Surgical options for treating severe heel fractures
Primary Subtalar Arthrodesis for Calcaneal Fractures to Optimize Performance: A Randomized Clinical Trial
This study is testing two different surgical methods for treating severe heel fractures to see which one helps patients get back to work faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 218 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 14 sites (Atlanta, Georgia and 13 other locations) |
| Trial ID | NCT06249126 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare two surgical approaches for managing displaced intra-articular calcaneus fractures, which are severe injuries to the heel. Participants will be randomly assigned to receive either Open Reduction and Internal Fixation (ORIF) combined with Primary Subtalar Arthrodesis (PSTA) or ORIF alone. The primary focus is to evaluate which treatment allows patients to return to work sooner, with participants completing patient-reported outcome measures to assess their recovery. The study seeks to address the challenges of poor postoperative outcomes and long-term pain associated with these fractures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older undergoing surgical treatment for specific types of displaced intra-articular calcaneus fractures.
Not a fit: Patients with certain types of fractures that do not meet the inclusion criteria or those with a BMI over 40 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery times and quality of life for patients with calcaneus fractures.
How similar studies have performed: Previous studies have shown poor outcomes for similar injuries, indicating a need for improved treatment options, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Undergoing operative treatment for displaced intra-articular calcaneus fracture * Sanders III and IV displaced intra-articular calcaneus fracture OR Sanders II with any of the following criteria: Bohler angle \< 0 degrees, open fracture, pain syndrome, substance use disorder * Age 18 or older * Able to follow up at site for 1 year Exclusion Criteria: * Planned surgery using extensile lateral approach * Sanders II displaced intra-articular calcaneus fracture without: Bohler angle \< 0 degrees, open fracture, pain syndrome, or substance * \<18 years of age * Body Mass Index (BMI) \>40 * Unable to follow up at site for 1 year * Patients that speak neither English or Spanish * Prisoner
Where this trial is running
Atlanta, Georgia and 13 other locations
- Emory University, Grady Memorial Research Hospital — Atlanta, Georgia, United States (Recruiting)
- Atrium Health Navicent — Macon, Georgia, United States (Recruiting)
- University of Kentucky — Lexington, Kentucky, United States (Not_yet_recruiting)
- Louisiana State University - University Medical Center New Orleans — New Orleans, Louisiana, United States (Not_yet_recruiting)
- University of Maryland Medical Center — Baltimore, Maryland, United States (Recruiting)
- NYC Health and Hospital/Bellevue — New York, New York, United States (Not_yet_recruiting)
- University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- Atrium Health Carolinas Medical Center — Charlotte, North Carolina, United States (Recruiting)
- OrthoCarolina Foot and Ankle Institute — Charlotte, North Carolina, United States (Recruiting)
- Atrium Health Cabarrus — Concord, North Carolina, United States (Recruiting)
- Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (Not_yet_recruiting)
- Prisma Health — Greenville, South Carolina, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Not_yet_recruiting)
- The University of Texas Medical Branch — Galveston, Texas, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Joseph R Hsu, MD — Wake Forest University Health Sciences
- Study coordinator: Christine Churchill
- Email: Christine.Churchill@advocatehealth.org
- Phone: 704-355-6947
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.