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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
  Purpose

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


Condition Intervention
Calcaneus Fractures
 Procedure: ORIF of Calcaneus with bone grafting
Procedure: ORIF of Calcaneus without bone grafting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Comparison of Open Reduction Internal Fixation of Calcaneus Fractures With and Without Tricortical Iliac Crest Bone Grafting

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

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

Enrollment: 49
Study Start Date: May 2000
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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
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
 Procedure: ORIF of Calcaneus without bone grafting
The calcaneus fracture will be surgically repaired with open reduction and internal fixation (ORIF) (no 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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00582686

Locations
United States, Alabama
The University of Alabama at Birmingham, Orthopaedic Trauma
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Rena L Stewart, MD The University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Rena Stewart, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00582686     History of Changes
Other Study ID Numbers: F990923008
Study First Received: December 20, 2007
Last Updated: June 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Calcaneus Fractures
Iliac Crest Bone Grafting
Open Reduction & Internal Fixation

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013