Utilization of a 3D Printed Mechanical Balancer During Total Knee Arthroplasty (TKA)

NYU Langone Health

Status: Not yet enrolling

Conditions: Total Knee Arthroplasty

Treatments: Device: 3D-Printed Mechanical Balancer

Study type: Interventional

Funder types: Other

Identifiers

NCT06654661

24-00350

Details and patient eligibility

About

The aim of this study is to test a 3D-printed mechanical balancer in a clinical setting during surgery to further evaluate the utility of the device. This will be a pilot prospective study of 50 patients undergoing primary total knee arthroplasty. Surgeons will utilize the device intraoperatively in addition to the standard of care practices of mechanical balancing. It will not guide clinical decision making.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Surgical candidates undergoing primary TKA

Exclusion criteria

• Patient is unable to provide written consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

TKA Patients

Experimental group

Description:

TKA patients will undergo total knee replacement as part of standard of care. The 3D printed mechanical balancer will be used at one timepoint during surgery while the patient is under anesthesia during their scheduled TKA surgery.

Treatment:

Device: 3D-Printed Mechanical Balancer