Treatment of Complex Pilon Fractures

Pilon Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06089525
• Other study ID #: 00150446
• Status: Recruiting
• Start date: August 25, 2023
• Est. completion date: December 25, 2023

Study information

• Verified date: October 2023
• Source: University of Kansas Medical Center
• Contact: Brent Wise, MD
• Phone: 913-588-6164
• Email: bwise3[@]kumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 25, 2023
• Est. primary completion date: December 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Pilon Fracture

Locations

Country	Name	City	State
United States	The University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Emory University

Country where clinical trial is conducted

United States, 

Outcome

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