Dr. Nicholas Cappello

I would like to share a good article from the NNew York Times. IT is an American impulse to covet the new and improved — whether it’s a faster computer, a smarter cellphone or a more fuel-efficient car. And in medicine, too, new drugs, devices and procedures have advanced patient care.

The implants, known as metal-on-metal hips, were regarded by device makers and surgeons as a major advance over previous designs that used both metal and plastic. Now federal regulators and medical researchers are scrambling to determine how many implant recipients have been injured by the devices, which can shed dangerous metallic debris through wear.

In a highly unusual move, the Food and Drug Administration last month ordered manufacturers of all metal hips to undertake emergency studies of patients. And lawmakers and others are now calling for a tightening of how the F.D.A. scrutinizes new implants — both before and after they are sold.

“As a non-American, I don’t completely understand it, but there is a phenomenon in the U.S., the latest and the greatest,” said Dr. Henrik Malchau, who practiced as an orthopedic surgeon in Sweden before going to Massachusetts General Hospital in Boston. “There was a patient demand to get these implants on the misconception that the latest was the best.”

Some experts, like Dr. Malchau, said they used a special type of metal-on-metal implant known as a resurfacing device in specific patients — mainly taller, middle-age men — because data showed that they worked in that small group. But as with many innovations, metal hips were marketed to all comers. For example, about 65 percent of the implants went to women and older patients, according to an estimate by a consulting firm, Exponent Inc. As it turned out, those two groups appear most prone to failures involving the devices.

Last year, DePuy, the orthopedics division of Johnson & Johnson, recalled one of its all-metal hips, the ASR, which was failing at a high rate. Another manufacturer, Zimmer Holdings, also briefly halted sales of one of its metal models, the Durom.  DePuy, Zimmer and other companies and doctors have said that most patients who received metal hips have done well.

THE modern artificial hip, which was developed by a British surgeon, Dr. John Charnley, in the 1960s, uses a relatively simple design. A metal “ball” made of cobalt and chromium replaces the top of the thigh bone, while a “cup,” typically made of plastic, serves as an artificial hip socket. By the 1990s, the devices were considered highly effective, with studies then finding that implants still worked a decade after surgery in 95 percent of patients.

Metal-on-metal implants, in which the cup is also made of a metal alloy, had been tried during those early decades, but were largely abandoned after tests found that patients had metal particles in their blood or organs, raising concerns about long-term health risks like cancer.

By 1996, Jonathan Black, an industry consultant and professor emeritus of bioengineering at Clemson University, warned in a medical journal article that the metal-on-metal design posed significant risks because little was known about the biological havoc that metallic debris might cause. He also argued that given the high success rate of existing designs, it would be statistically impossible to run enough studies to prove the new implants’ supposed superiority.

At the time, Mr. Black estimates, the all-metal implants accounted for only a tiny fraction of some 250,000 hips implanted annually in the United States. By 2008, they were used in one out of every three hip procedures.

What happened? In essence, the old technology was repackaged as new and cutting-edge, and warnings like Mr. Black’s were ignored and considered no longer relevant. This new generation of devices was manufactured differently and reflected better designs, advocates argued.

Companies and surgeons began promoting the new implants as the next big step in orthopedics, one that would let patients, particularly middle-age ones, do strenuous physical activities because their mechanics were more natural. And patients, intrigued by ads featuring celebrity athletes, also wanted such devices.

“I was a skier and a hiker,” said Kathleen Herlihy-Paoli, 55, a graphic designer in Missoula, Mont., who had both of her arthritic hips replaced two years ago with all-metal devices. “My doctors said these would last longer and enable more activity.”

For physicians, new products like the all-metal hips have several attractions, experts say. Along with the potential to improve care, new technology gives the doctor offering it a way to market his or her practice as different from that of a competitor.

An orthopedic surgeon in Los Gatos, Calif., Dr. Edward Littlejohn, was one of the hundreds of physicians nationwide who started implanting the all-metal devices soon after they were marketed. Dr. Littlejohn said he had long used implants made by DePuy, and believed the new all-metal devices were safe because they had passed F.D.A. muster. “I was a DePuy guy,” he explained.

