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    <recommendedItem id="20100101_19_400"
                     title="Fractured Evidence: Spine Repair Debate Heats Up"
                     score="0.011"
                     href="http://www.medpagetoday.com/Surgery/Orthopedics/tb/18303?impressionId=1265738602255"
                     
      &lt;p&gt;Hundreds of thousands have benefited from vertebroplasty, advocates insist. They say the minimally-invasive procedure has freed them from hospital beds and dependence on intravenous narcotics.&lt;/p&gt;
&lt;p&gt;Spine physicians swear that inserting a large-gauge needle into fractured vertebrae and injecting a cement compound to stabilize the bone hastens healing and helps relieve the often-crippling pain of compression fractures brought on by osteoporosis or metastatic disease.&lt;/p&gt;
&lt;p&gt;But two recently-published, randomized controlled trials  --  the gold standard of evidence-based medicine  --  say otherwise. As far as disability and pain relief were concerned, they found that vertebroplasty for osteoporotic vertebral compression fractures was no better than a sham procedure.&lt;/p&gt;
&lt;p&gt;Publication of the results triggered an outraged backlash from radiologists, for whom vertebroplasty is a bread-and-butter operation. The entire specialist community lambasted the studies  --  statistically and methodologically.&lt;/p&gt;
&lt;p&gt;But experts in evidence-based medicine argue that when profits are on the line, it&apos;s easy to be persuaded that studies are flawed.&lt;/p&gt;
&lt;p&gt;So the debate rages, with radiologists citing case after case of success, arguing that patients with the worst fractures will have no treatment alternatives if the nation&apos;s third-party payers  --  Medicare and the insurance companies&lt;strong&gt; -&lt;/strong&gt;- refuse to pay for the procedure anymore.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;The Studies&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;Both randomized, controlled studies were published last August in the &lt;em&gt;New England Journal of Medicine&lt;/em&gt;. They involved a combined total of about 200 patients. Each found that vertebroplasty did not yield significantly better results in terms of disability or short-term pain relief than sham procedures for patients with this type of vertebral fracture.&lt;/p&gt;
&lt;p&gt;In an e-mail to &lt;em&gt;MedPage Today&lt;/em&gt;, the author of one study, Rachelle Buchbinder, PhD, of Monash University in Australia, suggested that the research showed the procedure was ineffective.&lt;/p&gt;
&lt;p&gt;&quot;Based upon the results of both trials I don&apos;t think that this treatment should be offered in routine care,&quot; she declared.&lt;/p&gt;
&lt;p&gt;But the leader of the other trial, David Kallmes, MD, of the Mayo Clinic in Rochester, Minn., offered a different interpretation. He said the studies have been largely misunderstood by the trials&apos; critics&lt;strong&gt;.&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;&quot;I&apos;ve been practicing for 15 years and had strong confidence that the procedure was effective, and that&apos;s exactly what we showed,&quot; he said in a telephone interview.&lt;/p&gt;
&lt;p&gt;Mean baseline pain intensity on a 10-point scale was 6.9 in the vertebroplasty group and 7.2 in the sham-operated group in his trial, which had 131 patients. One month later, these scores had declined to 3.9 and 4.6, respectively.&lt;/p&gt;
&lt;p&gt;Kallmes said this degree of pain reduction with vertebroplasty &quot;exactly reproduces our prior experience.&quot; He vehemently denied that the findings were &quot;discordant&quot; with prior experience, as two statements from the Society of Interventional Radiology (SIR) put it.&lt;/p&gt;
&lt;p&gt;&quot;I don&apos;t know what they&apos;re talking about,&quot; Kallmes said. &quot;It is concordant.&quot;&lt;/p&gt;
&lt;p&gt;He said the real surprise was the effectiveness of the sham procedure, which should be the focus of follow-up investigations.&lt;/p&gt;
