Treatment of Complex Pilon Fractures

Study Overview
=================
Brief Summary
-----------------
This project intends to compare patient outcomes between patients undergoing ORIF compared to PA, or ankle fusion, following an acute pilon fracture. Limited literature comparing ORIF and ankle fusion as a primary procedure exists. Particularly, no present literature exists examining the novel arthrodesis surgical technique utilized in this study in conjunction with Opal sensor gait analysis data. This study will serve as a pilot study and assess patient gait, degree of pain, functional outcome scores, development of post-traumatic arthritis and/or infection, need for secondary surgery, and return to work time.

Official Title
-----------------
Treatment of Complex Pilon Fractures: A Pilot Study Comparing Primary Arthrodesis (PA) to Open Reduction and Internal Fixation (ORIF)

Conditions
-----------------
Pilon Fracture

Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open reduction and internal fixation (ORIF)<br>Patient has underwent ORIF to repair a pilon fracture. | |
| Primary arthrodesis (PA; ankle fusion)<br>Patient has underwent PA/ankle fusion to repair a pilon fracture. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle range of motion | Inversion and eversion range, and flexion versus extension range determined by the use of the Opal sensors | Collected only once; from 6 months post-op up to date of death from any cause | 
| Walking cadence | Steps per minute as determined by the use of the Opal Sensors | Collected only once; from 6 months post-op up to date of death from any cause | 
| Timed up-and-go | Time it takes to stand from seated, walk 10 feet forward, turn around, and sit back down, unassisted (determined by the use of the Opal sensors). | Collected only once; from 6 months post-op up to date of death from any cause | 
| Foot and ankle Outcome Score (FAOS) | Foot and ankle injury patient reported outcome measure (Scores range from 0 to 100, with higher scores indicating better foot and ankle surgical outcomes) | Collected only once; from 6 months post-op up to date of death from any cause | 
| 12 Item Short Form Survey (SF-12) | Patient reported outcome measures regarding health and daily activities (Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning) | Collected only once; from 6 months post-op up to date of death from any cause | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of infection and/or post-traumatic arthritis | Rate of patients being rehospitalized or returning for care beyond what is required due to infection or arthritis | From the date of surgery up until the date of death from any cause | 
| Need for secondary operation | Number of patients that required follow up surgery to their initially injured ankle | From the date of surgery up until the date of death from any cause | 
| Return to work time | Number of weeks it took for patients to return to work | From the date of surgery up until the date of death from any cause | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pilon Fracture