CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Calcium Sulfate + Antibiotics + Internal Fixationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02456194
NCT02456194N/ACompleted
CompareCT.gov

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

Ross Leighton·interventional·Posted May 28, 2015·Updated Sep 21, 2023

In Brief

A clinical study evaluating Calcium Sulfate + Antibiotics + Internal Fixation for Tibial Fractures and 2 related conditions. Completed, enrolled 30 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTibial Fractures, Intra-Articular Fractures, Fracture Fixation, Internal
CountriesCanada
CollaboratorsBiocomposites Ltd

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 28, 2015
Enrollment StartSep 1, 2015
Primary CompletionApr 1, 2019
Study CompletionMay 1, 2021
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 11.1 years ago

Interventions

Calcium Sulfate + Antibiotics + Internal Fixationdevice

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.