Trial Outcomes & Findings for Stability of the Medial Pivot Total Knee Prosthesis (NCT NCT02577978)
NCT ID: NCT02577978
Last Updated: 2023-05-19
Results Overview
Patient completed Oxford Knee Score questionnaire used to assess the patient's perspective of outcome following Total Knee Arthroplasty (TKA); score range is reported between 0-48 with improvement in outcomes reflected as a higher numerical value (e.g. a 'complete' return to pre-disease functionality would be reported as a score of 48)
COMPLETED
NA
61 participants
Pre-operatively on day of surgery, 6 weeks, 3 months, 6 months, 12 months and 24 months post-operatively
2023-05-19
Participant Flow
Participant milestones
| Measure |
Medacta Sphere
Ball-and-socket
Medacta GMK Sphere prosthesis
|
Medacta PS
Cam-and-post
Medacta GMK posterior stabilized prosthesis
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
29
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stability of the Medial Pivot Total Knee Prosthesis
Baseline characteristics by cohort
| Measure |
Medacta Sphere
n=25 Participants
Ball-and-socket
Medacta GMK Sphere prosthesis
|
Medacta PS
n=25 Participants
Cam-and-post
Medacta GMK posterior stabilized prosthesis
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 8 • n=5 Participants
|
64 years
STANDARD_DEVIATION 7 • n=7 Participants
|
66 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
32.8 kg/m^2
STANDARD_DEVIATION 5.82 • n=5 Participants
|
34.2 kg/m^2
STANDARD_DEVIATION 5.81 • n=7 Participants
|
33.5 kg/m^2
STANDARD_DEVIATION 5.81 • n=5 Participants
|
|
Pre-Operative Ambulatory Status
Unassisted
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Pre-Operative Ambulatory Status
Cane
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Pre-Operative Ambulatory Status
Walker
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Hypertension
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Diabetes Mellitus
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
History of VTE
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Pre-operative Narcotic Use
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Tobacco Use
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Coronary Artery Disease
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-operatively on day of surgery, 6 weeks, 3 months, 6 months, 12 months and 24 months post-operativelyPatient completed Oxford Knee Score questionnaire used to assess the patient's perspective of outcome following Total Knee Arthroplasty (TKA); score range is reported between 0-48 with improvement in outcomes reflected as a higher numerical value (e.g. a 'complete' return to pre-disease functionality would be reported as a score of 48)
Outcome measures
| Measure |
Medacta Sphere
n=25 Participants
Ball-and-socket
Medacta GMK Sphere prosthesis
|
Medacta PS
n=25 Participants
Cam-and-post
Medacta GMK posterior stabilized prosthesis
|
|---|---|---|
|
Oxford Knee Score (OKS) Pre-operative Through 2 Years Post-operative
Baseline Oxford Knee Score
|
16.31 score on a scale
Standard Deviation 7.66
|
19.88 score on a scale
Standard Deviation 9.39
|
|
Oxford Knee Score (OKS) Pre-operative Through 2 Years Post-operative
6 wk. Post Op Oxford Knee Score
|
29.96 score on a scale
Standard Deviation 9.64
|
28.52 score on a scale
Standard Deviation 8.77
|
|
Oxford Knee Score (OKS) Pre-operative Through 2 Years Post-operative
3 mo. Post Op Oxford Knee Score
|
32.0 score on a scale
Standard Deviation 11.35
|
32.7 score on a scale
Standard Deviation 9.47
|
|
Oxford Knee Score (OKS) Pre-operative Through 2 Years Post-operative
6 mo. Post Op Oxford Knee Score
|
33.67 score on a scale
Standard Deviation 8.9
|
36.41 score on a scale
Standard Deviation 10.58
|
|
Oxford Knee Score (OKS) Pre-operative Through 2 Years Post-operative
1 yr. Post Op Oxford Knee Score
|
39.16 score on a scale
Standard Deviation 9.97
|
35.81 score on a scale
Standard Deviation 11.33
|
|
Oxford Knee Score (OKS) Pre-operative Through 2 Years Post-operative
2 yr. Post Op Oxford Knee Score
|
40.41 score on a scale
Standard Deviation 8.56
|
38.28 score on a scale
Standard Deviation 11.8
|
PRIMARY outcome
Timeframe: Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.Veteran's RAND 12 Item Health Survey used to assess health-related quality of life, to estimate disease burden, and to evaluate disease-specific benchmarks. Scores for the Mental Composite Score (MCS) range from 5.2 to 76.3 and are evaluated as a summative T-score with population mean of 50 (Standard Deviation = 10);higher scores indicate improved mental wellness/function as reported by patients.
