NL-OMON36974已完成3 期
A Prospective, Randomized, Open-Label, Parallel-Group, Multicenter Study to Demonstrate the Superiority of Matrix-induced Autologous Chondrocyte Implantation (MACI® Implant) versus Arthroscopic Microfracture for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle including the Trochlea. - SUMMIT study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Genzyme
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion criteria during screening:
- •1. Provides written informed consent, and is able to read and understand the language and content of the study material, understand the requirements for follow-up visits and rehabilitation, and is willing to provide required information at the scheduled evaluations.
- •2. Symptomatic focal cartilage defects as defined by KOOS Pain score <55.
- •3. Age >=18 and <=55 years of age.
- •4. Agrees to provide a blood sample at the time of cartilage biopsy during the index arthroscopy for testing of HIV-1, HIV-2, hepatitis B, hepatitis C, and syphilis. ;Inclusion criteria during Index Arthroscopy
- •Patients must meet the following criteria during the index arthroscopy in order to be randomized to study treatment:
- •1. Modified Outerbridge Grade III or IV focal cartilage defect(s) located on the femoral condyles, including the trochlea that will allow treatment with the same surgical procedure as determined at randomization. Note: concurrent Outerbridge Grade I and II defects are acceptable on the patella or tibia if they remain untreated (or are treated with debridement only) at the time of the arthroscopy and/or arthrotomy.
- •2. Cartilage lesions determined by arthroscopy prior to randomization and treatment with at least 1 defect size >=3.0 cm2 on the femoral condyles and/or the trochlea (including osteochondritis dissecans lesions that do not require a bone graft).
- •3. Stable knee (i.e., anterior and posterior cruciate ligaments should be free of laxity as well as stable and intact). Ligament repair or reconstruction procedures are allowed prior to or concurrent with arthroscopy and/or arthrotomy.
- •4. Intact meniscus or partial meniscus (at least 50% of functional meniscus remaining). Meniscal repair or resection may be performed either staged or concurrent with the cartilage repair procedure provided that the surgeon is able to confirm that at least 50% of functional meniscus would remain after the corrective meniscal treatment.
排除标准
- •Exclusion criteria during screening:
- •1. Any surgery on the knee joint within 6 months prior to Screening (not including diagnostic arthroscopy).
- •2. Symptomatic musculoskeletal conditions in the lower limbs that could impede measurement of efficacy for the target knee joint.
- •3. In the target knee joint, patient requires or has a history of a total meniscectomy or meniscal allograft, or has a bucket handle tear or displaced tear that requires a meniscectomy removing >50% of the meniscus.
- •4. Malalignment requiring an osteotomy to correct tibial-femoral or patella-femoral alignment. Retinaculum releases are allowed if indicated to correct patella maltracking.
- •5. History of osteoarthritis (Kellgren-Lawrence Grade 3 or 4) in the target knee joint as diagnosed by clinically appropriate X-rays obtained at the Screening visit or within the previous 12 weeks.
- •6. Concomitant inflammatory disease or other condition that affects the joints (e.g., rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis).
- •7. History of septic arthritis in the target knee joint within 1 year prior to Screening.
- •8. Current malignancy or treatment for malignancy within the past 5 years, except nonmelanoma skin cancer.
- •9. Known history of anaphylaxis to gentamicin or any of the products used in the preparation and use of MACI implant.
- •10. Patients who, in the opinion of the investigator, have significant medical or psychosocial problems that warrant exclusion. Examples of significant problems include but are not limited to:
- •* Any condition that has potential for negatively impacting intra or post-operative course, e.g.,
- •Conditions that could severely impair wound healing, e.g., peripheral vascular disease (PVD)
- •Conditions that limit compliance with rehabilitation program, e.g., unstable or poorly controlled angina
- •Active infection, including unexplained fever (temperature >38.1°C) or antibiotic therapy within 1 week prior to Screening.
- •* Any condition that has potential for significantly limiting patient*s ability to assess post-operative knee function, e.g.,
- •PVD with symptomatic claudication
- •* Any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up, or compliance with any aspect of the study
- •* Patient is currently abusing drugs or alcohol or, in the opinion of the investigator, at high risk for poor compliance.
- •11. Previous investigational drug or device use within 3 months prior to Screening.
- •12. Females who are pregnant or lactating at the time of Screening (patients must agree to not become pregnant between the Screening visit and the surgical treatment visit, i.e., arthroscopy for those randomized to treatment with microfracture, and arthrotomy for those randomized to MACI implant treatment).
- •13. Ongoing litigation for compensation for musculoskeletal injuries or disorders.;Exclusion criteria during Index Arthroscopy
- •Patients meeting any of the following criteria during the index arthroscopy will not be eligible for randomization to study treatment.
- •1. Modified Outerbridge Grade III or IV defect(s) located on the patella or tibia.
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