Management of Traumatic Bone Defects in Tibial Plateau Fractures With Antibiotic-Impregnated Biodegradable Calcium Sulfate Beads: A Prospective Clinical Trial
Primary Purpose
Tibial Fractures, Intra-Articular Fractures, Fracture Fixation, Internal
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Calcium Sulfate + Antibiotics + Internal Fixation
Sponsored by
About this trial
This is an interventional treatment trial for Tibial Fractures
Eligibility Criteria
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.
Sites / Locations
- Alberta Health Services
- Horizon Health Network
- Memorial University of Newfoundland
- Halifax Infirmary
- Hopital du Sacre-Coeur de Montreal
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Calcium Sulfate + Antibiotics + Internal Fixation
Arm Description
Outcomes
Primary Outcome Measures
Resorption of Study Device
Number of participants with any study device remaining visible on CT
Secondary Outcome Measures
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.
Range of Motion
Range of knee motion (active flexion) in degrees
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Range of Motion
Range of knee motion (active flexion) in degrees
Range of Motion
Range of knee motion (active flexion) in degrees
Range of Motion
Range of knee motion (active flexion) in degrees
Resorption of Study Device
Number of participants with any study device remaining visible on x-ray
Resorption of Study Device
Number of participants with any study device remaining visible on x-ray
Resorption of Study Device
Number of participants with any study device remaining visible on x-ray
Full Information
NCT ID
NCT02456194
First Posted
May 26, 2015
Last Updated
November 10, 2022
Sponsor
Ross Leighton
Collaborators
Biocomposites Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02456194
Brief Title
Management of Traumatic Bone Defects in Tibial Plateau Fractures With Antibiotic-Impregnated Biodegradable Calcium Sulfate Beads: A Prospective Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
May 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ross Leighton
Collaborators
Biocomposites Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fractures, Intra-Articular Fractures, Fracture Fixation, Internal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Calcium Sulfate + Antibiotics + Internal Fixation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Calcium Sulfate + Antibiotics + Internal Fixation
Other Intervention Name(s)
STIMULAN Rapid Cure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Resorption of Study Device
Description
Number of participants with any study device remaining visible on CT
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Knee Injury Osteoarthritis Outcome Score - Pain Subscale
Description
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time Frame
Baseline
Title
Range of Motion
Description
Range of knee motion (active flexion) in degrees
Time Frame
6 weeks
Title
Subsidence of Joint Surface
Description
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.
Time Frame
6 weeks, 3 months, 6 months, 12 months
Title
Knee Injury Osteoarthritis Outcome Score - Pain Subscale
Description
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time Frame
6 weeks
Title
Knee Injury Osteoarthritis Outcome Score - Pain Subscale
Description
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time Frame
3 months
Title
Knee Injury Osteoarthritis Outcome Score - Pain Subscale
Description
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time Frame
6 months
Title
Knee Injury Osteoarthritis Outcome Score - Pain Subscale
Description
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time Frame
12 months
Title
Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale
Description
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time Frame
Baseline
Title
Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale
Description
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time Frame
6 weeks
Title
Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale
Description
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time Frame
6 months
Title
Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale
Description
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time Frame
3 months
Title
Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale
Description
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time Frame
12 months
Title
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale
Description
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time Frame
Baseline
Title
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale
Description
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time Frame
6 weeks
Title
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale
Description
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time Frame
3 months
Title
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale
Description
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time Frame
6 months
Title
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale
Description
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time Frame
12 months
Title
Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale
Description
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time Frame
Baseline
Title
Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale
Description
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time Frame
6 weeks
Title
Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale
Description
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time Frame
3 months
Title
Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale
Description
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time Frame
6 months
Title
Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale
Description
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time Frame
12 months
Title
Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale
Description
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time Frame
Baseline
Title
Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale
Description
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time Frame
6 weeks
Title
Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale
Description
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time Frame
3 months
Title
Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale
Description
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time Frame
6 months
Title
Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale
Description
Self-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Time Frame
12 months
Title
Range of Motion
Description
Range of knee motion (active flexion) in degrees
Time Frame
3 months
Title
Range of Motion
Description
Range of knee motion (active flexion) in degrees
Time Frame
6 months
Title
Range of Motion
Description
Range of knee motion (active flexion) in degrees
Time Frame
12 months
Title
Resorption of Study Device
Description
Number of participants with any study device remaining visible on x-ray
Time Frame
3 months
Title
Resorption of Study Device
Description
Number of participants with any study device remaining visible on x-ray
Time Frame
6 months
Title
Resorption of Study Device
Description
Number of participants with any study device remaining visible on x-ray
Time Frame
12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ross Leighton, MD
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Health Services
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada
Facility Name
Horizon Health Network
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C6Z8
Country
Canada
Facility Name
Memorial University of Newfoundland
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1C5S7
Country
Canada
Facility Name
Halifax Infirmary
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3h 1V7
Country
Canada
Facility Name
Hopital du Sacre-Coeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J1C5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Management of Traumatic Bone Defects in Tibial Plateau Fractures With Antibiotic-Impregnated Biodegradable Calcium Sulfate Beads: A Prospective Clinical Trial
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