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TKR With and Without the Use of Intra-operative Sensing

NCT04251442 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-04-26

No results posted yet for this study

Summary

The purpose of this study is to determine if there is a difference in clinical outcomes after total knee replacement (TKR) performed with traditional ligament balancing compared to use of intraoperative sensing technology (IOS) to balance ligaments. IOS is used to send real time information to a monitor within the operating room that assists your surgeon in making decisions about the balance of the ligaments in your knee and the proper insertion of implants. A total of 150 subjects will participate in this study at Hospital for Special Surgery.

The hypotheses are that the use of IOS technology will be associated with:

1. Better soft tissue balance during TKR than by manual balancing alone.
2. Higher patient reported clinical outcome measures (PROMs) following surgery.

Conditions

Interventions

DEVICE

OrthoSensor Verasense Technology

IOS is used to send real time information to a monitor within the operating room that assists your surgeon in making decisions about the balance of the ligaments in your knee and the proper insertion of implants.

Sponsors & Collaborators

  • Orthosensor, Inc.

    collaborator INDUSTRY

  • Hospital for Special Surgery, New York

    lead OTHER

Principal Investigators

  • Alejandro Gonzalez Della Valle, MD · Hospital for Special Surgery, New York

  • Kate Shanaghan · Hospital for Special Surgery, New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-31
Primary Completion
2020-10-30
Completion
2020-10-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04251442 on ClinicalTrials.gov