&lt;p&gt;It involved inserting needles into the spinal column and injecting short-acting painkillers such as lidocaine, as was also done with vertebroplasty prior to inserting needles into the fractured vertebrae and injecting the cement.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;The Flaws&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;Critics of the two studies cite a laundry list of complaints: too few patients, failure to meet enrollment, inclusion of patients with milder degrees of pain and disability than those usually treated.&lt;/p&gt;
&lt;p&gt;In a November commentary from SIR, issued in conjunction with &lt;em&gt;NEJM&apos;s &lt;/em&gt;publication of letters critical of the studies, J. Kevin McGraw, MD, of Riverside Radiology and Interventional Associates in Columbus, Ohio, highlighted the fact that Kallmes&apos; study originally called for 250 patients.&lt;/p&gt;
&lt;p&gt;Only 131 enrolled, and the vast majority  --  1,682 of 1,813 screened  --  were excluded, &quot;introducing significant selection bias into the study,&quot; he complained.&lt;/p&gt;
&lt;p&gt;McGraw also pointed out that Kallmes&apos; group didn&apos;t use screening MRI to ensure that a fracture was the cause of the patient&apos;s pain.&lt;/p&gt;
&lt;p&gt;In addition, he did some additional statistical noodling and found that if one additional patient had reported a favorable response in the vertebroplasty group, the &lt;em&gt;P&lt;/em&gt;-value would be 0.04, rather than a nonsignificant 0.06. Likewise, if one more patient had an unfavorable response in control group, the association&apos;s&lt;em&gt; P&lt;/em&gt;-value would become significant.&lt;/p&gt;
&lt;p&gt;Finally, in the crossover part of the trial, McGraw highlighted that 12% of patients in the vertebroplasty arm elected the sham procedure, while 43% of those who got the sham went for the real thing.&lt;/p&gt;
&lt;p&gt;&quot;The tremendous crossover rate speaks for some obvious benefit of vertebroplasty over sham and is worthy of a future adequately powered analysis to evaluate,&quot; McGraw wrote.&lt;/p&gt;
&lt;p&gt;As for the Buchbinder trial, McGraw said it was convoluted by selection bias, since two-thirds of patients came from a single center and their procedures were performed by a single radiologist. The commentary also criticizes the volume of cement injected into vertebrae as lower than normal.&lt;/p&gt;
&lt;p&gt;Similarly, the North American Spine Society issued a critique of patient selection criteria and outcome measures, and questioned whether the sham treatment was actually an active therapy. The statement suggested that dry needling might be a more appropriate control.&lt;/p&gt;
&lt;p&gt;One of the letters published in &lt;em&gt;NEJM&lt;/em&gt; also criticized the protocol requirement that patients undergo four weeks of medical therapy prior to enrollment in the trial. During that time, some fractures would have already healed, &quot;resulting in a study on healed fractures,&quot; a group of Australian physicians wrote.&lt;/p&gt;
&lt;p&gt;SIR president Brian F. Stainken, MD, took issue with the fact that patients with the most pain  --  typically older, osteoporotic women  --  weren&apos;t represented.&lt;/p&gt;
&lt;p&gt;McGraw said these patients would be the least likely to agree to be in a randomized trial with a 50% chance of receiving the sham treatment.&lt;/p&gt;
&lt;p&gt;&quot;Most people in severe pain won&apos;t enroll,&quot; Stainken said. &quot;At some level, research design has to take reality into consideration.&quot;&lt;/p&gt;
&lt;p&gt;&quot;The population with low-grade pain, that&apos;s the population these papers focused on,&quot; he continued. &quot;It&apos;s not clear what the right solution is for this group. But I think the contribution of these [two &lt;em&gt;NEJM&lt;/em&gt; studies] may be toward that.&quot;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;On the Defense&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;Kallmes, however, responded that there was no difference in baseline pain scores between patients entering the study and those considered eligible but refusing to participate.&lt;/p&gt;
&lt;p&gt;He also told &lt;em&gt;MedPage Today&lt;/em&gt; that he and colleagues &quot;enrolled patients that are very similar to those treated around the world.&quot;&lt;/p&gt;
