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

NYU Langone Health

Status: Terminated

Conditions: Knee Injuries

Treatments: Procedure: Spinal Surgery; Device: Verasense Knee System device

Study type: Interventional

Funder types: Other

Identifiers

NCT03053453

16-00129

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Standard of Care Spinal Surgery

Active Comparator group

Description:

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

Treatment:

Procedure: Spinal Surgery

Sensor Guided Spinal Surgery

Experimental group

Description:

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.

Treatment:

Device: Verasense Knee System device