OD-PHOENIX in Talus Osteochondral Lesion

NCT ID: NCT02736318

Last Updated: 2022-01-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-27
• Study Completion Date: 2021-09-07

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.

Conditions

Talus Osteochondral Defect

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

processed osteochondral allograft

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

Group Type: EXPERIMENTAL

OD-PHOENIX

Intervention Type: BIOLOGICAL

Decellularized, freeze-dried, irradiated osteochondral allograft

Interventions

OD-PHOENIX

Decellularized, freeze-dried, irradiated osteochondral allograft

Intervention Type: BIOLOGICAL

Other Intervention Names

Osteochondral allograft

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TBF Genie Tissulaire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AZ Monica

Antwerp, , Belgium

Poriya Medical Center

Tiberias, , Israel

Countries

Belgium; Israel

Other Identifiers

TBFLab

Identifier Type: -

Identifier Source: org_study_id