Trial Outcomes & Findings for Arthroscopic Labral Repair Versus Physical Therapy for Tears of the Acetabular Labrum (NCT NCT03909178)
NCT ID: NCT03909178
Last Updated: 2025-11-10
Results Overview
Full Name of Outcome: modified Harris Hip Score (mHHS) Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery. Scale of mHHS: Min: 0 Max: 100 Higher score indicates better hip functionally. No subscores or subscales. The mean changes in scores required to achieve a minimically clinically important difference is 6.9.
ACTIVE_NOT_RECRUITING
NA
110 participants
Baseline (pre-operative), 3 months, 6 months, 12 months
2025-11-10
Participant Flow
Participant milestones
| Measure |
Hip Arthroscopy Surgery With Acetabular Labral Repair
Hip Arthroscopy Surgery with Acetabular Labral Repair
Hip Arthroscopy Surgery with Acetabular Labral Repair: The research coordinator will, perform a baseline assessment, and randomize the patients into the study at this visit.
Randomization will be assigned utilizing an electronic randomization program. Patients are prospectively identified and randomized into one of two study arms: arthroscopic surgery (AS) or physical therapy (PT). A third study arm, dependent upon improvement with PT, was created as patients crossed over (CO) from PT to AS after a lack of improvement after a minimum of 8 weeks of PT. AS consisted of labral repair.
Any subject randomized to surgery will be seen by Dr. Martin to be consented separately for the arthroscopic procedure, which is standard of care. Those receiving surgical management will be scheduled for the post-operative physical therapy protocol within 2 weeks of their operative date, once a surgical date has been scheduled.
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Physical Therapy Focused on the Hip and Hemi-pelvis
Physical Therapy focusing on the hemipelvis strengthening, including the lower back, lower abdominal core, quadriceps, hamstrings, and gluteal muscles.
Physical Therapy Focused on the Hip and Hemi-pelvis: The research coordinator will, perform a baseline assessment, and randomize the patients into the study at this visit.
Randomization will be assigned utilizing an electronic randomization program. Patients are prospectively identified and randomized into one of two study arms: arthroscopic surgery (AS) or physical therapy (PT). A third study arm, dependent upon improvement with PT, was created as patients crossed over (CO) from PT to AS after a lack of improvement after a minimum of 8 weeks of PT. AS consisted of labral repair or debridement, if repair was not possible, and PT consisted of a uniform, comprehensive PT protocol guided by selected physical therapists.
Those randomized to the physical therapy side will be referred to PT. Those receiving conservative management will be scheduled for physical therapy.
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|---|---|---|
|
Overall Study
STARTED
|
57
|
53
|
|
Overall Study
COMPLETED
|
54
|
49
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Arthroscopic Labral Repair Versus Physical Therapy for Tears of the Acetabular Labrum
Baseline characteristics by cohort
| Measure |
SPT Group: Surgery and Physical Therapy
n=57 Participants
Patients randomized to the SPT group provided consent for arthroscopic acetabular labral repair with femoroacetabular osteoplasty. As previously described in various technique publications from our group, the senior surgeon's (S.D.M.) hip arthroscopy technique includes intra-articular fluid distension for initial portal placement,2 puncture capsulotomy,9 autograft capsular augmentation if insufficient or degenerative labral tissue is encountered,28,30 intermittent traction,37 sparing use of electrocautery,24 and preservation of the chrondrolabral junction.39 All SPT patients underwent a standardized postoperative physical therapy protocol developed jointly by the senior author (a sports medicine fellowship-trained orthopaedic surgeon) and the physical therapists. Patients were kept weightbearing as tolerated on crutches for 6 weeks to maintain a level pelvis without lurching when walking and were instructed to avoid impact loading exercises for 6 months. Appendix A (available in the online version of this article) provides the complete postoperative physical therapy protocol.
