Effects of Microfracture With/Without Collagen Augmentation in Patients Undergoing High Tibial Osteotomy: A Randomized, Controlled, Double-Blind Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- knee Injury and Osteoarthritis Outcome Score (KOOS)
研究概览
简要总结
The quality of cartilage regeneration after marrow stimulation is well documented to be unpredictable, because they do not regenerate consistent amount of cartilage. To overcome the shortcomings of the microfracture technique, various augmentation techniques using synthetic collagen matrix, scaffolds or plug devices have been developed. However, their efficacy remains unclear. The purpose of this prospective randomized controlled study is to evaluate whether the microfracture in combination with collagen gel augmentation could improve the quality of cartilage regeneration in patients undergoing medial open wedge high tibial osteotomy (HTO) for the treatment of medial unicompartmental knee osteoarthritis (OA).
详细描述
CartiFill™ (atelocollagen, Sewon Cellontech, Seoul, Korea) was developed to to provide a matrix stability and to maintain the blood clot in the defect site, which promoted the cartilage regeneration by mesenchymal stem cell . It was a atelocollagen, highly purified porcine derived type collagen І that has been modified to virtually eliminate the risk of rejection by removal of telopeptide.
The investigators randomized patients undergoing HTO in combination with microfracture to receive either microfracture alone (control group, n = 5) or microfracture with collagen augmentation (experimental group, n=6). At postoperative one year, the clinical outcome in terms of Visual Analogue Scale of pain level (VAS), Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score, and Tegner scores were evaluated. In addition, second look arthroscopic examination and biopsy of regenerated cartilage were carried out when the HTO plate was removed at postoperative one year. Biopsy specimens were graded by International Cartilage Repair Society Visual Assessment Scale (ICRS II scores). Finally, radiologic outcome in terms of Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores was assessed using follow up MRI undertaken at postoperative one year.
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, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged below 65 years with isolated medial compartment osteoarthritis
- •Good range of motion
- •No ligament instability
- •Having medicare insurance
排除标准
- •Diagnosis of severe tricompartment osteoarthritis indicated for total knee arthroplasty
- •Inflammatory arthritis(rheumatoid arthritis), osteonecrosis
- •Flexion contracture ≥ 15°
- •Knee range of motion < 120°
- •Joint instability
- •A history of knee joint infection and who refused to participate
结局指标
主要结局
knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: Change from Baseline score to score of postoperative 1 year.
International Knee Documentation Committee (IKDC) score
时间窗: Change from Baseline score to score of postoperative 1 year.
Tegner score
时间窗: Change from Baseline score to score of postoperative 1 year.
次要结局
- The MRI observation of cartilage repair tissue (MOCART) score(Preoperative & postoperative 1 year.)
- International Cartilage Repair Society (ICRS) II scoring system(Postoperative 1 year.)
研究者
Yong In
Professor
The Catholic University of Korea