Newton™ TKA Protocol for Total Knee Replacement

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Newton-Wellesley Hospital

No Placebo Group

Trial Summary

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.

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention Group: Patients whose TKA surgery was conducted using Exactech GPS navigationExperimental Treatment1 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 instrumentationActive Control1 Intervention

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