Dual Implant Versus Single Implant Distal End of Femur

May 8, 2024 updated by: Brandon James Yuan, Mayo Clinic

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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Baseline
Total number of subjects to be enrolled in the study
Baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Brandon Yuan, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

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)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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