|
PTA Group: Physical Therapy Alone
n=53 Participants
PTA patients were assigned a standardized, 24-week course of supervised, core-based PT. This course was designed in concert with physical therapists within our institution to help address symptoms of labral tear in patients older than 40 who had mild to moderate OA. Weeks
1 and 2 focused on normalizing gait, and weeks 3 through 24 focused on optimizing range of motion (ROM) while slowly integrating strength training. Unlike the prerandomization PT protocol, the PTA protocol was predominantly physical therapist-supervised (at least 1 in-person visit per week. Appendix B (available online) provides the complete 24- week PT protocol assigned to PTA patients.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
56 Participants
n=5 Participants
|
53 Participants
n=20 Participants
|
109 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Age, Continuous
|
49.6 years
n=5 Participants
|
49.1 years
n=20 Participants
|
49.4 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
30 Participants
n=20 Participants
|
62 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
23 Participants
n=20 Participants
|
48 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=5 Participants
|
47 Participants
n=20 Participants
|
100 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
5 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
44 participants
n=20 Participants
|
90 participants
n=40 Participants
|
|
Radiographic Osteoarthritis
|
1.22 units on a scale
n=5 Participants
|
1.27 units on a scale
n=20 Participants
|
1.24 units on a scale
n=40 Participants
|
|
Body Mass Index
|
27.1 kg/m^2
n=5 Participants
|
26.8 kg/m^2
n=20 Participants
|
26.9 kg/m^2
n=40 Participants
|
|
modified Harris Hip Score
|
65.3 units on a scale
n=5 Participants
|
63 units on a scale
n=20 Participants
|
64.2 units on a scale
n=40 Participants
|
|
VAS Pain Score
|
6.2 units on a scale
n=5 Participants
|
6.0 units on a scale
n=20 Participants
|
6.1 units on a scale
n=40 Participants
|
|
International Hip Outcome Tool - 33
|
38.9 units on a scale
n=5 Participants
|
37 units on a scale
n=20 Participants
|
38.0 units on a scale
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-operative), 3 months, 6 months, 12 monthsFull Name of Outcome: modified Harris Hip Score (mHHS) Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery. Scale of mHHS: Min: 0 Max: 100 Higher score indicates better hip functionally. No subscores or subscales. The mean changes in scores required to achieve a minimically clinically important difference is 6.9.
Outcome measures
| Measure |
SPT Group: Surgery and Physical Therapy
n=42 Participants
Patients randomized to the SPT group provided consent for arthroscopic acetabular labral repair with femoroacetabular osteoplasty. As previously described in various technique publications from our group, the senior surgeon's (S.D.M.) hip arthroscopy technique includes intra-articular fluid distension for initial portal placement,2 puncture capsulotomy,9 autograft capsular augmentation if insufficient or degenerative labral tissue is encountered,28,30 intermittent traction,37 sparing use of electrocautery,24 and preservation of the chrondrolabral junction.39 All SPT patients underwent a standardized postoperative physical therapy protocol developed jointly by the senior author (a sports medicine fellowship-trained orthopaedic surgeon) and the physical therapists. Patients were kept weightbearing as tolerated on crutches for 6 weeks to maintain a level pelvis without lurching when walking and were instructed to avoid impact loading exercises for 6 months. Appendix A (available in the online version of this article) provides the complete postoperative physical therapy protocol.
|
PTA Group: Physical Therapy Alone Group
n=39 Participants
PTA patients were assigned a standardized, 24-week course of supervised, core-based PT. This course was designed in concert with physical therapists within our institution to help address symptoms of labral tear in patients older than 40 who had mild to moderate OA. Weeks
1 and 2 focused on normalizing gait, and weeks 3 through 24 focused on optimizing range of motion (ROM) while slowly integrating strength training. Unlike the prerandomization PT protocol, the PTA protocol was predominantly physical therapist-supervised (at least 1 in-person visit per week. Appendix B (available online) provides the complete 24- week PT protocol assigned to PTA patients.
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|---|---|---|
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Change in mHHS Surveys From Preoperative to Various Postoperative Timepoints
mHHS improvement at 3 months
|
9.26 units on a scale
Interval 8.13 to 10.5
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4.42 units on a scale
Interval 3.66 to 5.18
|
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Change in mHHS Surveys From Preoperative to Various Postoperative Timepoints
mHHS improvement at 6 months
|
12.63 units on a scale
Interval 11.56 to 13.8
|
6.98 units on a scale
Interval 6.24 to 7.72
|
|
Change in mHHS Surveys From Preoperative to Various Postoperative Timepoints
mHHS improvement 12 months
|
17.32 units on a scale
Interval 16.12 to 18.62
|
12.63 units on a scale
Interval 12.27 to 12.99
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SECONDARY outcome
Timeframe: Baseline (pre-operative), 3 months, 6 months, 12 monthsFull Name of Outcome: HOS--Hip Outcome Score. Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery. Scale of HOS: Min: 0 Max: 100 No standardized scoring categories (i.e. excellent, good, fair, poor). Higher score indicates better hip functionally. The mean change in HOS score required to achieve a minimally clinically important difference is 8.8.
