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

Ross Leighton

Status: Completed

Conditions: Intra-Articular Fractures; Tibial Fractures; Fracture Fixation, Internal

Treatments: Device: Calcium Sulfate + Antibiotics + Internal Fixation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02456194

RL007

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Calcium Sulfate + Antibiotics + Internal Fixation

Experimental group

Treatment:

Device: Calcium Sulfate + Antibiotics + Internal Fixation