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

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2022-10-12

Brief Summary

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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

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Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control - Without the use of Verasense

Total Knee Replacement without the use of intraoperative sensors

Group Type SHAM_COMPARATOR

Control - Without the use of Verasense

Intervention Type PROCEDURE

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

Sensor-assisted TKR (Verasense)

Total Knee Replacement with the use of intraoperative sensors

Group Type ACTIVE_COMPARATOR

Sensor-assisted TKR (Verasense)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Control - Without the use of Verasense

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Subject must be a candidate for a primary PCL retaining total knee arthroplasty
* Subject must be diagnosed with one or more of the following conditions: osteoarthritis, avascular necrosis, rheumatoid or other inflammatory arthritis, post-traumatic arthritis
* Subject is between the age of 45 - 80 years
* Subject is likely to be available for all study visits
* Subject is able and willing to sign the informed consent and follow study procedures

Exclusion Criteria

* Prior total knee arthroplasty, ligament insufficiencies, prior surgeries such as ACL or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
* Range of Motion less than 90 degrees, flexion contracture of more than 20 degrees

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes