Utilization of a 3D Printed Mechanical Balancer During Total Knee Arthroplasty (TKA)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- NYU Langone Health
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Measured Balance Value of the Medial Side of Knee during TKA
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Surgical candidates undergoing primary TKA
Exclusion Criteria
- •Patient is unable to provide written consent
Arms & Interventions
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.
Intervention: 3D-Printed Mechanical Balancer (Device)
Outcomes
Primary Outcomes
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.
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
- Range of Motion at Post-Operative Visit(Up to Year 2 Post-Procedure)
- Cases of Revision Surgery(Up to Year 2)
- Range of Motion at Pre-Operative Visit(Baseline)