Focal Cartilage Defects in the Knee -A Randomized Controlled Trial Comparing Autologous Chondrocyte Implantation With Arthroscopic Debridement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- The Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life
研究概览
简要总结
82 patients aged 18-49 years with an isolated focal cartilage defect in the knee will be randomized to either receive autologous cartilage implantation 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 (European Quality of Life 5 dimensions) as well as clinical examination and radiological findings at 2 years (MRI).
详细描述
Details Focal cartilage defects in the knee - A randomized controlled trial comparing Autologous Chondrocyte Implantation with arthroscopic debridement Clinical Compare the effect of Autologous Chondrocyte Implantation (ACI) with arthroscopic debridement (AD) in patients with symptomatic full thickness knee cartilage injuries larger 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 ACI established as a recognized treatment method for larger lesions. Meta-analysis and systematic reviews have required well-designed, long-term, multicenter studies to evaluate clinical outcomes of ACI with the use of a "no treatment" group as a control group.
H0: There is no difference in KOOS QoL after ACI or AD from baseline to 24 months after surgery.
H1: There is a difference in KOOS QoL after ACI or AD from baseline to 24 months after surgery.
Questionnaires: KOOS, Tegner score, Lysholm score, EQ-5D, VAS (Visual analogue scale).
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 49 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 larger than 2 cm
- •Cartilage lesion ICRS grade 3 or
- •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 on HKA (hip-knee-ankle) radiographs
- •Systemic arthritis
- •Previous cartilage surgery
- •Obesity BMI > 30
- •Serious drig or alcohol abuse
- •Inability to answer questionnaires or partake in rehabilitation
- •Comorbidity that may influence surgery or rehabilitation
研究组 & 干预措施
Autologous Chondrocyte Implantation
A diagnostic arthroscopy of the knee joint.The lesion is stabilized down to the subchondral bone, but not through it. Cartilage biopsy is taken from the medial femoral notch. The harvested cartilage is transported to the cell culture Laboratory and cultured for two weeks. The chondrocyte implantation: A mini-open arthrotomy is performed and the lesion is curetted down to subchondral bone, avoiding bleeding. The lesion is measured and a template of sterile aluminum foil is used to cut out a matching piece of collagen sheet which is used to contain the cells in the defect. The flap is sutured to the lesion and sealed with fibrin glue, leaving and opening at the upper part for injection of the cells. The last opening is then closed with a last stitch and fibrin glue.
干预措施: Autologous Chondrocyte Implantation (Procedure)
Arthroscopic Debridement
The AD group will be subjected to a diagnostic arthroscopy with a full inspection of the knee joint to ensure the inclusion criteria are fulfilled. Lose bodies are removed, any meniscal pathology is addressed. Inflamed synovium is debrided. The lesion is stabilized by debridement around the edges and down to the subchondral bone using a ring curette, but not through it. Microfracture or any other cartilage treatment will not be performed.
No intra-articular local anesthetics will be used due to the possible harmful effect on cartilage [41-43].
All the operating surgeons will receive proper training in the operative procedure before study start.
干预措施: Arthroscopic Debridement (Procedure)
结局指标
主要结局
The Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life
时间窗: up to 24 months
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.
次要结局
- Visual Analogue Scale(preop, 3, 6, 12 and 24 months.)
- Range of motion(preop, 3, 6, 12 and 24 months.)
- Magnetic Resonance Imaging(24 months)
- A Hop test(24 months)
- The Knee Injury and Osteoarthritis Outcome Score (KOOS) Other domains(preop, 3, 6, 12 and 24 months.)
- Tegner Score(preop, 3, 6, 12 and 24 months.)
- Lysholm Knee Score(preop, 3, 6, 12 and 24 months.)
- EQ5D(preop, 3, 6, 12 and 24 months.)
研究者
Asbjorn Aroen
Professor
University Hospital, Akershus