Things started out great, he said. But about a year and some 40 implants later, patients started complaining of pain. One woman developed a condition that Dr. Littlejohn had rarely seen before: a buildup of gray-colored fluid around her hip. It was about then, Dr. Littlejohn said, that he realized he had leapt too soon.

Dr. Lawrence Dorr, a surgeon in Los Angeles who helped popularize all-metal hips, said they also appealed to doctors for a practical reason: they reduced the risk that a new hip would dislocate soon after implantation.

By using a metal cup, which is thinner than a plastic one, a surgeon could implant a bigger ball component, Dr. Dorr explained, which was less likely to dislocate than a smaller one. Recent research, however, suggests that such oversized components may be a part of the reason the devices shed metallic debris.

“I thought this could be a home run,” Dr. Dorr recalled. “Instead, it turned out to be a strikeout.”

There were skeptics along the way, like Nadim J. Hallab, an implants expert at Rush University Medical Center in Chicago. Dr. Hallab worked with surgeons who were disappointed with the earlier generation of all-metal devices, and they remained skeptical about the new ones. “I never thought this was going to fly,” he says.

But it was an about-face by Dr. Dorr in Los Angeles, that first sounded a public alarm. In 2007, he alerted fellow surgeons after some of his patients developed pain and had to have replacement operations. As the number of affected patients nationwide mounted, it emerged that the devices shared a trait with other failed innovations: most of them had been little tested.

UNDER F.D.A. rules, most all-metal hips don’t have to undergo clinical trials before sale. Instead, they are tested in labs on machines that simulate millions of steps to study the forces exerted by years of motion. Such wear is inevitable in an artificial hip; for example, tests showed that the type of plastic used in some plastic-metal hips shed particles that led to bone loss in some patients.

Similar tests of the all-metal implants did not point to problems, testing experts say. But in retrospect, they added, they think they understand why: the simulations were apparently based on idealized conditions, not on what would happen in the real world of doctors and patients. For example, all-metal devices proved less forgiving than metal-and-plastic ones to small variations in how they were implanted, with components sometimes striking together and generating debris.

Harry McKellop, a device testing expert at Los Angeles Orthopaedic Hospital, said it was his understanding that “most of the early metal-on-metal testing was not done under adverse conditions.”

While some metal implants have performed well in certain patients, the devices, as a group, are twice as likely as metal-and-plastic ones to require early replacement, according to data from Australia’s orthopedic registry, one of the most comprehensive databases on implants.

Most troublingly, damage from debris generated by metal implants is proving far more insidious than that caused by plastic particles. In some patients, it has caused crippling tissue and muscle damage, and has produced neurological problems in others.

The innovation cycle involving the hips has now entered a new phase: cleanup. Regulators, researchers and companies must assess the damage caused, and determine how to undo it.

ACCORDING to one estimate, about 500,000 patients in the United States may have gotten an all-metal hip in the past decade, raising the likelihood that tens of thousands will have painful early-replacement procedures. Even if the share of seriously injured patients stays low, as researchers hope, thousands are likely to be affected, experts estimate.

In early May, orthopedic specialists and company officials discussed how best to perform the special studies the F.D.A. is now requiring. Pitfalls may abound, specialists warned. For example, only certain labs are authorized to measure metallic ions in the blood, and diagnostic equipment, unless specifically calibrated, will not detect tissue damage.

There may also be some confusion about the advice coming from the F.D.A. and other authorities. Officials urge patients to contact their doctors if they experience pain, but internal damage may be occurring in some patients who are free of symptoms.

Ms. Herlihy-Paoli, the graphic designer, said her brother-in-law, a lawyer, urged her last year to get a blood test because he had a client with a failed metal hip. She said she thought it unnecessary because she felt fine, but when she did take the test it showed high levels of metallic ions.