&lt;p&gt;&quot;These studies were by far, by far, the best studies ever done,&quot; Kallmes declared.&lt;/p&gt;
&lt;p&gt;&quot;I have full confidence that if we had shown something different, that is, if we had found the procedure was more effective than placebo, people would have embraced it and said they were great studies,&quot; he continued.&lt;/p&gt;
&lt;p&gt;&quot;They would have said, &apos;Look at it, they were prospective, randomized, blinded, near 100% follow-up.&apos; They would have been held up as the paragon for how to do studies in the future  --  if we had reinforced people&apos;s preconceived notions.&quot;&lt;/p&gt;
&lt;p&gt;Richard Deyo, MD, MPH, professor of evidence-based medicine at Oregon Health &amp;amp; Science University in Portland and deputy editor of &lt;em&gt;Spine,&lt;/em&gt; told &lt;em&gt;MedPage Today&lt;/em&gt; that the studies are the best evidence to date regarding the effectiveness of vertebroplasty in these patients.&lt;/p&gt;
&lt;p&gt;&quot;No study is perfect, and these are not perfect, but I do think they&apos;re the best we have,&quot; Deyo said.&lt;/p&gt;
&lt;p&gt;Deyo said there was some validity to complaints that the studies enrolled too few patients, although both trials were adequately powered to detect a difference in pain reduction.&lt;/p&gt;
&lt;p&gt;&quot;If the benefit of this treatment were as enormous as many of the advocates argue,&quot; he said, &quot;then it would take a much smaller study to demonstrate a huge benefit.&quot;&lt;/p&gt;
&lt;p&gt;On the other hand, the studies were too small to evaluate the effects among various patient subgroups.&lt;/p&gt;
&lt;p&gt;Kallmes also criticized the societies&apos; press releases, charging they were written by some &quot;who haven&apos;t read the studies carefully.&quot;&lt;/p&gt;
&lt;p&gt;&quot;The societies are in a great position,&quot; he said. &quot;They have thought leaders that they can partner with to move the science forward. Moving the science forward is not done by sending out press releases.&quot;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Radiologists&apos; Concerns&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;SIR&apos;s reaction may not be surprising, given that radiologists are so vested in vertebroplasty. Medicare will pay physicians from $522 to $554 for a procedure on one vertebra performed in a hospital or outpatient surgery clinic  --  or more than $2,000 if it&apos;s conducted in the physician&apos;s office.&lt;/p&gt;
&lt;p&gt;The number of annual procedures varies from office to office, and radiologists provide varying estimates. McGraw said he performs about 150 vertebroplasties annually, and Stainken said the procedure accounts for about 20% of radiologists&apos; procedures, although that estimate &quot;may be a little high.&quot;&lt;/p&gt;

&lt;p&gt;One of the radiologists&apos; main concerns is that insurance companies will use the trials to justify ending coverage of vertebroplasty for osteoporotic spinal fractures.&lt;/p&gt;
&lt;p&gt;But insurers started playing that card long before the &lt;em&gt;NEJM&lt;/em&gt; trials were published.&lt;/p&gt;
&lt;p&gt;In a 2008 report, the Technology Evaluation Center of the Blue Cross and Blue Shield Association (BCBSA) concluded that neither vertebroplasty nor the related kyphoplasty  --  which restores compression-fractured vertebrae to their normal size with a balloon before the cement injection  --  had been demonstrated to be any better at improving net health outcomes than medical treatments.&lt;/p&gt;
&lt;p&gt;That same year, Wellpoint, the insurance giant with 35 million members, announced plans to classify both procedures &quot;investigational.&quot; That prompted a letter from SIR imploring the company to reconsider.&lt;/p&gt;
&lt;p&gt;Another spine physician, Christopher Bono, MD, of Brigham &amp;amp; Women&apos;s Hospital in Boston, told &lt;em&gt;MedPage Today &lt;/em&gt;that Aetna was also reconsidering coverage for vertebroplasty following the &lt;em&gt;NEJM&lt;/em&gt; publications.&lt;/p&gt;

&lt;p&gt;He said that he believed the firms would not end coverage entirely, but policies would be more restrictive.&lt;/p&gt;
