NCT05292313

Dual Implant Versus Single Implant Distal End of Femur

Enrolling by Invitation
NAAges 60+InterventionalTreatment
University of Utah
~80 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:Single distal femur implantDual distal femur implants

At a glance

Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Enrollment rate
Measured over 12-months, post-surgery
+3 more outcomes measured
Distal Femur Fracture
5 sites across 5 states
Minnesota1
New York1
Oregon1
Pennsylvania1
Utah1
  • Justin Haller, M.D. · PRINCIPAL_INVESTIGATOR · University of Utah Orthopaedics

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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,
Displaced fracture (\>2.5mm displacement, native or periprosthetic)

Exclusion

Associated major lower extremity fracture,
Ongoing infection,
History of metabolic bone disease (Paget's, etc),
Pathologic fracture,
Gustilo-Anderson Type 3B/3C open fractures,
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,
Bilateral femur fractures,
Unable to follow-up at treating institution for 12 months
  • Enrollment rate12-months, post-surgery

    Feasibility, defined by enrollment rate (80 patients across five sites)

  • Protocol adherence12-months, post-surgery

    Feasibility, defined by protocol adherence (≥90%)

  • Follow-up retention12-months, post-surgery

    Feasibility, defined by follow-up retention (≥85% at 12 months)

  • Data completeness12-months, post-surgery

    Feasibility, defined by data completeness (≥90%) for key secondary outcomes