Dual Implant Versus Single Implant Distal End of Femur

Pilot for Dual Implant Versus Single Implant Distal End of Femur (pDISIDE Femur)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Femur Fracture
• Intervention / Treatment: Procedure: Single Distal Femur Implant; Procedure: Dual Distal Femur Implant

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single Distal Femur Implant Group; 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; Single implant constructs will be either a retrograde intramedullary nail with interlocking screws or a single plate and screw construct.
Experimental: Dual Distal Femur Implant Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of study-eligible subjects	Total number of subjects to be enrolled in the study	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative times	Total recorded amount of time in minutes to complete the surgery	Duration of surgery, approximately 2-4 hours
Blood loss	Total amount of surgical blood loss, reported in mL.	Duration of surgery, approximately 2-4 hours
Hospitalization days	Total number of days a subject requires hospitalization after surgery	approximately 2-3 days
Early post-surgical complications	Number of subjects to experience venous thromboembolism (VTE), cardiopulmonary, and/or infectious complications after surgery	2 weeks post-surgery

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Brandon Yuan, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: September 2, 2023
• First Submitted That Met QC Criteria: September 2, 2023
• First Posted (Actual): September 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures
• Other Study ID Numbers: 22-004415

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No