Calcium Sulfate Spacer in Open Tibia Fractures

NCT ID: NCT03042546

Last Updated: 2023-02-10

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-05-29

Brief Summary

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

Detailed Description

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Conditions

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Open tíbia Fracture With Sub-segmental Bone Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Patients are blinded

Study Groups

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Calcium Sulphate

Group Type ACTIVE_COMPARATOR

Calcium Sulfate

Intervention Type DRUG

Calcium Sulfate with abx will be used in the defect

PMMA

Group Type ACTIVE_COMPARATOR

PMMA

Intervention Type DRUG

PMMA with abx will be used in the defect

Nothing

Group Type ACTIVE_COMPARATOR

No treatment

Intervention Type OTHER

The defect will not be treated

Interventions

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Calcium Sulfate

Calcium Sulfate with abx will be used in the defect

Intervention Type DRUG

PMMA

PMMA with abx will be used in the defect

Intervention Type DRUG

No treatment

The defect will not be treated

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Open tibia shaft fracture treated with an IMN

Exclusion Criteria

* None
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Claude Sagi

Professor, Orthopedics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claude Sagi

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Harborview Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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STUDY00002348

Identifier Type: -

Identifier Source: org_study_id

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