Postoperative Hip Bracing After Hip Arthroscopy

Femoroacetabular Impingement Syndrome Clinical Trial

Official title:

A Randomized Controlled Pilot Trial of Postoperative Hip Bracing After Arthroscopic Osteoplasty and Labral Repair for Femoroacetabular Impingement Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04599296
• Other study ID #: STUDY00010038
• Secondary ID: 5P30AR072572-02
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 60 Years

Eligibility

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.

• Any patient with planned iliopsoas tendon release for tendonitis at the time of surgery, or who undergoes iliopsoas tendon release on the day of surgery (this may be a confounding variable as this is study looking at ability of the hip brace to prevent hip flexor tendonitis after surgery).

• Non-English speaking patients (due to limited validation of the patient reported outcome measures in non-English speaking populations).

Related Conditions & MeSH terms

• Acetabular Labral Tear
• Femoracetabular Impingement
• Femoroacetabular Impingement Syndrome
• Syndrome

Intervention

Device:
• Hip brace
Hip brace

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
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.	at 6 week and 6 month after surgery date
Secondary	Patient using non-steroidal medication	yes / no	6 week and 6 month after surgery date
Secondary	Patient received cortisone injection to hip flexor sheath or bursa	yes / no	6 week and 6 month after surgery date
Secondary	Patient using opioid medication	yes / no	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.	3 weeks and 6 months after surgery date