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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University Hospital of North Norway
Sponsor:
Collaborator:
University of Tromso
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT01458782
First received: October 17, 2011
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Osteochondritis Dissecans
Osteoarthritis
Cartilage Injury
Osteonecrosis
Procedure: Treatment of cartilage defects in the knee
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Perceived treatment efficacy as change from baseline in KOOS score [ Time Frame: up to 10 years post-treatment ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Change from baseline in radiological signs of arthritis progression [ Time Frame: up to 10 years post-treatment ] [ Designated as safety issue: No ]
    Kellgren Larence grading system will be used for classification of osteoarthritis at baseline and 1, 2, 5 and 10 years post-treatment

  • Perceived treatment efficacy as change from baseline in Lysholm score [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
    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.

  • Time to failure [ Time Frame: Up to 10 yrs ] [ Designated as safety issue: No ]
    The number of months to clinically evident treatment failure defined as deterioration in either KOOS, Kellgren Larence or Lysholm score.


Estimated Enrollment: 80
Study Start Date: October 2011
Estimated Study Completion Date: October 2024
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ACI-C
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
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.
Other Names:
  • Autologous chondrocyte implantation
  • Autologous matrix induced chondrogenesis
Active Comparator: AMIC

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.
Other Names:
  • Autologous chondrocyte implantation
  • Autologous matrix induced chondrogenesis

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01458782

Contacts
Contact: Gunnar Knutsen, MD, PhD +4791860584 gunnar.knutsen@unn.no
Contact: Vegard Fossum, MD +477762600 vegard.fossum@unn.no

Locations
Norway
University Hospital of North Norway Recruiting
Tromso, Troms, Norway, 9016
Sub-Investigator: Vegard Fossum, MD         
Sub-Investigator: Anders Stahl, MD         
Sponsors and Collaborators
University Hospital of North Norway
University of Tromso
Investigators
Principal Investigator: Gunnar Knutsen, MD, PhD University Hospital of North Norway
  More Information

Publications:
Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT01458782     History of Changes
Other Study ID Numbers: 2011/1159-3
Study First Received: October 17, 2011
Last Updated: June 10, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Data Protection Authority

Keywords provided by University Hospital of North Norway:
Cartilage repair
Chondrocytes
Stemcells

Additional relevant MeSH terms:
Cartilage Diseases
Osteoarthritis
Osteonecrosis
Osteochondritis
Osteochondritis Dissecans
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Bone Diseases
Necrosis
Pathologic Processes
Connective Tissue Diseases

ClinicalTrials.gov processed this record on September 16, 2014