Navigation Links
AAOS Clinical Guideline for Treating Spinal Compression Fractures Presents More Questions Than Answers for Medical Community
Date:11/9/2010

WASHINGTON, Nov. 9, 2010 /PRNewswire/ -- The clinical practice guideline recently issued by the American Academy of Orthopaedic Surgeons (AAOS) for treating spinal compression fractures has left the medical community scratching its head about what to tell patients. Spinal compression fractures (also called vertebral compression fractures or VCFS) are the most common complication of osteoporosis, a disease that affects an estimated 44 million Americans, or 55 percent of adults age 50 and older. Approximately 700,000 new VCFs occur annually. They cause intractable pain and are a source of increased morbidity.

Of the 11 recommendations made by AAOS, more than half are rated as "inconclusive." According to AAOS, evidence quality was critical in supporting the practice guidelines and it didn't find enough high-quality evidence to support or oppose most non-surgical treatments, including traditional treatment options such as bed rest, analgesics, bracing, and physical therapy.

AAOS made only one "strong" recommendation. It was against the use of vertebroplasty, a minimally invasive procedure that involves injecting bone cement into the fracture to

stabilize and strengthen the vertebra. The group based its recommendation on the results of two studies published in the New England Journal of Medicine (NEJM). The studies compared vertebroplasty against a placebo procedure and found no statistically significant difference between the two.

But did the studies exhibit enough clinically efficiency to justify that recommendation? "No," says Dr. Wayne Olan, MD, Director of Interventional and Endovascular Neurosurgery at George Washington University Medical Faculty Associates in Washington, DC, and a consulting physician for neuroradiology at the National Institutes of Health in Bethesda, Md.

"The NEJM studies don't come close to the standards AAOS set for its guideline. Their methodology is flawed and their conclusions are at odds with more than 20 years of research studies that substantiate the efficacy of vertebroplasty."

Numerous commentaries from medical experts agree with Dr. Olan. They criticize Kallmes et al and Buchbinder et al for including patients with sub-acute and chronic fractures up to a year old, inconsistent use of the evidence of bone edema on MRI as an inclusion criteria, selection bias, statistical power of the sample size, the absence of a control group that did not get an intervention, and the high crossover from placebo to vertebroplasty.

A more rigorous study, says Dr. Olan, is "Vertebroplasty vs. Conservative Treatment in Osteoporotic Vertebral Compression Fractures" (VERTOS II), published recently in The Lancet.

VERTOS II is the largest, peer-reviewed study of vertebroplasty to date. In it, 202 patients with acute fractures confirmed by edema on MRI were randomly allocated to receive either vertebroplasty or conservative medical therapy. Patients receiving vertebroplasty had greater pain relief – as measured on a visual analog scale (VAS) – from the first day after the procedure to one year later than those treated conventionally. From baseline, the reductions in pain were 5.2 at 1 month and 5.7 at 1 year. Pain reductions in the control group were less substantial at 2.7 at 1 month and 3.7 at 1 year.

"Randomized, placebo-controlled trials provide only an approximation of the truth. Information from observational outcome studies is also important because patients and physicians in the real world don't always behave like those in clinical trials," says Dr. Olan.

"As physicians we need to weigh study results against our own experience. VERTOS II and the countless patients I've treated who have benefitted from vertebroplasty validate this procedure's efficacy."

In addition to his practice, Dr. Olan is clinical associate professor of radiology and neurological surgery at The George Washington University Medical Center in Washington, DC. He has participated in multiple clinical trials and published extensively on minimally invasive spinal interventions. He is also a frequent lecturer and instructor around the world regarding minimally invasive spinal techniques.

Disclosures:

Dr. Olan is a consultant with Stryker Interventional Spine and conducts vertebroplasty workshops supported by the company.


'/>"/>
SOURCE Wayne J. Olan
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
3. EpiCept Reports Expansion of Clinical Development For Licensed Cancer Compound
4. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
5. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
6. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
7. Millennium Initiates Clinical Trial to EVOLVE the Treatment of Patients with Newly Diagnosed Multiple Myeloma
8. Potential Safety Issue Identified in Ongoing Phase 2 Clinical Study of HCV-796
9. Clinical Trial Effectiveness: How Pharmas & Biotechs Save Cost with Savvy Investigator Management
10. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
11. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/13/2017)... 2017  New York City-based market research firm Kalorama Information ... aware of.  From new products to new costs, to the ... recently completed study, Potential Pipeline Disruptors . ... 1.  Age-Driven Growth - True Impact Moment Arriving ... the impact the growing population and, to a more extreme ...
(Date:7/11/2017)... , July 11, 2017  The global market ... revenues of approximately $394.1 million in 2016.  Although in ... of solid growth, in particular as a result of ... practice, and the recent introduction of a significant number ... for less-invasive testing of tumor biomarkers to guide treatment ...
(Date:7/10/2017)... Md. , July 10, 2017 The ... non-animal test methods, is the recipient of a VITROCELL® ... the PETA International Science Consortium. The device, which is ... used to expose human lung cells to airborne test ... IIVS will use the VITROCELL® system for testing combustible ...
Breaking Medicine Technology:
(Date:7/21/2017)... ... July 21, 2017 , ... ... selected to renovate and improve the Ramsey County Medical Examiners Facility located in ... Hospital, the $2.5 million project is scheduled to start in late 2017/early 2018. ...
(Date:7/21/2017)... ... 21, 2017 , ... Bernard R. Bach, Jr., MD, orthopaedic surgeon at Rush ... Society of Sports Medicine (AOSSM) , received the 2017 Robert E. Leach Sports Medicine ... Canada. This prestigious award is given annually to honor those who have made a ...
(Date:7/21/2017)... (PRWEB) , ... July 21, 2017 , ... ... 4th-year medical students improve their chances of acceptance to a residency in a ... who have earned degrees outside the U.S. , According to data released by ...
(Date:7/21/2017)... TORONTO, ONTARIO, CANADA (PRWEB) , ... July 21, ... ... with over 80% follow-up at 10 years, researchers from the Multicenter Orthopaedics Outcome ... knee-related quality of life a decade after surgery, though activity levels decline over ...
(Date:7/20/2017)... (PRWEB) , ... July 20, 2017 , ... ChenMed ... MD, has joined JenCare Senior Medical Center as Richmond Chief Medical Officer. ... School of Medicine, and Associate Chief Medical Officer of Ambulatory Services for the UVA ...
Breaking Medicine News(10 mins):