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

NCT06654661 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-04

No results posted yet for this study

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.

Conditions

  • Total Knee Arthroplasty

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.

Sponsors & Collaborators

Principal Investigators

  • Peter Walker · NYU Langone Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-12-31
Completion
2027-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06654661 on ClinicalTrials.gov