Newton™ TKA Protocol for Total Knee Replacement

Overseen By Catharine Tumpowsky, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Newton-Wellesley Hospital

Disqualifiers: Some medical conditions, others

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

Compensation: Varies

Number of Visits: 4

Duration: Hospital stay post-op

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods for knee replacement surgery to determine if they improve patient recovery. It compares two approaches: one using computer navigation to guide the surgery and another using traditional tools. The goal is to identify which method results in better outcomes for total knee replacement surgery. Ideal participants are patients at the Kaplan Joint Center scheduled for knee replacement surgery with a specific implant. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future knee replacement surgeries.

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 the Newton™ TKA Protocol is safe for total knee replacement?

Research studies have shown that computer guidance in total knee replacements (TKA) is generally safe and well-tolerated. This method ensures proper knee alignment, relieving pain and improving knee function post-surgery. Most studies report fewer errors in aligning knee components with computer guidance, resulting in more precise surgery and better patient outcomes.

One study found that this technique led to better outcomes compared to traditional methods, particularly in the months following surgery. Another analysis showed that robotic-assisted knee replacements, similar to computer-guided ones, achieve comparable results but require less time during surgery.

Overall, computer-guided TKA is considered safe and effective, with many patients experiencing better recovery and improved joint function after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Newton™ TKA Protocol because it uses computer navigation to enhance total knee replacement surgeries. Unlike traditional methods that rely on manual tools, this protocol integrates Exactech GPS navigation, providing real-time guidance to surgeons. This approach aims to improve the accuracy of implant placement, which could lead to better joint function and longevity. By offering a more precise surgical technique, the protocol has the potential to improve patient outcomes and recovery times, making it a promising advancement in knee replacement surgery.

What evidence suggests that the Newton™ TKA Protocol is effective for total knee replacement?

Research has shown that computer guidance in total knee replacement surgery can align the knee joint more accurately, which is crucial for better outcomes. In this trial, participants in the intervention group will undergo surgery using the Exactech GPS navigation system. Studies have demonstrated that this system can effectively fix joint issues, reduce pain, and improve joint function and patient quality of life after surgery. Compared to traditional methods, which the comparison group will use, computer-guided knee replacements often lead to better outcomes in the medium term. This technique also typically shortens surgery time compared to conventional methods. Overall, evidence supports that computer guidance can enhance the results of total knee replacement surgeries. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients at the Kaplan Joint Center, Newton Wellesley Hospital who are scheduled to have a total knee replacement (TKA) with a specific implant. It's not open to those with certain medical conditions that could interfere with the study.

Inclusion Criteria

Patients of Kaplan Joint Center, Newton Wellesley Hospital scheduled for TKA with a specific implant

Exclusion Criteria

Patients may be excluded due to some medical conditions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total knee arthroplasty (TKA) using either traditional instrumentation or the NewtonTM Knee Protocol with navigation assistance

Hospital stay post-op

In-patient hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including patient satisfaction and recovery assessments

One year

Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op

What Are the Treatments Tested in This Trial?

Interventions

• TKA using computer navigation

Trial Overview The study compares traditional TKA methods against the Newton™ Knee Protocol, which uses computer navigation and full arc of motion gap balancing to potentially improve patient recovery and clinical outcomes.

How Is the Trial Designed?

Group I: Intervention Group: Patients whose TKA surgery was conducted using Exactech GPS navigation Experimental Treatment 1 Intervention

The intervention group will include TKA patients whose surgery is conducted with a tibia first gap balancing surgical workflow using the NewtonTM Knee Protocol and navigation-assistance (ExachtechGPS®).

Group II: Comparison Group: TKA patients whose surgery was conducted with traditional, manual instrumentation Active Control 1 Intervention

The comparison groups includes TKA patients whose surgery is conducted using traditional, manual, non-navigated instrumentation.

Who Is Running the Clinical Trial?

Newton-Wellesley Hospital

Lead Sponsor

Trials

14

Recruited

4,800+

Exactech

Industry Sponsor

Trials

17

Recruited

30,400+

Published Research Related to This Trial

In a study of 87 patients undergoing robotic-assisted total knee arthroplasty (TKA), the navigation system demonstrated high accuracy in component positioning, with over 94% of measurements within 3° of the postoperative CT scan results.

The mean differences between the navigation software estimates and the actual postoperative CT scans were minimal, indicating that this robotic system can effectively assist in achieving precise alignment of knee components during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of CT with intra-operative navigation reported implant position utilising a robotic assisted technique in total knee arthroplasty. Sharma, N., Berera, V., Petterwood, J.[2022]

Citations

1. ovid.com ovid.com/journals/orth/pdf/10.3928/01477447-20131219-15~computer-navigation-and-total-knee-arthroplasty

Computer Navigation and Total Knee Arthroplasty Research has added evidence in favor of computer-navigated techniques over conven- tional surgery for total knee arthroplasty (TKA).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11541116/

Progress in Computer‐Assisted Navigation for Total Knee ... Research studies demonstrate that navigated TKA can effectively correct deformities, relieve pain, and improve postoperative joint function and quality of life.

3. arthroplasty.biomedcentral.com arthroplasty.biomedcentral.com/articles/10.1186/s42836-021-00100-9

After 25 years of computer-navigated total knee arthroplasty ... Computer navigation-assisted knee replacement demonstrates improved outcome compared with conventional knee replacement at mid-term follow ...

4. withpower.com withpower.com/trial/phase-total-knee-arthroplasty-tka-11-2024-a3456

Newton™ TKA Protocol for Total Knee Replacement Research shows that using computer navigation in total knee replacement surgery helps achieve more accurate alignment of the knee joint, which is important for ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0972978X2300346X

Navigated Versus Conventional Total Knee Arthroplasty There was a clinically significant reduction in the mean C-TKA operative time (87 min, σ = 16.6, 95% CI 76.4–98.8) compared N-TKA (97.6 min, σ = 16.9, 95% CI ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0972978X25000455

A systematic review and meta-analysis Robotic-assisted total knee arthroplasty results in shorter navigation working time with similar clinical outcomes compared to computer-navigated total knee ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3232352/

Computer Assisted Navigation in Knee Arthroplasty - PMC Most studies have reported that computer assisted navigation reduced the outliers of alignment and component malpositioning. However, additional sophisticated ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/os.13603

Computer Navigation Assisted Restricted Kinematic ... Computer assisted navigation achieved the level of accuracy required by rKA-TKA. rKA-TKA offered significantly better short-term outcomes than MA-TKA.