Knee Chondral or Osteochondral DefectPhase 3CartipatchNCT00560664
Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty: a Randomized Trial
A Phase 3 study testing Autologous chondrocytes transplantation and Mosaicoplasty in people with Knee Chondral or Osteochondral Defect, run by University Hospital, Brest at 12 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Knee Chondral or Osteochondral Defect
- What is being tested?
- Autologous chondrocytes transplantation and Mosaicoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 12 sitesFrance
- Study dates
- Apr 2007to Aug 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- pregnancy
- allergy
- arthrosis
- varus or valgus angle greater than 10°
- ACL laxity
- Severe chronic disease
- BMI > 30 Kg/m2
- HIV, B or C Hepatitis
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Orthopaedic surgery Departement Brest University Hospital
Brest, 29200
CHU de Caen
Caen, 14 033
Centre médico chirurgical de Dracy-Le-Fort
Dracy-le-Fort, 71 640
CHU de Grenoble
Grenoble, 38 042
Ch Versailles
Le Chesnay, 78 150
Clinique Chenieux
Limoges, 87 000
CHU de Lyon
Lyon, Lyon, 69300
CH Nord Mayenne
Mayenne, 53 103
CHU de Nancy
Nancy, 54 035
HIA Bégin
Saint-Mandé, 94 160
CHU de Strasbourg
Strasbourg, 67 400
Clinique du cours Dillon
Toulouse
About this study
Official title: Phase 3 Study Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty
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.
- Conditions
- Knee Chondral or Osteochondral Defect
- Being tested
- Autologous chondrocytes transplantation, Mosaicoplasty
- Keywords
- knee, chondral defect, osteochondral defect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous chondrocytes transplantationProcedure or surgery
Also called Tissue Bank France
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.
MosaicoplastyProcedure or surgery
Osteochondral patch are sampled and then implanted during the same surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Autologous chondrocytes transplantation Receives: Procedure: Autologous chondrocytes transplantation |
| 2 | Active comparator | Mosaicoplasty Receives: Procedure: Mosaicoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation scoring system
Measured: IKDC
Secondary outcomes (2)
MRI
Measured: at 2 years
Arthroscopy with biopsy
Measured: at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startApr 2007
- Primary completionOct 2012
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee Chondral or Osteochondral DefectStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- F DUBRANA, PhD MD, Principal investigator, University Hospital, Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560664
- Sponsor's protocol ID
- BB-01-C-01-OT
- Other IDs
- RB 06.031
- Acronym
- Cartipatch
- Status last verified
- Jul 2014
- First submitted
- 19 Nov 2007
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26742454
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty
- ClinicalTrials.gov ID
- NCT00560664
- Acronym / sponsor ID
- Cartipatch / BB-01-C-01-OT
- Conditions
- Knee Chondral or Osteochondral Defect
- Keywords
- knee, chondral defect, osteochondral defect
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Apr 2007
- Primary completion
- Oct 2012 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 20 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Autologous chondrocytes transplantationAutologous chondrocytes transplantation |
| 2 | Active comparator | Procedure: MosaicoplastyMosaicoplasty |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- pregnancy
- allergy
- arthrosis
- varus or valgus angle greater than 10°
- ACL laxity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous chondrocytes transplantationAlso: Tissue Bank FranceCartilage 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. | Procedure or surgery | 1 |
| MosaicoplastyOsteochondral patch are sampled and then implanted during the same surgical procedure | Procedure or surgery | 2 |
Primary outcome
Clinical evaluation scoring system
Time frame: IKDC
2 secondary outcomes
MRI
Time frame: at 2 years
Arthroscopy with biopsy
Time frame: at 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Results publication: PubMed 26742454Clave 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
F DUBRANA, PhD MD principal investigator
University Hospital, Brest
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Autologous chondrocytes transplantation and Mosaicoplasty in people with Knee Chondral or Osteochondral Defect, run by University Hospital, Brest at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation scoring system (time frame: IKDC). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00560664, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.