Wake Forest University Health Sciences
Management of severe injuries to the heel (displaced intra-articular calcaneus fractures) continues to be a major challenge for orthopedic surgeons. Previous studies have demonstrated poor outcomes, and results show that patients experience long-term pain and decreased quality of life postoperatively. Poor outcomes are driven by pain, in particular, which is linked to post-traumatic subtalar arthritis.
Calcaneus Fracture
Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA)
Open Reduction Internal Fixation (ORIF) only
NA
The goal of this clinical trial is to compare two surgical options for calcaneus fractures to determine best treatment for returning to work sooner in adults. Participants will be randomized to one of two treatment options and will be asked to complete patient reported outcome measure surveys. Researchers will compare Open Reduction and Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA) to ORIF alone to see which group returns to work at an earlier timepoint.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 218 participants |
| Masking : | NONE |
| Primary Purpose : | TREATMENT |
| Official Title : | Primary Subtalar Arthrodesis for Calcaneal Fractures to Optimize Performance: A Randomized Clinical Trial |
| Actual Study Start Date : | 2024-10 |
| Estimated Primary Completion Date : | 2026-12 |
| Estimated Study Completion Date : | 2026-12 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
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