A Prospective Clinical Study Evaluating the Newton™ TKA Protocol

Newton-Wellesley Hospital

Status: Not yet enrolling

Conditions: Total Knee Arthroplasty

Treatments: Procedure: TKA; Device: TKA using computer navigation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06678750

2024p002323

Details and patient eligibility

About

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

Full description

The purpose of this study is to evaluate patient outcomes, recovery, and patient/surgeon satisfaction of individuals who undergo a total knee arthroplasty (TKA) using mechanical instrumentation (non-navigated) compared to individuals who undergo a TKA with a tibia first gap balancing surgical workflow using the NewtonTM Knee Protocol and navigation-assistance (ExachtechGPS®).

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Comparison Group: TKA patients whose surgery was conducted with traditional, manual instrumentation

Active Comparator group

Description:

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

Treatment:

Procedure: TKA

Intervention Group: Patients whose TKA surgery was conducted using Exactech GPS navigation

Experimental group

Description:

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®).

Treatment:

Device: TKA using computer navigation