Calcium Sulfate Spacer in Open Tibia Fractures

Phase 4

Terminated

• Conditions: Open tíbia Fracture With Sub-segmental Bone Loss
• Interventions: Other: No treatment; Drug: PMMA; Drug: Calcium Sulfate

• Registration Number: NCT03042546
• Lead Sponsor: University of Washington

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-27
• Study Start: 2017-02-01
• Study First Submitted QC: 2017-02-01
• Study First Posted: 2017-02-03
• Primary Completion: 2018-05-29
• Study Completion: 2018-05-29
• Results First Submitted: 2019-04-22
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-07
• Last Update Submitted: 2023-02-07
• Results First Posted: 2023-02-10
• Last Update Posted: 2023-02-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Open tibia shaft fracture treated with an IMN

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nothing	No treatment	-
PMMA	PMMA	-
Calcium Sulphate	Calcium Sulfate	-

Primary Outcome Measures

Name	Time	Method
Number of Patients With a Nonunion	One Year	Radiographic healing at one year with no additional surgery

Trial Locations

Locations (1)

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States