Randomized Controlled Trial to Evaluate the Efficacy of a Neocartilage Implant in the Management of ICRS Grade 3 to 4 Articular Cartilage Lesions of the Knee
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 16
- 主要终点
- Knee Injury and Osteoarthritis Outcomes Scores (KOOS)
研究概览
简要总结
ISTO Technologies, Inc. is proposing a clinical study with 225 subjects, to establish the safety and efficacy of the Neocartilage Implant for the treatment of ICRS Grade 3 and 4 articular cartilage lesions of the knee compared to microfracture treatment.
详细描述
In the United States alone, more than 500,000 cartilage lesions per year require some treatment to reduce pain, restore joint mobility, and prevent further damage caused by the progression of osteoarthritis. The lack of effective cartilage repair approaches or products for restoration of defective articular cartilage to its native, hyaline morphology only continues to exacerbate the incidence of osteoarthritis as these initial defects enlarge and degrade over a 10 to 20 year period. The repair of cartilage, especially in the knee, remains a formidable clinical challenge. Regenerative medicine approaches to cartilage repair have only begun to be explored as possible options and there is a clear trend toward biological solutions for the repair and regeneration of damaged or diseased articular cartilage. The study was designed to compare how well the Neocartilage Implant works against the microfracture therapy, a widely used and accepted cartilage repair therapy. Data to be collected include Pain and Function in Daily Living scores, symptoms, Function in Sports and Recreation, and Knee Related Quality of Life. Additionally, MRI and X-rays will be collected to evaluate the cartilage repair progress. These assessments will be used through the five years of post-operative follow-up.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Generally, the following inclusion criteria must be met, however, this is not a complete list.
- •Male or Female between the ages of 18 and 60
- •(1) or (2) articular cartilage lesions of the distal femur ranging in no more than 5 cm2 each
- •Ipsilateral knee compartment has intact menisci (or meniscectomized remnant with > 5mm wide rim) and stable ligaments in the affected knee
- •3 months out from initiation of conservative non-surgical management (e.g.hyaluronic acid injection, activity modification) or previous minimal surgical intervention (e.g., arthroscopic lavage, debridement) or 12 months out from marrow stimulation for this condition
排除标准
- •Generally, if a potential participant meets any of the following criterions, they will not be eligible for this study. Additionally, more criteria will be evaluated to confirm eligibility as this list is not a complete list of criteria.
- •Osteoarthritis
- •Rheumatoid arthritis
- •History of septic or reactive arthritis
- •Gout or a history of gout or pseudo-gout in the affected knee
- •Osteochondritis dissecans or osteochondral lesions of the knee with bone loss > 6mm deep
- •Bipolar articular cartilage involvement (or kissing lesions) of the ipsilateral compartment (i.e., > than ICRS Grade 2 on the opposing articular surface)
- •Associated damage to the underlying subchondral bone requiring an osteochondral graft
- •Is pregnant or breast-feeding
- •Has a BMI > 35 (kg/m2)
- •Has prior total meniscectomy of either knee
- •Has received, within the past three months, intra-articular hyaluronic acid therapy, or steroid therapy
- •Has more than two clinically relevant chondral lesion(s) on the index knee
研究组 & 干预措施
Neocartilage Implant
Neocartilage Implant surgically implanted and affixed to subchondral bone using commercial fibrin during mini-open knee arthrotomy.
干预措施: Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft) (Biological)
Microfracture
Standard of care cartilage repair technique.
干预措施: Microfracture (Other)
结局指标
主要结局
Knee Injury and Osteoarthritis Outcomes Scores (KOOS)
时间窗: 36 months
Knee Injury and Osteoarthritis Outcomes Scores (KOOS) Pain and Function in Daily Living (ADL) subscales.
次要结局
- IKDC Knee Examination(Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years)
- Subject reported questionnaires(Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years)