Online 2006 Orthopaedic Basic Science Self-Assessment Examination

Disclaimer

The material presented in this special interest examination has been made available by the American Academy of Orthopaedic Surgeons^® for educational purposes only. This material is not intended to present the only, or necessarily the best, methods or procedures for the medical situations discussed, but rather is intended to represent an approach, view, statement, or opinion of the author(s) or producer(s), which may be helpful to others who face similar situations.

Some drugs or medical devices demonstrated in Academy courses or described in Academy print or electronic publications have not been cleared by the Food and Drug Administration (FDA) or have been cleared for specific uses only. The FDA has stated that it is the responsibility of the physician to determine the FDA clearance status of each drug or device he or she wishes to use in clinical practice.

At the time of this writing, bone screws placed posteriorly into vertebral elements have been cleared for use in this specific manner by the Food and Drug Administration (FDA) to provide immobilization and stabilization as an adjunct to fusion in the treatment of the following acute and chronic instability or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor and failed previous fusion (pseudoarthrosis). In addition, anterior vertebral body screws (cervical, thoracic, and lumbar) are Class II devices and can be used as labeled in vertebral bodies.

Furthermore, any statements about commercial products are solely the opinion(s) of the author(s) and do not represent an Academy endorsement or evaluation of these products. These statements may not be used in advertising or for any commercial purpose.

Use of PMMA Bone Cement in the Spine
The U.S. Food and Drug Administration (FDA) has expressed concern about potential serious patient care issues involved with the use of polymethlymethacrylate (PMMA) bone cement in the spine. A physician might insert the PMMA bone cement into vertebrae by various procedures, including vertebroplasty and kyphoplasty. Orthopaedic surgeons should be alert to possible complications.

PMMA bone cement is considered a device for FDA purposes. In October 1999, the FDA reclassified PMMA bone cement as a Class II device for its intended use "in arthroplastic procedures of the hip, knee and other joints for the fixation of polymer or metallic prosthetic implants to living bone." The use of a device for other than its FDA-cleared indication is an off-label use. Physicians may use a device off-label if they believe, in their best medical judgment, that its use is appropriate for a particular patient (e.g., tumors).

The use of PMMA bone cement in the spine is described in Academy educational courses, videotapes and publications for educational purposes only. As is the Academy's policy regarding all of its educational offerings, the fact that the use of PMMA bone cement in the spine is discussed does not constitute an Academy endorsement of this use.

Copyright © 2005 by the American Academy of Orthopaedic Surgeons^®

All rights reserved. No part of the Orthopaedic Basic Science Self-Assessment Examination may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise without the prior written permission of the publisher.