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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06089525
Other study ID # 00150446
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
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Completed NCT02609347 - Manual Therapy After Ankle/Hindfoot Fractures N/A
Withdrawn NCT01818466 - Anterior Tibiotalar Arthrodesis With Blade Plate Fixation N/A
Not yet recruiting NCT06182904 - Management of Pilon Fractures With Versus Without Fibula Fixation
Recruiting NCT03652753 - Pilon Fracture With Intra-articular Injection of N-Acetylcysteine (Pilon NAC) Phase 4
Completed NCT03562364 - Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries N/A
Completed NCT01126398 - Trauma Expectation Factor Trauma Outcome Measure
Completed NCT05141227 - Two-stage ORIF Vs Ex. Fix. in Complex Pilon Fractures N/A
Recruiting NCT05131321 - Primary Ankle Arthrodesis Versus Open Reduction and Internal Fixation for Fragility Fractures Around the Ankle in the Frail Elderly.