TerminatedNot Applicable

Antibiotic Loaded Calcium Sulfate RCT

Stopped: Sponsor decided not to pursue the study.

Canada100 participantsStarted 2020-01-01

Plain-language 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 undergoing treatment of infected tibial defects or infected tibial nonunions.

Who can participate

Age range16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ≥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 Criteria: * 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

What they're measuring

Number of re-operations

Timeframe: 2 years post-injury

Trial details

NCT IDNCT03875963

SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11-23

View on ClinicalTrials.gov More Fracture Non Union trials