&lt;p&gt;&quot;My gut sense is that payers are going to be much more selective in who they will pay for [regarding vertebroplasty],&quot; Bono said. &quot;They will ask for certain documentation and many more criteria than they did in the past.&quot;&lt;/p&gt;
&lt;p&gt;McGraw worries that seniors will be &quot;denied coverage when they are in the twilight of their lives and could possibly have long-standing suffering&quot; that &quot;could lead to their demise.&quot;&lt;/p&gt;
&lt;p&gt;Stainken said there&apos;s &quot;clear, unambiguous data that prolonged bed rest is the beginning of the cycle of decline for these patients. The key is to be able to do everything we can to ... keep these patients ambulatory and avoid that whole scenario.&quot;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Change is Hard&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;Deyo said money may partly explain the reluctance of physicians who perform vertebroplasties to scale back their use of the procedure.&lt;/p&gt;
&lt;p&gt;&quot;There are people who are making a living doing this, and you don&apos;t easily change what you do for a living,&quot; Deyo said.&lt;/p&gt;
&lt;p&gt;The man credited with coining the term &quot;evidence-based medicine&quot; agreed.&lt;/p&gt;
&lt;p&gt;&quot;If you are making money from a procedure, it is very easy to persuade yourself that new evidence that the procedure is ineffective is in some way flawed or limited to allow you to continue to make money on the procedure,&quot; Gordon Guyatt, MD, of McMaster University in Hamilton, Ontario, told &lt;em&gt;MedPage Today.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;&quot;When we have opinions and beliefs, we are very resistant to new evidence.&quot;&lt;/p&gt;
&lt;p&gt;Kallmes, too, said there are psychological reasons for not accepting the results: &quot;People just don&apos;t want to be convinced. They don&apos;t want to change their preconceived notions.&quot;&lt;/p&gt;
&lt;p&gt;&quot;They have this anecdotal experience,&quot; he added, &quot;but I can tell them anecdotes of miraculous results with the placebo. So if they do this same study themselves, they may find the same thing I found.&quot;&lt;/p&gt;
&lt;p&gt;Still, McGraw and Bono insisted the studies were too flawed to serve as the evidence base for clinical practice.&lt;/p&gt;
&lt;p&gt;&quot;Before we make these two studies the Holy Grail of evidentiary medicine with regard to vertebroplasty, we need to have larger trials,&quot; McGraw said.&lt;/p&gt;
&lt;p&gt;Bono said evidence-based medicine, properly implemented, has three components: reviewing and applying the best data, &quot;but also incorporating surgeon experience and patient preference.&quot;&lt;/p&gt;
&lt;p&gt;&quot;If you are just using the first, and I&apos;m a strong advocate for using data and literature and references, I think you&apos;re doing a disservice,&quot; he said. &quot;And then if you are misinterpreting the data or twisting the data or slanting the data, and eliminating the other two, you are really abusing the word evidence-based medicine.&quot;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Outcomes&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;So, will vertebroplasty go the way of other procedures that seemed to work clinically, but bombed in trials, such as knee arthroscopy for osteoarthritis?&lt;/p&gt;
&lt;p&gt;SIR is awaiting the results of VERTOS II, a 200-patient Dutch trial comparing vertebroplasty with conservative therapy in patients with painful, osteoporotic vertebral compression fractures. And Stainken called for large trials that will address several of the methodology issues raised with the &lt;em&gt;NEJM &lt;/em&gt;reports.&lt;/p&gt;
&lt;p&gt;With regard to the potential placebo effect, Kallmes said he has nearly completed a 20-patient, open-label study of a procedure like that used as the sham in the randomized trial  --  a spinal injection of short-acting painkillers.&lt;/p&gt;
&lt;p&gt;Also in the works is a comparative trial of vertebroplasty and balloon kyphoplasty, he said.&lt;/p&gt;
&lt;p&gt;Stainken said he has heard from colleagues who said they had slowed down or stopped doing the procedures after the studies were published, &quot;which is not unreasonable  --  to think it through and understand the situation.&quot;&lt;/p&gt;
