Autologous MatRix-Induced ChondrogenEsis ComPared With Microfracture for Focal ArtIcular CaRtilage Damage of the Hip (REPAIR): A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Hip function and health-related quality of life using the International Hip Outcome Tool (iHOT-33)
研究概览
简要总结
This is a pilot multi-centre RCT of 40 patients (ages 18-55 years, inclusive) undergoing primary hip arthroscopy with a focal articular cartilage defect of the acetabulum to compare the effect of using autologous matrix-induced chondrogenesis (AMIC) in comparison to microfracture on hip function, health-related quality of life, hip pain, cartilage regeneration, health utility, and any adverse events at 2 years. Follow-up will occur at 6 weeks, 6 months, 12 months, 18 months, and 24 months post-surgery.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The outcome assessors, those performing data entry and analysis, and patients will be blinded to the treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients aged 18-55 years
- •Hip pain lasting 6 months or more with no relief from documented non-operative modalities
- •Focal articular cartilage defects of the acetabulum on MRI, confirmed to be full thickness (International Cartilage Regeneration and Joint Preservation Society (ICRS) grade 3 or 4) during arthroscopic examination
- •Focal acetabular articular cartilage lesions measuring between 3 cm2 and 25 cm2 on MRI and confirmed on arthroscopic examination
- •Patient agrees to participate in the study-specific postoperative rehabilitation protocol
- •Patient can speak, read, and understand the language of the site
- •Patient has provided informed consent
排除标准
- •Cartilage defects of the femoral head
- •Previous surgery on the study hip
- •Traumatic chondral injury of the hip from a single event
- •Presence of advanced osteoarthritis (Tonnis grade 3) or any other acute or chronic inflammatory joint disease
- •Known hypersensitivity or allergy to porcine collagen
- •Acute or chronic infection at the surgical site
- •Evidence of hip dysplasia (i.e., lateral centre edge angle < 20˚)
- •Evidence of acetabular over coverage such as coxa profunda or coxa protrusion
- •Immunosuppressive or anti-proliferative medication use
- •Chronic pain syndromes
- •Significant medical co-morbidities (requiring assistance for activities of daily living (ADLs))
- •History of paediatric hip disease
- •Uncontrolled diabetes
- •Contraindications to MRI imaging (e.g. claustrophobia)
- •Patient is involved in ongoing legal or workplace claims
- •Patient is incarcerated
- •Patient is pregnant or breastfeeding
- •Patient who will likely have problems, in the judgement of the investigator, with maintaining follow-up
- •Any other reason(s) the investigator feels is relevant for excluding the patient
结局指标
主要结局
Hip function and health-related quality of life using the International Hip Outcome Tool (iHOT-33)
时间窗: Change from baseline to 24 months post-surgery
The iHOT-33 is designed to measure hip-specific health-related quality of life changes after treatment of active young patients with hip disorders. The total score is calculated as a simple mean of the responses ranging from 0 to 100, with 100 representing the best possible quality-of-life score.
次要结局
- Total number of adverse events(24 months post-surgery)
- Cartilage repair using the Magnetic Resonance Evaluation of the Repair of Cartilage in the Hip Score (MERCH) (scored from 0-100)(Change from baseline to 24 months post-surgery)
- Hip pain using the Visual Analogue Scale (VAS); 100-point scale(Change from baseline to 24 months post-surgery)
- Health utility using the Euro-Qol 5 Dimensions (EQ-5D); index score(Change from baseline to 24 months post-surgery)
研究者
Olufemi Ayeni
Professor
McMaster University