Dual Implant Versus Single Implant Distal End of Femur

Not Applicable

Recruiting

• Conditions: Femur Fracture
• Interventions: Procedure: Single Distal Femur Implant; Procedure: Dual Distal Femur Implant

• Registration Number: NCT06032299
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-02
• Study First Submitted QC: 2023-09-02
• Study First Posted: 2023-09-11
• Study Start: 2024-04-29
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-05
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Distal Femur Implant Group	Single Distal Femur Implant	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.
Dual Distal Femur Implant Group	Dual Distal Femur Implant	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.

Primary Outcome Measures

Name	Time	Method
Number of study-eligible subjects	Baseline	Total number of subjects to be enrolled in the study

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States