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ODPHOENIX2: Second Line Treatment of Knee Osteochondral Lesion With Treated Osteochondral Graft

Sponsor
TBF Genie Tissulaire (Industry)
Overall Status
Terminated
CT.gov ID
NCT02430558
Collaborator
(none)
10
Enrollment
1
Arm
62.3
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Patient with IKDC score < 65, pretreated with mosaicplasty or ACI ( with matrix or not) within > 18 months, with one or two osteochondral lesions are recruited to have treated osteochondral allografts in mosaicplasty.

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

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Second Line Treatment of Knee Osteochondral Lesion With Decellularized Treated Osteochondral Allograft. Phase IIa Trial
Actual Study Start Date :
Apr 5, 2016
Actual Primary Completion Date :
Jun 15, 2021
Actual Study Completion Date :
Jun 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: OD-PHOENIX

treatment of 1 to 5 osteochondral allograft cylinders in mosaic

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. improvement of IKDC score [18 months]

    Secondary Outcome Measures

    1. Knee Injury and Osteoarthritis Outcome Score (KOOS) [18 months]

    2. recellularization of tissue (arthroscopy and histology) [18 months]

      arthroscopy and histology

    3. integration of the tissue by imagery [18 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male and female patients between the ages of 18 and 55

    • osteochondral lesions of the knee due to trauma or osteochondritis dissecans or removal treatment ( lesion post autograft)

    • Osteochondral lesion > grade II- ICRS

    • One lesion or 2 concomitant lesions (tibial plateau, patella and condyles )at least one lesion has been pretreated by mosaicplasy or ACI. These treatment would have to have been made at least 18 months before inclusion

    • Presence of disabling and clinically meaningful symptoms (subjective IKDC < 65, no improvement for 3 months)

    • No significant obesity (BMI < 30)

    • Accompanying ligamentous and meniscal lesions, joint malalignment and patella femoral instability are authorized and corrected concurrently.

    • 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.

    • Presence of osteoarthritis, rheumatoid arthritis, any other condition of knee 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 without concomitant ligamentoplasty

    • 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

    No locations specified.

    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:
    NCT02430558
    Other Study ID Numbers:
    • 2015-A00002-47
    First Posted:
    Apr 30, 2015
    Last Update Posted:
    Jan 14, 2022
    Last Verified:
    Dec 1, 2021

    Study Results

    No Results Posted as of Jan 14, 2022