Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty: a Randomized Trial (Cartipatch)

Regional University Hospital Center (CHRU)

Status and phase: Completed; Phase 3

Conditions: Knee Chondral or Osteochondral Defect

Treatments: Procedure: Autologous chondrocytes transplantation; Procedure: Mosaicoplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT00560664

BB-01-C-01-OT

RB 06.031

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

1

Experimental group

Description:

Autologous chondrocytes transplantation

Treatment:

Procedure: Autologous chondrocytes transplantation

2

Active Comparator group

Description:

Mosaicoplasty

Treatment:

Procedure: Mosaicoplasty