NCT05292313

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Mar 2022Feb 2027

First Submitted

Initial submission to the registry

March 14, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

March 14, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 23, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

4.9 years

First QC Date

March 14, 2022

Last Update Submit

April 6, 2026

Conditions

Distal Femur Fracture

Keywords

Distal Femur FractureDual distal femur implantsSingle distal femur implant

Outcome Measures

Primary Outcomes (4)

  • Enrollment rate

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

    12-months, post-surgery

  • Protocol adherence

    Feasibility, defined by protocol adherence (≥90%)

    12-months, post-surgery

  • Follow-up retention

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

    12-months, post-surgery

  • Data completeness

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

    12-months, post-surgery

Secondary Outcomes (24)

  • Activity Measure for Post-Acute Care (AM-PAC)

    Immediately at the day of discharge after the surgery

  • Activity Measure for Post-Acute Care (AM-PAC)

    2-weeks, post-surgery

  • Activity Measure for Post-Acute Care (AM-PAC)

    6-weeks, post-surgery

  • Activity Measure for Post-Acute Care (AM-PAC)

    3-months, post surgery

  • Activity Measure for Post-Acute Care (AM-PAC)

    6-months, post-surgery

  • +19 more secondary outcomes

Study Arms (2)

Single distal femur implant

OTHER

Single implant constructs will be either a retrograde intramedullary nail with interlocking screws or a single plate and screw construct.

Procedure: Single distal femur implant

Dual distal femur implants

OTHER

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.

Procedure: Dual distal femur implants

Interventions

Single distal femur implantPROCEDURE

Single implant fixation

Single distal femur implant
Dual distal femur implantsPROCEDURE

Dual implant fixation

Dual distal femur implants

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

New York University

New York, New York, 10012, United States

Location

Oregon Health & Science Center

Portland, Oregon, 97239, United States

Location

University of Pittsburg Medical Center - Harrisburg

Harrisburg, Pennsylvania, 17101, United States

Location

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Femoral Fractures, Distal

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesLeg Injuries

Study Officials

  • Justin Haller, M.D.

    University of Utah Orthopaedics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 14, 2022

First Posted

March 23, 2022

Study Start

March 14, 2022

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(5)