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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by TBF Genie Tissulaire.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
TBF Genie Tissulaire
ClinicalTrials.gov Identifier:
NCT00945399
First received: July 23, 2009
Last updated: October 21, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Knee Chondral
Osteochondral Defect
Procedure: autologous chondrocyte implantation (CARTIPATCH® procedure)
Procedure: Microfracture
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Protocol Comparing a Microfracture Treatment to a CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions

Further study details as provided by TBF Genie Tissulaire:

Primary Outcome Measures:
  • Clinical evaluation scoring system: IKDC [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: October 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous Chondrocytes Implantation Procedure: autologous chondrocyte implantation (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.
Active Comparator: Microfracture Procedure: Microfracture
Tiny fractures are created at the cartilage surface to stimulate cartilage growth.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00945399

Contacts
Contact: Laurence BARNOUIN 33 (0)4 72 68 69 01 laurence.barnouin@tbf-lab.com

Locations
Belgium
Gent University Hospital, Dept of Orthopaedic Surgery Recruiting
Gent, Belgium, 9000
Contact: Fredrik ALMQVIST       fredrik.almqvist@UGent.be   
Principal Investigator: Fredrik ALMQVIST         
Sponsors and Collaborators
TBF Genie Tissulaire
  More Information

No publications provided

Responsible Party: Dr. Laurence Barnouin, General Manager, TBF génie Tissulaire
ClinicalTrials.gov Identifier: NCT00945399     History of Changes
Other Study ID Numbers: 2007-003481-18
Study First Received: July 23, 2009
Last Updated: October 21, 2010
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Norway: Norwegian Medicines Agency
Israel: Ministry of Health

Additional relevant MeSH terms:
Osteochondrosis
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014