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临床试验/NCT04599296
NCT04599296已完成不适用

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

University of Washington2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
2
主要终点
Patient Numerical Pain Ranking Scale (NPRS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

The treating surgeon, who is also the PI, will be blind to randomization.

入排标准

年龄范围
14 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

结局指标

主要结局

Patient Numerical Pain Ranking Scale (NPRS)

时间窗: 6 weeks after surgery date

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

次要结局

  • HOOS - Hip Disability and Osteoarthritis Outcome Score(at 6 week and 6 month after surgery date)
  • VR12 - Veteran RAND 12 Item Health Survey(at 6 week and 6 month after surgery date)
  • Patient Using Topical Non-steroidal Medication(6 week and 6 month after surgery date)
  • Patient Received Cortisone Injection to Hip Flexor Sheath or Bursa(6 week and 6 month after surgery date)
  • Patient Using Opioid Medication(6 week and 6 month after surgery date)
  • NPRS - Numerical Pain Ranking Scale(6 months after surgery date)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mia Hagen

Associate Professor, School of Medicine

University of Washington

研究点 (2)

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