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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Knee Chondral Osteochondral Defect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Autologous Chondrocytes Implantation

Group Type EXPERIMENTAL

CARTIPATCH® procedure

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Microfracture

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Microfracture

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No