Feeling panicked, she sought out Dr. Malchau in Boston, who discovered that debris had already started a reaction around one implant that was producing aberrant tissue growth. “I had a tumor growing there,” Ms. Herlihy-Paoli said. “If I had left the hip in, it would have started damaging the bone and muscle.”

Needless to say, surgeons, testing experts, implant company officials and regulators are all eager to find a way to prevent such problems with other new devices. The proposals include better pre-market testing, consistent product tracking and phased-in introductions of new products.

But many experts also want to ensure that too much second-guessing does not slow real innovation. Ultimately, the resolution of that quandary, some experts believe, may lie as much with the attitudes of doctors and patients as it does with regulation.

In the final day of the National Athletic Trainers’ Association Meeting and Clinical Symposia at the Morial Convention Center, three experts who deal in biological therapies presented the latest research on using stem cells and platelet-rich plasma (PRP) in treating sports injuries.

Sports medicine professionals around the country are beginning to use patients’ own blood matter — platelet-rich plasma and/or stem cells retrieved from the patient, and injecting the healing-rich material into injury sites to promote faster and more effective healing.

The most headline-grabbing example of this was Pittsburgh Steelers wide receiver Hines Ward, who was injected with PRP to jumpstart the healing process on his knee injury heading into the Super Bowl. He recovered enough to play in two weeks.

Tiger Woods was injected after his 2008 knee surgery. Baseball players Carlos Beltran, Cliff Lee and other professional athletes also reportedly have had PRP therapy. The procedure is allowed by the four major professional sports leagues, not regarded as a performance-enhancer any more than a knee brace. And it now has considerable buzz because of the star power using it.

The simplicity of the PRP procedure and the safety of it make it attractive to athletes who would rather try it than a traditional surgery or invasive treatment. It is still considered experimental by the medical insurance world, so most people pay out of pocket for the procedures.

It’s a simple process that begins with blood drawn from the front of the elbow — just as traditional blood samples are taken.

A citrate is added to the blood to inhibit clotting, and then the blood vial is placed in a centrifuge, which spins the matter into several components: plasma, platelets, white blood cells and red blood cells.

The plasma is then injected back into the patient at the injury site, usually with the aid of ultrasound guidance to make sure it is deposited in the optimal location.

The healing properties of the platelet-rich plasma go to work, supposedly fanning the healing process. Stem cells work similarly, only they can be extracted from the patient, cultured and multiplied outside the body before re-injecting them.

“You have lots of different tools, and those tools can be enhanced and used to help different areas,” Dr. Chris Centeno, a panelist who uses stem cells and PRP in his practice. “You can move cells from point A to point B and make more of them and use those to try to heal you.”

There is even talk about young athletes farming away their stem cells retrieved from bone marrow aspiration to have for use in future injuries.

The use of stem cells in the medical world isn’t new, but it is new to orthopedic medicine.

“We started doing some research in 2005, and in late 2007 we became convinced it was working and started offering it to our general surgery population rather than just research subjects, ” Centeno said.

His patients saw great reduction in pain and bounced back quicker than those who went for more traditional surgeries. Centeno said he is on a team that submitted a study for publication that includes 250 patients, and that study is encouraging for the field.

“I think PRP is exciting; I think it’s a new thing, ” Gerald Weniger, a certified athletic trainer althleticwho administers such injections in his Harrisonburg, Va., clinic. “Before we were doing it in our clinic, we had people coming to us and asking us to do it because they were so excited about what they were seeing in the news. We only got into it because people were asking us to do it.”

The problem is, there isn’t much research in the area.

Adding to the cloud of uncertainty is that there is no standard methods of collecting the material or administering it. So comparing one study that used volumes of PRP material and injected it into a human shoulder might not make an easy comparison to another study that used teaspoons of it in a rat’s leg.

