NCT02056834

chronOS Inject in Proximal Tibial Fractures

Prospective, Multi-Center, Observational Study Evaluating the Augmentation With Calcium Phosphate Cement (chronOS Inject) for Bone Defect After Internal Fixation of Proximal Tibial Fractures

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 36 (actual)
• Sponsor: Synthes GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Closed Proximal Tibial Fracture Schatzker I - VI
• Closed Proximal Tibial Fracture AO-OTA 41
• Closed Proximal Tibial Fracture AO-OTA 42

Interventions

Type	Name	Description
DEVICE	chronOS Inject	chronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-09-30
• Completion: 2012-09-30
• First posted: 2014-02-06
• Last updated: 2025-03-03
• Results posted: 2014-06-25

Locations

2 sites across 1 country: South Korea