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

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 Overview

• Status: Completed
• Conditions: Tibial Fractures; Intra-Articular Fractures; Fracture Fixation, Internal
• Intervention / Treatment: Device: Calcium Sulfate + Antibiotics + Internal Fixation

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • Alberta Health Services
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C6Z8
      • Horizon Health Network
  • Newfoundland and Labrador
    • Saint John's, Newfoundland and Labrador, Canada, A1C5S7
      • Memorial University of Newfoundland
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Halifax Infirmary
  • Quebec
    • Montreal, Quebec, Canada, H4J1C5
      • Hopital du Sacre-Coeur de Montreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Calcium Sulfate + Antibiotics + Internal Fixation	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.; Other Names: STIMULAN Rapid Cure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resorption of Study Device	Number of participants with any study device remaining visible on CT	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Injury Osteoarthritis Outcome Score - Pain Subscale	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.	Baseline
Range of Motion	Range of knee motion (active flexion) in degrees	6 weeks
Subsidence of Joint Surface	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.	6 weeks, 3 months, 6 months, 12 months
Knee Injury Osteoarthritis Outcome Score - Pain Subscale	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.	6 weeks
Knee Injury Osteoarthritis Outcome Score - Pain Subscale	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.	3 months
Knee Injury Osteoarthritis Outcome Score - Pain Subscale	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.	6 months
Knee Injury Osteoarthritis Outcome Score - Pain Subscale	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.	12 months
Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.	Baseline
Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.	6 weeks
Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.	6 months
Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.	3 months
Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.	12 months
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.	Baseline
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.	6 weeks
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.	3 months
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.	6 months
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.	12 months
Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.	Baseline
Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.	6 weeks
Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.	3 months
Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.	6 months
Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.	12 months
Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.	Baseline
Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.	6 weeks
Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.	3 months
Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.	6 months
Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale	Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.	12 months
Range of Motion	Range of knee motion (active flexion) in degrees	3 months
Range of Motion	Range of knee motion (active flexion) in degrees	6 months
Range of Motion	Range of knee motion (active flexion) in degrees	12 months
Resorption of Study Device	Number of participants with any study device remaining visible on x-ray	3 months
Resorption of Study Device	Number of participants with any study device remaining visible on x-ray	6 months
Resorption of Study Device	Number of participants with any study device remaining visible on x-ray	12 months

Collaborators and Investigators

• Sponsor: Ross Leighton
• Collaborators: Biocomposites Ltd
• Investigators: Principal Investigator: Ross Leighton, MD, Nova Scotia Health Authority

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: May 26, 2015
• First Submitted That Met QC Criteria: May 26, 2015
• First Posted (Estimated): May 28, 2015

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures; Intra-Articular Fractures; Physiological Effects of Drugs; Anti-Infective Agents; Calcium-Regulating Hormones and Agents; Calcium; Anti-Bacterial Agents
• Other Study ID Numbers: RL007