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NOT YET RECRUITING
NCT06654661
NA

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

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-06-01

Completion Date

2027-06-01

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

DEVICE

3D-Printed Mechanical Balancer

The 3D printed mechanical balancer is a surgeon-controlled handheld intraoperative tool used that provides a quantifiable measurement of force differences on the medial and lateral sides to guide achievement of a balanced knee. It will be used at one timepoint during scheduled TKA surgery while the patient is under anesthesia. Readings will be taken at 0, 45, and 90 degrees of flexion.

Locations (1)

NYU Langone Health

New York, New York, United States