Status:
TERMINATED
AS: Ankle Spacer for Talar Osteochondral Defects
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Osteochondral Defect of Talus
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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.
Detailed Description
Ankle sprains can result in talar osteochondral defects (OCDs) which have a significant impact on the quality of life of patients. When these OCDs are of large nature (anterior-posterior or medial-lat...
Eligibility Criteria
Inclusion
- 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
- -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 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)
Key Trial Info
Start Date :
December 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03303690
Start Date
December 5 2017
End Date
March 11 2020
Last Update
July 15 2020
Active Locations (1)
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1
Academic Medical Center
Amsterdam, North Holland, Netherlands, 1105AZ