Treatment of Complex Pilon Fractures

NCT ID: NCT06089525

Last Updated: 2023-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-25

Study Completion Date

2023-12-25

Brief Summary

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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

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Conditions

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Pilon Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Open reduction and internal fixation (ORIF)

Patient has underwent ORIF to repair a pilon fracture.

No interventions assigned to this group

Primary arthrodesis (PA; ankle fusion)

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Brent Wise

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Brent Wise, MD

Role: CONTACT

913-588-6164

David Turkowitch, BS

Role: CONTACT

Facility Contacts

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Dave Turkowitch, BS

Role: primary

Other Identifiers

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00150446

Identifier Type: -

Identifier Source: org_study_id

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