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

Tibial Fractures Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02456194
• Other study ID #: RL007
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: May 2021

Study information

• Verified date: November 2022
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2021
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Canada	Alberta Health Services	Calgary	Alberta
Canada	Halifax Infirmary	Halifax	Nova Scotia
Canada	Horizon Health Network	Moncton	New Brunswick
Canada	Hopital du Sacre-Coeur de Montreal	Montreal	Quebec
Canada	Memorial University of Newfoundland	Saint John's	Newfoundland and Labrador

Sponsors (2)

Lead Sponsor	Collaborator
Ross Leighton	Biocomposites Ltd

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resorption of Study Device	Number of participants with any study device remaining visible on CT	6 months
Secondary	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
Secondary	Range of Motion	Range of knee motion (active flexion) in degrees	6 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Range of Motion	Range of knee motion (active flexion) in degrees	3 months
Secondary	Range of Motion	Range of knee motion (active flexion) in degrees	6 months
Secondary	Range of Motion	Range of knee motion (active flexion) in degrees	12 months
Secondary	Resorption of Study Device	Number of participants with any study device remaining visible on x-ray	3 months
Secondary	Resorption of Study Device	Number of participants with any study device remaining visible on x-ray	6 months
Secondary	Resorption of Study Device	Number of participants with any study device remaining visible on x-ray	12 months