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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to year 2 for reporting.

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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