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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ORIF with Bone Grafting | Active Comparator | 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. |
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| ORIF without Bone Grafting | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Union and healing of Calcaneus Fracture | 3 month to 12 month healing period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rena L Stewart, MD | The University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham, Orthopaedic Trauma | Birmingham | Alabama | 35294 | United States |
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| ID | Term |
|---|---|
| D016025 | Bone Transplantation |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| ORIF of Calcaneus without bone grafting | Procedure | The calcaneus fracture will be surgically repaired with open reduction and internal fixation (ORIF) (no bone grafting) |
|
| D019637 |
| Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D014180 | Transplantation |