Trial Outcomes & Findings for Mini Stem Radiostereometric Analysis Study (NCT NCT01064531)
NCT ID: NCT01064531
Last Updated: 2020-04-09
Results Overview
Migration, or micromovement of the implant, was measured using RSA to compare the modular, short hip stem called the MIS Stem against a standard THA using Synergy Hip System.
Recruitment status
COMPLETED
Target enrollment
41 participants
Primary outcome timeframe
Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported
Results posted on
2020-04-09
Participant Flow
Subjects were enrolled by 1 investigator in Canada. The study period was from 30 Jun 2009 to 22 Apr 2016.
Preoperative evaluation was conducted following signing of the ICF but prior to randomization. A total of 41 subjects had surgery for either MIS Stem or Synergy implantation.
Unit of analysis: hips
Participant milestones
| Measure |
MIS Femoral Neck Stem
Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
|
Synergy Hip System
Standard total hip arthroplasty (THA) using total hip system.
|
|---|---|---|
|
Overall Study
STARTED
|
21 21
|
20 20
|
|
Overall Study
COMPLETED
|
18 18
|
13 13
|
|
Overall Study
NOT COMPLETED
|
3 3
|
7 7
|
Reasons for withdrawal
| Measure |
MIS Femoral Neck Stem
Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
|
Synergy Hip System
Standard total hip arthroplasty (THA) using total hip system.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Revision due to femoral stem loosening
|
1
|
0
|
|
Overall Study
Revision due to dislocation
|
0
|
1
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Mini Stem Radiostereometric Analysis Study
Baseline characteristics by cohort
| Measure |
MIS Femoral Neck Stem
n=21 Participants
Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
|
Synergy Hip System
n=20 Participants
Standard total hip arthroplasty (THA) using total hip system.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 7.93 • n=5 Participants
|
65.8 years
STANDARD_DEVIATION 10.84 • n=7 Participants
|
64.4 years
STANDARD_DEVIATION 9.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 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
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Height
|
171.4 cm
STANDARD_DEVIATION 9.12 • n=5 Participants
|
168.5 cm
STANDARD_DEVIATION 9.19 • n=7 Participants
|
170.0 cm
STANDARD_DEVIATION 9.16 • n=5 Participants
|
|
Weight
|
90.0 kg
STANDARD_DEVIATION 18.22 • n=5 Participants
|
88.0 kg
STANDARD_DEVIATION 23.60 • n=7 Participants
|
89.0 kg
STANDARD_DEVIATION 20.78 • n=5 Participants
|
|
BMI
|
30.7 kg/m^2
STANDARD_DEVIATION 6.25 • n=5 Participants
|
30.9 kg/m^2
STANDARD_DEVIATION 7.34 • n=7 Participants
|
30.8 kg/m^2
STANDARD_DEVIATION 6.72 • n=5 Participants
|
|
Primary Diagnosis: Charnley Classification
Avascular necrosis: A unilateral hip joint disease
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Primary Diagnosis: Charnley Classification
Osteoarthritis: A unilateral joint disease
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Primary Diagnosis: Charnley Classification
Osteoarthritis: B1 bilateral hip joint disease
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Primary Diagnosis: Charnley Classification
Osteoarthritis: C1 multi-joint arthroplasties
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reportedPopulation: Statistical comparisons were done using data from hips with all with RSA information at 2 years (20 MIS and 18 Synergy).
Migration, or micromovement of the implant, was measured using RSA to compare the modular, short hip stem called the MIS Stem against a standard THA using Synergy Hip System.
Outcome measures
| Measure |
MIS Femoral Neck Stem
n=20 Participants
Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
|
Synergy Hip System
n=18 Participants
Standard total hip arthroplasty (THA) using total hip system.
|
|---|---|---|
|
Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement)
Mean translation: Medial-lateral
|
0.204 mm
Interval -0.457 to 1.36
|
0.224 mm
Interval -0.158 to 0.975
|
|
Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement)
Mean translation: Proximal-distal
|
-0.942 mm
Interval -5.86 to 0.026
|
-0.322 mm
Interval -1.57 to 0.281
|
|
Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement)
Mean translation: Anterior-posterior
|
-0.031 mm
Interval -1.05 to 1.0
|
-0.328 mm
Interval -2.44 to 0.692
|
|
Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement)
Mean translation: Total three-dimensional
|
1.090 mm
Interval 0.063 to 6.11
|
0.728 mm
Interval 0.175 to 3.06
|
PRIMARY outcome
Timeframe: Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reportedPopulation: Statistical comparisons were done using data from hips with all with RSA information at 2 years (20 MIS and 18 Synergy).
