Comparison of Microfracture Treatment and CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions

Phase 3

Terminated

• Conditions: Knee Chondral; Osteochondral Defect
• Interventions: Procedure: CARTIPATCH® procedure; Procedure: Microfracture

• Registration Number: NCT00945399
• Lead Sponsor: TBF Genie Tissulaire

Brief Summary

CARTIPATCH® is an Autologous Chondrocyte Implantation product including functional cells in a matrix, indicated for the treatment of isolated osteocartilaginous lesions. The submitted protocol is a Phase III multicentric, prospective, controlled and randomized clinical trial, sponsored by TBF Génie Tissulaire, France. The main objective of the protocol is to compare the clinical improvement of the IKDC subjective score between the microfracture-treated group and the CARTIPATCH® chondrocyte graft-treated group , 18 months following surgery. Several secondary objectives were determined. The microfracture procedure will be conducted in one operative step, during arthroscopy and CARTIPATCH® procedure will be conducted in two operative steps:

1. Arthroscopy to collect cartilage;

2. Implantation following arthrotomy about 6 weeks following arthroscopy.

Both groups will follow the same rehabilitation program.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-07-23
• Study First Submitted QC: 2009-07-23
• Study First Posted: 2009-07-24
• Primary Completion: 2012-07
• Study Completion: 2014-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-25
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• isolated femoral osteochondral lesion
• aged 18 to 45
• grade 3 or 4 lesion (ICRS) sized 2,5 to 7,5cm2
• lesion depth under 10mm
• IKDC score below 55
• no prior surgical treatment

Exclusion Criteria

• pregnancy or breastfeeding
• allergy
• arthrosis
• varus or valgus angle greater than 6°
• kissing lesion
• affection of the patella
• excessive laxity
• meniscal pathology history
• severe chronic disease
• BMI > 30
• HIV, Hepatitis B, C, HTLV, Syphilis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autologous Chondrocytes Implantation	CARTIPATCH® procedure	-
Microfracture	Microfracture	-

Primary Outcome Measures

Name	Time	Method
Clinical evaluation scoring system: IKDC	18 months

Trial Locations

Locations (1)

Gent University Hospital, Dept of Orthopaedic Surgery; 🇧🇪 Gent, Belgium