NCT02456194

Management of Traumatic Bone Defects in Tibial Plateau Fractures With Antibiotic-Impregnated Biodegradable Calcium Sulfate Beads: A Prospective Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Ross Leighton · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a prospective clinical trial of tibial plateau fractures treated with internal fixation and a calcium sulfate graft which can be mixed with antibiotics and molded into various bead sizes for implantation into bone defects. The graft material chosen for this study is STIMULAN Rapid Cure (Biocomposites, UK), which is approved for use as a bone void filler and may be mixed with a variety of antibiotics. The combination of STIMULAN + antibiotic in bead form is the "study device". Our primary study aim is to look at resorption and remodeling of the study device into bone. Another important aim of the study is to look at subsidence, or collapse, of the joint surface.

Conditions

• Tibial Fractures
• Intra-Articular Fractures
• Fracture Fixation, Internal

Interventions

Type	Name	Description
DEVICE	Calcium Sulfate + Antibiotics + Internal Fixation	STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.

Timeline

• Start date: 2015-09-01
• Primary completion: 2019-04-01
• Completion: 2021-05-01
• First posted: 2015-05-28
• Last updated: 2023-09-21
• Results posted: 2023-09-21

Locations

5 sites across 1 country: Canada