Skip to content

Treatment of Complex Pilon Fractures

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06089525
Enrollment
30
Registered
2023-10-18
Start date
2023-08-25
Completion date
2023-12-25
Last updated
2023-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pilon Fracture

Keywords

Pilon Fracture

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.

Interventions

None listed

Sponsors

Emory University
CollaboratorOTHER
University of Kansas Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
12 Item Short Form Survey (SF-12)Collected only once; from 6 months post-op up to date of death from any causePatient reported outcome measures regarding health and daily activities (Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning)
Walking cadenceCollected only once; from 6 months post-op up to date of death from any causeSteps per minute as determined by the use of the Opal Sensors
Timed up-and-goCollected only once; from 6 months post-op up to date of death from any causeTime 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).
Foot and ankle Outcome Score (FAOS)Collected only once; from 6 months post-op up to date of death from any causeFoot and ankle injury patient reported outcome measure (Scores range from 0 to 100, with higher scores indicating better foot and ankle surgical outcomes)
Ankle range of motionCollected only once; from 6 months post-op up to date of death from any causeInversion and eversion range, and flexion versus extension range determined by the use of the Opal sensors

Secondary

MeasureTime frameDescription
Need for secondary operationFrom the date of surgery up until the date of death from any causeNumber of patients that required follow up surgery to their initially injured ankle
Return to work timeFrom the date of surgery up until the date of death from any causeNumber of weeks it took for patients to return to work
Presence of infection and/or post-traumatic arthritisFrom the date of surgery up until the date of death from any causeRate of patients being rehospitalized or returning for care beyond what is required due to infection or arthritis

Countries

United States

Contacts

Primary ContactBrent Wise, MD
bwise3@kumc.edu913-588-6164
Backup ContactDavid Turkowitch, BS
dturkowitch@kumc.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026