Outcome measures
| Measure |
SPT Group: Surgery and Physical Therapy
n=46 Participants
Patients randomized to the SPT group provided consent for arthroscopic acetabular labral repair with femoroacetabular osteoplasty. As previously described in various technique publications from our group, the senior surgeon's (S.D.M.) hip arthroscopy technique includes intra-articular fluid distension for initial portal placement,2 puncture capsulotomy,9 autograft capsular augmentation if insufficient or degenerative labral tissue is encountered,28,30 intermittent traction,37 sparing use of electrocautery,24 and preservation of the chrondrolabral junction.39 All SPT patients underwent a standardized postoperative physical therapy protocol developed jointly by the senior author (a sports medicine fellowship-trained orthopaedic surgeon) and the physical therapists. Patients were kept weightbearing as tolerated on crutches for 6 weeks to maintain a level pelvis without lurching when walking and were instructed to avoid impact loading exercises for 6 months. Appendix A (available in the online version of this article) provides the complete postoperative physical therapy protocol.
|
PTA Group: Physical Therapy Alone Group
n=44 Participants
PTA patients were assigned a standardized, 24-week course of supervised, core-based PT. This course was designed in concert with physical therapists within our institution to help address symptoms of labral tear in patients older than 40 who had mild to moderate OA. Weeks
1 and 2 focused on normalizing gait, and weeks 3 through 24 focused on optimizing range of motion (ROM) while slowly integrating strength training. Unlike the prerandomization PT protocol, the PTA protocol was predominantly physical therapist-supervised (at least 1 in-person visit per week. Appendix B (available online) provides the complete 24- week PT protocol assigned to PTA patients.
|
|---|---|---|
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Change HOS Surveys From Preoperative to Various Postoperative Timepoints
HOS improvement at 3 Months
|
13.36 units on a scale
Interval 8.21 to 18.51
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8.44 units on a scale
Interval 3.58 to 13.3
|
|
Change HOS Surveys From Preoperative to Various Postoperative Timepoints
HOS improvement at 6 Months
|
17.04 units on a scale
Interval 11.95 to 22.13
|
8.36 units on a scale
Interval 3.57 to 13.15
|
|
Change HOS Surveys From Preoperative to Various Postoperative Timepoints
HOS improvement at 12 Months
|
20.22 units on a scale
Interval 15.0 to 25.43
|
15.07 units on a scale
Interval 10.65 to 19.49
|
SECONDARY outcome
Timeframe: Baseline (pre-operative), 3 months, 6 months, 12 monthsFull Name of Outcome: Non-Arthritic Hip Score (NAHS) Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery: Scale of NAHS: Min: 0 Max: 100 No standardized scoring categories (i.e. excellent, good, fair, poor). Higher score indicates better hip functionally. No subscores or subscales. No specific score to indicate a minimally clinically important difference.
Outcome measures
| Measure |
SPT Group: Surgery and Physical Therapy
n=46 Participants
Patients randomized to the SPT group provided consent for arthroscopic acetabular labral repair with femoroacetabular osteoplasty. As previously described in various technique publications from our group, the senior surgeon's (S.D.M.) hip arthroscopy technique includes intra-articular fluid distension for initial portal placement,2 puncture capsulotomy,9 autograft capsular augmentation if insufficient or degenerative labral tissue is encountered,28,30 intermittent traction,37 sparing use of electrocautery,24 and preservation of the chrondrolabral junction.39 All SPT patients underwent a standardized postoperative physical therapy protocol developed jointly by the senior author (a sports medicine fellowship-trained orthopaedic surgeon) and the physical therapists. Patients were kept weightbearing as tolerated on crutches for 6 weeks to maintain a level pelvis without lurching when walking and were instructed to avoid impact loading exercises for 6 months. Appendix A (available in the online version of this article) provides the complete postoperative physical therapy protocol.
|
PTA Group: Physical Therapy Alone Group
n=44 Participants
PTA patients were assigned a standardized, 24-week course of supervised, core-based PT. This course was designed in concert with physical therapists within our institution to help address symptoms of labral tear in patients older than 40 who had mild to moderate OA. Weeks
1 and 2 focused on normalizing gait, and weeks 3 through 24 focused on optimizing range of motion (ROM) while slowly integrating strength training. Unlike the prerandomization PT protocol, the PTA protocol was predominantly physical therapist-supervised (at least 1 in-person visit per week. Appendix B (available online) provides the complete 24- week PT protocol assigned to PTA patients.
