Study Stopped
Manufacturing stopped
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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2008
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 23, 2009
CompletedFirst Posted
Study publicly available on registry
July 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedApril 28, 2015
April 1, 2015
3.8 years
July 23, 2009
April 25, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical evaluation scoring system: IKDC
18 months
Study Arms (2)
Autologous Chondrocytes Implantation
EXPERIMENTALMicrofracture
ACTIVE COMPARATORInterventions
Cartilage is harvested and treated for chondrocytes isolation and culture. After multiplication, the chondrocytes are transferred into a biomaterial support and surgically implanted.
Tiny fractures are created at the cartilage surface to stimulate cartilage growth.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gent University Hospital, Dept of Orthopaedic Surgery
Ghent, 9000, Belgium
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2009
First Posted
July 24, 2009
Study Start
October 1, 2008
Primary Completion
July 1, 2012
Study Completion
September 1, 2014
Last Updated
April 28, 2015
Record last verified: 2015-04