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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 : October 28, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


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

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2011
Primary Completion Date : October 2014
Estimated Study Completion Date : October 2024


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01458782


Locations
Norway
University Hospital of North Norway
Tromso, Troms, Norway, 9016
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
First Posted: October 25, 2011    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016

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

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