A Prospective, Double Blind, Single-centre, Randomised Controlled Trial Comparing Arthroscopic Autologous Matrix Induced Chondrogenesis (AMIC®) to Microfracture Alone in the Treatment of Osteochondral and Chondral Lesion in the Ankle (AMARTA)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Manchester Oxford Foot Questionnaire (MOX-FQ) walking/standing subscale
研究概览
简要总结
This clinical investigation is a prospective, double blind, single-centre, randomised controlled trial comparing arthroscopic autologous matrix induced chondrogenesis (AMIC®) to microfracture alone in the treatment of osteochondral and chondral lesion in the ankle to evaluate effectiveness, performance and safety of AMIC® procedure versus microfracture (MFx).
详细描述
This clinical investigation compares arthroscopic autologous matrix induced chondrogenesis (AMIC®) to microfracture alone in the treatment of osteochondral and chondral lesion in the ankle to evaluate effectiveness, performance and safety of AMIC® procedure versus microfracture (MFx). It is a prospective, double blind, single-centre, randomised controlled trial. The objective of this clinical investigation is to evaluate performance, effectiveness, and safety of AMIC® procedure versus Microfracture (MFx). The effectiveness of the treatment is measured by the difference in the walking/standing- part score taken from the Manchester Oxford Foot Questionnaire (MOX-FQ) from baseline to 12 months. The secondary endpoints concern clinical safety and performance. Patients will be randomized into two groups: Microfracture alone (MFx) or Bone Marrow Stimulation (Microfracture) with Chondro-Gide® (AMIC®). The investigational device will be assessed within its intended use.
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
Patients will be blinded to the surgical procedure (with or without membrane). The outcome assessor who will complete the AOFAS and TAS will not be the physician who performed the surgery, the examiner is blinded to the treatment group to which the patient was allocated.
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
- •Signed written informed consent
- •Diagnosis of symptomatic osteochondral or chondral lesion of the talus, deemed by surgeon amenable to arthroscopic treatment with debridement and microfracture
- •Age of 18-65 years
- •Subject is willing and able to comply with all study procedures, including visits, diagnostic procedures, the rehabilitation protocol and responding to patient questionnaire follow up
排除标准
- •Lesions smaller 1 square centimeters and greater than 4 square centimeters based on the MRI
- •Malalignment which is not corrected prior to or as part of same surgery
- •Established significant hindfoot arthritis
- •Patients who are unable to have an MRI scan
- •Chronic inflammatory arthritis or infectious arthritis
- •History of autoimmune disease or immunodeficiency
- •History of connective tissue disease
- •Intra-articular steroid use within the 3 months prior to enrolment
- •Other intra-articular injections (e.g., hyaluronic acid) within 3 months prior to enrolment
- •The patient is currently being treated with radiation, chemotherapy, immunosuppression, or systemic steroid therapy with a dose equivalent to more than 5 mg prednisolone
- •Pregnancy or lactation
- •Enrolled in another study, involved in the study (as a researcher/investigator/sponsor), or relative of someone directly involved in the clinical investigation
- •Active infection of the index ankle
- •Has been prescribed medication to treat osteoporosis
- •Any disorder or impairment that would interfere with evaluation of outcomes measures, such as neurological, degenerative muscular, psychiatric, or cognitive conditions
研究组 & 干预措施
AMIC®
Bone Marrow Stimulation (Microfracture) with Chondro-Gide®
干预措施: Chondro-Gide® (Device)
AMIC®
Bone Marrow Stimulation (Microfracture) with Chondro-Gide®
干预措施: Microfracture (MFx) (Procedure)
Microfracture (MFx)
Microfracture alone
干预措施: Microfracture (MFx) (Procedure)
结局指标
主要结局
Manchester Oxford Foot Questionnaire (MOX-FQ) walking/standing subscale
时间窗: difference from baseline to 12 months post-operative
The effectiveness of the treatment is measured by the difference in the walking/standing- part score taken from the the MOX-FQ from baseline to 12 months. Raw score values for the walking/standing part are between 0-28, where higher score mean a worse outcome. Raw scores are converted to a metric (0-100).
次要结局
- Manchester Oxford Foot Questionnaire (MOX-FQ) total(change at 12, 24 and 60 months from baseline)
- American Orthopaedic Foot and Ankle-Hind foot Score (AOFAS)(change at 12, 24 and 60 months from baseline)
- EuroQol-5 Dimensions 5 Level (EQ5D-5L)(change at 12, 24 and 60 months from baseline)
- Tegner activity scale (TAS)(change at 12, 24 and 60 months from pre-symptomatic score)
- Foot Functioning Index (FFI)(change at 12, 24 and 60 months from baseline)
- Safety endpoints(through study completion, an average of 5 years)
- Magnetic resonance Observation of Cartilage Repair Tissue (MOCART) score(change at 24 and 60 months from baseline)