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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new 3D-printed device used during knee replacement surgery. The goal is to evaluate how effectively the 3D-Printed Mechanical Balancer aids in mechanically balancing the knee during the operation. It serves as an additional tool for surgeons, complementing standard practices without altering any medical decisions. Individuals planning their first total knee replacement surgery might be suitable candidates for this study. As an unphased trial, it offers participants the chance to contribute to innovative surgical advancements.

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 prior data suggests that this 3D-printed mechanical balancer is safe for use in total knee replacement surgery?

Research has shown that using 3D-printed tools in surgeries, such as total knee replacements, is generally safe. Studies have found that these tools enhance surgical precision without causing additional harm. For instance, past research demonstrated that 3D-printed tools in knee surgeries did not result in more complications compared to traditional methods.

This specific 3D-printed mechanical balancer has undergone testing for its design and surgical application. Tests suggest it can be safely used during knee replacements. While no direct evidence of harm from this device exists, it is important to note that the research is still new.

As a pilot study, the aim is to gather more information about the device's usefulness and safety. Although no specific problems have been reported with this device so far, clinical trials like this are essential to confirm its safety on a larger scale. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 3D-Printed Mechanical Balancer because it offers a cutting-edge approach to total knee replacement surgery. Unlike traditional balancing techniques that rely on manual adjustments by the surgeon, this device uses 3D printing technology to create a customized, precise mechanical balancer tailored to each patient's anatomy. This innovation aims to improve the alignment and stability of the knee joint during surgery, potentially enhancing long-term outcomes and patient satisfaction. By integrating advanced technology into the surgical process, there is hope for more consistent results and faster recovery times compared to standard methods.

What evidence suggests that this 3D-printed device is effective for total knee replacement?

Research shows that 3D-printed tools can enhance the precision of knee replacement surgery. In this trial, participants undergoing total knee replacement will use a 3D-printed mechanical balancer during surgery. These tools improve knee alignment, which is crucial for postoperative knee function. Custom-made for each patient, they increase surgical accuracy. Studies suggest that this technology can make the surgery more efficient and may lead to better recovery. Although the long-term effects are still under investigation, early evidence supports that these devices can improve the accuracy of knee surgery. ^{1 2 6 7 8}

Who Is on the Research Team?

Peter Walker

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0968016023001618

Design and evaluation of a 3D printed mechanical ... The purpose of this study was to evaluate our design of 3D printed Balancer, and demonstrate how it could be used at surgery.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10493459/

The Role of 3D-Printed Patient-Specific Instrumentation in ... The utilization of 3D-printed PSI in TKA holds promise in enhancing surgical accuracy and efficiency. While the long-term outcomes are still lacking in the ...

3. cureus.com cureus.com/articles/421254-3d-printed-patient-specific-instrumentation-versus-conventional-techniques-in-total-knee-arthroplasty-a-systematic-review-and-meta-analysis

3D-Printed Patient-Specific Instrumentation Versus ... 3D-printed patient-specific instrumentation (PSI) in total knee arthroplasty (TKA) has been proposed to improve surgical precision and ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06654661

Utilization of a 3D Printed Mechanical Balancer During ... Measured Balance Value of the Lateral Side of Knee during TKA, Measured using the 3D-printed mechanical knee balancer. Day 1 (During TKA Procedure) ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1155/ijcp/8793065

Comparison of 3D Printing Technology and Artificial ... This study aimed to evaluate the efficacy of personalized 3D printing osteotomy guides and artificial intelligence (AI)-assisted surgical planning in total ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37597474/

Design and evaluation of a 3D printed mechanical ... The purpose of this study was to evaluate our design of 3D printed Balancer, and demonstrate how it could be used at surgery.

7. researchgate.net researchgate.net/publication/373238522_Design_and_evaluation_of_a_3D_printed_mechanical_balancer_for_soft_tissue_balancing_in_total_knee_replacement

Design and evaluation of a 3D printed mechanical ... Design and evaluation of a 3D printed mechanical balancer for soft tissue balancing in total knee replacement ... knee balance compared to pressure sensor data.

8. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-021-02646-5

Clinical and radiological outcomes in three-dimensional ... This study investigates whether three-dimensional (3D) printing-assisted revision total hip/knee arthroplasty could improve its clinical and radiological ...