Talus Osteochondral DefectPhase 1/2TBF3NCT02736318
OD-PHOENIX in Talus Osteochondral Lesion
A Phase 1/2 study testing OD-PHOENIX in people with Talus Osteochondral Defect, run by TBF Genie Tissulaire at 2 sites in 2 countries.
Trial summary
Treatment of osteochondral lesion of Talus with a devitalized viro-inativated sterile osteochondral graft. To avoid having to harvest autograft material from the knee, a processed allogeneic osteochondral can be used instead autograft. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Talus Osteochondral Defect
- What is being tested?
- OD-PHOENIX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 27 Jan 2017to 7 Sep 2021
- Phase
- Phase 1/2
- 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
- Male and female patients between the ages of 18 and 50
- Isolated osteochondral lesion of the talus due to trauma (fracture) or osteochondritis dissecans
- Osteochondral lesion > Anderson Grade I (MRI)
- 1 to 3 cm2 lesion
- Presence of disabling and clinically meaningful symptoms (subjective OMAS < 50)
- Patient who has been treated previously for this lesion, except if this treatment consisted of autologous osteochondral grafting
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- No significant obesity (BMI < 30)
- Patient able to understand, sign and date the informed consent form
- Patient affiliated with a national health insurance system or who is the beneficiary of such as system
- Women of childbearing age may not be included in the clinical trial unless their pregnancy test is negative. If this test is negative, they will be asked to use an effective birth control method during the entire the study.
Who cannot join
- Pregnant or breast feeding women: Women of childbearing age will be asked to undergo a pregnancy test before being enrolled into the study and to use an effective birth control method.
- Previous mosaicplasty treatment of this lesion
- Fracture or bone defect or subchondral lesion without cartilage involvement, untreated osteonecrosis, collapse of talar dome
- Presence of osteoarthritis, rheumatoid arthritis, excessive hindfoot deformity or any other condition of the talocural joint that, in the surgeon's opinion, is likely to compromise the allograft's outcome
- Excessive laxity or recurrent instability that could affect the score evaluation
- Presence of an ulcerative disease, heavy smoking, tuberculosis, chronic psychiatric disorder or disease requiring long-term treatment with a medication that would affect bone or joint metabolism
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- Persons with cancer or a history of cancer
- Persons deprived of their freedom by a judicial or administrative decision
- Adults subject to legal protection measures or who are unable to provide their consent
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Treatment of Osteochondral Lesion of Talus With Processed Osteochondral Allograft
Treatment of osteochondral lesion of Talus with a devitalized viro-inativated sterile osteochondral graft. To avoid having to harvest autograft material from the knee, a processed allogeneic osteochondral can be used instead autograft. The surgical technique is to implant in the osteochondral defect one to three products in the defect.
- Conditions
- Talus Osteochondral Defect
- Being tested
- OD-PHOENIX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OD-PHOENIXBiological
Also called Osteochondral allograft
Decellularized, freeze-dried, irradiated osteochondral allograft
| Study group | Role | What they receive |
|---|---|---|
| processed osteochondral allograft | Experimental | Implantation of 1 to 3 osteochondral products in osteochondral lesion of talus. Receives: Biological: OD-PHOENIX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the improvement in ankle function based on the OMAS at 24 months
questionnaire
Measured: 3 months, 6 months, 12 months, 18 months, 24 months
Secondary outcomes (3)
Clinical and functional improvement of the ankle by AOFAS score
questionnaire and clinical evaluation
Measured: 3 months, 6 months, 12 months, 18 months,24 months
Impairment improvement by FASS ( foot and ankle severity score)
questionnaire
Measured: 3 months, 6 months, 12 months, 18 months,24 months
Evaluate osteochondral graft integration with imaging
- CT-scan at 12 months, MRI 18- 24 months
Measured: 12 months, 18 months, 24 monts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study start27 Jan 2017
- Primary completion7 Sep 2021
- Study completion7 Sep 2021
Why it stopped: Low accrual rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Talus Osteochondral DefectStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT02736318
- Sponsor's protocol ID
- TBFLab
- Acronym
- TBF3
- Status last verified
- Dec 2021
- First submitted
- 1 Apr 2016
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Osteochondral Lesion of Talus With Processed Osteochondral Allograft
- ClinicalTrials.gov ID
- NCT02736318
- Acronym / sponsor ID
- TBF3 / TBFLab
- Conditions
- Talus Osteochondral Defect
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual rate
- Enrolment
- 12 participants (actual)
- Lead sponsor
- TBF Genie TissulaireIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2017 (actual)
- Primary completion
- 7 Sep 2021 (actual)
- Study completion
- 7 Sep 2021 (actual)
- First posted
- 13 Apr 2016 (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.
