Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06032299

Dual Implant Versus Single Implant Distal End of Femur

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Femur Fracture Femoral Fractures Fractures, Bone Leg Injuries Wounds and Injuries

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of study-eligible subjects

    Time frame: Baseline

    Total number of subjects to be enrolled in the study

Secondary outcomes

  1. Operative times

    Time frame: Duration of surgery, approximately 2-4 hours

    Total recorded amount of time in minutes to complete the surgery

  2. Blood loss

    Time frame: Duration of surgery, approximately 2-4 hours

    Total amount of surgical blood loss, reported in mL.

  3. Hospitalization days

    Time frame: approximately 2-3 days

    Total number of days a subject requires hospitalization after surgery

  4. 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2023
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.