NCT03042546TerminatedPhase 4
Calcium Sulfate Spacer in Open Tibia Fractures With Sub-segmental Bone Loss to Decrease the Need for Secondary Surgery
University of Washington1 site in 1 country1 target enrollmentStarted: February 1, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- University of Washington
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Number of Patients With a Nonunion
Study Overview
Brief Summary
Investigators will compare antibiotic impregnated Calcium sulfate versus PMMA versus nothing in these sub-segmental bone defects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Patients are blinded
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Open tibia shaft fracture treated with an IMN
Exclusion Criteria
- Not provided
Arms & Interventions
Calcium Sulphate
Active Comparator
Intervention: Calcium Sulfate (Drug)
PMMA
Active Comparator
Intervention: PMMA (Drug)
Nothing
Active Comparator
Intervention: No treatment (Other)
Outcomes
Primary Outcomes
Number of Patients With a Nonunion
Time Frame: One Year
Radiographic healing at one year with no additional surgery
Secondary Outcomes
No secondary outcomes reported
Investigators
Claude Sagi
Professor, Orthopedics
University of Washington
Study Sites (1)
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