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

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:

Genetics Home Reference related topics: familial osteochondritis dissecans

MedlinePlus related topics: Osteoarthritis Osteonecrosis

U.S. FDA Resources

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

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:

Knutsen G, Drogset JO, Engebretsen L, Grøntvedt T, Isaksen V, Ludvigsen TC, Roberts S, Solheim E, Strand T, Johansen O. A randomized trial comparing autologous chondrocyte implantation with microfracture. Findings at five years. J Bone Joint Surg Am. 2007 Oct;89(10):2105-12.

Knutsen G, Engebretsen L, Ludvigsen TC, Drogset JO, Grontvedt T, Solheim E, Strand T, Roberts S, Isaksen V, Johansen O. Autologous chondrocyte implantation compared with microfracture in the knee. A randomized trial. J Bone Joint Surg Am. 2004 Mar;86-A(3):455-64.

Benthien JP, Behrens P. The treatment of chondral and osteochondral defects of the knee with autologous matrix-induced chondrogenesis (AMIC): method description and recent developments. Knee Surg Sports Traumatol Arthrosc. 2011 Aug;19(8):1316-9. Epub 2011 Jan 14.

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:	November 8, 2012
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:

Osteochondritis Dissecans
Osteoarthritis
Osteochondritis
Osteonecrosis
Arthritis
Joint Diseases
Musculoskeletal Diseases

Rheumatic Diseases
Bone Diseases
Cartilage Diseases
Connective Tissue Diseases
Necrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013