Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

OD-PHOENIX in Talus Osteochondral Lesion (TBF3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02736318
Recruitment Status : Unknown
Verified April 2016 by TBF Genie Tissulaire.
Recruitment status was:  Not yet recruiting
First Posted : April 13, 2016
Last Update Posted : April 13, 2016
Sponsor:
Information provided by (Responsible Party):
TBF Genie Tissulaire

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
Talus Osteochondral Defect Other: processed osteochondral allograft Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Osteochondral Lesion of Talus With Processed Osteochondral Allograft
Study Start Date : April 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: processed osteochondral allograft
Implantation of 1 to 3 osteochondral products in osteochondral lesion of talus.
Other: processed osteochondral allograft
Other Name: OD-PHOENIX




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Clinical and functional improvement of the ankle by AOFAS score [ Time Frame: 3 months, 6 months, 12 months, 18 months,24 months ]
    questionnaire and clinical evaluation

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

  3. Evaluate osteochondral graft integration with imaging [ Time Frame: 12 months, 18 months, 24 monts ]
    - CT-scan at 12 months, MRI 18- 24 months



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736318


Contacts
Layout table for location contacts
Contact: Laurence Barnouin, MD laurence.barnouin@tbf-lab.com

Sponsors and Collaborators
TBF Genie Tissulaire

Layout table for additonal information
Responsible Party: TBF Genie Tissulaire
ClinicalTrials.gov Identifier: NCT02736318    
Other Study ID Numbers: TBFLab
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided