Postoperative Hip Bracing After Hip Arthroscopy

Not Applicable

Completed

• Conditions: Acetabular Labral Tear; Femoroacetabular Impingement Syndrome
• Interventions: Device: Hip brace

• Registration Number: NCT04599296
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-10-16
• Study First Posted: 2020-10-22
• Study Start: 2020-11-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hip Brace	Hip brace	This group will be assigned to wear a hip brace post surgery.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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 non-steroidal medication	6 week and 6 month after surgery date	yes / no
Patient received cortisone injection to hip flexor sheath or bursa	6 week and 6 month after surgery date	yes / no
Patient using opioid medication	6 week and 6 month after surgery date	yes / no
NPRS - numerical pain ranking scale	3 weeks and 6 months after surgery date	Validated pain scale, subject reported. Min 0, Max 10, Higher score means worse outcome.

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States