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

NCT ID: NCT02456194

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2021-05-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Calcium Sulfate + Antibiotics + Internal Fixation

Group Type: EXPERIMENTAL

Calcium Sulfate + Antibiotics + Internal Fixation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

STIMULAN Rapid Cure

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biocomposites Ltd

INDUSTRY

Sponsor Role: collaborator

Ross Leighton

OTHER

Sponsor Role: lead

Responsible Party

Ross Leighton

Orthopaedic Surgeon

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ross Leighton, MD

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Health Authority

Locations

Alberta Health Services

Calgary, Alberta, Canada

Horizon Health Network

Moncton, New Brunswick, Canada

Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, Canada

Halifax Infirmary

Halifax, Nova Scotia, Canada

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

RL007

Identifier Type: -

Identifier Source: org_study_id