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

96 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 treatment TKA using computer navigation?

Research shows that using computer navigation in total knee replacement surgery helps achieve more accurate alignment of the knee joint, which is important for the success of the surgery. Studies found that surgeries using this technology were more likely to be within 3 degrees of the ideal alignment compared to traditional methods. ^{1 2 3 4 5}

Is computer navigation in total knee replacement surgery safe?

The studies reviewed focus on the accuracy and effectiveness of computer navigation in knee replacement surgery, but they do not provide specific safety data. However, the use of computer navigation is increasing despite mixed recommendations, suggesting it is generally considered safe in practice. ^{1 2 3 6 7}

How is the Newton™ TKA Protocol for Total Knee Replacement different from other treatments?

The Newton™ TKA Protocol uses computer navigation and possibly robotic assistance to improve the precision and consistency of knee implant placement during surgery, which can lead to better alignment and potentially fewer complications compared to traditional methods. ^{3 8 9 10 11}

What is the purpose of this trial?

Evaluation of clinical outcomes and patient recovery in patients receiving TKA with traditional instrumentation systems compared to full arc of motion gap balancing using the Newton TM Knee Protocol

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Appropriateness of the Use of Navigation System in Total Knee Arthroplasty. [2022]

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

Imageless computer navigation in total knee arthroplasty provides superior short term functional outcomes: a meta-analysis. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison between navigated reported position and postoperative computed tomography to evaluate accuracy in a robotic navigation system in total knee arthroplasty. [2019]

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

Population-based Survivorship of Computer-navigated Versus Conventional Total Knee Arthroplasty. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

The limits of precision in conventionally instrumented computer-navigated total knee arthroplasty. [2021]

6. China pubmed.ncbi.nlm.nih.gov

[Early effectiveness of computer navigation-assisted total knee arthroplasty]. [2022]

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

The Reverse Fragility Index: Interpreting the Current Literature on Long-Term Survivorship of Computer-Navigated Versus Conventional TKA: A Systematic Review and Cross-Sectional Study of Randomized Controlled Trials. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Comparison of CT with intra-operative navigation reported implant position utilising a robotic assisted technique in total knee arthroplasty. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Increased accuracy in component positioning using an image-less robotic arm system in primary total knee arthroplasty: a retrospective study. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

Computer and robotic - assisted total knee arthroplasty: a review of outcomes. [2020]

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

Computer-Navigated and Robotic-Assisted Total Knee Arthroplasty: Increasing in Popularity Without Increasing Complications. [2022]