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A Randomized Trial Comparing ACI-C Versus AMIC for Repair of Cartilage Defects in the Knee
This study is currently Recruiting
November 2011 By University Hospital of North Norway
First Recieved on October 17, 2011
Last Updated on November 1, 2011
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
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.
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
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.
||Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
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.
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|
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.
|Ages Eligible for Study:||18 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- age between 18-60 yrs
- informed consent signed by patient
- symptomatic cartilage defect in the knee > 2 square cm
- alcohol or drug abuse during the last three yrs
- inflammatory joint disease
- serious illness
- Investigator: Gunnar Knutsen, MD, PhD - Principal Investigator - University Hospital of North Norway