&lt;p&gt;However, most have resumed performing the procedure, and demand for it continues, he added.&lt;/p&gt;
&lt;p&gt;Aman Patel, MD, an associate professor of radiology and neurosurgery at Mount Sinai School of Medicine in New York City, said he and his colleagues have not changed their practice since learning of the studies&apos; findings.&lt;/p&gt;
&lt;p&gt;However, he has started telling patients about the findings from the &lt;em&gt;NEJM&lt;/em&gt; studies so they can be fully informed of the existing evidence about the risks and benefits of vertebroplasty.&lt;/p&gt;
&lt;p&gt;&quot;I firmly believe this procedure benefits some, if not many, patients,&quot; Patel said.&lt;/p&gt;
&lt;p&gt;McGraw said he tells patients about the trials, but he also tells patients who he thinks would benefit from vertebroplasty that he doesn&apos;t believe the findings apply to them.&lt;/p&gt;
&lt;p&gt;He said one patient had initially declined the procedure after talking it over. &quot;That patient called me up a week later to proceed with vertebroplasty,&quot; he said.&lt;/p&gt;
&lt;p&gt;Even if the findings don&apos;t change the way spine doctors use vertebroplasty in the short term, Deyo suspects the results will lead to fewer procedures in the long run.&lt;/p&gt;
&lt;p&gt;Guyatt and Deyo predicted that eventually, a critical mass of evidence would be assembled  --  assuming future randomized studies replicate these results  --  that would convince even the most steadfast adherents.&lt;/p&gt;
&lt;p&gt;Also, the &lt;em&gt;NEJM&lt;/em&gt; studies could have an immediate effect in promoting more research by increasing the level of doubt about the procedure, Deyo said: &quot;I don&apos;t think we have the final word here.&quot;&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;Deyo, Guyatt, Patel, and Stainken reported having no relevant conflicts of interest.&lt;/p&gt;&lt;p&gt;Bono reported financial relationships other than research funding with Life Spine, Depuy, Medtronic, and Stryker, and research funding from Archus Orthopedics and Synthes Spine. He was lead author of the North American Spine Society&apos;s critique of the two randomized trials published in the &lt;em&gt;New England Journal of Medicine&lt;/em&gt;.&lt;/p&gt;&lt;p&gt;McGraw has had relationships with Cardinal Spine, Arthrocare Spine, and Hatch Medical.&lt;/p&gt;&lt;p&gt;Kallmes reported relationships with ArthroCare, Stryker, Cardinal, and Cook.&lt;/p&gt;&lt;p&gt;Buchbinder reported receiving research funding from Cook.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_264"
                     title="AAP Releases Tips on Preventing Soccer Injuries (CME/CE)"
                     score="0.002"
                     href="http://www.medpagetoday.com/Orthopedics/Orthopedics/tb/18098?impressionId=1265738602255"
                     
      &lt;p&gt;Coaches, parents, doctors and soccer officials can help prevent soccer-related injuries as the popularity of the sport grows, according to a report from the American Academy of Pediatrics.&lt;/p&gt;
&lt;p&gt;Although soccer is an effective way for children and teens to increase their physical activity, injury rates are higher than in many other contact sports, including field hockey, rugby, basketball, and football, according to Chris Koutures, MD, a pediatrician in Anaheim Hills, Calif., and Andrew Gregory, MD, of Vanderbilt University.&lt;/p&gt;
&lt;p&gt;Both are members of the AAP&apos;s Council on Sports Medicine and Fitness, which released the report in the February issue of &lt;em&gt;Pediatrics&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Risk of injury goes up when dirty play enters the game. In one study, 11.9% of girls&apos; soccer injuries and 11.4% of boys&apos; were attributed to illegal actions.&lt;/p&gt;
&lt;p&gt;&quot;There is consensus that proper rule enforcement and limitation of violent contact can reduce the risk of injury,&quot; Koutures and Gregory noted.&lt;/p&gt;
&lt;p&gt;&quot;Officials controlling the physicality of the game and emphasis on safe play with respect for one&apos;s opponents can both play significant roles in reducing contact injuries in soccer.&quot;&lt;/p&gt;
