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Calcium Sulfate Spacer in Open Tibia Fractures

NCT03042546 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-02-10

Study results available
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Summary

Investigators will compare antibiotic impregnated Calcium sulfate versus PMMA versus nothing in these sub-segmental bone defects.

Conditions

  • Open tíbia Fracture With Sub-segmental Bone Loss

Interventions

DRUG

Calcium Sulfate

Calcium Sulfate with abx will be used in the defect

DRUG

PMMA

PMMA with abx will be used in the defect

OTHER

No treatment

The defect will not be treated

Sponsors & Collaborators

Principal Investigators

  • Claude Sagi · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2018-05-29
Completion
2018-05-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03042546 on ClinicalTrials.gov