Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty: a Randomized Trial

NCT ID: NCT00560664

Last Updated: 2025-12-03

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2013-08-31

Brief Summary

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Numerous surgical techniques have been developped for the treatment of chondral and osteochondral defects of the knee. Among those techniques autologous chondrocyte transplantation (ACT) was promising but have potential drawbacks. A novel development by TBF is available. The aim of this randomized trial is to compared this new ACT technique to mosaicoplasty. Final outcomes were measured at 2 years using clinical evaluation scoring system (International Knee Documentation Committee), MRI and arthroscopy with biopsy. 64 patients are needed to detect a mean IKDC difference of at least 15 points with 90% power at a 5% alpha level. Twelve surgical centers in France are involved.

Detailed Description

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Conditions

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Knee Chondral or 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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1

Autologous chondrocytes transplantation

Group Type EXPERIMENTAL

Autologous chondrocytes transplantation

Intervention Type PROCEDURE

Cartilage was harvested, then transferred for cell isolation and culture. Cells are suspended in agarose and transferred to cylindrical molds and surgically implanted 4 weeks later.

2

Mosaicoplasty

Group Type ACTIVE_COMPARATOR

Mosaicoplasty

Intervention Type PROCEDURE

Osteochondral patch are sampled and then implanted during the same surgical procedure

Interventions

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Autologous chondrocytes transplantation

Cartilage was harvested, then transferred for cell isolation and culture. Cells are suspended in agarose and transferred to cylindrical molds and surgically implanted 4 weeks later.

Intervention Type PROCEDURE

Mosaicoplasty

Osteochondral patch are sampled and then implanted during the same surgical procedure

Intervention Type PROCEDURE

Other Intervention Names

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Tissue Bank France

Eligibility Criteria

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Inclusion Criteria

* isolated femoral osteochondral lesion
* aged 18 to 50
* grade 3 or 4 lesion (ICRS) sized 2,5 cm2 to 7,5 cm2.
* IKDC score below 55

Exclusion Criteria

* pregnancy
* allergy
* arthrosis
* varus or valgus angle greater than 10°
* ACL laxity
* Severe chronic disease
* BMI \> 30 Kg/m2
* HIV, B or C Hepatitis
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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F DUBRANA, PhD MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Brest

Locations

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CHU de Lyon

Lyon, Lyon, France

Site Status

Orthopaedic surgery Departement Brest University Hospital

Brest, , France

Site Status

CHU de Caen

Caen, , France

Site Status

Centre médico chirurgical de Dracy-Le-Fort

Dracy-le-Fort, , France

Site Status

CHU de Grenoble

Grenoble, , France

Site Status

Ch Versailles

Le Chesnay, , France

Site Status

Clinique Chenieux

Limoges, , France

Site Status

CH Nord Mayenne

Mayenne, , France

Site Status

CHU de Nancy

Nancy, , France

Site Status

HIA Bégin

Saint-Mandé, , France

Site Status

CHU de Strasbourg

Strasbourg, , France

Site Status

Clinique du cours Dillon

Toulouse, , France

Site Status

Countries

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France

References

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Clave A, Potel JF, Servien E, Neyret P, Dubrana F, Stindel E. Third-generation autologous chondrocyte implantation versus mosaicplasty for knee cartilage injury: 2-year randomized trial. J Orthop Res. 2016 Apr;34(4):658-65. doi: 10.1002/jor.23152. Epub 2016 Jan 18.

Reference Type RESULT
PMID: 26742454 (View on PubMed)

Other Identifiers

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RB 06.031

Identifier Type: -

Identifier Source: secondary_id

BB-01-C-01-OT

Identifier Type: -

Identifier Source: org_study_id

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