ACI-C Versus AMIC. A Randomized Trial Comparing Two Methods for Repair of Cartilage Defects in the Knee
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| First Received Date ICMJE | October 17, 2011 | ||||||||
| Last Updated Date | November 8, 2012 | ||||||||
| Start Date ICMJE | October 2011 | ||||||||
| Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE |
How long the treatment has been useful for the patient. Form: KOOS [ Time Frame: 1yr, 2 yrs, 5 yrs and 10 yrs ] [ Designated as safety issue: No ] KOOS and Lysholm score are used for clinical outcomes Kellgren Lawrence for OA |
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| Change History | Complete list of historical versions of study NCT01458782 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Time to failure [ Time Frame: Up to 10 yrs ] [ Designated as safety issue: No ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | 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. |
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| Detailed Description | Please see referenced articles (1-3) for details regarding ACI and AMIC |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| 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.
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 80 | ||||||||
| Estimated Completion Date | October 2024 | ||||||||
| Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Norway | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01458782 | ||||||||
| Other Study ID Numbers ICMJE | 2011/1159-3 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | University Hospital of North Norway | ||||||||
| Study Sponsor ICMJE | University Hospital of North Norway | ||||||||
| Collaborators ICMJE | University of Tromso | ||||||||
| Investigators ICMJE |
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| Information Provided By | University Hospital of North Norway | ||||||||
| Verification Date | October 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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