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NCT Number: NCT06654661

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

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.

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Key information

Conditions

Total Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Surgical candidates undergoing primary TKA

Exclusion criteria

  • Patient is unable to provide written consent

Treatment and study plan

3D-Printed Mechanical Balancer

Device

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.

Primary outcomes

  1. Measured Balance Value of the Medial Side of Knee during TKA

    Time frame: Day 1 (During TKA Procedure)

    Measured using the 3D-printed mechanical knee balancer.

  2. Measured Balance Value of the Lateral Side of Knee during TKA

    Time frame: Day 1 (During TKA Procedure)

    Measured using the 3D-printed mechanical knee balancer.

Secondary outcomes

  1. Range of Motion at Pre-Operative Visit

    Time frame: Baseline

  2. Range of Motion at Post-Operative Visit

    Time frame: Up to Year 2 Post-Procedure

    Evaluated using chart review.

  3. Cases of Revision Surgery

    Time frame: Up to Year 2

    Evaluated using chart review.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Warren

CONTACT

[email protected]

212-598-6245

Peter Walker

CONTACT

[email protected]

212-598-6000

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Oct 23, 2024
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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