Status:
TERMINATED
Antibiotic Loaded Calcium Sulfate RCT
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Biocomposites Ltd
Conditions:
Fracture Non Union
Infection
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
This is a multi-centered, prospective, randomized controlled trial comparing current standard of care for defect management to placement of antibiotic loaded Stimulan as a bone void filler in patients...
Detailed Description
There is a tremendous burden of disease associated with infected bone defects and infected nonunions and their management is challenging. Infected bone defects and nonunions have a profound clinical a...
Eligibility Criteria
Inclusion
- ≥16 years old.
- Isolated infected tibia defect or infected tibial nonunion (characterized by clinical symptoms present for greater than 90 days, the presence of necrotic bone, and bacteria cultured from prior procedures, surgical biopsy, or draining sinuses).
Exclusion
- Presence of previous vascular injury or pathologic fracture
- Associated lower limb injuries that would interfere with rehabilitation or outcome
- Refusal to participate
- Inability to provide informed consent
- Inability to speak/understand or read English without a registered interpreter.
- Allergy or sensitivity to Vancomycin or Tobramycin
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03875963
Start Date
January 1 2020
End Date
November 23 2022
Last Update
December 18 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5