Antibiotic loaded bone filler for Nonunion Fracture

N/A

Waitlist Available

Led By Emil Schemitsch, MD FRCS(C)

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years post-injury

Awards & highlights

Study Summary

This trial is testing a new way to treat infected bones that may be better than the current standard of care.

Eligible Conditions

Nonunion Fracture
Infections

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years post-injury

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years post-injury

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years post-injury for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of re-operations

Secondary outcome measures

Economic analysis

EuroQol Group Quality of Life Scale with 5 Dimensions and 5 Levels (EQ-5D-5L)

Functional Index In Trauma (FIX-IT) Measure

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Antibiotic loaded bone fillerExperimental Treatment1 Intervention

Patients will undergo irrigation and debridement, surgical stabilization as required, and defect management by placement of antibiotic loaded Stimulan as a bone void filler [calcium sulfate bone void filler (10 cc of STIMULAN(R) Rapid Cure, Biocomposites Ltd, UK) combined with the following antibiotic combination: 1g Vancomycin, 240mg Tobramycin]. The concurrent use of antibiotics is at the discretion of the treating physician.

Group II: Standard of careActive Control1 Intervention

Current standard of care treatment for infected tibial defects or infected tibial nonunions includes treatment with irrigation and debridement, surgical stabilization as required, and defect management as required including placement of a polymethyl methacrylate spacer with or without antibiotics. A second procedure may or may not occur 6-8 weeks later with removal of the cement spacer and bone grafting into the preserved defect. Concurrent use of antibiotics is at the discretion of the treating physician.

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