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Postoperative Hip Bracing After Hip Arthroscopy

Sponsor
University of Washington (Other)
Overall Status
Recruiting
CT.gov ID
NCT04599296
Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)
72
Enrollment
1
Location
2
Arms
20.9
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Hip brace
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients randomized to wearing a hip brace after surgery 36 Patients randomized to not wearing a hip brace after surgery 36Patients randomized to wearing a hip brace after surgery 36 Patients randomized to not wearing a hip brace after surgery 36
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The treating surgeon, who is also the PI, will be blind to randomization.
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Pilot Trial of Postoperative Hip Bracing After Arthroscopic Osteoplasty and Labral Repair for Femoroacetabular Impingement Syndrome
Actual Study Start Date :
Nov 1, 2020
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Hip Brace

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

Device: Hip brace
Hip brace
No Intervention: No Intervention

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. Patient using non-steroidal medication [6 week and 6 month after surgery date]

    yes / no

  4. Patient received cortisone injection to hip flexor sheath or bursa [6 week and 6 month after surgery date]

    yes / no

  5. Patient using opioid medication [6 week and 6 month after surgery date]

    yes / no

  6. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Washington Seattle Washington United States 98195

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Mia Hagen, MD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mia Hagen, Assistant Professor, School of Medicine, University of Washington
ClinicalTrials.gov Identifier:
NCT04599296
Other Study ID Numbers:
  • STUDY00010038
  • 5P30AR072572-02
First Posted:
Oct 22, 2020
Last Update Posted:
May 23, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Femoracetabular Impingement
Syndrome

Study Results

No Results Posted as of May 23, 2022