“I think we’ve got to slow down because there’s not a lot of research on it yet, ” Weniger said. “I think the research that’s been done is pretty (vague). There is a lot that shows PRP has a beneficial effect, and there is a lot that doesn’t show anything. I think we have to hash that all out. I think we certainly have to keep doing it so we can figure that out and keep trying on different things so we can narrow things down and get indications on whether it should be ligaments or muscles or tendons, and whether it should be used in acute settings or chronic settings.”

Corey Oshikoya, an athletic trainer with the Denver Broncos who sat on the panel as well, said his profession is trying to make up rehabilitation schedules on the fly as more and more players come in after PRP injections. If these athletes are recovering quicker, do you up their rehab schedule? So far the answer to that is no. He advised caution in ramping up rehabilitation steps.

“There is very little literature out there that displays or approaches how you should treat an athlete that has had PRP therapy, ” he said in his lecture. “We’re all kind of searching for answers

For joint replacement surgery, busy hospitals are better. A study published on June 7 in Arthritis and Rheumatism, a peer-reviewed journal of the American College of Rheumatology, found that patients who undergo elective total hip or knee arthroplasty at hospitals with lower surgical volumes had a higher risk of venous thromboembolism and one-year mortality following the procedure.

The authors theorize that the causes of complications at low-volume hospitals could be connected to hospital procedures and peri- and post-operative care processes. One example cited by the authors is the different types and levels of medication prescribed by physicians to prevent blood clots following elective joint replacement surgery. The authors also suggest that the outcome of surgery may well be affected by how much time elapses between initiation of clot prevention therapy and its cessation. Dr. Singh Jasvinder, M.D., M.P.H. of the University of Alabama, lead author of the study, concluded, “Further studies are needed to investigate whether the underlying reasons for poor surgical outcomes at low-volume hospitals are modifiable and which interventions may reduce complications for patients at these facilities.”

Researchers used the Pennsylvania Health Care Cost Containment Council database to identify the number of patients who underwent total hip replacement (n=10,187) and total knee replacement (n=19,418) surgery in 2002 in the state. The mean age of patients in both groups was 69 years, and men comprised 43% of the total hip replacement cohort and 35% of the total knee replacement group. Hospital volume was categorized by less than 25 surgeries, per year, for low-volume hospitals and 200 or more surgeries per year for high volume hospitals.

rthopedic surgeons in the United Kingdom are treating some of their younger patients who suffer from osteoarthritis with a new procedure that involves cementing metal to the damaged parts of the knee. This approach allows the younger patient to receive a partial knee replacement surgery but with fewer or none of the usual negative side effects associated with a more traditional joint replacement.

Osteoarthritis affects 8.5 million people in the United Kingdom and each year the National Health Service carries out more than 70,000 knee-replacement procedures. (Osteoarthritis of the knee develops when the cartilage that coats the bone wears away, either because of wear and tear, injury or genetic predisposition—leading to the bones grinding against one another and deteriorating.)

The particular surgical technique targets only the areas of the knee that have been damaged by the effects of osteoarthritis and, according to the surgeons who’ve written about this surgical technique, provides patients with greater post-operative mobility as compared to more traditional and invasive joint replacement surgery.

The new procedure requires the surgeon to clearly identify and map out which areas of the knee cartilage have become worn down due to osteoarthritis. Then, under general anesthetic or an epidural, the surgeon makes a small (3.5 inch wide) incision on the inside of the knee.

After filing down the rough sections of the knee the surgeon cements a thin shell of cobalt chrome to cover the affected part of the knee. To keep the metal surface from grinding against the bone or other sections of metal, a small plastic bearing is attached to the top of the tibia to replicate the role of the cartilage in the natural knee. Over time, bone tissue grows around the implanted surfaces to make them an integral part of the joint.

“We have patients who do very strenuous activities that they would not be able to do with a full knee replacement,” says David Barrett, professor of orthopedic engineering at Southampton University, who has been performing the operation since October. He says that with this procedure more of the original joint is conserved, none of the ligaments around or inside the knee are disturbed and the plastic insert can be renewed. Additionally, further compartments or areas of the knee can be resurfaced if the arthritis begins to affect other parts of the joint. Barrett has found that patients can get up and walk the same day and usually can go home after a few days.