&lt;p&gt;The U.S. Consumer Product Safety Commission (CPSC) estimated that there were 186,544 soccer-related injuries in 2006, with 80% occurring in athletes younger than 24. About 44% occurred in children and teens younger than 15, who have a higher risk of injury than their older counterparts.&lt;/p&gt;
&lt;p&gt;Most injuries are to the lower extremities, with ankle injuries accounting for up to 29% and knee injuries accounting for up to 36% of the total.&lt;/p&gt;
&lt;p&gt;Girls have a greater risk of knee injury and rupture of the anterior cruciate ligament, mostly from hyperextension of the knee when landing, cutting, or turning.&lt;/p&gt;
&lt;p&gt;Certain exercise programs focused on neuromuscular training have been shown effective for preventing knee injuries among adolescent girls. (See &lt;a href=&quot;http://www.medpagetoday.com/Orthopedics/Orthopedics/17887&quot; mce_href=&quot;http://www.medpagetoday.com/Orthopedics/Orthopedics/17887&quot; target=&quot;_blank&quot;&gt;Program Cuts Knee Injuries in Soccer&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;&quot;Pediatricians are encouraged to familiarize themselves with these programs and inform their patients on the availability and potential benefits,&quot; Koutures and Gregory wrote.&lt;/p&gt;
&lt;p&gt;Upper extremity injuries are much less common, accounting for 3% to 12% of the total.&lt;/p&gt;
&lt;p&gt;Soccer-related fatalities are rare and usually involve impact with the goalposts. According to the CPSC, there have been 28 deaths resulting from falling goalposts since 1979.&lt;/p&gt;
&lt;p&gt;Koutures and Gregory noted that guidelines have been developed by manufacturers and the CPSC on properly securing goalposts.&lt;/p&gt;
&lt;p&gt;Concussions occur at a rate similar to that seen in ice hockey and football players. Only about 3% of the total injuries are concussions, but the authors said there might be some under-reporting.&lt;/p&gt;
&lt;p&gt;About half of concussions (47%) are caused by a collision with another player, with the rest coming from contact with the ball (24%), the ground or goalpost (17%), or a combination of objects (10%).&lt;/p&gt;
&lt;p&gt;Koutures and Gregory noted that evidence does not support any adverse short- or long-term neurological consequences from heading the ball on purpose.&lt;/p&gt;
&lt;p&gt;&quot;However,&quot; they wrote, &quot;the AAP encourages heading of the ball only be taught when the child is willing to learn proper technique and has developed coordinated use of his or her head, neck, and trunk to properly contract the neck muscles and contact the ball with the forehead.&quot;&lt;/p&gt;
&lt;p&gt;The risk of eye and other facial injuries is considered low to moderate, according to the authors.&lt;/p&gt;
&lt;p&gt;Nevertheless, they wrote, &quot;protective eyewear is recommended for all participants in soccer ... and should be mandatory for athletes with only one functional eye or those with a past history of major eye surgery or trauma.&quot;&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The authors did not make any financial disclosures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_107"
                     title="Novel Tendon Shots Offered No Benefit over Exercise (CME/CE)"
                     score="-0.007"
                     href="http://www.medpagetoday.com/Orthopedics/Orthopedics/tb/17910?impressionId=1265738602255"
                     
      An experimental drug-and-exercise therapy for chronic Achilles tendinopathy didn&apos;t work in a Dutch study, researchers said.&lt;br&gt;
&lt;br&gt;Injections of platelet-rich plasma (PRP) combined with eccentric exercise gave no better results than exercise alone, according to Robert de Vos, MD, of Erasmus University Medical Center in Rotterdam, and colleagues.&lt;br&gt;
&lt;br&gt;The finding comes from the first randomized, placebo-controlled trial of the therapy, which appears to be gaining popularity on the basis of more limited studies, De Vos and colleagues reported in the Jan. 13 &lt;em&gt;Journal of the American Medical Association&lt;/em&gt;.&lt;br&gt;