Migration, or micromovement of the implant, was measured using RSA to compare the modular, short hip stem called the MIS Stem against a standard THA using Synergy Hip System.
Outcome measures
| Measure |
MIS Femoral Neck Stem
n=20 Participants
Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
|
Synergy Hip System
n=18 Participants
Standard total hip arthroplasty (THA) using total hip system.
|
|---|---|---|
|
Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Rotational Movement)
Mean rotation: Anterior-posterior
|
-0.475 degrees
Interval -2.7 to 0.19
|
-0.006 degrees
Interval -0.74 to 0.92
|
|
Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Rotational Movement)
Mean rotation: Internal-external
|
0.958 degrees
Interval -0.43 to 5.69
|
1.414 degrees
Interval -0.71 to 11.65
|
|
Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Rotational Movement)
Mean rotation: Varus-valgus tilt
|
-0.463 degrees
Interval -2.79 to 0.21
|
-0.091 degrees
Interval -1.29 to 0.17
|
SECONDARY outcome
Timeframe: PreoperativePopulation: Data from hips with all with RSA information at pre-operative visit (21 MIS and 20 Synergy).
The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (\<60). Higher scores delineated better results for the subject.
Outcome measures
| Measure |
MIS Femoral Neck Stem
n=21 Participants
Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
|
Synergy Hip System
n=20 Participants
Standard total hip arthroplasty (THA) using total hip system.
|
|---|---|---|
|
Preoperative Total Harris Hip Score (HHS)
Poor (60-69)
|
3 Participants
|
1 Participants
|
|
Preoperative Total Harris Hip Score (HHS)
Very Poor (<60)
|
16 Participants
|
18 Participants
|
|
Preoperative Total Harris Hip Score (HHS)
Excellent (90-100)
|
0 Participants
|
0 Participants
|
|
Preoperative Total Harris Hip Score (HHS)
Good (80-89)
|
1 Participants
|
0 Participants
|
|
Preoperative Total Harris Hip Score (HHS)
Fair (70-79)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 months postoperativePopulation: Data from hips with all with RSA information at 3 months (19 MIS and 16 Synergy).
The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (\<60). Higher scores delineated better results for the subject.
Outcome measures
| Measure |
MIS Femoral Neck Stem
n=19 Participants
Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
|
Synergy Hip System
n=16 Participants
Standard total hip arthroplasty (THA) using total hip system.
|
|---|---|---|
|
3 Months Postoperative Total Harris Hip Score (HHS)
Excellent (90-100)
|
10 Participants
|
7 Participants
|
|
3 Months Postoperative Total Harris Hip Score (HHS)
Good (80-89)
|
6 Participants
|
6 Participants
|
|
3 Months Postoperative Total Harris Hip Score (HHS)
Fair (70-79)
|
3 Participants
|
1 Participants
|
|
3 Months Postoperative Total Harris Hip Score (HHS)
Poor (60-69)
|
0 Participants
|
2 Participants
|
|
3 Months Postoperative Total Harris Hip Score (HHS)
Very Poor (<60)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 year postoperativePopulation: Data from hips with all with RSA information at 1 year (21 MIS and 15 Synergy).
The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (\<60). Higher scores delineated better results for the subject.
Outcome measures
| Measure |
MIS Femoral Neck Stem
n=21 Participants
Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
|
Synergy Hip System
n=15 Participants
Standard total hip arthroplasty (THA) using total hip system.
|
|---|---|---|
|
1 Year Postoperative Total Harris Hip Score (HHS)
Excellent (90-100)
|
15 Participants
|
10 Participants
|
|
1 Year Postoperative Total Harris Hip Score (HHS)
Good (80-89)
|
6 Participants
|
2 Participants
|
|
1 Year Postoperative Total Harris Hip Score (HHS)
Very Poor (<60)
|
0 Participants
|
0 Participants
|
|
1 Year Postoperative Total Harris Hip Score (HHS)
Fair (70-79)
|
0 Participants
|
2 Participants
|
|
1 Year Postoperative Total Harris Hip Score (HHS)
Poor (60-69)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 years postoperativePopulation: Data from hips with all with RSA information at 2 years (21 MIS and 16 Synergy).
