Trial Outcomes & Findings for Postoperative Hip Bracing After Hip Arthroscopy (NCT NCT04599296)
NCT ID: NCT04599296
Last Updated: 2025-05-01
Results Overview
Validated pain scale, subject reported. Min 0, Max 10, Higher score means worse outcome.
COMPLETED
NA
82 participants
6 weeks after surgery date
2025-05-01
Participant Flow
Participant milestones
| Measure |
Hip Brace
This group will be assigned to wear a hip brace post surgery.
Hip brace: Hip brace
|
No Brace
This group will not be assigned a hip brace after surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
41
|
|
Overall Study
Primary End Point
|
37
|
36
|
|
Overall Study
COMPLETED
|
30
|
27
|
|
Overall Study
NOT COMPLETED
|
11
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Hip Brace
n=37 Participants
This group will be assigned to wear a hip brace post surgery.
Hip brace: Hip brace
|
No Intervention
n=37 Participants
This group will not be assigned a hip brace after surgery.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 Years
STANDARD_DEVIATION 10 • n=37 Participants
|
34 Years
STANDARD_DEVIATION 9 • n=37 Participants
|
32.8 Years
STANDARD_DEVIATION 10.2 • n=74 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=37 Participants
|
21 Participants
n=37 Participants
|
45 Participants
n=74 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=37 Participants
|
16 Participants
n=37 Participants
|
29 Participants
n=74 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index
|
24 kilograms per meter squared
STANDARD_DEVIATION 5 • n=37 Participants
|
27 kilograms per meter squared
STANDARD_DEVIATION 8 • n=37 Participants
|
25.3 kilograms per meter squared
STANDARD_DEVIATION 7.0 • n=74 Participants
|
|
Smoking Status
Never
|
27 Participants
n=37 Participants
|
29 Participants
n=37 Participants
|
56 Participants
n=74 Participants
|
|
Smoking Status
Quit
|
9 Participants
n=37 Participants
|
8 Participants
n=37 Participants
|
17 Participants
n=74 Participants
|
|
Smoking Status
Current
|
1 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
1 Participants
n=74 Participants
|
|
Marijuana Use
Never
|
19 Participants
n=37 Participants
|
23 Participants
n=37 Participants
|
42 Participants
n=74 Participants
|
|
Marijuana Use
Quit
|
13 Participants
n=37 Participants
|
7 Participants
n=37 Participants
|
20 Participants
n=74 Participants
|
|
Marijuana Use
Current
|
5 Participants
n=37 Participants
|
7 Participants
n=37 Participants
|
12 Participants
n=74 Participants
|
|
Current Opioid Use
Yes
|
1 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
1 Participants
n=74 Participants
|
|
Current Opioid Use
No
|
36 Participants
n=37 Participants
|
37 Participants
n=37 Participants
|
73 Participants
n=74 Participants
|
|
Duration of Symptoms
Less than 1 year
|
10 Participants
n=37 Participants
|
13 Participants
n=37 Participants
|
23 Participants
n=74 Participants
|
|
Duration of Symptoms
1-3 years
|
14 Participants
n=37 Participants
|
9 Participants
n=37 Participants
|
23 Participants
n=74 Participants
|
|
Duration of Symptoms
Greater than 3 years
|
13 Participants
n=37 Participants
|
15 Participants
n=37 Participants
|
28 Participants
n=74 Participants
|
PRIMARY outcome
Timeframe: 6 weeks after surgery dateValidated pain scale, subject reported. Min 0, Max 10, Higher score means worse outcome.
Outcome measures
| Measure |
Hip Brace
n=37 Participants
This group will be assigned to wear a hip brace post surgery.
Hip brace: Hip brace
|
No Brace
n=36 Participants
This group will not be assigned a hip brace after surgery.
|
|---|---|---|
|
Patient Numerical Pain Ranking Scale (NPRS)
|
1.8 score on a scale
Interval 1.3 to 2.3
|
2.3 score on a scale
Interval 1.7 to 2.9
|
SECONDARY outcome
Timeframe: at 6 week and 6 month after surgery datePopulation: There was patient drop out between 6 week and 6 month time points, which is why there are fewer patients at the 6 month time point.
questionnaire used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process. Min 0, Max 100. Lower score means worse outcome.
Outcome measures
| Measure |
Hip Brace
n=37 Participants
This group will be assigned to wear a hip brace post surgery.
Hip brace: Hip brace
|
No Brace
n=36 Participants
This group will not be assigned a hip brace after surgery.
|
|---|---|---|
|
HOOS - Hip Disability and Osteoarthritis Outcome Score
6 week
|
73.9 score on a scale
Interval 68.5 to 79.3
|
71.6 score on a scale
Interval 65.9 to 77.3
|
|
HOOS - Hip Disability and Osteoarthritis Outcome Score
6 month
|
83.4 score on a scale
Interval 77.7 to 89.1
|
80.8 score on a scale
Interval 74.0 to 87.7
|
SECONDARY outcome
Timeframe: at 6 week and 6 month after surgery datePopulation: There was patient drop out between 6 week and 6 month time points, which is why there are fewer patients at the 6 month time point
general health outcome survey. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS and MCS are both 50 points. The United States population standard deviation is 10 points. Therefore, each increment of 10 points above or below 50 corresponds to one standard deviation away from the population average.
