Closed Proximal Tibial Fracture AO-OTA 41 Clinical Trial
Official title:
Prospective, Multi-Center, Observational Study Evaluating the Augmentation With Calcium Phosphate Cement (chronOS Inject) for Bone Defect After Internal Fixation of Proximal Tibial Fractures
The primary objective of this study is to observe the safety, the radiological and clinical outcomes of chronOS Inject after having been used as bone void filler in internal fixation of proximal tibial fractures.
The primary objective of this study was to observe the safety, the radiological and clinical
outcomes of chronOS Inject after having been used as bone void filler in internal fixation
of proximal tibial fractures. Secondary objectives were to assess the surgeon's satisfaction
in using chronOS Inject and patient satisfaction post surgery.
The study was planned to be a multi-center, prospective, observational study. Patients with
proximal tibial fractures of type Schatzker I - VI, AO-Müller-Orthopaedic Trauma Association
(AO-OTA) 41, AO-OTA 42 with bone defect were assessed for eligibility to enter the study.
Patients eligible for the study were followed over time to twelve months after surgery.
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Observational Model: Cohort, Time Perspective: Prospective