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Left knee w/ mild pain and crepitance
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Degenerative disc disease w/ revision laminectomy
|
1.5%
1/68 • Number of events 1 • The time of operation through 2 years postoperatively.
|
0.00%
0/66 • The time of operation through 2 years postoperatively.
|
|
Musculoskeletal and connective tissue disorders
Back pain; dx degenerative disc disease and thoracic sprain
|
0.00%
0/68 • The time of operation through 2 years postoperatively.
|
1.5%
1/66 • Number of events 1 • The time of operation through 2 years postoperatively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60