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

TBF Genie Tissulaire

Status and phase: Terminated; Phase 3

Conditions: Osteochondral Defect; Knee Chondral

Treatments: Procedure: Microfracture; Procedure: CARTIPATCH® procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT00945399

2007-003481-18

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Autologous Chondrocytes Implantation

Experimental group

Treatment:

Procedure: CARTIPATCH® procedure

Microfracture

Active Comparator group

Treatment:

Procedure: Microfracture