Knee ChondralPhase 3NCT00945399
Comparison of Microfracture Treatment and CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions
A Phase 3 study testing CARTIPATCH® procedure and Microfracture in people with Knee Chondral and Osteochondral Defect, run by TBF Genie Tissulaire at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Knee Chondral, Osteochondral Defect
- What is being tested?
- CARTIPATCH® procedure and Microfracture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2008to Sep 2014
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- pregnancy or breastfeeding
- allergy
- arthrosis
- varus or valgus angle greater than 6°
- kissing lesion
- affection of the patella
Show all 11Show fewer
- excessive laxity
- meniscal pathology history
- severe chronic disease
- BMI > 30
- HIV, Hepatitis B, C, HTLV, Syphilis
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Gent University Hospital, Dept of Orthopaedic Surgery
Ghent, 9000
About this study
Official title: Phase III Protocol Comparing a Microfracture Treatment to a CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions
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.
- Conditions
- Knee Chondral, Osteochondral Defect
- Being tested
- CARTIPATCH® procedure, Microfracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARTIPATCH® procedureProcedure or surgery
Cartilage is harvested and treated for chondrocytes isolation and culture. After multiplication, the chondrocytes are transferred into a biomaterial support and surgically implanted.
MicrofractureProcedure or surgery
Tiny fractures are created at the cartilage surface to stimulate cartilage growth.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Chondrocytes Implantation | Experimental | Not described Receives: Procedure: CARTIPATCH® procedure |
| Microfracture | Active comparator | Not described Receives: Procedure: Microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation scoring system: IKDC
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startOct 2008
- Primary completionJul 2012
- Study completionSep 2014
Why it stopped: Manufacturing stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ChondralStudies of the same condition, open and under way.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- TBF Genie Tissulaire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945399
- Sponsor's protocol ID
- 2007-003481-18
- Status last verified
- Apr 2015
- First submitted
- 23 Jul 2009
- Last updated
- 28 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Protocol Comparing a Microfracture Treatment to a CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions
- ClinicalTrials.gov ID
- NCT00945399
- Acronym / sponsor ID
- 2007-003481-18
- Conditions
- Knee Chondral, Osteochondral Defect
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Manufacturing stopped
- Enrolment
- 40 participants (actual)
- Lead sponsor
- TBF Genie TissulaireIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 24 Jul 2009 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous Chondrocytes Implantation | Experimental | Procedure: CARTIPATCH® procedure |
| Microfracture | Active comparator | Procedure: Microfracture |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- pregnancy or breastfeeding
- allergy
- arthrosis
- varus or valgus angle greater than 6°
- kissing lesion
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 |
|---|---|---|
| CARTIPATCH® procedureCartilage is harvested and treated for chondrocytes isolation and culture. After multiplication, the chondrocytes are transferred into a biomaterial support and surgically implanted. | Procedure or surgery | Autologous Chondrocytes Implantation |
| MicrofractureTiny fractures are created at the cartilage surface to stimulate cartilage growth. | Procedure or surgery | Microfracture |
Primary outcome
Clinical evaluation scoring system: IKDC
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Manufacturing stopped). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CARTIPATCH® procedure and Microfracture in people with Knee Chondral and Osteochondral Defect, run by TBF Genie Tissulaire at 1 site in Belgium.
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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 was stopped early (reason given: Manufacturing stopped). Results are not available in the source record.
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: IKDC (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2015.