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Recruiting NCT06286670

Single Versus Dual Implant Fixation of Distal Femur Fractures

No phase Interventional Articular Fractures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Single Implant Fixation, Dual Implant Fixation.
Who it may be relevant to
Registry conditions: Articular Fractures. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Single Implant Versus Dual Implant Fixation of Distal Femur Extra Articular and Complete Articular Fractures - PRORP

Overview

The goal of this clinical trial is to compare two types of surgical fixation in patients with specific kinds of distal femur fractures. The main questions it aims to answer is which operation for distal femur fractures is better for efficient return to work and everyday activities.

Detailed description

Fractures of the distal femur are severe and common injuries sustained by Wounded Warriors in combat. Despite advances in implant technology, these injuries continue to have an unacceptably high rate of nonunion (failure to heal) of approximately 20%. This adverse outcome requires additional surgery to achieve fracture healing, which prolongs recovery and further delays return to duty often beyond one year after injury. The goal of this study is to investigate a potential treatment for distal femur fractures that has the potential to improve the likelihood of fracture healing and accelerate return of patient function during the healing process.

Interventions

  • Procedure Single Implant Fixation
    Single implant fixation with either a precontoured lateral locking plate or an intramedullary nail.
  • Procedure Dual Implant Fixation
    Dual implant fixation with either a lateral locking plate plus an intramedullary nail or a lateral locking plate plus a supplemental medial plate.

Primary outcome measures

  • Return to Work - International Physical Activity Questionnaire (IPAQ) Scores [Time frame: Week 6]
  • Return to Work - International Physical Activity Questionnaire (IPAQ) Scores [Time frame: Month 3]
  • Return to Work - International Physical Activity Questionnaire (IPAQ) Scores [Time frame: Month 6]
  • Return to Work - International Physical Activity Questionnaire (IPAQ) Scores [Time frame: Month 12]
Secondary outcome measures (12)
  • Number of Unions [Time frame: 6-week, 3, 6, 12 months]
  • Number of Resource Utilizations [Time frame: 6-week, 3, 6, 12 month]
  • Number of Reoperations [Time frame: 6-week, 3, 6, 12 months]
  • Number of Complications [Time frame: 6-week, 3, 6, 12 months]
  • Time to Walking Without an Assistive Device [Time frame: 6-week, 3, 6, 12 months]
  • Prescribed Weight Bearing Status [Time frame: 6-week, 3, 6, 12 months]
  • Fear of Movement - Change in Tampa Scale for Kinesiophobia (TSK) Scores [Time frame: 6-week, 3, 6, 12 months]
  • Health Related Quality of Life - Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Scores [Time frame: 6-week, 3, 6, 12 months]
  • Global Health Status - Change in Veterans RAND 12 Item Health Survey (VR12) Scores [Time frame: 6-week, 3, 6, 12 months]
  • Change in the Work Productivity and Activity Impairment Questionnaire Scores [Time frame: 6-week, 3, 6, 12 months]
  • Change in Numeric Pain Rating [Time frame: 6-week, 3, 6, 12 months]
  • Change in Pain Inventory (BPI) [Time frame: 6-week, 3, 6, 12 months]

Eligibility criteria

Inclusion criteria

  • Age greater than or equal to 18 years
  • Surgically treated displaced distal femur extra articular or complete articular fractures

Exclusion criteria

  • Patients with injury features that preclude treatment with 2 implants
  • Patients unlikely to follow-up due to homelessness, or planning follow up at another institution
  • Body Mass Index (BMI) > 40
  • Injury due to ground level fall
  • Patient that speaks neither English or Spanish
  • Patients with multisystem injuries that could preclude return to work
  • < 18 years of age
  • Prisoner

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 16 centers
  • University of Alabama Birmingham — Birmingham
  • Cedars-Sinai Medical Center — Los Angeles
  • Emory University, Grady Memorial Research Hospital — Atlanta
  • Atrium Health Navicent — Macon
  • Louisiana State University — New Orleans
  • University of Maryland, Shock Trauma Center — Baltimore
  • NYC Health and Hospital/Bellevue — New York
  • University of North Carolina Chapel Hill — Chapel Hill
  • … and 8 more centers

Identifiers

NCT: NCT06286670 · IRB00108312 · HT94252311075

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