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

Not Applicable

Completed

• Conditions: Fracture Fixation, Internal; Tibial Fractures; Intra-Articular Fractures
• Interventions: Device: Calcium Sulfate + Antibiotics + Internal Fixation

• Registration Number: NCT02456194
• Lead Sponsor: Ross Leighton

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-26
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-28
• Study Start: 2015-09
• Primary Completion: 2019-04
• Study Completion: 2021-05
• Status Verified: 2022-11
• Results First Submitted: 2022-11-10
• Results First Submitted QC: 2022-11-10
• Last Update Submitted: 2022-11-10
• Results First Posted: 2023-09-21
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Adult (skeletally mature) men or women;
• Acute, closed, tibial plateau fractures, Schatzker grade 1 through 5;
• Internal fixation and use of study device per protocol;
• Fracture repair within 30 days of injury;
• Signed informed consent to participate in study.

Exclusion Criteria

• Uncontrolled diabetes;
• Severe degenerative or metabolic bone disease;
• Malignancy;
• Severe vascular or neurologic disease;
• Alcoholism;
• Substance abuse;
• Use of systemic steroids;
• Immunosuppressive therapy;
• Hypercalcaemia;
• Renal-compromised patients;
• Osteomyelitis or chronic infection in the study limb;
• Women who are pregnant or breast-feeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Calcium Sulfate + Antibiotics + Internal Fixation	Calcium Sulfate + Antibiotics + Internal Fixation	-

Primary Outcome Measures

Name	Time	Method
Resorption of Study Device	6 months	Number of participants with any study device remaining visible on CT

Secondary Outcome Measures

Name	Time	Method
Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale	12 months	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Resorption of Study Device	12 months	Number of participants with any study device remaining visible on x-ray
Knee Injury Osteoarthritis Outcome Score - Pain Subscale	12 months	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Range of Motion	12 months	Range of knee motion (active flexion) in degrees
Subsidence of Joint Surface	6 weeks, 3 months, 6 months, 12 months	Amount of collapse of the joint surface, measured in mm, on plain x-ray. Reported as number of participants with at least 2mm of subsidence on x-ray.
Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale	12 months	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale	12 months	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale	12 months	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.

Trial Locations

Locations (5)

Horizon Health Network; 🇨🇦 Moncton, New Brunswick, Canada

Halifax Infirmary; 🇨🇦 Halifax, Nova Scotia, Canada

Hopital du Sacre-Coeur de Montreal; 🇨🇦 Montreal, Quebec, Canada

Alberta Health Services; 🇨🇦 Calgary, Alberta, Canada

Memorial University of Newfoundland; 🇨🇦 Saint John's, Newfoundland and Labrador, Canada