Dual Implant Versus Single Implant Distal End of Femur

Femur Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06032299
• Other study ID #: 22-004415
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fracture

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic Minnesota	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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