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Completed

NCT Number: NCT04599296

Postoperative Hip Bracing After Hip Arthroscopy

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.

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Key information

Age range

14 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Hip brace

Device

Hip brace

Primary outcomes

  1. Patient Numerical Pain Ranking Scale (NPRS)

    Time frame: 6 weeks after surgery date

    Validated pain scale, subject reported. Min 0, Max 10, Higher score means worse outcome.

Secondary outcomes

  1. HOOS - Hip Disability and Osteoarthritis Outcome Score

    Time frame: 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.

  2. VR12 - Veteran RAND 12 Item Health Survey

    Time frame: 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.

  3. Patient Using Topical Non-steroidal Medication

    Time frame: 6 week and 6 month after surgery date

    Number of patient using a topical nonsteroidal medication is listed here.

  4. Patient Received Cortisone Injection to Hip Flexor Sheath or Bursa

    Time frame: 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.

  5. Patient Using Opioid Medication

    Time frame: 6 week and 6 month after surgery date

    Number of patients using opioids is listed here.

  6. NPRS - Numerical Pain Ranking Scale

    Time frame: 6 months after surgery date

    Validated pain scale, subject reported. Min 0, Max 10, Higher score means worse outcome.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 22, 2020
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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