NCT01132508

Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 33 (actual)
• Sponsor: Synthes GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Case series of tibial plateau fractures using Norian Drillable.

Detailed description

This study is a multi-center, non-randomized prospective case series of tibial plateau fractures using Norian Drillable to fill bone voids, to evaluate OR time, blood loss, complications, ease of use, fracture stabilization and patient function and pain over time.

Conditions

• Tibial Fractures

Interventions

Type	Name	Description
DEVICE	Norian Drillable Bone Void Filler	Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler

Timeline

• Start date: 2008-09-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2010-05-28
• Last updated: 2015-06-11
• Results posted: 2015-06-11

Locations

6 sites across 4 countries: Australia, China, Netherlands, Norway