&lt;br&gt;The popularity of the treatment has also been fueled by its connection to professional athletes, most notably golfer Tiger Woods, who reported received PRP injections last year to speed his recovery from knee surgery.&lt;br&gt;
&lt;br&gt;The theory behind the practice is that the platelets lead to a release of growth factors that participate in tissue repair.&lt;p&gt;&lt;/p&gt;
&lt;p&gt;But support for the theory has been based on laboratory studies and clinical trials that had &quot;important limitations,&quot; the researchers said, including lack of a control group or blinding procedure.&lt;/p&gt;
&lt;p&gt;To fill the gap, de Vos and colleagues enrolled 54 patients being treated at The Hague Medical Center for chronic tendinopathy two to seven centimeters above the Achilles tendon insertion.&lt;/p&gt;
&lt;p&gt;They were randomly assigned to get injections of PRP derived from their own venous blood or a saline placebo, combined with 12 weeks of eccentric exercises. The investigators noted that platelet-rich plasma injections are generally performed now in association with exercise programs.&lt;/p&gt;
&lt;p&gt;The primary endpoint was change from baseline to six, 12, and 24 weeks on the Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire, which evaluates pain score and activity level.&lt;/p&gt;
&lt;p&gt;The fluid  --  saline or plasma  --  was injected through three ultrasound-guided punctures in the tendon. Through each puncture, five small depots of fluid were left in the damaged area of the tendon, the researchers reported.&lt;/p&gt;
&lt;p&gt;Based on the questionnaire, both groups improved significantly from baseline through 24 weeks. Those getting plasma improved by 21.7 points, while those getting saline placebo improved by 20.5 points.&lt;/p&gt;
&lt;p&gt;There was no significant difference between the groups at 24 weeks or at any other evaluation time point, the researchers found.&lt;/p&gt;
&lt;p&gt;The improvement in both groups can probably be attributed to the exercise program, the researchers said, although part of it might be due to a placebo effect among those getting saline.&lt;/p&gt;
&lt;p&gt;One limitation of the study, the researchers said, is that the number of platelets and the quantity of growth factors in the injections was not known.&lt;/p&gt;
&lt;p&gt;It is also not clear how long such growth factors remained in the tendon; there is a possibility that they might have diffused away rapidly, lessening their effect, the authors noted.&lt;/p&gt;
&lt;p&gt;Such limitations mean it&apos;s too early to junk the idea entirely, according to Victor Ibrahim, MD, of the National Rehabilitation Hospital in Washington, D.C., who was not part of the study.&lt;/p&gt;
&lt;p&gt;It may be, he told&lt;em&gt; MedPage Today&lt;/em&gt;, that the exercise component of the study in effect squeezed the active factors out of the tendon. It may also be that the injection protocol, while &quot;reasonable,&quot; was not the most effective one, he said.&lt;/p&gt;
&lt;p&gt;Patients have begun to regard PRP as a &quot;miracle cure,&quot; Ibrahim said, but the study implies that the &quot;foundations of recovery need to be rehabilitation.&quot;&lt;/p&gt;
&lt;p&gt;&quot;A good therapy program really beats out anything that we have so far when it comes to injections, whether it&apos;s steroids or platelet-rich plasma,&quot; he said.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was supported by by Biomet Biologics of Warsaw, Ind.&lt;/p&gt;&lt;p&gt;The researchers reported no conflicts.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
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                     title="Program Cuts Knee Injuries in Soccer (CME/CE)"
                     score="-0.007"
                     href="http://www.medpagetoday.com/Orthopedics/Orthopedics/tb/17887?impressionId=1265738602255"
                     
      A combined exercise and educational program produced a significant reduction in knee injuries among young female soccer players, researchers found.&lt;br&gt;
&lt;br&gt;Injuries that did occur were less severe among players who took part in the program, Liisa Byberg, PhD, of Uppsala University in Sweden, and colleagues reported in the Jan. 11 &lt;em&gt;Archives of Internal Medicine&lt;/em&gt;.&lt;br&gt;
