Treatment of Complex Pilon Fractures

NCT06089525 | Unknown

• 1 other identifier: 00150446
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Pilon Fracture

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Presence of infection and/or post-traumatic arthritis

  From the date of surgery up until the date of death from any cause

• Need for secondary operation

  From the date of surgery up until the date of death from any cause

• Return to work time

  From the date of surgery up until the date of death from any cause

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals over the age of 18 that have undergone an ORIF or PA surgery for an acute pilon fracture at either KUMC or Emory University Hospital.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Emory University: collaborator

Study Sites (1)

The University of Kansas Medical Center

Kansas City, Kansas, 66103, United States

RECRUITING

Central Study Contacts

Brent Wise, MD

CONTACT

913-588-6164; bwise3@kumc.edu

David Turkowitch, BS

CONTACT

dturkowitch@kumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: October 18, 2023
• Study Start: August 25, 2023
• Primary Completion: December 25, 2023
• Study Completion: December 25, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

US (1)