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

Osteochondral Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00945399
• Other study ID #: 2007-003481-18
• Status: Terminated
• Phase: Phase 3
• First received: July 23, 2009
• Last updated: April 25, 2015
• Start date: October 2008
• Est. completion date: September 2014

Study information

• Verified date: April 2015
• Source: TBF Genie Tissulaire
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsNorway: Norwegian Medicines AgencyIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: September 2014
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Chondral
• Osteochondral Defect

Intervention

Procedure:
• CARTIPATCH® procedure
Cartilage is harvested and treated for chondrocytes isolation and culture. After multiplication, the chondrocytes are transferred into a biomaterial support and surgically implanted.
• Microfracture
Tiny fractures are created at the cartilage surface to stimulate cartilage growth.

Locations

Country	Name	City	State
Belgium	Gent University Hospital, Dept of Orthopaedic Surgery	Gent

Sponsors (1)

Lead Sponsor	Collaborator
TBF Genie Tissulaire

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical evaluation scoring system: IKDC		18 months	No