NCT01458782

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: University Hospital of North Norway · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Osteochondritis Dissecans
• Osteoarthritis
• Cartilage Injury
• Osteonecrosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-10-01
• Primary completion: 2016-12-15
• Completion: 2025-12-30
• First posted: 2011-10-25
• Last updated: 2025-02-17
• Results posted: 2025-02-17

Locations

1 site across 1 country: Norway