UnknownNot Applicable

Treatment of Complex Pilon Fractures

United States30 participantsStarted 2023-08-25

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ankle range of motion

Timeframe: Collected only once; from 6 months post-op up to date of death from any cause

Walking cadence

Timeframe: Collected only once; from 6 months post-op up to date of death from any cause

Timed up-and-go

Timeframe: Collected only once; from 6 months post-op up to date of death from any cause

Foot and ankle Outcome Score (FAOS)

Timeframe: Collected only once; from 6 months post-op up to date of death from any cause

12 Item Short Form Survey (SF-12)

Timeframe: Collected only once; from 6 months post-op up to date of death from any cause

Trial details

NCT IDNCT06089525

SponsorUniversity of Kansas Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-25

Contact for this trial

Brent Wise, MD

913-588-6164 bwise3@kumc.edu

View on ClinicalTrials.gov More Pilon Fracture trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Ankle range of motion

Timeframe: Collected only once; from 6 months post-op up to date of death from any cause

Walking cadence

Timeframe: Collected only once; from 6 months post-op up to date of death from any cause

Timed up-and-go

Timeframe: Collected only once; from 6 months post-op up to date of death from any cause

Foot and ankle Outcome Score (FAOS)

Timeframe: Collected only once; from 6 months post-op up to date of death from any cause

12 Item Short Form Survey (SF-12)

Timeframe: Collected only once; from 6 months post-op up to date of death from any cause