Treatment of Complex Pilon Fractures

Recruiting

• Conditions: Pilon Fracture

• Registration Number: NCT06089525
• Lead Sponsor: University of Kansas Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-25
• Study First Submitted: 2023-09-13
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-12
• Last Update Submitted: 2023-10-12
• Study First Posted: 2023-10-18
• Last Update Posted: 2023-10-18
• Primary Completion: 2023-12-25
• Study Completion: 2023-12-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

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Exclusion Criteria

Anyone under the age of 18 years. Pregnant women.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Foot and ankle Outcome Score (FAOS)	Collected only once; from 6 months post-op up to date of death from any cause	Foot 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 motion	Collected only once; from 6 months post-op up to date of death from any cause	Inversion and eversion range, and flexion versus extension range determined by the use of the Opal sensors
Walking cadence	Collected only once; from 6 months post-op up to date of death from any cause	Steps per minute as determined by the use of the Opal Sensors
12 Item Short Form Survey (SF-12)	Collected only once; from 6 months post-op up to date of death from any cause	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)
Timed up-and-go	Collected only once; from 6 months post-op up to date of death from any cause	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States