Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty: a Randomized Trial

Phase 3

Completed

• Conditions: Knee Chondral or Osteochondral Defect

• Registration Number: NCT00560664
• Lead Sponsor: University Hospital, Brest

Brief Summary

Numerous surgical techniques have been developped for the treatment of chondral and osteochondral defects of the knee. Among those techniques autologous chondrocyte transplantation (ACT) was promising but have potential drawbacks. A novel development by TBF is available. The aim of this randomized trial is to compared this new ACT technique to mosaicoplasty. Final outcomes were measured at 2 years using clinical evaluation scoring system (International Knee Documentation Committee), MRI and arthroscopy with biopsy. 64 patients are needed to detect a mean IKDC difference of at least 15 points with 90% power at a 5% alpha level. Twelve surgical centers in France are involved.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-11-19
• Study First Submitted QC: 2007-11-19
• Study First Posted: 2007-11-20
• Primary Completion: 2012-10
• Study Completion: 2013-08
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-30
• Last Update Posted: 2014-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• isolated femoral osteochondral lesion
• aged 18 to 50
• grade 3 or 4 lesion (ICRS) sized 2,5 cm2 to 7,5 cm2.
• IKDC score below 55

Exclusion Criteria

• pregnancy
• allergy
• arthrosis
• varus or valgus angle greater than 10°
• ACL laxity
• Severe chronic disease
• BMI > 30 Kg/m2
• HIV, B or C Hepatitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical evaluation scoring system	IKDC

Secondary Outcome Measures

Name	Time	Method
MRI	at 2 years
Arthroscopy with biopsy	at 2 years

Trial Locations

Locations (12)

Orthopaedic surgery Departement Brest University Hospital; 🇫🇷 Brest, France

CHU de Caen; 🇫🇷 Caen, France

Centre médico chirurgical de Dracy-Le-Fort; 🇫🇷 Dracy-Le-Fort, France

CHU de Grenoble; 🇫🇷 Grenoble, France

Ch Versailles; 🇫🇷 Le Chesnay, France

Clinique Chenieux; 🇫🇷 Limoges, France

CHU de Lyon; 🇫🇷 Lyon, France

CH Nord Mayenne; 🇫🇷 Mayenne, France

CHU de Nancy; 🇫🇷 Nancy, France

HIA Bégin; 🇫🇷 Saint Mandé, France

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