Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
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: October 29, 2014
Last verified: October 2014

October 17, 2011
October 29, 2014
October 2011
October 2014   (final data collection date for primary outcome measure)
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
How long the treatment has been useful for the patient. Form: KOOS [ Time Frame: 1yr, 2 yrs, 5 yrs and 10 yrs ] [ Designated as safety issue: No ]
KOOS and Lysholm score are used for clinical outcomes Kellgren Lawrence for OA
Complete list of historical versions of study NCT01458782 on ClinicalTrials.gov Archive Site
  • 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.
Time to failure [ Time Frame: Up to 10 yrs ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Osteochondritis Dissecans
  • Osteoarthritis
  • Cartilage Injury
  • Osteonecrosis
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: 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.
    Intervention: Procedure: Treatment of cartilage defects in the knee
  • 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

    Intervention: Procedure: Treatment of cartilage defects in the knee

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
October 2024
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01458782
2011/1159-3
No
University Hospital of North Norway
University Hospital of North Norway
University of Tromso
Principal Investigator: Gunnar Knutsen, MD, PhD University Hospital of North Norway
University Hospital of North Norway
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP