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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30AR072572-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hip Brace | Active Comparator | This group will be assigned to wear a hip brace post surgery. |
|
| No Intervention | No Intervention | This group will not be assigned a hip brace after surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hip brace | Device | Hip brace |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Numerical Pain Ranking Scale (NPRS) | Validated pain scale, subject reported. Min 0, Max 10, Higher score means worse outcome. | 6 weeks after surgery date |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 6 week and 6 month after surgery date |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mia Hagen, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30647926 | Background | Adib F, Johnson AJ, Hennrikus WL, Nasreddine A, Kocher M, Yen YM. Iliopsoas tendonitis after hip arthroscopy: prevalence, risk factors and treatment algorithm. J Hip Preserv Surg. 2018 Dec 24;5(4):362-369. doi: 10.1093/jhps/hny049. eCollection 2018 Dec. | |
| 26671201 | Background | Schairer WW, Nwachukwu BU, McCormick F, Lyman S, Mayman D. Use of Hip Arthroscopy and Risk of Conversion to Total Hip Arthroplasty: A Population-Based Analysis. Arthroscopy. 2016 Apr;32(4):587-93. doi: 10.1016/j.arthro.2015.10.002. Epub 2015 Dec 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hip Brace | This group will be assigned to wear a hip brace post surgery. Hip brace: Hip brace |
| FG001 | No Brace | This group will not be assigned a hip brace after surgery. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Total number that reached postoperative at two weeks that had baseline data collected
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| ID | Title | Description |
|---|---|---|
| BG000 | Hip Brace | This group will be assigned to wear a hip brace post surgery. Hip brace: Hip brace |
| BG001 | No Intervention | This group will not be assigned a hip brace after surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Numerical Pain Ranking Scale (NPRS) | Validated pain scale, subject reported. Min 0, Max 10, Higher score means worse outcome. | Posted | Mean | 95% Confidence Interval | score on a scale | 6 weeks after surgery date |
|
|
6 months for each patient
No difference from set definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hip Brace | This group will be assigned to wear a hip brace post surgery. Hip brace: Hip brace |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Numbness | Nervous system disorders | Systematic Assessment | Temporary decrease sensation on operative extremity |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mia Hagen, Associate Professor | University of Washington | 206-598-3404 | smia@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 17, 2020 | Dec 31, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 17, 2020 | Dec 31, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D057925 | Femoracetabular Impingement |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Patients randomized to wearing a hip brace after surgery 36 Patients randomized to not wearing a hip brace after surgery 36
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The treating surgeon, who is also the PI, will be blind to randomization.
| 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. |
| at 6 week and 6 month after surgery date |
| Patient Using Topical Non-steroidal Medication | Number of patient using a topical nonsteroidal medication is listed here. | 6 week and 6 month after surgery date |
| 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. | 6 week and 6 month after surgery date |
| Patient Using Opioid Medication | Number of patients using opioids is listed here. | 6 week and 6 month after surgery date |
| NPRS - Numerical Pain Ranking Scale | Validated pain scale, subject reported. Min 0, Max 10, Higher score means worse outcome. | 6 months after surgery date |
| 23916639 | Background | Bozic KJ, Chan V, Valone FH 3rd, Feeley BT, Vail TP. Trends in hip arthroscopy utilization in the United States. J Arthroplasty. 2013 Sep;28(8 Suppl):140-3. doi: 10.1016/j.arth.2013.02.039. Epub 2013 Aug 1. |
| 32604156 | Background | Yao JJ, Cook SB, Gee AO, Kweon CY, Hagen MS. What Is the Survivorship After Hip Arthroscopy for Femoroacetabular Impingement? A Large-database Study. Clin Orthop Relat Res. 2020 Oct;478(10):2266-2273. doi: 10.1097/CORR.0000000000001370. |