The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (\<60). Higher scores delineated better results for the subject.
Outcome measures
| Measure |
MIS Femoral Neck Stem
n=21 Participants
Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
|
Synergy Hip System
n=16 Participants
Standard total hip arthroplasty (THA) using total hip system.
|
|---|---|---|
|
2 Years Postoperative Total Harris Hip Score (HHS)
Excellent (90-100)
|
14 Participants
|
7 Participants
|
|
2 Years Postoperative Total Harris Hip Score (HHS)
Very Poor (<60)
|
1 Participants
|
0 Participants
|
|
2 Years Postoperative Total Harris Hip Score (HHS)
Good (80-89)
|
4 Participants
|
6 Participants
|
|
2 Years Postoperative Total Harris Hip Score (HHS)
Fair (70-79)
|
2 Participants
|
3 Participants
|
|
2 Years Postoperative Total Harris Hip Score (HHS)
Poor (60-69)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 years postoperativePopulation: Data from hips with all with RSA information at 3 years (15 MIS and 13 Synergy).
The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (\<60). Higher scores delineated better results for the subject.
Outcome measures
| Measure |
MIS Femoral Neck Stem
n=15 Participants
Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
|
Synergy Hip System
n=13 Participants
Standard total hip arthroplasty (THA) using total hip system.
|
|---|---|---|
|
3 Years Postoperative Total Harris Hip Score (HHS)
Very Poor (<60)
|
1 Participants
|
0 Participants
|
|
3 Years Postoperative Total Harris Hip Score (HHS)
Excellent (90-100)
|
12 Participants
|
9 Participants
|
|
3 Years Postoperative Total Harris Hip Score (HHS)
Good (80-89)
|
2 Participants
|
1 Participants
|
|
3 Years Postoperative Total Harris Hip Score (HHS)
Fair (70-79)
|
0 Participants
|
2 Participants
|
|
3 Years Postoperative Total Harris Hip Score (HHS)
Poor (60-69)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 5 years postoperativePopulation: Data from hips with all with RSA information at 5 years (17 MIS and 12 Synergy).
The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (\<60). Higher scores delineated better results for the subject.
Outcome measures
| Measure |
MIS Femoral Neck Stem
n=17 Participants
Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
|
Synergy Hip System
n=12 Participants
Standard total hip arthroplasty (THA) using total hip system.
|
|---|---|---|
|
5 Years Postoperative Total Harris Hip Score (HHS)
Excellent (90-100)
|
9 Participants
|
8 Participants
|
|
5 Years Postoperative Total Harris Hip Score (HHS)
Good (80-89)
|
4 Participants
|
3 Participants
|
|
5 Years Postoperative Total Harris Hip Score (HHS)
Very Poor (<60)
|
1 Participants
|
0 Participants
|
|
5 Years Postoperative Total Harris Hip Score (HHS)
Fair (70-79)
|
3 Participants
|
0 Participants
|
|
5 Years Postoperative Total Harris Hip Score (HHS)
Poor (60-69)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: PreoperativePopulation: Data from hips with all with RSA information at pre-operative visit (21 MIS and 20 Synergy).
The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life. Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms.
Outcome measures
| Measure |
MIS Femoral Neck Stem
n=21 Participants
Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
|
Synergy Hip System
n=20 Participants
Standard total hip arthroplasty (THA) using total hip system.
|
|---|---|---|
|
Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Sports/ Recreational Activities (0-100)
|
27.1 score on a scale
Standard Deviation 19.70
|
22.8 score on a scale
Standard Deviation 15.08
|
|
Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Symptoms and Stiffness (0-100)
|
47.4 score on a scale
Standard Deviation 17.58
|
40.5 score on a scale
Standard Deviation 16.05
|
|
Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Pain (0-100)
|
37.1 score on a scale
Standard Deviation 17.73
|
33.5 score on a scale
Standard Deviation 17.44
|
|
Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Daily Living (0-100)
|
41.0 score on a scale
Standard Deviation 19.52
|
33.4 score on a scale
Standard Deviation 16.97
|
|
Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Quality of Life (0-100)
|
23.2 score on a scale
Standard Deviation 14.27
|
23.4 score on a scale
Standard Deviation 13.43
|
SECONDARY outcome
Timeframe: 3 months postoperativePopulation: Data from hips with all with RSA information at 3 months (19 MIS and 16 Synergy).
