Dual Implant Versus Single Implant Distal End of Femur

Mayo Clinic

Status: Active, not recruiting

Conditions: Femur Fracture

Treatments: Procedure: Dual Distal Femur Implant; Procedure: Single Distal Femur Implant

Study type: Interventional

Funder types: Other

Identifiers

NCT06032299

22-004415

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Single Distal Femur Implant Group

Active Comparator group

Description:

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.

Treatment:

Procedure: Single Distal Femur Implant

Dual Distal Femur Implant Group

Experimental group

Description:

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.

Treatment:

Procedure: Dual Distal Femur Implant