A ProSpective, MulticEnter, Concurrently Controlled Clinical Study of Chondro-Gide® ArticUlar Cartilage CoveR for the Treatment of Large Chondral Lesions in the KnEe (SECURE)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 82
- 试验地点
- 27
- 主要终点
- Patients achieving composite clinical success (CCS) at 24 months follow-up, with CCS
研究概览
简要总结
Multi-center, prospective, concurrently controlled, non-randomized, double-blind (patient and assessor). Treatment of large chondral lesions in the knee with microfracture plus the Chondro-Gide® ACC is non-inferior to treatment of small chondral lesions treated with microfracture alone.
详细描述
The study evaluates the investigational treatment for treating large chondral lesions of the knee to the control treatment of microfracture alone for treating small lesions.Eligible patients with a large lesion will be treated with microfracture plus the Chondro-Gide® ACC and compared to patients with small lesions that are treated with microfracture alone. Outcome measures to be assessed include patient reported outcomes and freedom from certain adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Signed written informed consent
- •One symptomatic knee with cartilage defect on the medial femoral condyle, lateral femoral condyle, or trochlea, identified MRI or arthroscopy
- •Between 18 and 55 years of age
- •Subject is willing and able to comply with all study procedures, including visits, diagnostic procedures, and the rehabilitation protocol
排除标准
- •BMI ≥ 30 kg/m2
- •Symptomatic contralateral knee
- •Diagnosis of radiographic osteoarthritis with Kellgren-Lawrence grade 3 or more
- •Prior surgical treatment of the cartilage using microfracture, mosaicplasty, or autologous chondrocyte implantation (debridement and lavage are acceptable if the procedure was at least 3 months prior to enrollment)
- •Patella dysplasia
- •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 enrollment
- •Other intra-articular injections (e.g. hyaluronic acid) within 3 months prior to enrollment
- •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 lack of adequate contraceptives if a female of child-bearing potential
- •Enrolled in another study, involved in the study (as a researcher/investigator/sponsor), or relative of someone directly involved in the study
- •Active infection of the index knee
- •Previous diagnosis of osteoporosis as diagnosed by DEXA, bone densitometry or CT scan
- •Any disorder or impairment that would interfere with evaluation of outcomes measures, such as neurological, degenerative muscular, psychiatric, or cognitive conditions
- •History or current substance or alcohol abuse as defined by the DSM-V
- •Any other medical condition that the investigator determines would interfere with the validity of the study
- •Known allergy to porcine collagen
- •Symptom duration greater than 36 months
研究组 & 干预措施
Control Arm
Patients with small chondral lesions of the knee
干预措施: Microfracture (Procedure)
Investigational Group
Patients with large chondral lesions of the knee
干预措施: Microfracture plus placement of Chondro-Gide® ACC (Device)
结局指标
主要结局
Patients achieving composite clinical success (CCS) at 24 months follow-up, with CCS
时间窗: 24 Months
The CCS is defined as a patient meeting all of the three following criteria: 1. Improvement in the Pain sub-scale of the Knee Injury and Osteoarthritis Outcomes Score (KOOS) between baseline to 24 months follow-up 2. Improvement in function, defined as an improvement in the International Knee Documentation Committee (IKDC) score between baseline to 24 months follow-up 3. Freedom from device- or procedure-related serious adverse events (SAEs) or secondary surgical intervention related to the device, procedure, or treated lesion
次要结局
- Magnetic Resonance Observation of Cartilage Score(3 months, 24 months)
- Knee Injury and Osteoarthritis Outcome Score(Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months)
- Patient satisfaction(6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months)
- Tegner Activity Scale(6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months)
- Employment status(Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months)
- EuroQol-5 Dimension (EQ-5D)(Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months)