A Prospective Clinical Study Evaluating the Newton™ TKA Protocol

NCT06678750 | Withdrawn FDA Device

• 1 other identifier: 2024p002323
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• Knee alignment and soft tissue balance

  Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op

• Knee alignment and soft tissue balance

  One time (during surgery)

Study Arms (2)

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

ACTIVE COMPARATOR

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

Procedure: TKA

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

EXPERIMENTAL

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

Interventions

TKA using computer navigation DEVICE

TKA using Exactech GPS Newton Knee protocol

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

TKA PROCEDURE

TKA using manual instrumentation

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of Kaplan Joint Center, Newton Wellesley Hospital scheduled for TKA with a specific implant

You may not qualify if:

• Patients may be excluded due to some medical conditions

Sponsors & Collaborators

• Newton-Wellesley Hospital: lead
• Exactech: collaborator

Study Sites (1)

Kaplan Joint Center, Newton Wellesley Hospital

Newton, Massachusetts, 02468, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 7, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 20, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)