Outcome measures
| Measure |
Hip Brace
n=37 Participants
This group will be assigned to wear a hip brace post surgery.
Hip brace: Hip brace
|
No Brace
n=36 Participants
This group will not be assigned a hip brace after surgery.
|
|---|---|---|
|
VR12 - Veteran RAND 12 Item Health Survey
Mental Component Summary 6 weeks
|
53.1 score on a scale
Interval 50.2 to 56.1
|
49.0 score on a scale
Interval 44.8 to 53.3
|
|
VR12 - Veteran RAND 12 Item Health Survey
Physical Component Summary 6 weeks
|
38.2 score on a scale
Interval 34.4 to 42.0
|
37.1 score on a scale
Interval 33.7 to 40.6
|
|
VR12 - Veteran RAND 12 Item Health Survey
Mental Component Summary 6 months
|
52.2 score on a scale
Interval 48.1 to 56.3
|
51.1 score on a scale
Interval 46.9 to 55.3
|
|
VR12 - Veteran RAND 12 Item Health Survey
Physical Component Summary 6 months
|
47.0 score on a scale
Interval 43.6 to 50.4
|
46.3 score on a scale
Interval 42.6 to 50.0
|
SECONDARY outcome
Timeframe: 6 week and 6 month after surgery datePopulation: There was patient drop out between 6 week and 6 month time points, which is why there are fewer patients at the 6 month time point. Additionally, at the 6 month mark we have HOOS outcome scores for a higher number of patients than we have this secondary outcome measures due to incomplete final capture of information at this time point.
Number of patient using a topical nonsteroidal medication is listed here.
Outcome measures
| Measure |
Hip Brace
n=37 Participants
This group will be assigned to wear a hip brace post surgery.
Hip brace: Hip brace
|
No Brace
n=36 Participants
This group will not be assigned a hip brace after surgery.
|
|---|---|---|
|
Patient Using Topical Non-steroidal Medication
6 week
|
1 Participants
|
3 Participants
|
|
Patient Using Topical Non-steroidal Medication
6 month
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 week and 6 month after surgery datePopulation: There was patient drop out between 6 week and 6 month time points, which is why there are fewer patients at the 6 month time point. Additionally, at the 6 month mark we have HOOS outcome scores for a higher number of patients than we have this secondary outcome measures due to incomplete final capture of information at this time point.
Number of patients who received a cortisone injection to hip flexor sheath or bursa is listed here.
Outcome measures
| Measure |
Hip Brace
n=37 Participants
This group will be assigned to wear a hip brace post surgery.
Hip brace: Hip brace
|
No Brace
n=36 Participants
This group will not be assigned a hip brace after surgery.
|
|---|---|---|
|
Patient Received Cortisone Injection to Hip Flexor Sheath or Bursa
6 week
|
0 Participants
|
0 Participants
|
|
Patient Received Cortisone Injection to Hip Flexor Sheath or Bursa
6 month
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 week and 6 month after surgery datePopulation: There was patient drop out between 6 week and 6 month time points, which is why there are fewer patients at the 6 month time point. Additionally, at the 6 month mark we have HOOS outcome scores for a higher number of patients than we have this secondary outcome measures due to incomplete final capture of information at this time point.
Number of patients using opioids is listed here.
Outcome measures
| Measure |
Hip Brace
n=37 Participants
This group will be assigned to wear a hip brace post surgery.
Hip brace: Hip brace
|
No Brace
n=36 Participants
This group will not be assigned a hip brace after surgery.
|
|---|---|---|
|
Patient Using Opioid Medication
6 week
|
2 Participants
|
1 Participants
|
|
Patient Using Opioid Medication
6 month
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months after surgery dateValidated pain scale, subject reported. Min 0, Max 10, Higher score means worse outcome.
Outcome measures
| Measure |
Hip Brace
n=30 Participants
This group will be assigned to wear a hip brace post surgery.
Hip brace: Hip brace
|
No Brace
n=27 Participants
This group will not be assigned a hip brace after surgery.
|
|---|---|---|
|
NPRS - Numerical Pain Ranking Scale
|
1.6 score on a scale
Interval 1.0 to 2.3
|
1.9 score on a scale
Interval 1.1 to 2.6
|
Adverse Events
Hip Brace
No Brace
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hip Brace
n=37 participants at risk
This group will be assigned to wear a hip brace post surgery.
Hip brace: Hip brace
|
No Brace
n=36 participants at risk
This group will not be assigned a hip brace after surgery.
|
|---|---|---|
|
Nervous system disorders
Numbness
|
8.1%
3/37 • Number of events 3 • 6 months for each patient
No difference from set definitions.
|
5.6%
2/36 • Number of events 2 • 6 months for each patient
No difference from set definitions.
|
Additional Information
Dr. Mia Hagen, Associate Professor
University of Washington
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place