osteochondral defects of the talus
Conditions
Interventions
All included patients will be treated by means of surgical implantation of the Ankle Spacer prosthesis in an open manner replacing the talar side of the tibiotalar joint.
Sponsors
Academic Medical Centre (Investigator-initiated trial)
Eligibility
Inclusion criteria
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
Exclusion criteria: -severe ankle malalignement.(> 5° varus/valgus). -fracture 30 kg/m2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter is the measurement of the NRS pain during walking/normal weight-bearing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Other outcome measures will include pain evaluation using the NRS pain at rest and during stair climbing, the AOFAS, FAOS, and SF-36 physical and mental component scale. Range of Motion (ROM) will also be registered in degrees of dorsi- and plantarflexion and will be measured using a goniometer Other study parameters that will be recorded are demographic data (sex, age, etc.) and also radiographic evaluations to evaluate loosening and subsidence (radiographs). Complications, implant survivorship (revision rate), operation time, adverse events, and length of hospital stay will also be recorded. | — |
Contacts
Public ContactJari Dahmen
Department of Orthopedic Surgery, Room G4-264
Outcome results
None listed