Newton™ TKA Protocol for Total Knee Replacement

N/A

Waitlist Available

Research Sponsored by Newton-Wellesley Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op

Awards & highlights

No Placebo-Only Group

Summary

This trial compared patient outcomes and recovery after knee replacement surgery using traditional instruments versus a new technique called the Newton TM Knee Protocol.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed, typical risks associated with knee replacement surgery may include pain, swelling, infection risk at the surgical site, blood clots, or issues related to anesthesia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient recovery from TKA by measuring medication consumption

Patient recovery from TKA by measuring number of PT visits

Patient recovery from TKA by measuring number of outpatient visits

+5 more

Secondary study objectives

Knee alignment and soft tissue balance

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

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