Osteoarthritis Clinical Trial
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
Verified date | February 2019 |
Source | University Hospital of North Norway |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | October 2024 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Norway | University Hospital of North Norway | Tromso | Troms |
Lead Sponsor | Collaborator |
---|---|
University Hospital of North Norway | University of Tromso |
Norway,
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. doi: 10.1007/s00167-010-1356-1. Epub 2011 Jan 14. — View Citation
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. — View Citation
Knutsen G, Engebretsen L, Ludvigsen TC, Drogset JO, Grøntvedt 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Perceived treatment efficacy as change from baseline in KOOS score | 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 | up to 10 years post-treatment | |
Secondary | Change from baseline in radiological signs of arthritis progression | Kellgren Larence grading system will be used for classification of osteoarthritis at baseline and 1, 2, 5 and 10 years post-treatment | up to 10 years post-treatment | |
Secondary | Perceived treatment efficacy as change from baseline in Lysholm score | 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. | up to 10 years | |
Secondary | Time to failure | The number of months to clinically evident treatment failure defined as deterioration in either KOOS, Kellgren Larence or Lysholm score. | Up to 10 yrs |
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