Outcome measures
| Measure |
Medacta Sphere
n=25 Participants
Ball-and-socket
Medacta GMK Sphere prosthesis
|
Medacta PS
n=25 Participants
Cam-and-post
Medacta GMK posterior stabilized prosthesis
|
|---|---|---|
|
Veteran's RAND 12 (VR-12) Mental Composite Score (MCS) Through 2 Years Post Operative
2 yr. VR-12 MCS
|
54.83 score on a scale
Standard Deviation 9.54
|
54.78 score on a scale
Standard Deviation 10.27
|
|
Veteran's RAND 12 (VR-12) Mental Composite Score (MCS) Through 2 Years Post Operative
Baseline VR-12 MCS
|
44.97 score on a scale
Standard Deviation 14.13
|
54.33 score on a scale
Standard Deviation 12.35
|
|
Veteran's RAND 12 (VR-12) Mental Composite Score (MCS) Through 2 Years Post Operative
6 wk. VR-12 MCS
|
49.25 score on a scale
Standard Deviation 14.69
|
59 score on a scale
Standard Deviation 7.18
|
|
Veteran's RAND 12 (VR-12) Mental Composite Score (MCS) Through 2 Years Post Operative
3 mo. VR-12 MCS
|
51.11 score on a scale
Standard Deviation 11.74
|
53.71 score on a scale
Standard Deviation 12.71
|
|
Veteran's RAND 12 (VR-12) Mental Composite Score (MCS) Through 2 Years Post Operative
6 mo. VR-12 MCS
|
53.6 score on a scale
Standard Deviation 11.79
|
53.85 score on a scale
Standard Deviation 10.75
|
|
Veteran's RAND 12 (VR-12) Mental Composite Score (MCS) Through 2 Years Post Operative
1 yr. VR-12 MCS
|
53.7 score on a scale
Standard Deviation 11.22
|
54.09 score on a scale
Standard Deviation 12.47
|
PRIMARY outcome
Timeframe: Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.Veteran's RAND 12 Item Health Survey used to assess health-related quality of life, to estimate disease burden, and to evaluate disease-specific benchmarks. Scores for the Physical Composite Score (MCS) range from 6.3 to 71.8 and are evaluated as a summative T-score with population mean of 50 (Standard Deviation = 10);higher scores indicate improved physical wellness/function as reported by patients.
Outcome measures
| Measure |
Medacta Sphere
n=25 Participants
Ball-and-socket
Medacta GMK Sphere prosthesis
|
Medacta PS
n=25 Participants
Cam-and-post
Medacta GMK posterior stabilized prosthesis
|
|---|---|---|
|
Veteran's RAND 12 (VR-12) Physical Composite Score (PCS) Through 2 Years Post Operative
Baseline VR-12 PCS
|
26.74 score on a scale
Standard Deviation 8.3
|
23.92 score on a scale
Standard Deviation 6.71
|
|
Veteran's RAND 12 (VR-12) Physical Composite Score (PCS) Through 2 Years Post Operative
1 yr. VR-12 PCS
|
46.36 score on a scale
Standard Deviation 12.22
|
42.48 score on a scale
Standard Deviation 12.54
|
|
Veteran's RAND 12 (VR-12) Physical Composite Score (PCS) Through 2 Years Post Operative
6 wk. VR-12 PCS
|
34.5 score on a scale
Standard Deviation 8.1
|
34.02 score on a scale
Standard Deviation 11.1
|
|
Veteran's RAND 12 (VR-12) Physical Composite Score (PCS) Through 2 Years Post Operative
3 mo. VR-12 PCS
|
38.27 score on a scale
Standard Deviation 12.58
|
35.9 score on a scale
Standard Deviation 10.28
|
|
Veteran's RAND 12 (VR-12) Physical Composite Score (PCS) Through 2 Years Post Operative
6 mo. VR-12 PCS
|
39.5 score on a scale
Standard Deviation 10.23
|
42.1 score on a scale
Standard Deviation 11.25
|
|
Veteran's RAND 12 (VR-12) Physical Composite Score (PCS) Through 2 Years Post Operative
2 yr. VR-12 PCS
|
42.76 score on a scale
Standard Deviation 11.08
|
46.01 score on a scale
Standard Deviation 12.85
|
PRIMARY outcome
Timeframe: Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.Patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function. Values are reported as T-scores with a reference population mean of 50 (SD=10); for the Physical Function domain higher scores indicated improved physical function as reported by the patient
