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OpenTrials
Completed

NCT Number: NCT00582686

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

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

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Key information

Conditions

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Alabama at Birmingham, Orthopaedic Trauma

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 of Calcaneus without bone grafting

Procedure

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

Primary outcomes

  1. Union and healing of Calcaneus Fracture

    Time frame: 3 month to 12 month healing period

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Acronym: CALCANEUS

Important dates

Study start
2000
Primary completion
2008
Study completion
2008
First posted
Dec 28, 2007
Registry last updated
Oct 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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