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

The University of Alabama at Birmingham

Status: Completed

Conditions: Calcaneus Fractures

Treatments: Procedure: ORIF of Calcaneus with bone grafting; Procedure: ORIF of Calcaneus without bone grafting

Study type: Interventional

Funder types: Other

Identifiers

NCT00582686

F990923008

Details and patient eligibility

About

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

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

ORIF with Bone Grafting

Active Comparator group

Description:

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.

Treatment:

Procedure: ORIF of Calcaneus with bone grafting

ORIF without Bone Grafting

Active Comparator group

Description:

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

Treatment:

Procedure: ORIF of Calcaneus without bone grafting