Outcome measures
| Measure |
Medacta Sphere
n=25 Participants
Ball-and-socket
Medacta GMK Sphere prosthesis
|
Medacta PS
n=25 Participants
Cam-and-post
Medacta GMK posterior stabilized prosthesis
|
|---|---|---|
|
PROMIS Computerized Adaptive Tests (CATs) for Physical Function Through 2 Years Post-operative
Baseline PROMIS Physical Function
|
32.92 score on a scale
Standard Deviation 4.44
|
31.24 score on a scale
Standard Deviation 5.27
|
|
PROMIS Computerized Adaptive Tests (CATs) for Physical Function Through 2 Years Post-operative
6 wk. PROMIS Physical Function
|
38.38 score on a scale
Standard Deviation 6.95
|
39.96 score on a scale
Standard Deviation 6.45
|
|
PROMIS Computerized Adaptive Tests (CATs) for Physical Function Through 2 Years Post-operative
3 mo. PROMIS Physical Function
|
42.12 score on a scale
Standard Deviation 8.14
|
41.32 score on a scale
Standard Deviation 6.76
|
|
PROMIS Computerized Adaptive Tests (CATs) for Physical Function Through 2 Years Post-operative
6 mo. PROMIS Physical Function
|
43.81 score on a scale
Standard Deviation 7.26
|
45.36 score on a scale
Standard Deviation 9.09
|
|
PROMIS Computerized Adaptive Tests (CATs) for Physical Function Through 2 Years Post-operative
1 yr. PROMIS Physical Function
|
48.06 score on a scale
Standard Deviation 9.22
|
48.9 score on a scale
Standard Deviation 10.25
|
|
PROMIS Computerized Adaptive Tests (CATs) for Physical Function Through 2 Years Post-operative
2 yr. PROMIS Physical Function
|
49.17 score on a scale
Standard Deviation 7.84
|
46.5 score on a scale
Standard Deviation 8.97
|
PRIMARY outcome
Timeframe: Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.Patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function. Values are reported as T-scores with a reference population mean of 50 (SD=10); for the Pain Interference domain an increased value indicates greater severity/frequency of pain reported by the patient.
Outcome measures
| Measure |
Medacta Sphere
n=25 Participants
Ball-and-socket
Medacta GMK Sphere prosthesis
|
Medacta PS
n=25 Participants
Cam-and-post
Medacta GMK posterior stabilized prosthesis
|
|---|---|---|
|
PROMIS Computerized Adaptive Tests (CATs) for Pain Interference Through 2 Years Post-operative
Baseline PROMIS Pain Interference
|
66.03 score on a scale
Standard Deviation 4.73
|
65.88 score on a scale
Standard Deviation 7.39
|
|
PROMIS Computerized Adaptive Tests (CATs) for Pain Interference Through 2 Years Post-operative
6 wk. PROMIS Pain Interference
|
58.23 score on a scale
Standard Deviation 8.59
|
58.2 score on a scale
Standard Deviation 7.62
|
|
PROMIS Computerized Adaptive Tests (CATs) for Pain Interference Through 2 Years Post-operative
3 mo. PROMIS Pain Interference
|
55.9 score on a scale
Standard Deviation 11.48
|
55.53 score on a scale
Standard Deviation 9.9
|
|
PROMIS Computerized Adaptive Tests (CATs) for Pain Interference Through 2 Years Post-operative
6 mo. PROMIS Pain Interference
|
52.83 score on a scale
Standard Deviation 9.31
|
53.27 score on a scale
Standard Deviation 12.35
|
|
PROMIS Computerized Adaptive Tests (CATs) for Pain Interference Through 2 Years Post-operative
1 yr. PROMIS Pain Interference
|
46.65 score on a scale
Standard Deviation 11.22
|
49.98 score on a scale
Standard Deviation 11.22
|
|
PROMIS Computerized Adaptive Tests (CATs) for Pain Interference Through 2 Years Post-operative
2 yr. PROMIS Pain Interference
|