The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life. Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms.
Outcome measures
| Measure |
MIS Femoral Neck Stem
n=19 Participants
Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
|
Synergy Hip System
n=16 Participants
Standard total hip arthroplasty (THA) using total hip system.
|
|---|---|---|
|
3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Symptoms and Stiffness (0-100)
|
81.8 score on a scale
Standard Deviation 9.75
|
77.2 score on a scale
Standard Deviation 17.41
|
|
3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Pain (0-100)
|
85.1 score on a scale
Standard Deviation 12.40
|
76.9 score on a scale
Standard Deviation 18.59
|
|
3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Daily Living (0-100)
|
81.9 score on a scale
Standard Deviation 11.63
|
76.0 score on a scale
Standard Deviation 18.51
|
|
3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Sports/ Recreational Activities (0-100)
|
67.4 score on a scale
Standard Deviation 17.87
|
61.3 score on a scale
Standard Deviation 20.82
|
|
3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Quality of Life (0-100)
|
67.1 score on a scale
Standard Deviation 17.03
|
66.0 score on a scale
Standard Deviation 20.02
|
SECONDARY outcome
Timeframe: 1 year postoperativePopulation: Data from hips with all with RSA information at 1 year (21 MIS and 15 Synergy).
The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life. Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms.
Outcome measures
| Measure |
MIS Femoral Neck Stem
n=21 Participants
Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
|
Synergy Hip System
n=15 Participants
Standard total hip arthroplasty (THA) using total hip system.
|
|---|---|---|
|
1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Symptoms and Stiffness (0-100)
|
87.9 score on a scale
Standard Deviation 11.68
|
81.0 score on a scale
Standard Deviation 13.39
|
|
1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Pain (0-100)
|
85.0 score on a scale
Standard Deviation 11.54
|
80.8 score on a scale
Standard Deviation 17.52
|
|
1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Daily Living (0-100)
|
85.1 score on a scale
Standard Deviation 11.44
|
76.0 score on a scale
Standard Deviation 18.77
|
|
1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Sports/ Recreational Activities (0-100)
|
77.1 score on a scale
Standard Deviation 19.09
|
66.3 score on a scale
Standard Deviation 26.60
|
|
1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Quality of Life (0-100)
|
76.2 score on a scale
Standard Deviation 18.39
|
72.5 score on a scale
Standard Deviation 18.87
|
SECONDARY outcome
Timeframe: 2 years postoperativePopulation: Data from hips with all with RSA information at 2 years (21 MIS and 16 Synergy).
The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life. Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms.
Outcome measures
| Measure |
MIS Femoral Neck Stem
n=21 Participants
Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
|
Synergy Hip System
n=16 Participants
Standard total hip arthroplasty (THA) using total hip system.
|
|---|---|---|
|
2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Daily Living (0-100)
|
82.4 score on a scale
Standard Deviation 17.61
|
72.1 score on a scale
Standard Deviation 22.41
|
|
2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Symptoms and Stiffness (0-100)
|
87.9 score on a scale
Standard Deviation 11.57
|
82.2 score on a scale
Standard Deviation 12.11
|
|
2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Pain (0-100)
|
84.2 score on a scale
Standard Deviation 15.80
|
81.7 score on a scale
Standard Deviation 21.09
|
|
2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Sports/ Recreational Activities (0-100)
|
76.8 score on a scale
Standard Deviation 20.46
|
74.6 score on a scale
Standard Deviation 23.88
|
|
2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Quality of Life (0-100)
|
83.3 score on a scale
Standard Deviation 20.57
|
75.4 score on a scale
Standard Deviation 16.84
|
SECONDARY outcome
Timeframe: 3 years postoperativePopulation: Data from hips with all with RSA information at 3 years (15 MIS and 13 Synergy).
The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life. Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms.