|
|---|---|---|
|
Change NAHS Surveys From Preoperative to Various Postoperative Timepoints
3 Months improvement NAHS score
|
12.91 units on a scale
Interval 7.58 to 17.3
|
5.26 units on a scale
Interval 0.57 to 9.95
|
|
Change NAHS Surveys From Preoperative to Various Postoperative Timepoints
6 Months improvement NAHS score
|
19.40 units on a scale
Interval 14.45 to 24.36
|
8.68 units on a scale
Interval 4.06 to 13.29
|
|
Change NAHS Surveys From Preoperative to Various Postoperative Timepoints
12 Months improvement NAHS score
|
21.88 units on a scale
Interval 16.79 to 26.96
|
14.94 units on a scale
Interval 10.56 to 19.32
|
SECONDARY outcome
Timeframe: Baseline (pre-operative), 3 months, 6 months, 12 monthsFull Name of Outcome: International Hip Outcome Tool--33 Questions Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery. Scale of iHOT-33: Min: 0 Max: 100 No standardized scoring categories (i.e. excellent, good, fair, poor). Higher score indicates better hip functionally. No subscores or subscales The mean changes in iHOT-33 scores required to achieve minimally clinically important difference is 15.1.
Outcome measures
| Measure |
SPT Group: Surgery and Physical Therapy
n=46 Participants
Patients randomized to the SPT group provided consent for arthroscopic acetabular labral repair with femoroacetabular osteoplasty. As previously described in various technique publications from our group, the senior surgeon's (S.D.M.) hip arthroscopy technique includes intra-articular fluid distension for initial portal placement,2 puncture capsulotomy,9 autograft capsular augmentation if insufficient or degenerative labral tissue is encountered,28,30 intermittent traction,37 sparing use of electrocautery,24 and preservation of the chrondrolabral junction.39 All SPT patients underwent a standardized postoperative physical therapy protocol developed jointly by the senior author (a sports medicine fellowship-trained orthopaedic surgeon) and the physical therapists. Patients were kept weightbearing as tolerated on crutches for 6 weeks to maintain a level pelvis without lurching when walking and were instructed to avoid impact loading exercises for 6 months. Appendix A (available in the online version of this article) provides the complete postoperative physical therapy protocol.
|
PTA Group: Physical Therapy Alone Group
n=44 Participants
PTA patients were assigned a standardized, 24-week course of supervised, core-based PT. This course was designed in concert with physical therapists within our institution to help address symptoms of labral tear in patients older than 40 who had mild to moderate OA. Weeks
1 and 2 focused on normalizing gait, and weeks 3 through 24 focused on optimizing range of motion (ROM) while slowly integrating strength training. Unlike the prerandomization PT protocol, the PTA protocol was predominantly physical therapist-supervised (at least 1 in-person visit per week. Appendix B (available online) provides the complete 24- week PT protocol assigned to PTA patients.
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|---|---|---|
|
Change iHOT--33 Surveys From Preoperative to Various Postoperative Timepoints
3 Months iHOT improvement
|
18.37 units on a scale
Interval 10.59 to 24.14
|
4.53 units on a scale
Interval -1.69 to 10.76
|
|
Change iHOT--33 Surveys From Preoperative to Various Postoperative Timepoints
6 Months iHOT improvement
|
25.28 units on a scale
Interval 18.59 to 31.96
|
13.23 units on a scale
Interval 7.09 to 19.37
|
|
Change iHOT--33 Surveys From Preoperative to Various Postoperative Timepoints
12 Months iHOT improvement
|
33.55 units on a scale
Interval 26.85 to 40.24
|
20.53 units on a scale
Interval 14.76 to 26.3
|
SECONDARY outcome
Timeframe: Baseline (pre-operative), 3 months, 6 months, 12 monthsFull Name of Outcome: Lower Extremity Functional Scale (LEFS) Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery. Scale of LEFS: Min: 0 Max: 100 No standardized scoring categories (i.e. excellent, good, fair, poor). Higher score indicates better hip functionally. There is no designated improvement that is deemed to be a minimally clinically important difference
Outcome measures
| Measure |
SPT Group: Surgery and Physical Therapy
n=46 Participants
Patients randomized to the SPT group provided consent for arthroscopic acetabular labral repair with femoroacetabular osteoplasty. As previously described in various technique publications from our group, the senior surgeon's (S.D.M.) hip arthroscopy technique includes intra-articular fluid distension for initial portal placement,2 puncture capsulotomy,9 autograft capsular augmentation if insufficient or degenerative labral tissue is encountered,28,30 intermittent traction,37 sparing use of electrocautery,24 and preservation of the chrondrolabral junction.39 All SPT patients underwent a standardized postoperative physical therapy protocol developed jointly by the senior author (a sports medicine fellowship-trained orthopaedic surgeon) and the physical therapists. Patients were kept weightbearing as tolerated on crutches for 6 weeks to maintain a level pelvis without lurching when walking and were instructed to avoid impact loading exercises for 6 months. Appendix A (available in the online version of this article) provides the complete postoperative physical therapy protocol.
