By means of the Ankle Spacer patients will be implanted, the clinical and radiological results of which will be prospectively recorded and analyzed at different points in time.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* age ranging from 18 to 80 years
* talar osteochondral defect (multiple degenerative talar cysts present, and/or prior failed surgical treatment and/or multiple defects and/or large (\>15mm))
* willing to receive surgical implantation of the Ankle Spacer
* has been informed of the nature of the study and provided written consent
* The subject and treating physician agree that the subject will return for all required post-procedure follow-up visits
* failed previous conservative treatment
* complaints for at least 6 months
Exclusion Criteria:
* -severe ankle malalignement.(\> 5° varus/valgus).
* fracture \< 6 months - tendinitis - diabetes mellitus / rheumathoid arthritis
* advanced osteoporosis
* grade two or higher (Kellgren-Lawrence-Score) ankle joint degeneration on the tibia side.
* any ankle deformation that does not allow proper rasping of the cartilage and/or proper seating of the desired sized implant, as described in the surgical technique.
* blood supply limitations and previous infections, which may retard healing.
* foreign-body sensitivity. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.
* active infection or blood supply limitations.
* conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period, including severe neuro-arthropathy.
* pathological conditions, such as insufficient quantity or…
What they're measuring
1
NRS during walking/weightbearing
Timeframe: 2 years postoperatively
Trial details
NCT IDNCT03303690
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)