Osteochondral Defect of Talus Clinical Trial
Official title:
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
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.
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-lateral diameter >1.5cm in diameter), cystic, have failed prior surgical treatment, or when there are multiple present on the talar articular surface, surgical care by means of fixation or bone marrow stimulation is contra-indicated. An ankle arthrodesis or fusion can be considered, but this results in functional limitation due to a decreased range of motion (ROM). In order to serve for a bone sparing prosthesis procedure, preserve range of motion, optimize physical functioning and to resurface the talus, the Ankle Spacer has been developed. It is a one-piece implant system that replaces the articulating upper talus surface of the tibio-talar joint, and offers several implant sizes in order to fit to the different talus sizes. It is anatomically designed to the native upper talus surface to provide an optimal fit to the distal articular surface. It has a rough titanium plasma spray (TPS) coated under surface with two posts and spikes for implant fixation. The rough surface enables secondary fixation by means of bone ingrowth and the spikes at the posterior part of the prosthesis allowing for optimal adherence of the implant and for minimal iatrogenic damage upon fixation. By these means, the anatomical situation and the natural congruency of the ankle joint are mirrored to a optimal extent. Despite the fact that no clinical trials have been published on this specific implant, it is hypothesized that the 5-year postoperative clinical outcomes concerning pain and prosthesis survival will be considered good. ;