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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06654661

Enrollment

Registered

2024-10-23

Start date

2026-06-01

Completion date

2027-06-01

Last updated

2026-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Arthroplasty

Brief 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.

Interventions

DEVICE3D-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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Surgical candidates undergoing primary TKA

Exclusion criteria

* Patient is unable to provide written consent

Design outcomes

Primary

Measure	Time frame	Description
Measured Balance Value of the Medial Side of Knee during TKA	Day 1 (During TKA Procedure)	Measured using the 3D-printed mechanical knee balancer.
Measured Balance Value of the Lateral Side of Knee during TKA	Day 1 (During TKA Procedure)	Measured using the 3D-printed mechanical knee balancer.

Secondary

Measure	Time frame	Description
Range of Motion at Pre-Operative Visit	Baseline	—
Range of Motion at Post-Operative Visit	Up to Year 2 Post-Procedure	Evaluated using chart review.
Cases of Revision Surgery	Up to Year 2	Evaluated using chart review.

Countries

United States

Contacts

CONTACTDaniel Warren

Daniel.waren@nyulangone.org212-598-6245

CONTACTPeter Walker

Peter.walker@nyulangone.org212-598-6000

PRINCIPAL_INVESTIGATORPeter Walker

NYU Langone Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026