Acetabular Labral Tear, Femoroacetabular Impingement Syndrome
Conditions
Brief summary
Hip arthroscopy for treatment of femoroacetabular impingement syndrome (FAIS) involves reshaping of the osseous sources of impingement (osteoplasty) and treatment of impingement-associated labral tears with labral repair. Postoperative hip braces are advocated to decrease postoperative pain by offloading hip musculature. However there are no studies looking at efficacy of hip braces after hip arthroscopy, and on average 50% of high-volume hip arthroscopists use bracing. The objective of this study is to use a randomized controlled trial to test the cited benefits of postoperative hip bracing on short term patient reported pain scores, validated hip-specific pain scores, and physical exam findings of hip flexor tendonitis.
Detailed description
Hip arthroscopy for treatment of femoroacetabular impingement syndrome (FAIS) involves reshaping of the osseous sources of impingement (osteoplasty) and treatment of impingement-associated labral tears with labral repair. The hip joint is subluxated with traction to accomplish this procedure. The diagnoses of FAIS and the incidence of hip arthroscopy have both increased dramatically in the last 20 years in the US -- in a recent study using IBM Marketscan to evaluate rates of hip arthroscopic treatment of FAIS, the investigators found this incidence doubled from 1.2 to 2.1 per 100,000 person-years in just a 3-year period. Despite the increasing incidence of hip arthroscopy in the US, on a recent review the investigators have found few evidence-based studies on postoperative care. A particular area of debate is the use of postoperative hip braces. Postoperative hip braces are advocated to decrease postoperative pain by offloading hip musculature. They may also prevent overuse of the hip flexors by supporting the hip during gait. However there are no studies looking at efficacy of hip braces after hip arthroscopy, and on average 50% of high-volume hip arthroscopists use bracing. The utility of bracing is important because hip braces are expensive (averaging $350-$600): if there are over 7000 hip arthroscopies performed nationwide and 50% of surgeons use hip braces, this amounts to over $2,000,000. The investigator's overall objective is to use a randomized controlled trial to test the cited benefits of postoperative hip bracing on short term patient reported pain scores, validated hip-specific pain scores, and physical exam findings of hip flexor tendonitis.
Interventions
DEVICEHip brace
Hip brace
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
The treating surgeon, who is also the PI, will be blind to randomization.
Intervention model description
Patients randomized to wearing a hip brace after surgery 36 Patients randomized to not wearing a hip brace after surgery 36
Eligibility
Sex/Gender
ALL
Age
14 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patient age 14-60 on date of surgery * Patient seen at the institution for the study * Patient scheduled to undergo arthroscopic osteoplasty and labral repair for femoroacetabular impingement syndrome.
Exclusion criteria
* Any patient anyone who cannot follow up in person in clinic for the 6-week postoperative visit. * Non-English speaking patients (due to limited validation of the patient reported outcome measures in non-English speaking populations).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Numerical Pain Ranking Scale (NPRS) | 6 weeks after surgery date | Validated pain scale, subject reported. Min 0, Max 10, Higher score means worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VR12 - Veteran RAND 12 Item Health Survey | at 6 week and 6 month after surgery date | 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. |
| Patient Using Topical Non-steroidal Medication | 6 week and 6 month after surgery date | Number of patient using a topical nonsteroidal medication is listed here. |
| HOOS - Hip Disability and Osteoarthritis Outcome Score | at 6 week and 6 month after surgery date | 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. |
| Patient Using Opioid Medication | 6 week and 6 month after surgery date | Number of patients using opioids is listed here. |
| NPRS - Numerical Pain Ranking Scale | 6 months after surgery date | Validated pain scale, subject reported. Min 0, Max 10, Higher score means worse outcome. |
| Patient Received Cortisone Injection to Hip Flexor Sheath or Bursa | 6 week and 6 month after surgery date | Number of patients who received a cortisone injection to hip flexor sheath or bursa is listed here. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hip Brace This group will be assigned to wear a hip brace post surgery.
Hip brace: Hip brace | 37 |
| No Intervention This group will not be assigned a hip brace after surgery. | 37 |
| Total | 74 |
Baseline characteristics
| Characteristic | No Intervention | Total | Hip Brace |
|---|---|---|---|
| Age, Continuous | 34 Years STANDARD_DEVIATION 9 | 32.8 Years STANDARD_DEVIATION 10.2 | 32 Years STANDARD_DEVIATION 10 |
| Body Mass Index | 27 kilograms per meter squared STANDARD_DEVIATION 8 | 25.3 kilograms per meter squared STANDARD_DEVIATION 7 | 24 kilograms per meter squared STANDARD_DEVIATION 5 |
| Current Opioid Use No | 37 Participants | 73 Participants | 36 Participants |
| Current Opioid Use Yes | 0 Participants | 1 Participants | 1 Participants |
| Duration of Symptoms 1-3 years | 9 Participants | 23 Participants | 14 Participants |
| Duration of Symptoms Greater than 3 years | 15 Participants | 28 Participants | 13 Participants |
| Duration of Symptoms Less than 1 year | 13 Participants | 23 Participants | 10 Participants |
| Marijuana Use Current | 7 Participants | 12 Participants | 5 Participants |
| Marijuana Use Never | 23 Participants | 42 Participants | 19 Participants |
| Marijuana Use Quit | 7 Participants | 20 Participants | 13 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 21 Participants | 45 Participants | 24 Participants |
| Sex: Female, Male Male | 16 Participants | 29 Participants | 13 Participants |
| Smoking Status Current | 0 Participants | 1 Participants | 1 Participants |
| Smoking Status Never | 29 Participants | 56 Participants | 27 Participants |
| Smoking Status Quit | 8 Participants | 17 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 36 |
| other Total, other adverse events | 3 / 37 | 2 / 36 |
| serious Total, serious adverse events | 0 / 37 | 0 / 36 |
Outcome results
Primary
Patient Numerical Pain Ranking Scale (NPRS)
Validated pain scale, subject reported. Min 0, Max 10, Higher score means worse outcome.
