πŸ›οΈ Verified NIH Record β€’ Updated 2026-03-02

Utilization of a 3D Printed Mechanical Balancer During Total Knee Arthroplasty (TKA) (NCT06654661)

🟑 Not Yet Recruiting Observational / Diagnostic βš™οΈ Medical Device Protocol Sponsor: NYU Langone Health

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: NYU Langone Health β€” New York, New York

Age range: 18 Years

πŸ§ͺ Interventions in This Study

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (1 Sites)

  • NYU Langone Health β€” New York, New York

πŸ“ž Contact the Study Coordinator

Phone: (212) 598-6245

Email: Daniel.waren@nyulangone.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—