44.7 score on a scale
Standard Deviation 8.63
|
46.97 score on a scale
Standard Deviation 10.96
|
PRIMARY outcome
Timeframe: Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.Patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function. Values are reported as T-scores with a reference population mean of 50 (SD=10); for the Pain Behavior domain an increased value indicates greater severity/frequency of pain reported by the patient
Outcome measures
| Measure |
Medacta Sphere
n=25 Participants
Ball-and-socket
Medacta GMK Sphere prosthesis
|
Medacta PS
n=25 Participants
Cam-and-post
Medacta GMK posterior stabilized prosthesis
|
|---|---|---|
|
PROMIS Computerized Adaptive Tests (CATs) for Pain Behavior Through 2 Years Post-operative
Baseline PROMIS Pain Behavior
|
60.98 score on a scale
Standard Deviation 3.22
|
60.92 score on a scale
Standard Deviation 4.88
|
|
PROMIS Computerized Adaptive Tests (CATs) for Pain Behavior Through 2 Years Post-operative
6 wk. PROMIS Pain Behavior
|
56.79 score on a scale
Standard Deviation 7.27
|
58.49 score on a scale
Standard Deviation 3.6
|
|
PROMIS Computerized Adaptive Tests (CATs) for Pain Behavior Through 2 Years Post-operative
3 mo. PROMIS Pain Behavior
|
54.14 score on a scale
Standard Deviation 7.78
|
53.6 score on a scale
Standard Deviation 9.41
|
|
PROMIS Computerized Adaptive Tests (CATs) for Pain Behavior Through 2 Years Post-operative
6 mo. PROMIS Pain Behavior
|
53.2 score on a scale
Standard Deviation 8.72
|
51.25 score on a scale
Standard Deviation 9.27
|
|
PROMIS Computerized Adaptive Tests (CATs) for Pain Behavior Through 2 Years Post-operative
1 yr. PROMIS Pain Behavior
|
45.92 score on a scale
Standard Deviation 11.31
|
47.95 score on a scale
Standard Deviation 12.43
|
|
PROMIS Computerized Adaptive Tests (CATs) for Pain Behavior Through 2 Years Post-operative
2 yr. PROMIS Pain Behavior
|
42.76 score on a scale
Standard Deviation 9.09
|
46.29 score on a scale
Standard Deviation 10.36
|
PRIMARY outcome
Timeframe: 12 months post-operativelyPatient completed questionnaire used to assess the patients' ability to forget about a joint as a result of successful treatment. Every question is scored 1 (never) to 5 (mostly) according to the selected response categories. Thus, the raw score ranges from 12 to 60 where a high score indicates an improved outcome. The raw score is linearly transformed to a 0-100 scale and then reversed to obtain the final score with higher scores indicating improved physical function/reduced impact of symptoms on activity: Final score = 100 - ((sum(item01 to item12) - 12)/48\*100)
Outcome measures
| Measure |
Medacta Sphere
n=25 Participants
Ball-and-socket
Medacta GMK Sphere prosthesis
|
Medacta PS
n=25 Participants
Cam-and-post
Medacta GMK posterior stabilized prosthesis
|
|---|---|---|
|
Total Score Calculated Using the Forgotten Joint Score in Order to Assess the Subject's Ability to Forget the Artificial Joint in Everyday Life
|
57.1 score on a scale
Standard Deviation 37.6
|
54.6 score on a scale
Standard Deviation 41.6
|
PRIMARY outcome
Timeframe: Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.The International Knee Documentation Committe (IKDC) Questionnaire is a subjective scale that provides patients with an overall function score based on a summative score for 3 sub categories (knee function, sports activities, pain/symptoms). A score between 0-100 is obtained as the sum of scores for each individual question, with increasing composite scores correlating positively with patient functional status/quality of life.
