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

Primary Purpose

Knee Chondral, Osteochondral Defect

Status
Terminated
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
CARTIPATCH® procedure
Microfracture
Sponsored by
TBF Genie Tissulaire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Chondral

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Gent University Hospital, Dept of Orthopaedic Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Autologous Chondrocytes Implantation

Microfracture

Arm Description

Outcomes

Primary Outcome Measures

Clinical evaluation scoring system: IKDC

Secondary Outcome Measures

Full Information

First Posted
July 23, 2009
Last Updated
April 25, 2015
Sponsor
TBF Genie Tissulaire
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1. Study Identification

Unique Protocol Identification Number
NCT00945399
Brief Title
Comparison of Microfracture Treatment and CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions
Official Title
Phase III Protocol Comparing a Microfracture Treatment to a CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
Manufacturing stopped
Study Start Date
October 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TBF Genie Tissulaire

4. Oversight

5. Study Description

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: Arthroscopy to collect cartilage; Implantation following arthrotomy about 6 weeks following arthroscopy. Both groups will follow the same rehabilitation program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Chondral, Osteochondral Defect

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous Chondrocytes Implantation
Arm Type
Experimental
Arm Title
Microfracture
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
CARTIPATCH® procedure
Intervention Description
Cartilage is harvested and treated for chondrocytes isolation and culture. After multiplication, the chondrocytes are transferred into a biomaterial support and surgically implanted.
Intervention Type
Procedure
Intervention Name(s)
Microfracture
Intervention Description
Tiny fractures are created at the cartilage surface to stimulate cartilage growth.
Primary Outcome Measure Information:
Title
Clinical evaluation scoring system: IKDC
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Gent University Hospital, Dept of Orthopaedic Surgery
City
Gent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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