Status:

ENROLLING_BY_INVITATION

Dual Implant Versus Single Implant Distal End of Femur

Lead Sponsor:

University of Utah

Conditions:

Distal Femur Fracture

Eligibility:

All Genders

60-100 years

Phase:

NA

Brief Summary

The investigators overall study objective is to determine the difference in outcomes for patients over 60 years of age with a displaced distal femur fracture treated with dual distal femur implants (d...

Detailed Description

The incidence of distal femur fractures in elderly patients continues to increase, most recently having an incidence of 8.7/100,000/year. This trend likely accompanies the aging population and the inc...

Eligibility Criteria

Inclusion

  • Patient age 60 years or greater,
  • Femur fracture distal to the femoral diaphysis,
  • Operative treatment within 72 hours of presenting to the treating hospital,
  • Patient was previously ambulatory,
  • Fracture amendable to either single or dual implant fixation,
  • Informed consent can be obtained from the patient, family member, or power of attorney.

Exclusion

  • Associated major lower extremity fracture,
  • Ongoing infection,
  • History of metabolic bone disease (Paget's, etc),
  • Pathologic fracture,
  • Open fracture,
  • Severe cognitive impairment (Six Item Screener with 3 or more errors),
  • Stage 5 Parkinson's disease,
  • Significant femoral bone loss requiring planned staged bone grafting,
  • Vascular injury.

Key Trial Info

Start Date :

March 14 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 1 2027

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT05292313

Start Date

March 14 2022

End Date

February 1 2027

Last Update

October 31 2025

Active Locations (1)

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1

University of Utah Orthopaedic Center

Salt Lake City, Utah, United States, 84112