Outcome measures
| Measure |
MIS Femoral Neck Stem
n=15 Participants
Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
|
Synergy Hip System
n=13 Participants
Standard total hip arthroplasty (THA) using total hip system.
|
|---|---|---|
|
3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Daily Living (0-100)
|
86.0 score on a scale
Standard Deviation 19.38
|
73.0 score on a scale
Standard Deviation 23.15
|
|
3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Symptoms and Stiffness (0-100)
|
88.0 score on a scale
Standard Deviation 17.91
|
81.9 score on a scale
Standard Deviation 17.26
|
|
3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Pain (0-100)
|
84.0 score on a scale
Standard Deviation 18.51
|
85.8 score on a scale
Standard Deviation 17.45
|
|
3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Sports/ Recreational Activities (0-100)
|
77.9 score on a scale
Standard Deviation 22.76
|
75.0 score on a scale
Standard Deviation 19.93
|
|
3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Quality of Life (0-100)
|
82.1 score on a scale
Standard Deviation 22.39
|
79.8 score on a scale
Standard Deviation 25.91
|
SECONDARY outcome
Timeframe: 5 years postoperativePopulation: Data from hips with all with RSA information at 3 years (17 MIS and 12 Synergy).
The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life. Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms.
Outcome measures
| Measure |
MIS Femoral Neck Stem
n=17 Participants
Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
|
Synergy Hip System
n=12 Participants
Standard total hip arthroplasty (THA) using total hip system.
|
|---|---|---|
|
5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Symptoms and Stiffness (0-100)
|
85.3 score on a scale
Standard Deviation 15.96
|
84.4 score on a scale
Standard Deviation 20.12
|
|
5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Daily Living (0-100)
|
76.7 score on a scale
Standard Deviation 21.51
|
71.0 score on a scale
Standard Deviation 25.33
|
|
5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Sports/ Recreational Activities (0-100)
|
68.4 score on a scale
Standard Deviation 30.09
|
50.0 score on a scale
Standard Deviation 45.54
|
|
5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Pain (0-100)
|
81.2 score on a scale
Standard Deviation 18.95
|
78.1 score on a scale
Standard Deviation 25.45
|
|
5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Quality of Life (0-100)
|
71.0 score on a scale
Standard Deviation 28.38
|
75.0 score on a scale
Standard Deviation 29.07
|
SECONDARY outcome
Timeframe: PreoperativePopulation: Data from all enrolled hips who received a study device (21 MIS and 20 Synergy).
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Outcome measures
| Measure |
MIS Femoral Neck Stem
n=21 Participants
Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
|
Synergy Hip System
n=20 Participants
Standard total hip arthroplasty (THA) using total hip system.
|
|---|---|---|
|
Preoperative Radiographic Assessments
Evidence of Femoral Component Failure · No
|
21 Participants
|
20 Participants
|
|
Preoperative Radiographic Assessments
No Problems on Checklist · Yes
|
21 Participants
|
20 Participants
|
|
Preoperative Radiographic Assessments
No Problems on Checklist · No
|
0 Participants
|
0 Participants
|
|
Preoperative Radiographic Assessments
Acetabular Cup Subsidence · Yes
|
0 Participants
|
0 Participants
|
|
Preoperative Radiographic Assessments
Acetabular Cup Subsidence · No
|
21 Participants
|
20 Participants
|
|
Preoperative Radiographic Assessments
Stem Subsidence · Yes
|
0 Participants
|
0 Participants
|
|
Preoperative Radiographic Assessments
Stem Subsidence · No
|
21 Participants
|
20 Participants
|
|
Preoperative Radiographic Assessments
Evidence of Acetabular Component Failure · Yes
|
0 Participants
|
0 Participants
|
|
Preoperative Radiographic Assessments
Evidence of Acetabular Component Failure · No
|
21 Participants
|
20 Participants
|
|
Preoperative Radiographic Assessments
Evidence of Femoral Component Failure · Yes
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 months postoperativePopulation: Data from hips with all with RSA information at 3 months (19 MIS and 16 Synergy).
