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TBF3: OD-PHOENIX in Talus Osteochondral Lesion

Sponsor
TBF Genie Tissulaire (Industry)
Overall Status
Terminated
CT.gov ID
NCT02736318
Collaborator
(none)
12
Enrollment
2
Locations
1
Arm
55.3
Actual Duration (Months)
6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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. The surgical technique is to implant in the osteochondral defect one to three products in the defect.

Condition or Disease Intervention/Treatment Phase
  • Biological: OD-PHOENIX
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Osteochondral Lesion of Talus With Processed Osteochondral Allograft
Actual Study Start Date :
Jan 27, 2017
Actual Primary Completion Date :
Sep 7, 2021
Actual Study Completion Date :
Sep 7, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: processed osteochondral allograft

Implantation of 1 to 3 osteochondral products in osteochondral lesion of talus.

Biological: OD-PHOENIX
Decellularized, freeze-dried, irradiated osteochondral allograft
Other Names:
  • Osteochondral allograft

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Determine the improvement in ankle function based on the OMAS at 24 months [3 months, 6 months, 12 months, 18 months, 24 months]

      questionnaire

    Secondary Outcome Measures

    1. Clinical and functional improvement of the ankle by AOFAS score [3 months, 6 months, 12 months, 18 months,24 months]

      questionnaire and clinical evaluation

    2. Impairment improvement by FASS ( foot and ankle severity score) [3 months, 6 months, 12 months, 18 months,24 months]

      questionnaire

    3. Evaluate osteochondral graft integration with imaging [12 months, 18 months, 24 monts]

      - CT-scan at 12 months, MRI 18- 24 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    • 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.

    Exclusion Criteria:

    • 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

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AZ Monica Antwerp Belgium 2100
    2 Poriya Medical Center Tiberias Israel 1528001

    Sponsors and Collaborators

    • TBF Genie Tissulaire

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TBF Genie Tissulaire
    ClinicalTrials.gov Identifier:
    NCT02736318
    Other Study ID Numbers:
    • TBFLab
    First Posted:
    Apr 13, 2016
    Last Update Posted:
    Jan 14, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 14, 2022