AS: Ankle Spacer
- Conditions
- osteochondral defects of the talus
- Registration Number
- NL-OMON26265
- Lead Sponsor
- Academic Medical Centre (Investigator-initiated trial)
- Brief Summary
p to now, there have no clinical studies been published with regards to the Ankle Spacer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
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))
Exclusion Criteria
-severe ankle malalignement.(> 5° varus/valgus).
-fracture < 6 months - tendinitis - diabetes mellitus / reumathoid arthritis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary study parameter is the measurement of the NRS pain during walking/normal weight-bearing.
- Secondary Outcome Measures
Name Time Method 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.<br>