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Utilization of a 3D Printed Mechanical Balancer During Total Knee Arthroplasty (TKA)
Sponsor: NYU Langone Health
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
Conditions
Interventions
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