Treatment of osteochondral lesion of Talus with a devitalized viro-inativated sterile osteochondral graft. To avoid having to harvest autograft material from the knee, a processed allogeneic osteochondral can be used instead autograft. The surgical technique is to implant in the osteochondral defect one to three products in the defect.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| processed osteochondral allograft | Experimental | Biological: OD-PHOENIXImplantation of 1 to 3 osteochondral products in osteochondral lesion of talus. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male and female patients between the ages of 18 and 50
- Isolated osteochondral lesion of the talus due to trauma (fracture) or osteochondritis dissecans
- Osteochondral lesion > Anderson Grade I (MRI)
- 1 to 3 cm2 lesion
- Presence of disabling and clinically meaningful symptoms (subjective OMAS < 50)
Key exclusion criteria (9 listed)
- Pregnant or breast feeding women: Women of childbearing age will be asked to undergo a pregnancy test before being enrolled into the study and to use an effective birth control method.
- Previous mosaicplasty treatment of this lesion
- Fracture or bone defect or subchondral lesion without cartilage involvement, untreated osteonecrosis, collapse of talar dome
- Presence of osteoarthritis, rheumatoid arthritis, excessive hindfoot deformity or any other condition of the talocural joint that, in the surgeon's opinion, is likely to compromise the allograft's outcome
- Excessive laxity or recurrent instability that could affect the score evaluation
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 |
|---|---|---|
| OD-PHOENIXAlso: Osteochondral allograftDecellularized, freeze-dried, irradiated osteochondral allograft | Biological | processed osteochondral allograft |
Primary outcome
Determine the improvement in ankle function based on the OMAS at 24 months
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months
questionnaire
3 secondary outcomes
Clinical and functional improvement of the ankle by AOFAS score
Time frame: 3 months, 6 months, 12 months, 18 months,24 months
Impairment improvement by FASS ( foot and ankle severity score)
Time frame: 3 months, 6 months, 12 months, 18 months,24 months
Evaluate osteochondral graft integration with imaging
Time frame: 12 months, 18 months, 24 monts
Results and safety
The study was stopped early (reason given: Low accrual rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Talus Osteochondral Defect
RecruitingPhase 3
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
Chondral Defect, Articular Cartilage Defect
Active, not recruiting
Clinical Outcome After Episealer Talus Implant in Treatment of Osteochondral Lesion of the Talus
Osteochondral Defect
Active, not recruitingObservational study
Ten Years Follow-up After the Arthroscopic Repair of Osteochondral Lesions of the Talus Via Autologous Matrix-induced Chondrogenesis (AMIC)
Osteochondral Defect of Talus
Enrolling by invitationObservational study
Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM)
Avascular Necrosis of the Talus, Talar Osteochondral Defect of Ankle
Enrolling by invitation
Gait Pattern Analysis After Arthroscopic Treament of Osteochondral Defects of Talus
Osteochondral Defects of Talus, Gait Analysis
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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing OD-PHOENIX in people with Talus Osteochondral Defect, run by TBF Genie Tissulaire at 2 sites in 2 countries.
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 10 inclusion and 9 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 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Israel. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Low accrual rate). 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?
Determine the improvement in ankle function based on the OMAS at 24 months (time frame: 3 months, 6 months, 12 months, 18 months, 24 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 14 Jan 2022.