ACI-C Versus AMIC. A Randomized Trial Comparing Two Methods for Repair of Cartilage Defects in the Knee

Study Overview
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Brief Summary
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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.

Detailed Description
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Please see referenced articles (1-3) for details regarding ACI and AMIC

Official Title
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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

Conditions
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Osteochondritis Dissecans, Osteoarthritis, Cartilage Injury, Osteonecrosis

Intervention / Treatment
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* Procedure: Treatment of cartilage defects in the knee


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18-60 yrs informed consent signed by patient symptomatic cartilage defect in the knee > 2 square cm Exclusion Criteria: alcohol or drug abuse during the last three yrs inflammatory joint disease serious illness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT, Two arms ACI-C and AMIC
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ACI-C<br>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. | Procedure: Treatment of cartilage defects in the knee<br>* Two groups, either ACI or AMIC. ACI includes an arthroscopy for harvesting of cartilage 3-4 weeks prior to the open cartilage surgery. AMIC includes only open surgery at one setting.<br>* Other names: Autologous matrix induced chondrogenesis;|
| Active Comparator: AMIC<br>Autologous matrix induced chondrogenesis. Microfracture of the defect and covering using the collagen membrane (ChondroGide). Please see reference 3 for details regarding AMIC | Procedure: Treatment of cartilage defects in the knee<br>* Two groups, either ACI or AMIC. ACI includes an arthroscopy for harvesting of cartilage 3-4 weeks prior to the open cartilage surgery. AMIC includes only open surgery at one setting.<br>* Other names: Autologous matrix induced chondrogenesis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived treatment efficacy as change from baseline in KOOS score | Perceived treatment effectiveness will be assessed on the basis of self-administered KOOS questionnaire. The questionnaire data will be collected at 1, 2, 5 and 10 years post-treatment | up to 10 years post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in radiological signs of arthritis progression | Kellgren Larence grading system will be used for classification of osteoarthritis at baseline and 1, 2, 5 and 10 years post-treatment | up to 10 years post-treatment | 
| Perceived treatment efficacy as change from baseline in Lysholm score | Perceived treatment effectiveness with respect to clinical outcome will be assessed on the basis of self-administered Lysholm questionnaire. The questionnaire data will be collected at 1, 2, 5 and 10 years post-treatment. | up to 10 years | 
| Time to failure | The number of months to clinically evident treatment failure defined as deterioration in either KOOS, Kellgren Larence or Lysholm score. | Up to 10 yrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cartilage repair, Chondrocytes, Stemcells