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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01458782
Other study ID # 2011/1159-3
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 2011
Est. completion date October 2024

Study information

Verified date February 2019
Source University Hospital of North Norway
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

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

Study Design


Intervention

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.

Locations

Country Name City State
Norway University Hospital of North Norway Tromso Troms

Sponsors (2)

Lead Sponsor Collaborator
University Hospital of North Norway University of Tromso

Country where clinical trial is conducted

Norway, 

References & Publications (3)

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

Outcome

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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