Comparing outcomes of two surgical methods for complex ankle fractures
Treatment of Complex Pilon Fractures: A Pilot Study Comparing Primary Arthrodesis (PA) to Open Reduction and Internal Fixation (ORIF)
This study is testing which surgical method, either fixing the ankle with plates or fusing the joint, helps people with complex ankle fractures recover better and feel less pain.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT06089525 on ClinicalTrials.gov |
What this trial studies
This project aims to compare patient outcomes between those undergoing open reduction and internal fixation (ORIF) and those receiving ankle fusion (PA) after an acute pilon fracture. The study will assess various factors including gait analysis, pain levels, functional outcomes, and complications such as post-traumatic arthritis and infections. It will utilize a novel arthrodesis surgical technique alongside Opal sensor gait analysis data to gather comprehensive insights. This pilot study will help fill the gap in existing literature regarding these surgical approaches.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have sustained a multifragmented acute pilon fracture and are receiving either ORIF or PA.
Not a fit: Patients under 18 years old or pregnant women will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the most effective surgical treatment for complex pilon fractures, improving patient recovery and outcomes.
How similar studies have performed: Limited literature exists comparing ORIF and ankle fusion, making this study's approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Individuals receiving ORIF or PA for a multifragmented acute pilon fracture occuring at the joint surface over the age of 18 from 2018 to present at The University of Kansas Medical Center (KUMC) or Emory University Hospital. Exclusion Criteria: Anyone under the age of 18 years. Pregnant women.
Where this trial is running
Kansas City, Kansas
- The University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Study coordinator: Brent Wise, MD
- Email: bwise3@kumc.edu
- Phone: 913-588-6164
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.