Tibial FracturesNCT02456194
Management of Traumatic Bone Defects in Tibial Plateau Fractures With Antibiotic-Impregnated Biodegradable Calcium Sulfate Beads: A Prospective Clinical Trial
A study testing Calcium Sulfate + Antibiotics + Internal Fixation in people with Tibial Fractures and Intra-Articular Fractures, run by Ross Leighton at 5 sites in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tibial Fractures, Intra-Articular Fractures, Fracture Fixation, Internal
- What is being tested?
- Calcium Sulfate + Antibiotics + Internal Fixation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesCanada
- Study dates
- Sep 2015to May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Uncontrolled diabetes;
- Severe degenerative or metabolic bone disease;
- Malignancy;
- Severe vascular or neurologic disease;
- Alcoholism;
- Substance abuse;
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Alberta Health Services
Calgary, Alberta, T2N 1N4
Halifax Infirmary
Halifax, Nova Scotia, B3h 1V7
Horizon Health Network
Moncton, New Brunswick, E1C6Z8
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J1C5
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, A1C5S7
About this study
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.
- Being tested
- Calcium Sulfate + Antibiotics + Internal Fixation
- Medical subject headings
- Tibial Fractures, Intra-Articular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Sulfate + Antibiotics + Internal FixationDevice
Also called STIMULAN Rapid Cure
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.
| Study group | Role | What they receive |
|---|---|---|
| Calcium Sulfate + Antibiotics + Internal Fixation | Experimental | Not described Receives: Device: Calcium Sulfate + Antibiotics + Internal Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resorption of Study Device
Number of participants with any study device remaining visible on CT
Measured: 6 months
Secondary outcomes (33)
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.
Measured: Baseline
Range of Motion
Range of knee motion (active flexion) in degrees
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Range of Motion
Range of knee motion (active flexion) in degrees
Measured: 3 months
Range of Motion
Range of knee motion (active flexion) in degrees
Measured: 6 months
Range of Motion
Range of knee motion (active flexion) in degrees
Measured: 12 months
Resorption of Study Device
Number of participants with any study device remaining visible on x-ray
Measured: 3 months
Resorption of Study Device
Number of participants with any study device remaining visible on x-ray
Measured: 6 months
Resorption of Study Device
Number of participants with any study device remaining visible on x-ray
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startSep 2015
- Primary completionApr 2019
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tibial FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ross Leighton
- Sponsor type
- University, hospital or other
- Collaborators
- Biocomposites Ltd
- Responsible party
- Sponsor-investigator, Ross Leighton, Nova Scotia Health Authority
- Investigators
- Ross Leighton, MD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456194
- Sponsor's protocol ID
- RL007
- Status last verified
- Nov 2022
- First submitted
- 26 May 2015
- Last updated
- 21 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Traumatic Bone Defects in Tibial Plateau Fractures With Antibiotic-Impregnated Biodegradable Calcium Sulfate Beads: A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT02456194
- Acronym / sponsor ID
- RL007
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ross LeightonUniversity, hospital or other
- Collaborators
- Biocomposites Ltd
- Study start
- Sep 2015
- Primary completion
- Apr 2019 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 28 May 2015 (estimated)
- Results
- Posted 21 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Calcium Sulfate + Antibiotics + Internal Fixation | Experimental | Device: Calcium Sulfate + Antibiotics + Internal Fixation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- Uncontrolled diabetes;
- Severe degenerative or metabolic bone disease;
- Malignancy;
- Severe vascular or neurologic disease;
- Alcoholism;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium Sulfate + Antibiotics + Internal FixationAlso: STIMULAN Rapid CureSTIMULAN 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. | Device | Calcium Sulfate + Antibiotics + Internal Fixation |
Primary outcome
Resorption of Study Device
Time frame: 6 months
Number of participants with any study device remaining visible on CT
33 secondary outcomes
Knee Injury Osteoarthritis Outcome Score - Pain Subscale
Time frame: Baseline
Range of Motion
Time frame: 6 weeks
Subsidence of Joint Surface
Time frame: 6 weeks, 3 months, 6 months, 12 months
Knee Injury Osteoarthritis Outcome Score - Pain Subscale
Time frame: 6 weeks
Knee Injury Osteoarthritis Outcome Score - Pain Subscale
Time frame: 3 months
Knee Injury Osteoarthritis Outcome Score - Pain Subscale
Time frame: 6 months
Knee Injury Osteoarthritis Outcome Score - Pain Subscale
Time frame: 12 months
Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale
Time frame: Baseline
Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale
Time frame: 6 weeks
Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale
Time frame: 6 months
Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale
Time frame: 3 months
Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale
Time frame: 12 months
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale
Time frame: Baseline
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale
Time frame: 6 weeks
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale
Time frame: 3 months
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale
Time frame: 6 months
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale
Time frame: 12 months
Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale
Time frame: Baseline
Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale
Time frame: 6 weeks
Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale
Time frame: 3 months
Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale
Time frame: 6 months
Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale
Time frame: 12 months
Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale
Time frame: Baseline
Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale
Time frame: 6 weeks
Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale
Time frame: 3 months
Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale
Time frame: 6 months
Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale
Time frame: 12 months
Range of Motion
Time frame: 3 months
Range of Motion
Time frame: 6 months
Range of Motion
Time frame: 12 months
Resorption of Study Device
Time frame: 3 months
Resorption of Study Device
Time frame: 6 months
Resorption of Study Device
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Tibial Fractures
Not yet recruiting
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Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
RecruitingPhase 3
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
Open tíbia Fracture
Not yet recruiting
Personalized Weight-Bearing With Smart Crutch Tips After Surgery for Tibial Plateau Fractures
Tibial Plateau Fracture
Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ross Leighton, MD principal investigator
Nova Scotia Health Authority
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium Sulfate + Antibiotics + Internal Fixation in people with Tibial Fractures and Intra-Articular Fractures, run by Ross Leighton at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resorption of Study Device (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.