Focal Cartilage Defects in the Knee - A Randomized Controlled Trial Comparing Arthroscopic Microfracture With Arthroscopic Debridement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life
研究概览
简要总结
114 patients between 18 and 50 years with an isolated focal cartilage defect in the knee will be randomized to either receive arthroscopic microfracture or arthroscopic debridement. Both groups will then undergo a systematic physiotherapy training regime for 6-9 months. The groups will then be compared for results, after 3, 6, 12 and 24 months, by using validated patient reported outcome scores (Lysholm, KOOS, Tegner) and EQ5D as well as clinical examination and radiological findings at 2 years (MRI).
详细描述
Focal cartilage defects in the knee - A randomized controlled trial comparing arthroscopic microfracture with arthroscopic debridement.
Clinical compare the effect of arthroscopic microfracture (MF) with arthroscopic debridement (AD) in patients with symptomatic full thickness knee cartilage injuries less than 2cm2.
Focal cartilage injuries in the knee might have devastating effect both in the short term and in the long term. Various surgical treatment options are available, with microfracture the most used technique globally. Meta-analysis and systematic reviews have required well-designed, long-term, multicenter studies to evaluate clinical outcomes of microfracture with the use of a "no treatment" group as a control group.
H0: There is no difference in KOOS QoL after AM or AD 24 months after surgery. H1: There is a difference in KOOS QoL after AM or AD 24 months after surgery.
Questionnaires: KOOS, Tegner score, Lysholm score, EQ-5D, VAS. Physical examination: range of motion and hop test. Radiology: x-ray and MRI of the knee.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single symptomatic lesion of the trochlea, medial or lateral femoral condyle of the knee less than 2 cm2
- •Cartilage lesion ICRS grade 3 or 4
- •More than 50 % of the menisci intact
- •Ligamentous stable knee
- •Lysholm Score < 75
- •Acceptable range of motion (5-105 degrees)
排除标准
- •Osteoarthritis
- •Malalignment > 5 degrees measured clinically, and if uncertainty on HKA radiographs
- •Systemic arthritis
- •Previous cartilage surgery except OCD fixation
- •Obesity BMI > 30
- •Serious drig or alcohol abuse
- •Inability to answer questionnaires or partake in rehabilitation
- •Comorbidity that may influence surgery or rehabilitation
- •Pregnancy
结局指标
主要结局
Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life
时间窗: 24 months follow up
The KOOS is a validated patient oriented outcome measure validated to use in cartilage Research. It assesses five domains, and the Fifth domain (knee related quality of life) will be the primary endpoint in this study. The primary aim is where the primary aim is the difference in KOOS QoL subscore in the AM group compared to the AD group at 24 months follow up. It is not planned any interim analysis before 24 months follow up.
次要结局
- EQ5D(24 months follow up)
- Magnetic Resonance Imaging (MRI) of the cartilage defect(24 months follow up)
- The Knee Injury and Osteoarthritis Outcome Score (KOOS) Other domains(24 months follow up)
- Tegner Score(24 months follow up)
- Lysholm Knee Score(24 months follow up)
- Visual Analog Scale(24 months follow up)
- Range of motion(24 months follow up)
- A Hop test(24 months follow up)
研究者
Asbjorn Aroen
Professor
University Hospital, Akershus