Status:

ACTIVE_NOT_RECRUITING

Dual Implant Versus Single Implant Distal End of Femur

Lead Sponsor:

Mayo Clinic

Conditions:

Femur Fracture

Eligibility:

All Genders

60+ years

Phase:

NA

Brief Summary

This research study is being conducted to examine the effect of two versus one fixation device for fixation of distal femur fractures.

Eligibility Criteria

Inclusion

  • 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 :

April 29 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 1 2026

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06032299

Start Date

April 29 2024

End Date

February 1 2026

Last Update

October 20 2025

Active Locations (1)

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Mayo Clinic Minnesota

Rochester, Minnesota, United States, 55905