Recruiting

Complex Pilon FracturesTreatment of Complex Pilon Fractures

Sponsor:

University of Kansas Medical Center

Code:

NCT06089525

Conditions

Pilon Fracture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Pilon Fracture

Study ID

NCT06089525

Start date

Aug 25, 2023

Status verified date

Oct, 2023

Completion date

Dec 25, 2023

Anticipated

Primary completion date

Dec 25, 2023

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Open reduction and internal fixation (ORIF)

Patient has underwent ORIF to repair a pilon fracture.

Primary arthrodesis (PA; ankle fusion)

Patient has underwent PA/ankle fusion to repair a pilon fracture.

Primary outcome measure

Ankle range of motion [ Time Frame: Collected only once; from 6 months post-op up to date of death from any cause ]
Walking cadence [ Time Frame: Collected only once; from 6 months post-op up to date of death from any cause ]
Timed up-and-go [ Time Frame: Collected only once; from 6 months post-op up to date of death from any cause ]
Foot and ankle Outcome Score (FAOS) [ Time Frame: Collected only once; from 6 months post-op up to date of death from any cause ]
12 Item Short Form Survey (SF-12) [ Time Frame: Collected only once; from 6 months post-op up to date of death from any cause ]

Central Contacts and Locations

Central contacts

Brent Wise, MD

913-588-6164 bwise3@kumc.edu

David Turkowitch, BS

dturkowitch@kumc.edu

Locations

The University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66103

Contacts

Dave Turkowitch, BS

dturkowitch@kumc.edu

Principal Investigator:

Brent Wise, MD

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Oct 18, 2023

Last verified

Oct, 2023

Keywords

Pilon Fracture

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2023-10-18.