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

Calcaneus Fractures Clinical Trial

— CALCANEUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00582686
• Other study ID #: F990923008
• Status: Completed
• Phase: N/A
• First received: December 20, 2007
• Last updated: September 28, 2013
• Start date: May 2000
• Est. completion date: March 2008

Study information

• Verified date: September 2013
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Calcaneus Fractures
• Fractures, Bone

Intervention

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

Locations

Country	Name	City	State
United States	The University of Alabama at Birmingham, Orthopaedic Trauma	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Union and healing of Calcaneus Fracture		3 month to 12 month healing period	No