“Bursitis is a common cause of musculoskeletal pain and often prompts orthopaedic consultation,” said study author Daniel Aaron, MD, a clinical instructor in the department of orthopaedics at Brown University in Providence, R.I. “One of the challenges facing clinicians is to differentiate bursitis from conditions with similar symptoms, including arthritis, tendinitis, fracture, tendon or ligament injury and tumor. Additionally, bursitis arises from infectious and noninfectious causes, and distinguishing between the two can be challenging.

All types of bursitis often can be successfully managed non-surgically, and possible treatments include:

• use of ice packs or compressive dressings;
• activity modification that may reduce stress or irritation;
• administration of nonsteroidal anti-inflammatory drugs (NSAIDs) or antibiotics;
• corticosteroid injections (knee and elbow);
• stretching exercises; and/or
• change of footwear (heel).

Surgery may be required in patients whose symptoms remain following these treatments and in certain situations when infection is involved.

Dr. Aaron said in most cases, the best way to prevent bursitis is to vary physical activity, avoiding repetitive activities that may increase stress and trauma on the joints. Padding surrounding the knee or elbow joints may help prevent repetitive trauma which could lead to bursitis in those areas. Finally, losing extra weight which may be causing stress on joints, particularly of the hips and knees, is also recommended.

With great weather on tap, weekend warriors are jumping full-tilt into their favorite sports.

Exercise is great, but a few words of caution might be warranted for those who spent the snowy winter and wet spring in hibernation.

 The best example is that of the multi-purpose stadiums that were built in the 1970s. These were built with the old “Astroturf,” a very hard surface. Think of a carpet on concrete. Many of the baseball players who played on those surfaces had knee problems later on in their lives. Another sport with a hard court is basketball. To add to that, basketball is a stop-and-start sport, which is very brutal on the knees.

If someone is rehabilitating from an injury, we frequently start them back on running on softer surfaces such as grass or on a cinder track. The newer artificial surfaces for track and field try to address the hardness problem and their role in the preservation of the lower-extremity health of the athletes.

 Sports injuries vary with age

I see many weekend warriors. These are people in their third decade and beyond. They are more prone to certain injuries, such as Achilles tendon ruptures and patella (knee) tendon ruptures. I see a lot of 40- and 45-year-olds that tear the Achilles. It comes from some aging degeneration. People in their 60s are more prone to quadriceps (thigh) tendon ruptures. Bill Clinton did this.

Injuries of the upper extremities often go with racquet sports and some overhead-throwing sports. Orthopedists often see overuse injuries in the older age groups. Rotator cuff tendonitis and tennis elbow are common. Tennis elbow affects the tendons on the outside of the arm, and golfer’s elbow involves those on the inside. These can happen at any age.

How do you know whether you should go to the doctor for a sports injury?

You should see the doctor if:

• A lower extremity is injured, and you can’t put any weight on it. That condition would immediately need evaluation to make sure that nothing is broken.
• There is a change in sensation. That would occur if an artery is damaged or there is a significant nerve injury.
• There is an inability to move a particular joint.
• There is bleeding. That would indicate the need for immediate attention.
• There is a deformity noted.

People don’t have to run to the doctor for everything. If none of the five criteria are present, you can try the RICE test: rest, ice, compression and elevation.

It is important, though, to monitor your injury over the course of the first 48 hours. If the injury doesn’t improve or worsens, you might consider seeing the doctor. RICE can sometimes involve immobilization, too.

If you think that you have a fracture, you would want to see the doctor right away. Fractures generally swell quickly and significantly. A fracture is any cracked or broken bone. There is no degree in the word “fracture.” It does not imply that the break is minor. A break is a break.surgeon always prescribe surgery?

It is a misconception that when someone walks into an orthopedic surgeon’s office that surgery is necessarily the first option. In addition to a physical exam, the doctor might use imaging modalities, such as the X-ray, MRI, CT scan, ultrasound and others to determine the extent of the injury.