Time frame: 6 weeks after surgery date
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Hip Brace | Patient Numerical Pain Ranking Scale (NPRS) | 1.8 score on a scale |
| No Brace | Patient Numerical Pain Ranking Scale (NPRS) | 2.3 score on a scale |
Secondary
HOOS - Hip Disability and Osteoarthritis Outcome Score
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.
Time frame: at 6 week and 6 month after surgery date
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Hip Brace | HOOS - Hip Disability and Osteoarthritis Outcome Score | 6 week | 73.9 score on a scale |
| Hip Brace | HOOS - Hip Disability and Osteoarthritis Outcome Score | 6 month | 83.4 score on a scale |
| No Brace | HOOS - Hip Disability and Osteoarthritis Outcome Score | 6 week | 71.6 score on a scale |
| No Brace | HOOS - Hip Disability and Osteoarthritis Outcome Score | 6 month | 80.8 score on a scale |
Secondary
NPRS - Numerical Pain Ranking Scale
Validated pain scale, subject reported. Min 0, Max 10, Higher score means worse outcome.
Time frame: 6 months after surgery date
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Hip Brace | NPRS - Numerical Pain Ranking Scale | 1.6 score on a scale |
| No Brace | NPRS - Numerical Pain Ranking Scale | 1.9 score on a scale |
Secondary
Patient Received Cortisone Injection to Hip Flexor Sheath or Bursa
Number of patients who received a cortisone injection to hip flexor sheath or bursa is listed here.
Time frame: 6 week and 6 month after surgery date
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hip Brace | Patient Received Cortisone Injection to Hip Flexor Sheath or Bursa | 6 week | 0 Participants |
| Hip Brace | Patient Received Cortisone Injection to Hip Flexor Sheath or Bursa | 6 month | 4 Participants |
| No Brace | Patient Received Cortisone Injection to Hip Flexor Sheath or Bursa | 6 week | 0 Participants |
| No Brace | Patient Received Cortisone Injection to Hip Flexor Sheath or Bursa | 6 month | 0 Participants |
Secondary
Patient Using Opioid Medication
Number of patients using opioids is listed here.
Time frame: 6 week and 6 month after surgery date
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hip Brace | Patient Using Opioid Medication | 6 week | 2 Participants |
| Hip Brace | Patient Using Opioid Medication | 6 month | 1 Participants |
| No Brace | Patient Using Opioid Medication | 6 week | 1 Participants |
| No Brace | Patient Using Opioid Medication | 6 month | 0 Participants |
Secondary
Patient Using Topical Non-steroidal Medication
Number of patient using a topical nonsteroidal medication is listed here.
Time frame: 6 week and 6 month after surgery date
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hip Brace | Patient Using Topical Non-steroidal Medication | 6 month | 1 Participants |
| Hip Brace | Patient Using Topical Non-steroidal Medication | 6 week | 1 Participants |
| No Brace | Patient Using Topical Non-steroidal Medication | 6 month | 2 Participants |
| No Brace | Patient Using Topical Non-steroidal Medication | 6 week | 3 Participants |
Secondary
VR12 - Veteran RAND 12 Item Health Survey
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.
Time frame: at 6 week and 6 month after surgery date
Population: 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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Hip Brace | VR12 - Veteran RAND 12 Item Health Survey | Mental Component Summary 6 months | 52.2 score on a scale |
| Hip Brace | VR12 - Veteran RAND 12 Item Health Survey | Physical Component Summary 6 weeks | 38.2 score on a scale |
| Hip Brace | VR12 - Veteran RAND 12 Item Health Survey | Physical Component Summary 6 months | 47.0 score on a scale |
| Hip Brace | VR12 - Veteran RAND 12 Item Health Survey | Mental Component Summary 6 weeks | 53.1 score on a scale |
| No Brace | VR12 - Veteran RAND 12 Item Health Survey | Mental Component Summary 6 weeks | 49.0 score on a scale |
| No Brace | VR12 - Veteran RAND 12 Item Health Survey | Physical Component Summary 6 months | 46.3 score on a scale |
| No Brace | VR12 - Veteran RAND 12 Item Health Survey | Physical Component Summary 6 weeks | 37.1 score on a scale |
| No Brace | VR12 - Veteran RAND 12 Item Health Survey | Mental Component Summary 6 months | 51.1 score on a scale |