Evaluation of Patient Reported Outcomes (PRO) After Total Knee Arthroplasty (TKA) Under Spinal Anesthesia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-06

Study Completion Date

2022-07-13

Brief Summary

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The purpose of this study will be to evaluate and compare patients undergoing total knee arthroplasty (TKA) with sensor guidance versus that of a standard technique. Each patient will be assessed for the difference between passive, soft tissue controlled, pressure balance and muscle activated pressure balance.

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Detailed Description

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Conditions

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Knee Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized prospective study looking at the impact sensor guidance has on the outcome of patients and comparing to that of patients with a standard technique.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard of Care Spinal Surgery

Patients will be given spinal anesthesia with 2.6 mL of 0.5% isobaric bupivacaine.

Group Type ACTIVE_COMPARATOR

Spinal Surgery

Intervention Type PROCEDURE

TKA under standard of care spinal surgery.

Sensor Guided Spinal Surgery

The Verasense Knee System device (OrthoSensor inc., Dania Beach, Florida) is a sterile sensor system that replaces the tibial insert trials used during surgery. The sensor contains a microprocessor and integrated nanosensor system, which wirelessly transmits real-time data to a portable graphic display unit used for read-out of the data. The sensor measures and localizes peak load at the medial and lateral tibiofemoral joint interfaces. Loading data is thereby captured intra-operatively through the full range of movement (ROM) using the sensor system.

Group Type EXPERIMENTAL

Verasense Knee System device

Intervention Type DEVICE

Sensor measures and localizes peak load at the medial and lateral tibiofemoral joint interfaces. Loading data is thereby captured intra-operatively through the full range of movement (ROM) using the sensor system.

Interventions

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Spinal Surgery

TKA under standard of care spinal surgery.

Intervention Type PROCEDURE

Verasense Knee System device

Sensor measures and localizes peak load at the medial and lateral tibiofemoral joint interfaces. Loading data is thereby captured intra-operatively through the full range of movement (ROM) using the sensor system.

Intervention Type DEVICE

Other Intervention Names

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OrthoSensor

Eligibility Criteria

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Inclusion Criteria

* Patients will be screened for eligibility based on whether they have chronic knee pain as a result of an arthritis-related condition.
* Patient with chronic knee pain who is indicated for total hip or knee replacement surgery
* Patient is at least 50 years of age
* Patient is willing to participate in pre- and postoperative surveys

Exclusion Criteria

* Failure to complete pre-operative surveys.
* Revision Total Knee Arthroplasty
* Prior ipsilateral knee surgery such as ligament reconstruction or osteotomy
* Contralateral Total Knee Arthroplasty
* Prior tibial plateau fracture
* Ligamentous Insufficiency
* History of fibromyalgia, chronic fatigue syndrome

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No