&lt;br&gt;The program, which was aimed at improving body control and reducing strain on the knee joint among players 13 to 19, did not require additional equipment and could be worked into a typical soccer practice.&lt;br&gt;
&lt;br&gt;Only three of the 48 teams who participated reported less than 75% compliance with the intervention.&lt;p&gt;&lt;/p&gt;
&lt;p&gt;&quot;The high compliance rate in this study suggests that the program is easy to implement and incorporate into regular soccer practice,&quot; the researchers wrote.&lt;/p&gt;
&lt;p&gt;In an accompanying editorial, Mitchell Katz, MD, of the San Francisco Department of Public Health, and Rita Redberg, MD, of the University of California San Francisco, said preventing injuries in team sports should be a health priority.&lt;/p&gt;
&lt;p&gt;&quot;Undoubtedly, part of the success of the intervention derives from its development by a physician in collaboration with an orthopedic surgeon, a physiotherapist, and soccer coaches, specifically for female soccer players,&quot; they wrote.&lt;/p&gt;
&lt;p&gt;This approach &quot;is likely to be successful not only in preventing other soccer-related injuries but also in preventing injuries in other competitive sports such as football, basketball, and tennis.&quot;&lt;/p&gt;
&lt;p&gt;Knee injuries among young female soccer players are expected to increase because of the growing popularity of women&apos;s soccer worldwide, Byberg and colleagues noted. Females also appear to have higher injury rates than males.&lt;/p&gt;
&lt;p&gt;To help address this problem, Byberg and her colleagues developed HarmoKnee, a soccer-specific warmup and exercise routine designed to improve motor skills, body control, strength, and muscle activation. The intervention also included education about injury risk for the athletes, parents, and coaches.&lt;/p&gt;
&lt;p&gt;In one Swedish county  --  Uppland  --  48 soccer teams agreed to perform the intervention. The exercise portion was performed twice a week during the preseason and once a week during the season.&lt;/p&gt;
&lt;p&gt;In another county  --  Dalarna  --  49 teams continued to train as usual for the entire season.&lt;/p&gt;
&lt;p&gt;By the end of the season, there had been three knee injuries in the intervention group and 13 in the control group.&lt;/p&gt;
&lt;p&gt;There were five injuries to the anterior cruciate ligament, all in the control group, which &quot;is important because these injuries often require long rehabilitation and frequently lead to permanently reduced function and early retirement from soccer,&quot; the researchers noted in the journal.&lt;/p&gt;
&lt;p&gt;After adjustment for several factors related to injury risk, the exercise program was associated with significant reductions in total knee injuries (rate ratio 0.17, 95% CI 0.04 to 0.64) and noncontact injuries (rate ratio 0.06, 95% CI 0.01 to 0.46).&lt;/p&gt;
&lt;p&gt;The injuries that did occur were less severe in the intervention group. All three were considered major, but each player returned to action within six months.&lt;/p&gt;
&lt;p&gt;In the control group, however, 11 of the 13 injuries were considered severe, and only four of the players were able to play within six months.&lt;/p&gt;
&lt;p&gt;Compliance with the intervention extended beyond the study  --  a year later, 44% of the teams were still performing at least part of the exercise program and 19% were performing it in its entirety.&lt;/p&gt;
&lt;p&gt;The researchers noted that the study was limited by the lack of individual-level data, the low number of injuries, and the possibly biased measurement of compliance.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;This study was supported by Folksam, the Uppsala County Council, the Swedish Athletic Institute of Education in Uppland, the Uppland Football Association, the Dalarna Football Association, and the Department of Research and Development, Uppsala Primary Care, Uppsala County Council.&lt;/p&gt;&lt;p&gt;Neither the study authors nor the editorialists made any financial disclosures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
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