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Outcome measures
| Measure |
MIS Femoral Neck Stem
n=19 Participants
Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
|
Synergy Hip System
n=16 Participants
Standard total hip arthroplasty (THA) using total hip system.
|
|---|---|---|
|
3 Months Postoperative Radiographic Assessments
No Problems on Checklist · Yes
|
19 Participants
|
16 Participants
|
|
3 Months Postoperative Radiographic Assessments
No Problems on Checklist · No
|
0 Participants
|
0 Participants
|
|
3 Months Postoperative Radiographic Assessments
Acetabular Cup Subsidence · Yes
|
0 Participants
|
0 Participants
|
|
3 Months Postoperative Radiographic Assessments
Acetabular Cup Subsidence · No
|
19 Participants
|
16 Participants
|
|
3 Months Postoperative Radiographic Assessments
Stem Subsidence · Yes
|
0 Participants
|
0 Participants
|
|
3 Months Postoperative Radiographic Assessments
Stem Subsidence · No
|
19 Participants
|
16 Participants
|
|
3 Months Postoperative Radiographic Assessments
Evidence of Acetabular Component Failure · Yes
|
0 Participants
|
0 Participants
|
|
3 Months Postoperative Radiographic Assessments
Evidence of Acetabular Component Failure · No
|
19 Participants
|
16 Participants
|
|
3 Months Postoperative Radiographic Assessments
Evidence of Femoral Component Failure · Yes
|
0 Participants
|
0 Participants
|
|
3 Months Postoperative Radiographic Assessments
Evidence of Femoral Component Failure · No
|
19 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 1 year postoperativePopulation: Data from hips with all with RSA information at 1 year (20 MIS and 15 Synergy).
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Outcome measures
| Measure |
MIS Femoral Neck Stem
n=20 Participants
Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
|
Synergy Hip System
n=15 Participants
Standard total hip arthroplasty (THA) using total hip system.
|
|---|---|---|
|
1 Year Postoperative Radiographic Assessments
No Problems on Checklist · Yes
|
15 Participants
|
11 Participants
|
|
1 Year Postoperative Radiographic Assessments
No Problems on Checklist · No
|
5 Participants
|
4 Participants
|
|
1 Year Postoperative Radiographic Assessments
Acetabular Cup Subsidence · Yes
|
0 Participants
|
0 Participants
|
|
1 Year Postoperative Radiographic Assessments
Acetabular Cup Subsidence · No
|
20 Participants
|
15 Participants
|
|
1 Year Postoperative Radiographic Assessments
Stem Subsidence · Yes
|
0 Participants
|
0 Participants
|
|
1 Year Postoperative Radiographic Assessments
Stem Subsidence · No
|
20 Participants
|
15 Participants
|
|
1 Year Postoperative Radiographic Assessments
Evidence of Acetabular Component Failure · Yes
|
0 Participants
|
0 Participants
|
|
1 Year Postoperative Radiographic Assessments
Evidence of Acetabular Component Failure · No
|
20 Participants
|
15 Participants
|
|
1 Year Postoperative Radiographic Assessments
Evidence of Femoral Component Failure · Yes
|
0 Participants
|
0 Participants
|
|
1 Year Postoperative Radiographic Assessments
Evidence of Femoral Component Failure · No
|
20 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 2 years postoperativePopulation: Data from hips with all with RSA information at 2 years (21 MIS and 16 Synergy).
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Outcome measures
| Measure |
MIS Femoral Neck Stem
n=21 Participants
Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
|
Synergy Hip System
n=16 Participants
Standard total hip arthroplasty (THA) using total hip system.
|
|---|---|---|
|
2 Years Postoperative Radiographic Assessments
No Problems on Checklist · Yes
|
11 Participants
|
12 Participants
|
|
2 Years Postoperative Radiographic Assessments
No Problems on Checklist · No
|
10 Participants
|
4 Participants
|
|
2 Years Postoperative Radiographic Assessments
Acetabular Cup Subsidence · Yes
|
0 Participants
|
0 Participants
|
|
2 Years Postoperative Radiographic Assessments
Acetabular Cup Subsidence · No
|
21 Participants
|
16 Participants
|
|
2 Years Postoperative Radiographic Assessments
Stem Subsidence · No
|
20 Participants
|
16 Participants
|
|
2 Years Postoperative Radiographic Assessments
Evidence of Acetabular Component Failure · Yes
|
0 Participants
|
0 Participants
|
|
2 Years Postoperative Radiographic Assessments
Stem Subsidence · Yes
|
1 Participants
|
0 Participants
|
|
2 Years Postoperative Radiographic Assessments
Evidence of Acetabular Component Failure · No
|
21 Participants
|
16 Participants
|
|
2 Years Postoperative Radiographic Assessments
Evidence of Femoral Component Failure · Yes
|
0 Participants
|
0 Participants
|
|
2 Years Postoperative Radiographic Assessments
Evidence of Femoral Component Failure · No
|
21 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 3 years postoperativePopulation: Data from all enrolled hips who received a study device (15 MIS and 13 Synergy).
