Osteoarthritis Clinical Trial
Official title:
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
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.
Please see referenced articles (1-3) for details regarding ACI and AMIC ;
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