A Randomized Trial Comparing Autologous Chondrocyte Implantation Using Collagen Membrane (ACI-C) Versus (Autologous Matrix Induced Chondrogenesis) AMIC for Repair of Cartilage Defects in the Knee
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Comparison Between the Two Groups of Mean Change From Baseline in Knee Injury and Osteoarthritis Outcome Score Total (KOOS) at Two Years.
研究概览
简要总结
ACI-C versus AMIC: A controlled randomized trial comparing Autologous Chondrocyte Implantation ( ACI) and Autologous Matrix Induced Chondrogenesis (AMIC) for repair of cartilage defects in the knee.
Eighty patients (Forty in each group) having symptomatic cartilage defects in their knee are planned to include in this study.
Both techniques will use the ChondroGide membrane from Geistlich to cover the defects. ACI includes an arthroscopy to harvest cartilage for cell cultivation in our lab located in Tromso. 3-4 weeks later using a mini arthrotomy the cells will be implanted under the ChondroGide membrane.
The AMIC group will be listed for a mini arthrotomy, cleaning of the defect, microfracture and cover of the defect using the same ChondroGide membrane.
In both groups stitches and fibrin glue will be used to fix the membrane.
Inclusion criteria:
Age between 18-60, Informed consent signed by patient, Symptomatic cartilage defect. Size more than 2 square cm.
Exclusion criteria Alcohol or drug abuse during the last three years, Inflammatory joint disease, Serious illness
Preoperative examination and follow up: Clinical examination and registration of KOOS (a validated knee score), VAS (visual analog pain scale) and Lysholm knee score. Radiographs of the involved knee including weightbearing standing radiographs of both knees. Kellgren- Lawrence classification will be used for grading of OA.
Patients will be checked after 1, 2, 5 and 10 years following surgery. Symptomatic patients having a new cartilage resurfacing operation or prosthesis will be listed as failures of the initial treatment.
Hypothesis: AMIC will be equal to ACI, and if that is the case this would be a benefit for the patients and the society. AMIC is much cheaper compared to ACI (needing an expensive cell cultivation and two surgeries).
Data will be analyzed using the SPSS statistical package.
详细描述
Please see referenced articles (1-3) for details regarding ACI and AMIC
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18-60 yrs
- •informed consent signed by patient
- •symptomatic cartilage defect in the knee > 2 square cm
排除标准
- •alcohol or drug abuse during the last three yrs
- •inflammatory joint disease
- •serious illness
研究组 & 干预措施
ACI-C
Autologous chondrocyte implantation using collagen membrane (ChondroGide) Please see reference 1 and 2 for details regarding ACI. In this study we are using the collagen membrane instead of periosteum- the other details are exactly the same as in our previous RCT.
干预措施: Treatment of cartilage defects in the knee (Procedure)
AMIC
Autologous matrix induced chondrogenesis. Microfracture of the defect and covering using the collagen membrane (ChondroGide).
Please see reference 3 for details regarding AMIC
干预措施: Treatment of cartilage defects in the knee (Procedure)
结局指标
主要结局
Comparison Between the Two Groups of Mean Change From Baseline in Knee Injury and Osteoarthritis Outcome Score Total (KOOS) at Two Years.
时间窗: 2-years follow-up.
KOOS is a knee-specific instrument, developed to assess the patients opinion about their knee and associated problems. It holds 42 items in 5 sub-scales (pain, other symptoms, function in daily living, function in sport and recreation and knee-related quality of life). The questionnaire yields a total score ranging from 0-100. A higher score indicates better knee function. The reported number is the mean change in KOOS total score from baseline after two years for each group. A positive number represents an improved knee function score.
Comparison Between the Two Groups of Mean Change From Baseline in Knee Injury and Osteoarthritis Outcome Score Total (KOOS) at Five Years.
时间窗: 5-years follow-up
KOOS is a knee-specific instrument, developed to assess the patients opinion about their knee and associated problems. It holds 42 items in 5 sub-scales (pain, other symptoms, function in daily living, function in sport and recreation and knee-related quality of life). The questionnaire yields a total score ranging from 0-100. A higher score indicates better knee function. The reported number is the mean change in KOOS total score from baseline after two years for each group. A positive number represents an improved knee function score.
次要结局
- Comparison Between the Two Groups of Mean Change From Baseline in a Visual Analogue Scale (VAS) Pain Score at Two Years.(2-years follow-up.)
- Comparison Between the Two Groups of Mean Change From Baseline in Lysholm Score at Two Years.(2-years follow-up.)
- Failure(5-years follow-up)
- Comparison Between the Two Groups of Mean Change From Baseline in Lysholm Score at Five Years.(Five-year follow-up)
- Comparison Between the Two Groups of Mean Change From Baseline in a Visual Analogue Scale (VAS) Pain Score at Five Years(Five-years follow-up.)
- Kellgren-Lawrence Baseline vs 5-years in Each Group(5-year follow-up)
- Failure(2-years follow-up)