Frequently, there are non-operative treatments available, such as rest, immobilization, slow return to function and physical therapy. Obviously, though, there are certain injuries that do require immediate surgical attention, such as open fractures and some dislocations. Orthopedic surgeons are best equipped to decide how to treat a particular injury.

How can a person keep from being injured?

The orthopedic surgeon’s role is also trying to prevent injury. Unfortunately, my first contact with patients is generally when they come to the office after having been injured.

To prevent injury, people should do warm-ups before playing sports, which would include a light jog and stretching. The hamstrings and the quadriceps as well as other muscles should be stretched. That way, the first time you fire a muscle in a burst, such as in a run, it won’t tear.

As you swelter this summer dont forget about the most important substance to put in your body, water.

If you think of your body as a machine, water is the ”oil” that keeps everything working smoothly. Even if you do nothing special, your body loses about three quarts of water a day through elimination, urination, perspiration and respiration. This loss is usually replaced by the water in foods and drinks without your having to think much about it. To be on the safe side, try to drink at least six to eight eight-ounce glasses a day. You can get just as dehydrated in cold weather as in hot, but this time without realizing how dry you are. In many cool weather activities – running, tennis, hiking, ice skating, skiing, traveling by air or simply visiting at high altitudes – you can easily lose a quart or more of water before your thirst signal lets you know it.

A quart or two might not sound like much when you learn that the average adult body contains 40 to 50 quarts of water, 40 percent of which is found inside cells. But with a loss of just 5 percent of body water (about 2 1/2 quarts), your skin shrinks and muscles become weak. You may feel fatigued, irritable, dizzy, headachy and drained of energy. In fact, the debilitation many people felt in last summer’s heat wave may have been due as much to insufficient hydration as to the heat and humidity.

Thirst, unfortunately, is not much help. It’s a signal evolution designed to prevent severe dehydration. It kicks in when your body is in serious trouble, long after you should have begun drinking water to replenish your losses. The thirst signal shuts off well before you’ve drunk enough. So you cannot afford to rely on thirst; you must use knowledge and good sense.

Furthermore, the beverages many people choose to quench thirst are often counterproductive. Instead of hydrating the body, they are diuretics that cause the body to lose water. Among popular diuretic beverages are all alcohol-containing drinks and caffeinated tea, coffee and soft drinks. Or the chosen beverages may be so loaded with dissolved solids (sugared drinks and milk, for example) that they increase the body’s water needs rather than satisfy them.

Plain water, with or without carbonation, is the best way to replace lost water. Cold water is absorbed faster than hot. Second best are tomato and other vegetable juices, pure unsweetened fruit juices diluted with water or seltzer and decaffeinated coffee and tea. On cold days you might try hot water with lemon or lime juice.

You may not seem to sweat much when the air is dry and cool, but you do. Sweating is your body’s primary cooling mechanism. when your muscles are working hard. You may be unaware of the perspiration because it evaporates so quickly. Also, a lot of moisture is lost unnoticed when you breathe rapidly. (Those are water droplets that create the ”smoke” you exhale on very cold days.) A good rule is to weigh yourself unclothed before your workout and then again right afterward. Drink one pint (16 ounces) of water for every pound you lose. You do not have to worry about replacing the salt lost in sweating unless you have dropped 5 to 10 pounds in an event.

Cold water is the fastest and safest way to hydrate an ordinary athlete. Sports drinks, like Gatorade, which contain sugar and salt, were intended for superathletes, like marathoners, long-distance cyclists and triathletes, whose events last for hours. It is best to avoid carbonated drinks when exercising, since they can cause bloating and stomach cramps.

* Illness. Common symptoms of illness, including fever, diarrhea and vomiting, can severely deplete the body of water. The resulting dehydration can make you feel even worse and compound the ailment by disabling the body’s ability to fight off and flush out infectious organisms. Adequate water is also important to countering congestion when you have a cold or cough. If dehydration becomes severe, it could result in an attack of kidney stones or gout.