|
PTA Group: Physical Therapy Alone Group
n=44 Participants
PTA patients were assigned a standardized, 24-week course of supervised, core-based PT. This course was designed in concert with physical therapists within our institution to help address symptoms of labral tear in patients older than 40 who had mild to moderate OA. Weeks
1 and 2 focused on normalizing gait, and weeks 3 through 24 focused on optimizing range of motion (ROM) while slowly integrating strength training. Unlike the prerandomization PT protocol, the PTA protocol was predominantly physical therapist-supervised (at least 1 in-person visit per week. Appendix B (available online) provides the complete 24- week PT protocol assigned to PTA patients.
|
|---|---|---|
|
Change LEFS Surveys From Preoperative to Various Postoperative Timepoints
3 Months improvements LEFS
|
6.74 units on a scale
Interval 2.13 to 11.36
|
5.11 units on a scale
Interval 0.81 to 9.42
|
|
Change LEFS Surveys From Preoperative to Various Postoperative Timepoints
6 Months improvements LEFS
|
15.61 units on a scale
Interval 11.05 to 20.17
|
6.77 units on a scale
Interval 2.53 to 11.01
|
|
Change LEFS Surveys From Preoperative to Various Postoperative Timepoints
12 Months improvements LEFS
|
18.46 units on a scale
Interval 13.78 to 23.14
|
12.18 units on a scale
Interval 8.18 to 16.19
|
SECONDARY outcome
Timeframe: Baseline (pre-operative), 3 months, 6 months, 12 monthsAt routine follow-up visits patients will be asked to rate hip pain using the VAS (Visual Analog Scale) Score Min: 0--no pain Max: 10--worst pain experienced in their life Increments of 1. Categories: 1--3: mild pain 4--6: moderate pain 7--10: severe pain There is no reduction in VAS score that is considered a minimally clinically important difference.
Outcome measures
| Measure |
SPT Group: Surgery and Physical Therapy
n=46 Participants
Patients randomized to the SPT group provided consent for arthroscopic acetabular labral repair with femoroacetabular osteoplasty. As previously described in various technique publications from our group, the senior surgeon's (S.D.M.) hip arthroscopy technique includes intra-articular fluid distension for initial portal placement,2 puncture capsulotomy,9 autograft capsular augmentation if insufficient or degenerative labral tissue is encountered,28,30 intermittent traction,37 sparing use of electrocautery,24 and preservation of the chrondrolabral junction.39 All SPT patients underwent a standardized postoperative physical therapy protocol developed jointly by the senior author (a sports medicine fellowship-trained orthopaedic surgeon) and the physical therapists. Patients were kept weightbearing as tolerated on crutches for 6 weeks to maintain a level pelvis without lurching when walking and were instructed to avoid impact loading exercises for 6 months. Appendix A (available in the online version of this article) provides the complete postoperative physical therapy protocol.
|
PTA Group: Physical Therapy Alone Group
n=44 Participants
PTA patients were assigned a standardized, 24-week course of supervised, core-based PT. This course was designed in concert with physical therapists within our institution to help address symptoms of labral tear in patients older than 40 who had mild to moderate OA. Weeks
1 and 2 focused on normalizing gait, and weeks 3 through 24 focused on optimizing range of motion (ROM) while slowly integrating strength training. Unlike the prerandomization PT protocol, the PTA protocol was predominantly physical therapist-supervised (at least 1 in-person visit per week. Appendix B (available online) provides the complete 24- week PT protocol assigned to PTA patients.
|
|---|---|---|
|
Degree of Improvement on Hip VAS Pain Score
3 Months VAS change
|
3.02 units on a scale
Interval 2.21 to 3.83
|
1.05 units on a scale
Interval 0.24 to 1.86
|
|
Degree of Improvement on Hip VAS Pain Score
6 Months VAS change
|
3.67 units on a scale
Interval 2.96 to 4.39
|
0.79 units on a scale
Interval -0.13 to 1.71
|
|
Degree of Improvement on Hip VAS Pain Score
12 Months VAS change
|
3.51 units on a scale
Interval 2.92 to 4.09
|
2.21 units on a scale
Interval 0.78 to 3.63
|
Adverse Events
SPT Group: Surgery and Physical Therapy
PTA Group: Physical Therapy Alone.
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