OD-PHOENIX in Talus Osteochondral Lesion (TBF3)

Treatment of Osteochondral Lesion of Talus With Processed Osteochondral Allograft

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.

Study Overview

• Status: Terminated
• Conditions: Talus Osteochondral Defect
• Intervention / Treatment: Biological: OD-PHOENIX

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2100
    • AZ Monica
• Israel
  • Tiberias, Israel, 1528001
    • Poriya Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the improvement in ankle function based on the OMAS at 24 months	questionnaire	3 months, 6 months, 12 months, 18 months, 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical and functional improvement of the ankle by AOFAS score	questionnaire and clinical evaluation	3 months, 6 months, 12 months, 18 months,24 months
Impairment improvement by FASS ( foot and ankle severity score)	questionnaire	3 months, 6 months, 12 months, 18 months,24 months
Evaluate osteochondral graft integration with imaging	- CT-scan at 12 months, MRI 18- 24 months	12 months, 18 months, 24 monts

Collaborators and Investigators

• Sponsor: TBF Genie Tissulaire

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2017
• Primary Completion (Actual): September 7, 2021
• Study Completion (Actual): September 7, 2021

Study Registration Dates

• First Submitted: April 1, 2016
• First Submitted That Met QC Criteria: April 7, 2016
• First Posted (Estimate): April 13, 2016

Study Record Updates

• Last Update Posted (Actual): January 14, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: TBFLab

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No