Outcome measures
| Measure |
Medacta Sphere
n=25 Participants
Ball-and-socket
Medacta GMK Sphere prosthesis
|
Medacta PS
n=25 Participants
Cam-and-post
Medacta GMK posterior stabilized prosthesis
|
|---|---|---|
|
International Knee Documentation Committee (IKDC) Questionnaire Assessed Through 2 Years Post-op
Baseline IKDC Composite
|
35.82 score on a scale
Standard Deviation 8.72
|
35.97 score on a scale
Standard Deviation 6.97
|
|
International Knee Documentation Committee (IKDC) Questionnaire Assessed Through 2 Years Post-op
6 wk. IKDC Composite
|
42.38 score on a scale
Standard Deviation 11.19
|
43.91 score on a scale
Standard Deviation 7.68
|
|
International Knee Documentation Committee (IKDC) Questionnaire Assessed Through 2 Years Post-op
3 mo. IKDC Composite
|
50.41 score on a scale
Standard Deviation 11.44
|
44.5 score on a scale
Standard Deviation 10.4
|
|
International Knee Documentation Committee (IKDC) Questionnaire Assessed Through 2 Years Post-op
6 mo. IKDC Composite
|
48.72 score on a scale
Standard Deviation 12.08
|
48.52 score on a scale
Standard Deviation 11.73
|
|
International Knee Documentation Committee (IKDC) Questionnaire Assessed Through 2 Years Post-op
1 yr. IKDC Composite
|
57.97 score on a scale
Standard Deviation 13.79
|
52.66 score on a scale
Standard Deviation 13.23
|
|
International Knee Documentation Committee (IKDC) Questionnaire Assessed Through 2 Years Post-op
2 yr. IKDC Composite
|
51.26 score on a scale
Standard Deviation 8.67
|
49.3 score on a scale
Standard Deviation 10.56
|
PRIMARY outcome
Timeframe: 12 months post-operativelyPhysician completed Knee Society Score questionnaire used to measure a patient's functional ability before and after total knee arthroplasty (TKA); score range is reported between 0-100 with improvement in outcomes reflected as a higher numerical value (e.g. a 'complete' return to pre-disease functionality would be reported as a score of 100)
Outcome measures
| Measure |
Medacta Sphere
n=25 Participants
Ball-and-socket
Medacta GMK Sphere prosthesis
|
Medacta PS
n=25 Participants
Cam-and-post
Medacta GMK posterior stabilized prosthesis
|
|---|---|---|
|
Score for the Knee Society Score (KSS) Knee Component at 1 Year Post-operatively
|
88.1 score on a scale
Standard Deviation 9.5
|
86.0 score on a scale
Standard Deviation 12.6
|
PRIMARY outcome
Timeframe: 12 months post-operativelyPhysician completed Knee Society Score questionnaire used to measure a patient's functional ability before and after total knee arthroplasty (TKA); score range is reported between 0-100 with improvement in outcomes reflected as a higher numerical value (e.g. a 'complete' return to pre-disease functionality would be reported as a score of 100)
Outcome measures
| Measure |
Medacta Sphere
n=25 Participants
Ball-and-socket
Medacta GMK Sphere prosthesis
|
Medacta PS
n=25 Participants
Cam-and-post
Medacta GMK posterior stabilized prosthesis
|
|---|---|---|
|
Score for the Knee Society Score (KSS) Function Component at 1 Year Post-operatively
|
81.4 score on a scale
Standard Deviation 17.9
|
77.4 score on a scale
Standard Deviation 22.5
|
SECONDARY outcome
Timeframe: 1 year post-operativelyUsed for grading the stability of the knee in various degrees of flexion according to section 4 of the International Knee Documentation Committee's Knee Ligament Standard Evaluation Form where normal (-1 to 2 mm); nearly normal (3 to 5 mm); abnormal (6 to 10 mm); severely abnormal (\>10 mm)
Outcome measures
| Measure |
Medacta Sphere
n=25 Participants
Ball-and-socket
Medacta GMK Sphere prosthesis
|
Medacta PS
n=25 Participants
Cam-and-post
Medacta GMK posterior stabilized prosthesis
|
|---|---|---|
|
Assessing Knee Stability Using the KT-1000 Arthrometer (at 30 Degrees)
|
5.6 millimeters
Standard Deviation 1.9
|
10.2 millimeters
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: 1 year post-operativelyUsed for grading the stability of the knee in various degrees of flexion according to section 4 of the International Knee Documentation Committee's Knee Ligament Standard Evaluation Form where normal (-1 to 2 mm); nearly normal (3 to 5 mm); abnormal (6 to 10 mm); severely abnormal (\>10 mm)
Outcome measures
| Measure |
Medacta Sphere
n=25 Participants
Ball-and-socket
Medacta GMK Sphere prosthesis
|
Medacta PS
n=25 Participants
Cam-and-post
Medacta GMK posterior stabilized prosthesis
|
|---|---|---|
|
Assessing Knee Stability Using the KT-1000 Arthrometer (at 90 Degrees)
|
4.1 millimeters
Standard Deviation 2.0
|
5.6 millimeters
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Between 6 months and 1 year post-operativelyUsed to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three metres, turn around, walk back to the chair, and sit down.
Outcome measures
| Measure |
Medacta Sphere
n=25 Participants
Ball-and-socket
Medacta GMK Sphere prosthesis
|
Medacta PS
n=25 Participants
Cam-and-post
Medacta GMK posterior stabilized prosthesis
|
|---|---|---|
|
Get-up-and-Go Test
|
10.2 seconds
Standard Deviation 3.7
|
10.5 seconds
Standard Deviation 5.0
|
Adverse Events
Medacta Sphere
Medacta PS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place