Dual Implant Versus Single Implant Distal End of Femur

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
University of Utah
Study ID
NCT05292313
Status
Enrolling By Invitation

Conditions

  • Distal Femur Fracture

Eligibility Criteria

Sex
ALL
Age
60 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Single distal femur implant — PROCEDURE
    Single implant fixation
  • Dual distal femur implants — PROCEDURE
    Dual implant fixation

Study Details

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 (dual plate or IMN/plate) vs. a single distal femur implant (plate or IMN).

Key Dates

Start date
Mar 14, 2022
Status verified
Apr 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Single distal femur implant
    Single implant constructs will be either a retrograde intramedullary nail with interlocking screws or a single plate and screw construct.
  • Other: Dual distal femur implants
    Dual implant constructs will either be an intramedullary nail with an additional plate and screw construct or dual (two plates in any orientation) plate and screw construct.

Primary Outcome Measure

Enrollment rate [ Time Frame: 12-months, post-surgery ]

Locations (5)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-
New York UniversityNew YorkNew York10012-
Oregon Health & Science CenterPortlandOregon97239-
University of Pittsburg Medical Center - HarrisburgHarrisburgPennsylvania17101-
University of Utah Orthopaedic CenterSalt Lake CityUtah84112-

Find similar trials in Rochester, MN

By research site
Mayo Clinic· Rochester, MNNew York University· New York, NYOregon Health & Science Center· Portland, ORUniversity of Pittsburg Medical Center - Harrisburg· Harrisburg, PAUniversity of Utah Orthopaedic Center· Salt Lake City, UT

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