Trial to Compare the Efficacy of Two Surgical Techniques for Articular Cartilage Repair in the Knee: The Use of Cultured Chondrocytes Vs. the Use of Cultured Bone Marrow Aspirate Cells.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Clinical outcome
研究概览
简要总结
Study Title: A study to compare two articular cartilage repair techniques in the knee joint: The use of Cultured Chondrocytes Vs. Cultured bone marrow aspiration cells.
Study hypothesis: We start with the hypothesis that both treatments are equally effective.
Trial Design: The participating patients will be divided into two groups, each group receiving either one of the treatment modalities. This study will not be randomised or blinded. Both procedures will be done at the Spire Alexandra Hospital by Professor A. A Shetty, who is one half of the team that devised both techniques. The post-operative rehabilitation process will be the same for both groups.
Trial Participants: All participants will be from patients attending Professor Shetty's clinic at the Spire Alexandra Hospital.
Planned Sample Size: 50 patients in each group
Follow-up duration: The participating patients will be followed up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years following the surgery by visits to the clinic and assessed clinically. The surgical outcomes will be measured by by IKDC, KOOS and Lysholm scores; cartilage growth will be measured by the MOCART score.
Planned Trial Period: Two to three years
Primary Objective: To establish superiority, if any, of either procedure over the other by studying pain relief, cartilage growth and improvement in function.
Primary Endpoint: At the end of the 2 year follow up for all participating patients.
详细描述
BACKGROUND:
Articular cartilage repair in the knee is aimed at young patients with area(s) of cartilage loss and no deformity of the knee. These patients aren't indicated for a knee replacement. Articular cartilage repair leads to improvement of symptoms of pain, locking and function. Traditionally, articular cartilage repair has always involved exposing the entire knee joint with an arthrotomy. This, though effective, would lead to a large scar, longer hospital stay, longer rehabilitation and its associated complications. Also, the use of Bone Marrow Aspirate Cells (BMAC) for the purpose of cartilage repair has long been debated with both sides having valid arguments and good surgical results.
RATIONALE:
In our study, one method (Cultured Chondrocytes) requires an arthroscopy and an arthrotomy, takes 6 weeks to complete and is followed by 6 weeks of partial weight bearing on the operated leg. The other method (Cultured BMAC) is done arthroscopically, followed by 4 injections into the affected knee and takes 6 weeks to complete which includes 6 weeks of partial weight bearing on the operated leg.
Both procedures have shown encouraging results in terms of pain relief, cartilage growth and improved function. The use of cultured chondrocytes requires two surgeries and takes a total of 12 weeks till the patient can walk without support while the use of cultured BMAC involves only one surgery and can have the patient walking unsupported in 6 weeks. This study aims to ascertain if either technique is superior to the other.
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
- None
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
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged 18 years to 65 years.
- •Diagnosed with articular cartilage defect in the knee (ICRS/Outerbridge grade III/IV cartilage lesions as assessed on MRI scan).
- •No other significant medical co-morbidities, as assessed by pre-operatively, that could interfere with surgery results of trial eg. Hypertension, COPD etc.
- •Participant has clinically acceptable laboratory and ECG tests at pre-assessment clinic.
- •Able (in the Investigators opinion) and willing to comply with all study requirements.
- •Up to 3 lesions of sizes 2-8 cm2
排除标准
- •Generalized and/or inflammatory arthritis
- •Active joint inflammation
- •More than 5 degrees of varus or valgus deformity
- •Age below 18 and over 65 years
- •More than 4 lesions
- •Lesions more than 8 cm2
- •Significant co-morbidities or classified as ASA grade 3/4
结局指标
主要结局
Clinical outcome
时间窗: 2 years
This study aims to compare two techniques of articular cartilage repair in the knee, namely the use of cultured chondrocytes and the use of cultured bone marrow aspirate cells (BMAC). The principal objective of is to ascertain and assess the superiority, if any, of either surgical technique over the other. The superiority will be assessed with by the IKDC, KOOS, Lysholm scores measured pre- and post-operatively.
Radiological outcome
时间窗: 2 years
This study aims to compare two techniques of articular cartilage repair in the knee, namely the use of cultured chondrocytes and the use of cultured bone marrow aspirate cells (BMAC). The principal objective of is to ascertain and assess the superiority, if any, of either surgical technique over the other. The radiological superiority will be assessed with by MOCART scores measured pre- and post-operatively.
次要结局
未报告次要终点