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

Not Applicable

Completed

• Conditions: Calcaneus Fractures
• Interventions: Procedure: ORIF of Calcaneus with bone grafting; Procedure: ORIF of Calcaneus without bone grafting

• Registration Number: NCT00582686
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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

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.

Study Timeline

• Study Start: 2000-05
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-27
• Study First Posted: 2007-12-28
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-28
• Last Update Posted: 2013-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ORIF with Bone Grafting	ORIF of Calcaneus 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.
ORIF without Bone Grafting	ORIF of Calcaneus 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

Primary Outcome Measures

Name	Time	Method
Union and healing of Calcaneus Fracture	3 month to 12 month healing period

Trial Locations

Locations (1)

The University of Alabama at Birmingham, Orthopaedic Trauma; 🇺🇸 Birmingham, Alabama, United States