A Prospective Clinical Study Evaluating the Newton™ TKA Protocol

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™ Knee Protocol: A Prospective Clinical Study

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

Study Overview

• Status: Withdrawn
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Procedure: TKA; Device: TKA using computer navigation

Detailed 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®).

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Newton, Massachusetts, United States, 02468
      • Kaplan Joint Center, Newton Wellesley Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: TKA; TKA using manual instrumentation
Experimental: 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®).	Device: TKA using computer navigation; TKA using Exactech GPS Newton Knee protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction with TKA using patient reported KOOS JR Questionnaire	The KOOS, JR combines the pain, symptoms, and functional limitations into a single score.	Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op
Patient satisfaction with TKA using Oxford Knee Score (OKS) Questionnaire	The OKS is a patient reported questionnaire that measures function and pain with a single score.	Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op
Patient satisfaction with TKA using Forgotten Joint Score (FJS) Questionnaire	The Forgotten Joint Score assesses the ability of the patient to forget about their joint given successful treatment by assigning a single score to a series of questions.	Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op
Patient recovery from TKA using time from hospital stay to discharge	The time of in-patient hospital stay will be measured (in hours).	Post-op measure in hours
Patient recovery from TKA by measuring number of outpatient visits	Number of outpatient visits (scheduled and unscheduled)	One year post-op
Patient recovery from TKA by measuring number of PT visits	Number of post-op PT visits	One year post-op
Patient recovery from TKA by measuring medication consumption	Post-op, prescription medication will be recorded in number of pills and dosage	One year post-op
Patient recovery from TKA by measuring use of assisted walking devices	Patient recovery from TKA by measuring the number of days using an assisted walking device following surgery.	One year post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee alignment and soft tissue balance	Telemetric x-rays will be used to assess the angles and evaluate the joint line status pre- and post-operatively.	Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op
Knee alignment and soft tissue balance	Patients receiving a TKA NewtonTM Knee, soft-tissue balance will be measured intra-operatively by placing the Newton distractor at the trial reduction stage and acquiring the corresponding joint laxities through the arc of motion.	One time (during surgery)

Collaborators and Investigators

• Sponsor: Newton-Wellesley Hospital
• Collaborators: Exactech

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Actual): November 7, 2024

Study Record Updates

• Last Update Posted (Actual): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 14, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024p002323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes