Dual Implant Versus Single Implant Distal End of Femur

NCT06032299 | Active Not Recruiting

• 1 other identifier: 22-004415
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Femur Fracture

Outcome Measures

Primary Outcomes (1)

• Number of study-eligible subjects

  Total number of subjects to be enrolled in the study

  Baseline

Secondary Outcomes (4)

• Operative times

  Duration of surgery, approximately 2-4 hours

• Blood loss

  Duration of surgery, approximately 2-4 hours

• Hospitalization days

  approximately 2-3 days

• Early post-surgical complications

  2 weeks post-surgery

Study Arms (2)

Single Distal Femur Implant Group

ACTIVE COMPARATOR

Subjects will receive one of two types of implants for the distal femur fracture. The single implant will be either a plate and screws or a rod. The type of single implant used will be determined by the surgeon based on the characteristics of the fracture.

Procedure: Single Distal Femur Implant

Dual Distal Femur Implant Group

EXPERIMENTAL

Subjects will receive two implants for fixation of the distal femur fracture. The dual implant will be either 2 plates with screws or a plate with screws and a rod. The type of dual implant used will be determined by the surgeon based on the characteristics of the fracture.

Procedure: Dual Distal Femur Implant

Interventions

Single Distal Femur Implant PROCEDURE

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

Single Distal Femur Implant Group

Dual Distal Femur Implant PROCEDURE

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.

Dual Distal Femur Implant Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Brandon Yuan, MD

  Mayo Clinic

  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: Principal Investigator

Study Record Dates

• First Submitted: September 2, 2023
• First Posted: September 11, 2023
• Study Start: April 29, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)