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. - AS: Ankle Spacer

Academisch Medisch Centrum0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年4月15日

试验速览

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•- 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

•- 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)

发起方