Utilization of a 3D Printed Mechanical Balancer During Total Knee Arthroplasty (TKA)
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2024
CompletedFirst Posted
Study publicly available on registry
October 23, 2024
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
Study Completion
Last participant's last visit for all outcomes
June 1, 2027
March 4, 2026
March 1, 2026
7 months
October 22, 2024
March 2, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Range of Motion at Pre-Operative Visit
Baseline
Range of Motion at Post-Operative Visit
Up to Year 2 Post-Procedure
Cases of Revision Surgery
Up to Year 2
Study Arms (1)
TKA Patients
EXPERIMENTALTKA 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Surgical candidates undergoing primary TKA
You may not qualify if:
- Patient is unable to provide written consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Walker
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2024
First Posted
October 23, 2024
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
June 1, 2027
Last Updated
March 4, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.