CREST: A Randomized Controlled Trial Comparing Inter-portal Hip Capsular Repair vs. No Repair Following Hip Arthroscopy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 250
- 试验地点
- 6
- 主要终点
- Hip Function
研究概览
简要总结
Capsular REpair randomiSed controlled Trial (CREST) is a multi-center, randomized controlled trial with a sample size of 240 patients (120 patients in each group). The primary outcome measure is functional outcome as measured by the change in Hip Outcome Score at 6 months with secondary outcomes being hip range of motion, i-HOT 12, overall satisfaction, and VAS. Patients are stratified based on gender. Patients, outcome assessors, and data analysts are blinded to surgical allocation. Using an intention-to-treat approach, outcome analyses will be performed using an analysis of covariance and descriptive statistics.
详细描述
Background Femoroacetabular impingement (FAI) is a well-described condition that causes hip pain in young to middle age adults. Cross sectional studies have estimated that the prevalence of hip impingement ranges from 14-17% among asymptomatic young adults and nearly 95% among competitive athletes. FAI occurs as a result of a size and shape mismatch between the femoral head and the acetabulum. There are two subtypes of FAI: Cam type and Pincer type. Cam type is caused by a misshaped femoral head and pincer is caused by an over coverage of the acetabular rim. Most patients have a mixed type of Cam and pincer impingement that involves some degree of an abnormally shaped femoral neck and over coverage of the acetabulum. Arthroscopic treatment for FAI has demonstrated promising results. It has been shown to alleviate pain and improve function with good return to sport rates in young athletes with FAI.
Although arthroscopic treatment for FAI has provided promising results, there is much debate over treatment of the capsule after arthroscopic surgery. Surgeons usually either choose to perform a capsulotomy or a partial capsulectomy during arthroscopic surgery to increase their viewing space in order to perform procedures to address intra-articular pathologies.
The hip capsule is made up of four components: The iliofemoral, pubofemoral, and ischiofemoral ligaments and the zona orbicularis. The iliofemoral has been shown to be the strongest of these ligaments and the most important stabilizer in resisting anterior translation and hip dislocation. During arthroscopic hip surgery, surgeons often use an interportal cut made between the mid-anterior and anterolateral portal to allow visualization of the joint. Surgeons may choose to either leave the capsule open or repair it. As techniques have evolved, more interest has been placed on repairing the capsule in order to improve stability following arthroscopic hip surgery. Frank et al. recently reported that patients undergoing T-capsulotomy with complete closure had improved outcomes compared to patients who received only partial closure. Wylie et al. recently showed improved post-operative patient reported outcomes (PROs) following revision hip arthroscopy in order to repair the capsule.
The goal of the CREST is to evaluate functional stability and patient reported outcome scores following capsular repair after arthroscopic hip surgery for FAI.
Overview of study design
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Criteria: Inclusion Criteria:
- •Adults aged 18 to 50 (men or women)
- •Hip pain for greater than 3 months that has failed non-operative treatment (physical therapy, NSAIDS, rest)
- •FAI documented on X-Ray or Magnetic resonance imaging (MRI) or magnetic resonance arthrogram (MRA)
- •Intraoperative labral repair or intact labrum
- •Informed consent from the participant
- •Ability to comprehend and speak English and the study design.
- •Pre-operative
排除标准
- •are the following:
- •Hypermobility/Ehlers-Danlos syndrome
- •Evidence of hip dysplasia (Center edge angle less than 20)
- •Previous surgery or trauma of the affected hip
- •Severe acetabular deformities such as circumferential labral ossification, acetabular protrusion20
- •Inflammatory/ autoimmune disease
- •Immunosuppressant medication
- •Significant medical co-morbidities such as uncontrolled diabetes, hypertension, congestive heart failure, etc.
- •Severe mental or physical disability requiring assistance in daily living
- •History of pediatric hip disease with previous operation (developmental dysplasia, Legg-Calve-Perthes, Slipped capital femoral epiphysis)
- •Presence of advanced hip osteoarthritis (Tonnis grade 2 or 3)18
- •Worker's compensation status
- •Intraoperative microfracture, or other procedure that would alter postoperative rehabilitation
- •Intraoperative labral debridement or labral reconstruction
- •Peri-trochanteric or deep gluteal space arthroscopy
- •Avascular necrosis
- •Intra-operative exclusion criteria are the following:
- •Labral debridement
- •Labral reconstruction
- •Poor quality capsular tissue
- •Hyperlaxity based on excessive subluxation of the joint greater than 2 cm with standard 50 pounds of traction
- •Concomitant procedures such as MFX and iliopsoas lengthening will be included
研究组 & 干预措施
Hip Capsule Repair
Patients in the intervention group (Hip capsule repair) will undergo initial diagnostic arthroscopy of the hip. Two to three standard portals (anterolateral, mid anterior, distal antero-lateral, posterolateral) will be used during the entire procedure to assess and treat the patient. After establishing standard portals, an interportal capsulotomy is completed to allow for complete evaluation of the central compartment of the hip. In the central compartment, significant and obvious pathologies will be addressed accordingly. Following addressing central compartment pathologies, cam impingement type lesions in the peripheral compartment will be treated. Once all pathologies are addressed, the interportal capsulotomy10 will be repaired by using simple interrupted sutures with absorbable suture (Number 1 Vicryl). Three to four simples sutures will be placed and tied using arthroscopic technique.
干预措施: Hip Capsule Repair (Procedure)
No Hip Capsule Repair (Control)
Patients in the control group (no hip capsule repair) have the same portals utilized and will have the same interportal capsulotomy performed. They will have all central and peripheral compartment pathologies addressed in the same way that the study group does. At the conclusion of the case, the hip capsule will be left open and not repaired.
结局指标
主要结局
Hip Function
时间窗: Baseline, 6 months
The main outcome assessed will be hip function including change in percentage of Hip outcome score (HOS score) from baseline to 6 month follow-up. The subscale of ADL (activities of daily living) and Sport will be utilized. each HOS subscale is calculated from 0 to 100%, with 100% being the best score.
次要结局
- Hip ROM(Baseline, 6 months)
- Visual Analog Pain Score Progression(Baseline, 6 months)
研究者
Aaron Krych
Professor of Orthopedics
Mayo Clinic