OD-PHOENIX in Talus Osteochondral Lesion (TBF3)

TBF Genie Tissulaire

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Talus Osteochondral Defect

Treatments

Biological: OD-PHOENIX

Study type

Interventional

Funder types

Industry

Identifiers

NCT02736318

TBFLab

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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