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Outcome measures
| Measure |
MIS Femoral Neck Stem
n=15 Participants
Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
|
Synergy Hip System
n=13 Participants
Standard total hip arthroplasty (THA) using total hip system.
|
|---|---|---|
|
3 Years Postoperative Radiographic Assessments
No Problems on Checklist · Yes
|
8 Participants
|
7 Participants
|
|
3 Years Postoperative Radiographic Assessments
No Problems on Checklist · No
|
7 Participants
|
6 Participants
|
|
3 Years Postoperative Radiographic Assessments
Acetabular Cup Subsidence · Yes
|
0 Participants
|
0 Participants
|
|
3 Years Postoperative Radiographic Assessments
Acetabular Cup Subsidence · No
|
15 Participants
|
13 Participants
|
|
3 Years Postoperative Radiographic Assessments
Stem Subsidence · Yes
|
0 Participants
|
0 Participants
|
|
3 Years Postoperative Radiographic Assessments
Stem Subsidence · No
|
15 Participants
|
13 Participants
|
|
3 Years Postoperative Radiographic Assessments
Evidence of Acetabular Component Failure · Yes
|
0 Participants
|
0 Participants
|
|
3 Years Postoperative Radiographic Assessments
Evidence of Acetabular Component Failure · No
|
15 Participants
|
13 Participants
|
|
3 Years Postoperative Radiographic Assessments
Evidence of Femoral Component Failure · Yes
|
0 Participants
|
0 Participants
|
|
3 Years Postoperative Radiographic Assessments
Evidence of Femoral Component Failure · No
|
15 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 5 years postoperativePopulation: Data from all enrolled hips who received a study device (17 MIS and 12 Synergy).
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Outcome measures
| Measure |
MIS Femoral Neck Stem
n=17 Participants
Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
|
Synergy Hip System
n=12 Participants
Standard total hip arthroplasty (THA) using total hip system.
|
|---|---|---|
|
5 Years Postoperative Radiographic Assessments
Evidence of Femoral Component Failure · No
|
17 Participants
|
12 Participants
|
|
5 Years Postoperative Radiographic Assessments
No Problems on Checklist · Yes
|
13 Participants
|
11 Participants
|
|
5 Years Postoperative Radiographic Assessments
No Problems on Checklist · No
|
4 Participants
|
1 Participants
|
|
5 Years Postoperative Radiographic Assessments
Acetabular Cup Subsidence · Yes
|
0 Participants
|
0 Participants
|
|
5 Years Postoperative Radiographic Assessments
Acetabular Cup Subsidence · No
|
17 Participants
|
12 Participants
|
|
5 Years Postoperative Radiographic Assessments
Stem Subsidence · Yes
|
0 Participants
|
0 Participants
|
|
5 Years Postoperative Radiographic Assessments
Stem Subsidence · No
|
17 Participants
|
12 Participants
|
|
5 Years Postoperative Radiographic Assessments
Evidence of Acetabular Component Failure · Yes
|
0 Participants
|
0 Participants
|
|
5 Years Postoperative Radiographic Assessments
Evidence of Acetabular Component Failure · No
|
17 Participants
|
12 Participants
|
|
5 Years Postoperative Radiographic Assessments
Evidence of Femoral Component Failure · Yes
|
0 Participants
|
0 Participants
|
Adverse Events
MIS Femoral Neck Stem
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Synergy Hip System
Serious events: 4 serious events
Other events: 15 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
MIS Femoral Neck Stem
n=21 participants at risk
Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
|
Synergy Hip System
n=20 participants at risk
Standard total hip arthroplasty (THA) using total hip system.
|
|---|---|---|
|
Product Issues
Loose femoral stem
|
4.8%
1/21 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
0.00%
0/20 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Subluxed patella/medial patellar retinacular repair
|
0.00%
0/21 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
5.0%
1/20 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis total knee replacement
|
0.00%
0/21 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
5.0%
1/20 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Product Issues
Adverse soft tissue reaction secondary to dual taper from modular neck
|
4.8%
1/21 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
0.00%
0/20 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Blood and lymphatic system disorders
Stroke
|
0.00%
0/21 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
5.0%
1/20 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Hip dislocation
|
0.00%
0/21 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
5.0%
1/20 • Number of events 2 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Hip instability
|
0.00%
0/21 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
5.0%
1/20 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Unresectable pancreatic cancer
|
0.00%
0/21 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
5.0%
1/20 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
Other adverse events
| Measure |
MIS Femoral Neck Stem
n=21 participants at risk
Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options.
|
Synergy Hip System
n=20 participants at risk
Standard total hip arthroplasty (THA) using total hip system.
|
|---|---|---|
|
Infections and infestations
Superficial wound infection
|
4.8%
1/21 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
0.00%
0/20 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Injury, poisoning and procedural complications
Leg Pain
|
4.8%
1/21 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
0.00%
0/20 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Torn meniscus
|
4.8%
1/21 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
0.00%
0/20 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
33.3%
7/21 • Number of events 8 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
30.0%
6/20 • Number of events 9 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Degenerative changes with narrowing of the joint line and osteophytic changes
|
4.8%
1/21 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
0.00%
0/20 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Injury, poisoning and procedural complications
Fall
|
4.8%
1/21 • Number of events 2 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
0.00%
0/20 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Radiographic review finding of 5mm stem subsidence from fibrous ingrowth hip stem
|
4.8%
1/21 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
0.00%
0/20 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Injury, poisoning and procedural complications
Stem revision right hip replacement
|
4.8%
1/21 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
0.00%
0/20 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Trochanteric bursitis
|
14.3%
3/21 • Number of events 4 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
10.0%
2/20 • Number of events 2 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Gastrointestinal disorders
Bleeding duodenal ulcer
|
4.8%
1/21 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
0.00%
0/20 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Gastrointestinal disorders
Subphrenic abscess
|
4.8%
1/21 • Number of events 2 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
0.00%
0/20 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Infections and infestations
Stitch abscess
|
4.8%
1/21 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
5.0%
1/20 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Femoral hernia
|
4.8%
1/21 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
0.00%
0/20 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Medial compartmental arthritis
|
4.8%
1/21 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
0.00%
0/20 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Infections and infestations
Cellulitis
|
4.8%
1/21 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
5.0%
1/20 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
4.8%
1/21 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
0.00%
0/20 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Product Issues
Reaction to metal debris/ metal allergy
|
4.8%
1/21 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
0.00%
0/20 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Injury, poisoning and procedural complications
Pain in study hip
|
4.8%
1/21 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
5.0%
1/20 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Nervous system disorders
Partial peroneal nerve palsy
|
4.8%
1/21 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
0.00%
0/20 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain/soreness/discomfort
|
4.8%
1/21 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
0.00%
0/20 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Stress shielding as indicated on radiographic findings CRF
|
9.5%
2/21 • Number of events 2 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
5.0%
1/20 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Blood and lymphatic system disorders
Lysis over greater trochanter of total hip replacement
|
4.8%
1/21 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
0.00%
0/20 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Pain in anterior aspect of knee possible flare-up of scar tissue
|
4.8%
1/21 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
0.00%
0/20 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
4.8%
1/21 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
0.00%
0/20 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Hip dislocation
|
0.00%
0/21 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
10.0%
2/20 • Number of events 4 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Injury, poisoning and procedural complications
Fractured ankle
|
0.00%
0/21 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
5.0%
1/20 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
L2-3,L4-5 Spinal stenosis;L5-S1 right-sided lateral recess stenosis, iatrogenic dural tear L4-5
|
0.00%
0/21 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
5.0%
1/20 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Greater trochanteric pain
|
0.00%
0/21 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
5.0%
1/20 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Nonoperative tibial plateau fracture
|
0.00%
0/21 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
5.0%
1/20 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.00%
0/21 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
5.0%
1/20 • Number of events 1 • From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60