| 29028436 | Background | Shin JJ, McCrum CL, Mauro CS, Vyas D. Pain Management After Hip Arthroscopy: Systematic Review of Randomized Controlled Trials and Cohort Studies. Am J Sports Med. 2018 Nov;46(13):3288-3298. doi: 10.1177/0363546517734518. Epub 2017 Oct 13. |
| 21566069 | Background | Philippon MJ, Decker MJ, Giphart JE, Torry MR, Wahoff MS, LaPrade RF. Rehabilitation exercise progression for the gluteus medius muscle with consideration for iliopsoas tendinitis: an in vivo electromyography study. Am J Sports Med. 2011 Aug;39(8):1777-85. doi: 10.1177/0363546511406848. Epub 2011 May 12. |
| 27173983 | Background | Domb BG, Sgroi TA, VanDevender JC. Physical Therapy Protocol After Hip Arthroscopy: Clinical Guidelines Supported by 2-Year Outcomes. Sports Health. 2016 Jul;8(4):347-54. doi: 10.1177/1941738116647920. Epub 2016 May 12. |
| 25980403 | Background | Gupta A, Suarez-Ahedo C, Redmond JM, Gerhardt MB, Hanypsiak B, Stake CE, Finch NA, Domb BG. Best Practices During Hip Arthroscopy: Aggregate Recommendations of High-Volume Surgeons. Arthroscopy. 2015 Sep;31(9):1722-7. doi: 10.1016/j.arthro.2015.03.023. Epub 2015 May 14. |
| 28969949 | Background | Cvetanovich GL, Lizzio V, Meta F, Chan D, Zaltz I, Nho SJ, Makhni EC. Variability and Comprehensiveness of North American Online Available Physical Therapy Protocols Following Hip Arthroscopy for Femoroacetabular Impingement and Labral Repair. Arthroscopy. 2017 Nov;33(11):1998-2005. doi: 10.1016/j.arthro.2017.06.045. Epub 2017 Sep 29. |
| 30467580 | Background | Bolia IK, Briggs KK, Matheny L, Philippon MJ. Survey results from an international hip course: comparison between experts and non-experts on hip arthroscopy clinical practice and post-operative rehabilitation. Knee Surg Sports Traumatol Arthrosc. 2020 Apr;28(4):1270-1275. doi: 10.1007/s00167-018-5289-4. Epub 2018 Nov 22. |
| 28948037 | Background | Truntzer JN, Shapiro LM, Hoppe DJ, Abrams GD, Safran MR. Hip arthroscopy in the United States: an update following coding changes in 2011. J Hip Preserv Surg. 2017 Mar 23;4(3):250-257. doi: 10.1093/jhps/hnx004. eCollection 2017 Aug. |
| Background | Hagen M, Westermann R, Lynch T, Rosneck J. Rehabilitation for Femoroacetabular Impingement: Conservative Care and Postoperative Practice. J Hip Surg. 2018;02(04):189-193. doi:10.1055/s-0038-1676448 |
| 41164948 | Derived | Hagen MS, Meier E, Wigton C, Son M, Kweon CY. A Randomized Controlled Trial of Postoperative Hip Bracing After Arthroscopic Osteoplasty and Labral Repair for Femoroacetabular Impingement Syndrome. Am J Sports Med. 2025 Dec;53(14):3332-3340. doi: 10.1177/03635465251388408. Epub 2025 Oct 30. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kilograms per meter squared |
|
| Smoking Status | Count of Participants | Participants |
|
| Marijuana Use | Count of Participants | Participants |
|
| Current Opioid Use | Count of Participants | Participants |
|
| Duration of Symptoms | Count of Participants | Participants |
|
| Participants |
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | at 6 week and 6 month after surgery date |
|
|
|
| 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. | 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 | Posted | Mean | 95% Confidence Interval | score on a scale | at 6 week and 6 month after surgery date |
|
|
|
| Secondary | Patient Using Topical Non-steroidal Medication | Number of patient using a topical nonsteroidal medication is listed here. | 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. | Posted | Count of Participants | Participants | 6 week and 6 month after surgery date |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 6 week and 6 month after surgery date |
|
|
|
| Secondary | Patient Using Opioid Medication | Number of patients using opioids is listed here. | 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. | Posted | Count of Participants | Participants | 6 week and 6 month after surgery date |
|
|
|
| Secondary | NPRS - Numerical Pain Ranking Scale | Validated pain scale, subject reported. Min 0, Max 10, Higher score means worse outcome. | Posted | Mean | 95% Confidence Interval | score on a scale | 6 months after surgery date |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 3 |
| 37 |
| EG001 | No Brace | This group will not be assigned a hip brace after surgery. | 0 | 36 | 0 | 36 | 2 | 36 |
|
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| Current |
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| Current |
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| Greater than 3 years |
|
| 6 month |
|
|
| Physical Component Summary 6 weeks |
|
|
| Mental Component Summary 6 months |
|
|
| Physical Component Summary 6 months |
|
|
| 6 month |
|
|
| 6 month |
|
|
| 6 month |
|
|