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Verasense (OrthoSensor Inc.) for use during total knee arthroplasty |
HAYES, Inc. |
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Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation HAYES, Inc.. Verasense (OrthoSensor Inc.) for use during total knee arthroplasty. Lansdale: HAYES, Inc.. Healthcare Technology Brief Publication. 2016 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). Indexing Status Subject indexing assigned by CRD MeSH Arthroplasty, Replacement, Knee; Humans; Osteoarthritis, Knee; Postoperative Complications Language Published English Country of organisation United States English summary An English language summary is available. Address for correspondence HAYES, Inc., 157 S. Broad Street, Suite 200, Lansdale, PA 19446, USA. Tel: 215 855 0615; Fax: 215 855 5218 Email: hayesinfo@hayesinc.com AccessionNumber 32017000045 Date abstract record published 04/01/2017 |
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