OD-PHOENIX in Talus Osteochondral Lesion (NCT02736318) | Clinical Trial Compass
TerminatedPhase 1/2
OD-PHOENIX in Talus Osteochondral Lesion
Stopped: Low accrual rate
Belgium, Israel12 participantsStarted 2017-01-27
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Excessiv…
What they're measuring
1
Determine the improvement in ankle function based on the OMAS at 24 months