A Supervised Physical Therapy Program vs. Arthroscopic Surgery for Femoroacetabular Impingement: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Hip Outcome Score - ADL Subscale at 24 Months
研究概览
简要总结
The purpose of this study is to compare the outcomes for patients that receive two different treatments used for FAI (Femoroacetabular Impingement). The programs are 1) a 6-week supervised physical therapy program and 2) arthroscopic surgery. Enrollment is limited to patients that have already been determined surgical candidates. The study is following patients for a 2-year period.
详细描述
This study plans to enroll a total of 60 Tricare beneficiaries primarily from the Madigan Healthcare System with a diagnosis of FAI that are surgical candidates and have already failed at least six weeks of conservative treatment.
This is a randomized controlled study comparing outcomes for the standard treatment for FAI and/or acetabular labral pathology (arthroscopy with or without labral repair) versus physical therapy. For subjects in the arthroscopy group, the surgery will be performed by the Orthopedic Surgical Service at Madigan Army Medical Center.
Subjects randomized to the physical therapy group will follow a treatment plan implemented by a physical therapist within the Madigan Army Healthcare System.
After consent, subjects will be randomized into one of two arms (Group I = hip arthroscopy, Group II = physical therapy). Group I will undergo hip arthroscopy with or without labral repair. Group II will follow a FAI-based physical therapy program x 12 sessions (6 weeks).
The arthroscopy group will complete outcome measures at time of consent and following surgery at 6 months, 1 year and 2 year time periods. Subjects in this group will follow a standardized post-operative rehabilitation protocol.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tricare beneficiaries between the ages of 18 and 65
- •Diagnosis of FAI and/or labral pathology confirmed by a combination of the following:
- •Pain at the anterior hip or groin
- •Pain with hip flexion
- •Positive FADIR test
- •Patient report relief of pain after intra-articular injection
- •Surgical candidate for hip arthroscopy defined by (must have both):
- •No less than 2 mm of joint space based on imaging (CT scan, radiographs and MR arthrogram)
- •Positive crossover sign and/or alpha angle >50 deg based on imaging (CT scan, radiographs and MR arthrogram)
- •Failed 6 weeks of conservative management
排除标准
- •Pregnancy
- •Has other concurrent systemic disease that may affect the condition (cancer, rheumatoid arthritis, or other systemic arthralgia/arthritis)
- •Has had surgery on the same hip that will be analyzed in the study
- •Diagnosis of hip osteoarthritis is more likely
- •Clearing the lumbar spine reproduces the patient's hip symptoms
- •Plans to move/relocate out of the local area within 6 months
- •Pending litigation for their hip condition
- •Unable to give informed consent to participate in the study
- •Unable to speak or read or write in English (due to inability to fill out outcome measures)
结局指标
主要结局
Hip Outcome Score - ADL Subscale at 24 Months
时间窗: 24 months
The Hip Outcome Score is designed to assess higher-level activities (i.e. those required in athletics) and has demonstrated validity in a study of patients at a mean of three years following hip arthroscopy. Additionally, a 2011 study states that the HOS has the greatest amount of clinimetric evidence (rigor of rating scales and indexes for the description of clinical phenomena). Only three published patient-reported outcome instruments utilized to assess FAI and labral pathology use clinimetric evidence and the HOS was identified as the most proven instrument. The HOS ADL Subscale consisted of 19 questions, each scored on a 5-point scale from 0 (unable to do) to 4 (no difficulty). The final score is calculated by taking the raw score, dividing it by the number of total questions answered multipled by 4 x 100 for a final score that ranges from 0 to 100%, with lower scores associated with greater limitation in Activities of Daily Living (ADL).
Hip Outcome Score - Sport Subscale at 24 Months
时间窗: 24 months
The Hip Outcome Score is designed to assess higher level activities (i.e. those required in athletics) and has demonstrated validity in a study of patients at a mean of three years following hip arthroscopy. Additionally, a 2011 study states that the HOS has the greatest amount of clinimetric evidence (rigor of rating scales and indexes for the description of clinical phenomena). Only three published patient-reported outcome instruments utilized to assess FAI and labral pathology use clinimetric evidence and the HOS was identified as the most proven instrument. The HOS Sport Subscale consists of 9 questions, each scored on a 5-point scale from 0 (unable to do) to 4 (no difficulty). The final score is calculated by taking the raw score, dividing it by the number of total questions answered multipled by 4 x 100 for a final score that ranges from 0 to 100%, with lower scores associated with greater limitations in Sports-related activities.
次要结局
- Group Differences in International Hip Outcome Score (IHOT33) to 24 Months(24 months)
- Global Rating of Change Score of 3+ or Higher (Minimum Clinically Important Change)(24 months)
研究者
Dan Rhon
Director of Physical Therapy, Department of PM&R
Madigan Army Medical Center