A prospective trial on the clinical efficacy of the Ankle Spacer for the surgical treatment of large, multiple, cystic and secondary or tertiary osteochondral defects of the talus.

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 25

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 / reumathoid 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 quality of bone (e.g., cystic changes or severe osteopenia), which may compromise implant fixation.
- currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints.
- Inability to be brought back to the surgery site for long term follow-up evaluations or the subject is unwilling to fill out the appropriate evaluation forms
- adiposity grade I (BMI > 30 kg/m2)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter is the measurement of the NRS pain during<br /><br>walking/normal weight-bearing. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Other outcome measures will include pain evaluation using the NRS pain at rest<br /><br>and during stair climbing, the AOFAS, FAOS, and SF-36 physical and mental<br /><br>component scale. Range of Motion (ROM) will also be registered in degrees of<br /><br>dorsi- and plantarflexion and will be measured using a goniometer<br /><br><br /><br>Other study parameters that will be recorded are demographic data (sex, age,<br /><br>etc.) and also radiographic evaluations to evaluate loosening and subsidence<br /><br>(radiographs). Complications, implant survivorship (revision rate), operation<br /><br>time, adverse events, and length of hospital stay will also be recorded. </p><br>