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Gait and Functional Improvement in Total Knee Arthroplasty With the Use of Verasense for Soft Tissue Balancing

NCT02290119 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-02-06

No results posted yet for this study

Summary

The primary objectives of this study are to understand the effects of soft-tissue balancing on Gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty and correlate Intra-operative subjective feel with OrthoSensor Outputs

Secondary objectives are to quantify and observe:

* Pain medication use
* Swelling
* Muscle strength and girth
* Gait efficiency
* Patient satisfaction
* Activity levels, functional return (i.e., back to work, resume normal activities)
* Patient perception of a balanced knee

Conditions

Interventions

DEVICE

Sensor-assisted TKR (Verasense)

Verasense is a single use, disposable device embedded with microelectronics into a standard tibial trial to provide dynamic, intraoperative feedback regarding limb alignment, tibiofemoral position and quantitative pressure at peak contact points in the medial and lateral compartments during total knee replacement surgery. Utilizing sensor-derived data, the surgeon can now evaluate intercompartmental loading throughout the range of motion, and correct for soft-tissue abnormalities while receiving real-time feedback regarding joint balance.

PROCEDURE

Control - Without the use of Verasense

Patients in this cohort will undergo manual total knee replacement without the use of Verasense

Sponsors & Collaborators

  • Orthosensor, Inc.

    lead INDUSTRY

Principal Investigators

  • Ron Delanois, MD · Sinai Hospital of Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2022-10-12
Completion
2022-10-12
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 NCT02290119 on ClinicalTrials.gov