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Open Reduction Internal Fixation of Calcaneus Fractures With and Without Bone Graft

NCT ID: NCT00582686

Last Updated: 2013-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-31

Study Completion Date

2008-03-31

Brief Summary

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The purpose of this study is to compare patient functional outcomes for surgical fixation of calcaneus fractures with and without tricortical iliac crest bone grafting

Detailed Description

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This study was designed as a randomized, prospective evaluation of patients who have sustained an intra-articular calcaneus fracture that requires open reduction with internal fixation as the preferred method of treatment. Patients who desire to participate in this study will be randomized into one of two groups. Group A will be made up of patients that undergo open reduction with internal fixation and Tricortical iliac crest bone grafting. Group B will consist of patients that undergo open reduction with internal fixation without bone grafting. All other surgical techniques and management of the fracture and patient will remain unchanged.

Conditions

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Calcaneus Fractures

Keywords

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Calcaneus Fractures Iliac Crest Bone Grafting Open Reduction & Internal Fixation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ORIF with Bone Grafting

This study will be designed as a randomized, prospective, blinded evaluation of patients who have sustained an intra-articular calcaneous fracture that would require open reduction with internal fixation as the preferred method of treatment. Group A will be made up of patients that undergo ORIF and Tricortical iliac crest bone grafting.

Group Type ACTIVE_COMPARATOR

ORIF of Calcaneus with bone grafting

Intervention Type PROCEDURE

The calcaneus fracture will be surgically repaired with open reduction and internal fixation (ORIF) and Tricortical Iliac Crest bone grafting

ORIF without Bone Grafting

This study will be designed as a randomized, prospective, blinded evaluation of patients who have sustained an intra-articular calcaneous fracture that would require open reduction with internal fixation as the preferred method of treatment. Group B will consist of patients that undergo open reduction with internal fixation without bone grafting

Group Type ACTIVE_COMPARATOR

ORIF of Calcaneus without bone grafting

Intervention Type PROCEDURE

The calcaneus fracture will be surgically repaired with open reduction and internal fixation (ORIF) (no bone grafting)

Interventions

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ORIF of Calcaneus with bone grafting

The calcaneus fracture will be surgically repaired with open reduction and internal fixation (ORIF) and Tricortical Iliac Crest bone grafting

Intervention Type PROCEDURE

ORIF of Calcaneus without bone grafting

The calcaneus fracture will be surgically repaired with open reduction and internal fixation (ORIF) (no bone grafting)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* intra-articular calcaneus fractures requiring open reduction and internal fixation
* Adult patient (19 years or older)
* Mental capacity to comply with post-operative regimen, evaluation and data collection

Exclusion Criteria

* non-operative fractures for primary or secondary reasons
* prior surgery to the hindfoot of the involved lower extremity
* inability to comply with post-operative regimen, evaluation and data collection
* inability or unwillingness to give informed consent
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rena L Stewart, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Alabama at Birmingham

Locations

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The University of Alabama at Birmingham, Orthopaedic Trauma

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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F990923008

Identifier Type: -

Identifier Source: org_study_id