Authors' objectives: Total knee arthroplasty (TKA) utilization in the United States more than doubled from 1999 to 2008, with an increase of 134% and is expected to double again by the year 2017. An estimated 15% to 20% of TKA recipients are unsatisfied with the amount of pain relief and functional improvement they have long term. Although many factors may contribute to poor outcomes, malalignment of the implant in particular has been associated with poor clinical outcomes, early implant loosening, premature implant wear, and arthroplasty failure. Approximately 28% to 40% of patients who undergo TKA in major arthroplasty centers have malalignment large enough to potentially cause clinical problems or ultimately require revision surgery. Unsuccessful TKA may lead to need for revision surgery, which currently imparts an estimated burden of $2.7 billion dollars in the United States alone. Description of Technology: This health technology assessment focuses on the use of the disposable Verasense sensor-embedded tibial device (OrthoSensor) for primary and revision TKA. Verasense is a single-use tibial polymer trial with embedded sensors that wirelessly communicate via miniature integrated circuits and microprocessors with OrthoSensor's proprietary LinkStation and cloud-based iQ software. Information derived from the sensor-embedded tibial trial includes intraoperative kinetic-based information regarding the full range of knee motion and forces applied to the joint from soft tissue tension and rotation as associated with the knee prosthesis. As part of soft-tissue balancing, the sensor-embedded tibial device incorporates accelerometers, which show tibial axial alignment and overall hip-to-ankle mechanical axial alignment. Currently, the Verasense device is limited to use with 3 types of prosthetic devices and is available in 3 models for the following: (1) Journey II and Legion Knee Systems (Smith & Nephew); (2) Triathlon Knee System (Stryker); and (3) Nexgen Complete Knee System (Zimmer Biomet). Patient Population: The Verasense sensor-embedded tibial trial has been cleared for use in both primary and revision TKA. Clinical Alternatives: Clinical alternatives to sensor-assisted TKA measurements include conventional manual alignment (e.g., using spacer blocks, t.actile navigation with hands, manual gap balancing, and tissue balancing by adjusting the fit of the prosthetic components) and alignment via computer-assisted navigation (image or imageless).

Project Status: Completed

Year Published: 2016

URL for published report: The report may be purchased from: http://www.hayesinc.com/hayes/crd/?crd=50426

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: HAYES, Inc.

Contact Address: 157 S. Broad Street, Suite 200, Lansdale, PA 19446, USA. Tel: 215 855 0615; Fax: 215 855 5218

Contact Name: saleinfo@hayesinc.com

Contact Email: saleinfo@hayesinc.com

Copyright: 2014 Winifred S. Hayes, Inc