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NCT05792189 · ClinicalTrials.gov registry record · NA

Distal Femur Fx: ORIF(Open Reduction and Internal Fixation) vs DFR (Distal Femur Replacement Total Knee Arthroplasty)

A NA study of Distal Femur Fracture, sponsored by University of Florida.

Recruiting
Registry status
NA
Development phase
100
Enrollment target
1
Study location

NCT05792189: Recruiting NA study of Distal Femur Fracture, sponsored by University of Florida.

NCT05792189 is a NA study of Distal Femur Fracture that is actively recruiting participants, run by University of Florida. The registered enrollment target is 100 participants, below the 133-participant average among 4 other Distal Femur Fracture trials with a reported enrollment target (25% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05792189, a NA study of Distal Femur Fracture, is actively recruiting participants, sponsored by University of Florida.

RECRUITING
Registry status
NA
Development phase
100 participants
Enrollment target
1
Study location

Study Summary

Supracondylar femur periprosthetic fractures about a total knee arthroplasty (TKA) are a catastrophic and challenging complication of TKA and unfortunately are increasing in incidence. Fixation of these fractures can be challenging due to altered anatomy for the TKA and the presence of the metallic femoral component and have a relatively high complication rate. As a result, some surgeons elect to treat these fractures with a distal femur replacement total knee arthroplasty (DFR). The purpose of this study is to prospectively evaluate periprosthetic femur fractures treated with ORIF or DFR and compare various outcomes measures (Get up and go times, KOOS Jr score)

Primary Outcome

Subjects will perform the Timed Up and Go Test, This test is used to assess mobility. Subjects are asked to wear regular footwear and can use their walking device as needed. Subjects begin by sitting in a standard armchair. Next participants are instructed to walk 10 feet to a designated line at a normal pace. Once they reach the line they are to turn and walk back to the chair and sit down. The test starts on the study staff go signal and ends once the subject is fully seated in the chair.

Conditions Studied

Distal Femur Fracture

Interventions

  • OTHER Timed Up and Go Test on subjects with ORIF of distal femur fractures
  • OTHER Koos Jr assesment on subjects with ORIF of distal femur fractures
  • OTHER Timed Up and Go Test on subjects with DFR of distal femur fracture
  • OTHER Koos Jr assesment on subjects with DFR of distal femur fracture

Study Locations (1)

Florida

  • UF & Shands Orthopaedics and Sports Medicine Institute - Gainesville

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2023-04-12
Est. Completion 2029-04-01
Phase NA
University of Florida

1,106 total trials

What NCT05792189 shows while recruiting

NCT05792189 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 4 other Distal Femur Fracture trials with a reported enrollment target (25% lower).

The record links to 1 condition, with Distal Femur Fracture appearing as the primary indexed condition, and to 4 interventions - of which Timed Up and Go Test on subjects with ORIF of distal femur fractures is the first listed.

NCT05792189 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT05792189 about?

NCT05792189 is a clinical study titled "Distal Femur Fx: ORIF(Open Reduction and Internal Fixation) vs DFR (Distal Femur Replacement Total Knee Arthroplasty)". Supracondylar femur periprosthetic fractures about a total knee arthroplasty (TKA) are a catastrophic and challenging complication of TKA and unfortunately are increasing in incidence. Fixation of these fractures can be challenging due to altered anatomy for the TKA and the presence of the metallic ...

What is the current status of trial NCT05792189?

This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2023-04-12. Estimated completion is 2029-04-01.

What conditions does trial NCT05792189 study?

This clinical trial studies the following conditions: Distal Femur Fracture.

What interventions are being tested in trial NCT05792189?

The interventions under investigation include: Timed Up and Go Test on subjects with ORIF of distal femur fractures (OTHER), Koos Jr assesment on subjects with ORIF of distal femur fractures (OTHER), Timed Up and Go Test on subjects with DFR of distal femur fracture (OTHER), Koos Jr assesment on subjects with DFR of distal femur fracture (OTHER).

Who is sponsoring clinical trial NCT05792189?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05792189 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT05792189

Source: ClinicalTrials.gov NCT05792189, the US trial registry maintained by the National Library of Medicine. NCT05792189 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.