Overview

This trial is active, not recruiting.

Conditions osteochondritis dissecans, osteoarthritis, cartilage injury, osteonecrosis
Treatment treatment of cartilage defects in the knee
Phase phase 2/phase 3
Sponsor University Hospital of North Norway
Collaborator University of Tromso
Start date October 2011
End date October 2014
Trial size 80 participants
Trial identifier NCT01458782, 2011/1159-3

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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.
treatment of cartilage defects in the knee Autologous chondrocyte implantation
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.
(Active Comparator)
Autologous matrix induced chondrogenesis. Microfracture of the defect and covering using the collagen membrane (ChondroGide). Please see reference 3 for details regarding AMIC
treatment of cartilage defects in the knee Autologous chondrocyte implantation
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.

Primary Outcomes

Measure
Perceived treatment efficacy as change from baseline in KOOS score
time frame: up to 10 years post-treatment

Secondary Outcomes

Measure
Change from baseline in radiological signs of arthritis progression
time frame: up to 10 years post-treatment
Perceived treatment efficacy as change from baseline in Lysholm score
time frame: up to 10 years
Time to failure
time frame: Up to 10 yrs

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

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
Principal investigator Gunnar Knutsen, MD, PhD
Description Please see referenced articles (1-3) for details regarding ACI and AMIC
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University Hospital of North Norway.