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Device
3D-Printed Device for Total Knee Replacement
N/A
Waitlist Available
Led By Peter Walker
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to year 2
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test a 3D-printed device during knee surgery to see how helpful it is. They will be testing it on 50 patients and the surgeons will use the device during surgery
Who is the study for?
This trial is for patients who are scheduled to undergo a primary total knee replacement. The study will include those who meet specific health criteria suitable for the surgery.
What is being tested?
Surgeons will use a new tool, a 3D-printed mechanical balancer, during knee replacement surgeries. This device is tested alongside standard balancing techniques but won't influence decisions during surgery.
What are the potential side effects?
Since the mechanical balancer is used as an aid during surgery and not implanted, it does not have direct side effects like medications do. However, typical surgical risks still apply.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to year 2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to year 2
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Measured Balance Value of the Lateral Side of Knee during TKA
Measured Balance Value of the Medial Side of Knee during TKA
Secondary study objectives
Cases of Revision Surgery
Range of Motion at Post-Operative Visit
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TKA PatientsExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,413 Previous Clinical Trials
855,722 Total Patients Enrolled
Peter WalkerPrincipal InvestigatorNYU Langone Health