Clinical trial NCT02456194: Management of Traumatic Bone Defects in Tibial Plateau Fractures With Antibiotic-Impregnated Biodegradable Calcium Sulfate Beads: A Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tibial Fractures
Intra-Articular Fractures
Fracture Fixation, Internal
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Biocomposites Ltd
First posted: 2015-05-28
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Resorption of Study Device
timeFrame: 6 months
Secondary outcomes:
measure: Knee Injury Osteoarthritis Outcome Score - Pain Subscale
timeFrame: Baseline
measure: Range of Motion
timeFrame: 6 weeks
measure: Subsidence of Joint Surface
timeFrame: 6 weeks, 3 months, 6 months, 12 months
measure: Knee Injury Osteoarthritis Outcome Score - Pain Subscale
timeFrame: 6 weeks
measure: Knee Injury Osteoarthritis Outcome Score - Pain Subscale
timeFrame: 3 months
measure: Knee Injury Osteoarthritis Outcome Score - Pain Subscale
timeFrame: 6 months
measure: Knee Injury Osteoarthritis Outcome Score - Pain Subscale
timeFrame: 12 months
measure: Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale
timeFrame: Baseline
measure: Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale
timeFrame: 6 weeks
measure: Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale
timeFrame: 6 months
measure: Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale
timeFrame: 3 months
measure: Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale
timeFrame: 12 months
measure: Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale
timeFrame: Baseline
measure: Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale
timeFrame: 6 weeks
measure: Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale
timeFrame: 3 months
measure: Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale
timeFrame: 6 months
measure: Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale
timeFrame: 12 months
measure: Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale
timeFrame: Baseline
measure: Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale
timeFrame: 6 weeks
measure: Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale
timeFrame: 3 months
measure: Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale
timeFrame: 6 months
measure: Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale
timeFrame: 12 months
measure: Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale
timeFrame: Baseline
measure: Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale
timeFrame: 6 weeks
measure: Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale
timeFrame: 3 months
measure: Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale
timeFrame: 6 months
measure: Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale
timeFrame: 12 months
measure: Range of Motion
timeFrame: 3 months
measure: Range of Motion
timeFrame: 6 months
measure: Range of Motion
timeFrame: 12 months
measure: Resorption of Study Device
timeFrame: 3 months
measure: Resorption of Study Device
timeFrame: 6 months
measure: Resorption of Study Device
timeFrame: 12 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Health Services
state: Alberta
city: Moncton
country: Canada
facility: Horizon Health Network
state: New Brunswick
city: Saint John's
country: Canada
facility: Memorial University of Newfoundland
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Halifax Infirmary
state: Nova Scotia
city: Montreal
country: Canada
facility: Hopital du Sacre-Coeur de Montreal
state: Quebec
Study officials:
affiliation: Nova Scotia Health Authority
name: Ross Leighton, MD
role: PRINCIPAL_INVESTIGATOR
References: