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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00582686
Acronym
CALCANEUS
Enrollment
49
Registered
2007-12-28
Start date
2000-05-31
Completion date
2008-03-31
Last updated
2013-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calcaneus Fractures

Keywords

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

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.

Interventions

PROCEDUREORIF 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

PROCEDUREORIF of Calcaneus without bone grafting

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

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Union and healing of Calcaneus Fracture3 month to 12 month healing period

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026