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

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ClinicalTrials.gov Identifier: NCT01458782
Recruitment Status : Active, not recruiting
First Posted : October 25, 2011
Last Update Posted : February 19, 2019
Sponsor:
Collaborator:
University of Tromso
Information provided by (Responsible Party):
University Hospital of North Norway

Tracking Information
First Submitted Date  ICMJE October 17, 2011
First Posted Date  ICMJE October 25, 2011
Last Update Posted Date February 19, 2019
Study Start Date  ICMJE October 2011
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2012)
Perceived treatment efficacy as change from baseline in KOOS score [ Time Frame: up to 10 years post-treatment ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 24, 2011)
How long the treatment has been useful for the patient. Form: KOOS [ Time Frame: 1yr, 2 yrs, 5 yrs and 10 yrs ]
KOOS and Lysholm score are used for clinical outcomes Kellgren Lawrence for OA
Change History Complete list of historical versions of study NCT01458782 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2012)
  • Change from baseline in radiological signs of arthritis progression [ Time Frame: up to 10 years post-treatment ]
    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 ]
    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 ]
    The number of months to clinically evident treatment failure defined as deterioration in either KOOS, Kellgren Larence or Lysholm score.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2011)
Time to failure [ Time Frame: Up to 10 yrs ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ACI-C Versus AMIC. A Randomized Trial Comparing Two Methods for Repair of Cartilage Defects in the Knee
Official Title  ICMJE 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
Brief 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
RCT, Two arms ACI-C and AMIC
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteochondritis Dissecans
  • Osteoarthritis
  • Cartilage Injury
  • Osteonecrosis
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 24, 2011)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2024
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01458782
Other Study ID Numbers  ICMJE 2011/1159-3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital of North Norway
Study Sponsor  ICMJE University Hospital of North Norway
Collaborators  ICMJE University of Tromso
Investigators  ICMJE
Principal Investigator: Gunnar Knutsen, MD, PhD University Hospital of North Norway
PRS Account University Hospital of North Norway
Verification Date February 2019

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