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.

Study Overview

• Status: Not yet recruiting
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Device: 3D-Printed Mechanical Balancer

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Warren; Phone Number: 212-598-6245; Email: Daniel.waren@nyulangone.org
• Study Contact Backup: Name: Peter Walker; Phone Number: 212-598-6000; Email: Peter.walker@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Surgical candidates undergoing primary TKA

Exclusion Criteria:

• Patient is unable to provide written consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: TKA Patients; TKA patients will undergo total knee replacement as part of standard of care. The 3D printed mechanical balancer will be used at one timepoint during surgery while the patient is under anesthesia during their scheduled TKA surgery.

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Peter Walker, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: October 22, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 24-00350

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Daniel.waren@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Daniel.waren@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No