Prospective Comparison of Open Reduction Internal Fixation of Calcaneus Fractures With and Without Tricortical Iliac Crest Bone Grafting
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- Union and healing of Calcaneus Fracture
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
ORIF with Bone Grafting
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.
Intervention: ORIF of Calcaneus with bone grafting (Procedure)
ORIF without Bone Grafting
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
Intervention: ORIF of Calcaneus without bone grafting (Procedure)
Outcomes
Primary Outcomes
Union and healing of Calcaneus Fracture
Time Frame: 3 month to 12 month healing period
Secondary Outcomes
No secondary outcomes reported