A Prospective Clinical Study Evaluating the Newton™ TKA Protocol
NCT ID: NCT06678750
Last Updated: 2025-10-17
Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2024-12-31
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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.
TKA
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®).
TKA using computer navigation
TKA using Exactech GPS Newton Knee protocol
Interventions
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TKA using computer navigation
TKA using Exactech GPS Newton Knee protocol
TKA
TKA using manual instrumentation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Exactech
INDUSTRY
Newton-Wellesley Hospital
OTHER
Responsible Party
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Christopher M. Melnic, MD
Principal Investigator
Locations
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Kaplan Joint Center, Newton Wellesley Hospital
Newton, Massachusetts, United States
Countries
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Other Identifiers
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2024p002323
Identifier Type: -
Identifier Source: org_study_id
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