3D-Printed Device for Total Knee Replacement

Overseen By Peter Walker

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Unable to provide consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

50 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the 3D-Printed Mechanical Balancer treatment for total knee replacement?

Research shows that using 3D printing technology in knee replacement surgery can improve the alignment and tracking of knee components, which are important for successful outcomes. Additionally, sensor-guided techniques, similar to the 3D-Printed Mechanical Balancer, have been shown to improve patient satisfaction and clinical results compared to traditional methods. ^{1 2 3 4 5}

Is the 3D-Printed Device for Total Knee Replacement safe for humans?

The research on 3D-printed devices for knee replacement, like the mechanical balancer, shows they are designed to help surgeons balance knee ligaments during surgery, which is important for a successful outcome. These devices are easy to use and provide precise information, but specific safety data for humans is not detailed in the available studies. ^{5 6 7 8 9}

How is the 3D-Printed Mechanical Balancer treatment for total knee replacement unique?

The 3D-Printed Mechanical Balancer is unique because it provides surgeons with precise numerical data to achieve knee balance during surgery by measuring forces on the knee's condyles, allowing for accurate ligament adjustments and bone cuts without the need for electronics or software. ^{1 2 8 9 10}

What is the purpose of this trial?

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.

Research Team

Peter Walker

Principal Investigator

NYU Langone Health

Eligibility Criteria

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.

Inclusion Criteria

I am a candidate for my first total knee replacement surgery.

Exclusion Criteria

Patient is unable to provide written consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo total knee arthroplasty with the use of a 3D-printed mechanical balancer during the procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for range of motion and cases of revision surgery post-operatively

Up to 2 years

Treatment Details

Interventions

• 3D-Printed Mechanical Balancer

Trial Overview 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.

Participant Groups

Group I: TKA Patients Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Findings from Research

The eLibra Dynamic Ligament Balancing Device provides surgeons with precise, real-time force measurements during total knee arthroplasty, enhancing the accuracy of ligament balancing.

By using objective dynamic data instead of static landmarks, this device improves the surgical process, potentially leading to better outcomes in knee replacement surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soft tissue balance in total knee arthroplasty with a force sensor. Camarata, DA.[2022]

References

1. China pubmed.ncbi.nlm.nih.gov

[Effectiveness of total knee arthroplasty using three-dimensional printing technology for knee osteoarthritis accompanied with extra-articular deformity]. [2023]

2. China pubmed.ncbi.nlm.nih.gov

[Effect of three-dimensional printing guide plate on improving femoral rotational alignment and patellar tracking in total knee arthroplasty]. [2022]

3. China pubmed.ncbi.nlm.nih.gov

[Short-term effectiveness of total knee arthroplasty assisted by three-dimensional printing osteotomy navigation template]. [2021]

4. China pubmed.ncbi.nlm.nih.gov

[Total knee arthroplasty with 3D printing technique versus conventional surgery: comparison of the outcomes]. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of Sensor-Guided Knee Balancing Compared to Standard Balancing Technique in Total Knee Arthroplasty. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Soft tissue balance in total knee arthroplasty with a force sensor. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A miniaturised actuation system embedded in an instrumented knee implant for postoperative ligament imbalance correction. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Design and evaluation of a 3D printed mechanical balancer for soft tissue balancing in total knee replacement. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Principles of a 3D printed mechanical device for total knee balancing. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Finite element lifetime prediction of a miniature adjustable orthopedic device. [2020]