Knee Chondral or Osteochondral Defect
Conditions
Keywords
knee, chondral defect, osteochondral defect
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.
Interventions
PROCEDUREAutologous chondrocytes transplantation
Cartilage was harvested, then transferred for cell isolation and culture. Cells are suspended in agarose and transferred to cylindrical molds and surgically implanted 4 weeks later.
PROCEDUREMosaicoplasty
Osteochondral patch are sampled and then implanted during the same surgical procedure
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
University Hospital, Brest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical evaluation scoring system | IKDC |
Secondary
| Measure | Time frame |
|---|---|
| Arthroscopy with biopsy | at 2 years |
| MRI | at 2 years |
Countries
France
Outcome results
None listed