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

Not Applicable

Not yet recruiting

• Conditions: Total Knee Arthroplasty

• Registration Number: NCT06654661
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-22
• Study First Submitted QC: 2024-10-22
• Study First Posted: 2024-10-23
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-17
• Study Start: 2025-06-01
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Surgical candidates undergoing primary TKA

Exclusion Criteria

• Patient is unable to provide written consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States