Clinical trial NCT04599296: Postoperative Hip Bracing After Hip Arthroscopy
Official title: A Randomized Controlled Pilot Trial of Postoperative Hip Bracing After Arthroscopic Osteoplasty and Labral Repair for Femoroacetabular Impingement Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoroacetabular Impingement Syndrome
Acetabular Labral Tear
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2020-10-22
Enrollment: 82
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients randomized to wearing a hip brace after surgery 36 Patients randomized to not wearing a hip brace after surgery 36
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Patient Numerical Pain Ranking Scale (NPRS)
timeFrame: 6 weeks after surgery date
Secondary outcomes:
measure: HOOS - Hip Disability and Osteoarthritis Outcome Score
timeFrame: at 6 week and 6 month after surgery date
measure: VR12 - Veteran RAND 12 Item Health Survey
timeFrame: at 6 week and 6 month after surgery date
measure: Patient Using Topical Non-steroidal Medication
timeFrame: 6 week and 6 month after surgery date
measure: Patient Received Cortisone Injection to Hip Flexor Sheath or Bursa
timeFrame: 6 week and 6 month after surgery date
measure: Patient Using Opioid Medication
timeFrame: 6 week and 6 month after surgery date
measure: NPRS - Numerical Pain Ranking Scale
timeFrame: 6 months after surgery date
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Mia Hagen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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