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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™ 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
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®).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Kaplan Joint Center, Newton Wellesley Hospital
Newton, Massachusetts, United States
Start Date
December 1, 2024
Primary Completion Date
June 1, 2026
Completion Date
June 1, 2026
Last Updated
October 20, 2025
TKA using computer navigation
DEVICE
TKA
PROCEDURE
Lead Sponsor
Newton-Wellesley Hospital
Collaborators
NCT07456787
NCT06929871
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07347821