A Prospective Clinical Study Evaluating the Newton™ TKA Protocol

NCT ID: NCT06678750

Last Updated: 2025-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-31

Study Completion Date

2026-06-30

Brief Summary

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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

Detailed Description

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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®).

Conditions

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Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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

Group Type ACTIVE_COMPARATOR

TKA

Intervention Type PROCEDURE

TKA using manual instrumentation

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

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 Type EXPERIMENTAL

TKA using computer navigation

Intervention Type DEVICE

TKA using Exactech GPS Newton Knee protocol

Interventions

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TKA using computer navigation

TKA using Exactech GPS Newton Knee protocol

Intervention Type DEVICE

TKA

TKA using manual instrumentation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Exactech

INDUSTRY

Sponsor Role collaborator

Newton-Wellesley Hospital

OTHER

Sponsor Role lead

Responsible Party

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Christopher M. Melnic, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kaplan Joint Center, Newton Wellesley Hospital

Newton, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2024p002323

Identifier Type: -

Identifier Source: org_study_id

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