Postoperative Hip Bracing After Hip Arthroscopy

NCT04599296 | Completed Results FDA Device

• 2 other identifiers: STUDY000100385P30AR072572-02
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoroacetabular Impingement Syndrome; Acetabular Labral Tear

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• HOOS - Hip Disability and Osteoarthritis Outcome Score

  at 6 week and 6 month after surgery date

• VR12 - Veteran RAND 12 Item Health Survey

  at 6 week and 6 month after surgery date

• Patient Using Topical Non-steroidal Medication

  6 week and 6 month after surgery date

• Patient Received Cortisone Injection to Hip Flexor Sheath or Bursa

  6 week and 6 month after surgery date

• Patient Using Opioid Medication

  6 week and 6 month after surgery date

Study Arms (2)

Hip Brace

ACTIVE COMPARATOR

This group will be assigned to wear a hip brace post surgery.

Device: Hip brace

No Intervention

NO INTERVENTION

This group will not be assigned a hip brace after surgery.

Interventions

Hip brace DEVICE

Hip brace

Hip Brace

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (13)

• 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.

  PMID: 30647926 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.

  PMID: 26671201 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.

  PMID: 23916639 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.

  PMID: 32604156 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.

  PMID: 29028436 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.

  PMID: 21566069 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.

  PMID: 27173983 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.

  PMID: 25980403 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.

  PMID: 28969949 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.

  PMID: 30467580 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.

  PMID: 28948037 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

  BACKGROUND

• 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.

  PMID: 41164948 DERIVED

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Mia Hagen, Associate Professor
• Organization: University of Washington

smia@uw.edu

206-598-3404

Study Officials

• Mia Hagen, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The treating surgeon, who is also the PI, will be blind to randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Medicine

Model Details: Patients randomized to wearing a hip brace after surgery 36 Patients randomized to not wearing a hip brace after surgery 36

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 22, 2020
• Study Start: November 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 1, 2025
• Results First Posted: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)