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

Phase III Protocol Comparing a Microfracture Treatment to a CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00945399

Enrollment

Registered

2009-07-24

Start date

2008-10-31

Completion date

2014-09-30

Last updated

2015-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Chondral, Osteochondral Defect

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.

Interventions

PROCEDURECARTIPATCH® procedure

Cartilage is harvested and treated for chondrocytes isolation and culture. After multiplication, the chondrocytes are transferred into a biomaterial support and surgically implanted.

PROCEDUREMicrofracture

Tiny fractures are created at the cartilage surface to stimulate cartilage growth.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
Clinical evaluation scoring system: IKDC	18 months

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026