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

NCT00582686 | Completed

• 1 other identifier: F990923008
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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

Conditions

Calcaneus Fractures

Keywords

Calcaneus Fractures; Iliac Crest Bone Grafting; Open Reduction & Internal Fixation

Outcome Measures

Primary Outcomes (1)

• Union and healing of Calcaneus Fracture

  3 month to 12 month healing period

Study Arms (2)

ORIF with Bone Grafting

ACTIVE COMPARATOR

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.

Procedure: ORIF of Calcaneus with bone grafting

ORIF without Bone Grafting

ACTIVE COMPARATOR

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

Procedure: ORIF of Calcaneus without bone grafting

Interventions

ORIF of Calcaneus with bone grafting PROCEDURE

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

ORIF with Bone Grafting

ORIF of Calcaneus without bone grafting PROCEDURE

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

ORIF without Bone Grafting

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

The University of Alabama at Birmingham, Orthopaedic Trauma

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Interventions

Bone Transplantation

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Orthopedic Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Rena L Stewart, MD

  The University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 28, 2007
• Study Start: May 1, 2000
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: October 1, 2013

Record last verified: 2013-09

Locations

US (1)