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A Prospective Clinical Study Evaluating the Newton™ TKA Protocol

NCT06678750 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-10-17

No results posted yet for this study

Summary

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

Conditions

  • Total Knee Arthroplasty

Interventions

DEVICE

TKA using computer navigation

TKA using Exactech GPS Newton Knee protocol

PROCEDURE

TKA

TKA using manual instrumentation

Sponsors & Collaborators

  • Exactech

    collaborator INDUSTRY

  • Newton-Wellesley Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06678750 on ClinicalTrials.gov