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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Calcaneus Fractures

Intervention / Treatment
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* Procedure: ORIF of Calcaneus with bone grafting
* Procedure: ORIF of Calcaneus without bone grafting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ORIF with Bone Grafting<br>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<br>* The calcaneus fracture will be surgically repaired with open reduction and internal fixation (ORIF) and Tricortical Iliac Crest bone grafting<br>|
| Active Comparator: ORIF without Bone Grafting<br>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<br>* The calcaneus fracture will be surgically repaired with open reduction and internal fixation (ORIF) (no bone grafting)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Union and healing of Calcaneus Fracture |  | 3 month to 12 month healing period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Calcaneus Fractures, Iliac Crest Bone Grafting, Open Reduction & Internal Fixation