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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Rena Stewart, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT00582686

First received: December 20, 2007

Last updated: June 1, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 20, 2007

Last Updated Date

June 1, 2012

Start Date ^ICMJE

May 2000

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Union and healing of Calcaneus Fracture [ Time Frame: 3 month to 12 month healing period ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00582686 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Prospective Comparison of Open Reduction Internal Fixation of Calcaneus Fractures With and Without Tricortical Iliac Crest Bone Grafting

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Calcaneus Fractures

Intervention ^ICMJE

Procedure: 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
Procedure: ORIF of Calcaneus without bone grafting
The calcaneus fracture will be surgically repaired with open reduction and internal fixation (ORIF) (no bone grafting)

Study Arm (s)

Active Comparator: 1, A
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.

Intervention: Procedure: ORIF of Calcaneus with bone grafting
Active Comparator: 2, B
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

Intervention: Procedure: ORIF of Calcaneus without bone grafting

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

August 2012

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00582686

Other Study ID Numbers ^ICMJE

F990923008

Has Data Monitoring Committee

Responsible Party

Rena Stewart, University of Alabama at Birmingham

Study Sponsor ^ICMJE

University of Alabama at Birmingham

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Rena L Stewart, MD

The University of Alabama at Birmingham

Information Provided By

University of Alabama at Birmingham

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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