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http://www.nytimes.com/2002/07/10/health/10CND-KNEE.html

Study Casts Doubt on Value of Popular Knee Surgery

By GINA KOLATA

popular and expensive knee operation for arthritis does not work, researchers report. Their study, comparing it to sham surgery, found that patients who got the real operation did no better than those who got a placebo procedure.

The operation is used to treat people with osteoarthritis — the type that occurs with aging — who are having pain and difficulty moving despite treatment with drugs like those that reduce inflammation. It involves making three small incisions in the knee, inserting an arthroscope, an instrument the size of a ballpoint pen, to see the joint, and then either flushing debris from the knee or shaving rough areas of cartilage from the joint and then flushing it. At least 225,000 patients have one or the other of these operations each year, at a cost to the nation of more than $1 billion.

Now, in a study published on Thursday in The New England Journal of Medicine, investigators at the Houston Veterans Affairs Medical Center and Baylor College of Medicine report that while patients often said they felt better after the surgery, their improvement was just wishful thinking.

"Here we are doing all this surgery on people and it's all a sham," said Dr. Baruch Brody, an ethicist at Baylor who helped design the study.

The 180 patients who participated were randomly assigned to have their arthritic knees flushed clean or to have their knee joints scraped, then flushed, or to have placebo surgery in which they were sedated and while surgeons simulated an operation, making cuts in their knee so the patients would not know if they had the surgery.

After they recovered from the operations, all the patients, on average, said their knee pain had improved. They continued to say they were better for the two years that the researchers followed their progress. But tests of knee functions revealed that the operation had not helped. And those who got the placebo surgery reported feeling just as good as those who had had the real operation.

"On the self-report scales, everyone was better," said Dr. Nelda P. Wray, who is chief of the section of health services research at Baylor. But, she added, "on the objective scale, no one was better at any time point."

Some orthopedists, like Dr. Kenneth Fine of George Washington University School of Medicine, said they had long wondered about the operation and now the study shows they were right.

Dr. Fine said that while he did the operation, he had doubted it because it seemed to do nothing for the underlying arthritis. "There are pretty good success rates in terms of patient satisfaction, but I have always been skeptical," he said. As for other doctors, he said, "I hope it helps them to think about what they are doing."

Dr. William J. Tipton, Jr., who is executive vice president and chief executive of the American Academy of Orthopedic Surgeons, also said he had questioned the operation.

"I'm both a patient and a physician," Dr. Tipton said, explaining that he himself has osteoarthritis. "My knee is buckling now, but I'm not going to have arthroscopy done. I recognize that it's not going to help."

But, Dr. Tipton said, he would hate to see insurers refuse to pay. If that happens, he said, orthopedists will protest.

"This is where eyebrows are going to be raised," he said. "There's going to be a certain group of physicians who are very upset. This is another example of managed care at its lowest, with payers calling the shots. I think it's not good medicine."

Dr. Tipton said he would like to see the study repeated a few times and then let doctors decide whether to do the operation. "Gradually, physicians would say to their patients: `I know you've seen a lot about arthroscopy, but you know what? It doesn't work very well for osteoarthritis of the knee.' "

For now, said another orthopedic surgeon, Dr. Douglas Jackson of Long Beach, Calif., "I don't think it will change how we do things." Dr. Jackson, who is past president of the American Academy of Orthopedic Surgeons, said the study's population was not typical of what he sees in his private practice but that he would tell his patients about their experience. "I will inform them of the study and what it found — in this group of predominantly men in a veterans hospital, it wasn't any better than a sham."

The study began when an orthopedic surgeon at the V.A. center, Dr. J. Bruce Moseley, who is now the team physician for the Houston Rockets and the Houston Comets, approached Dr. Wray suggesting a study that would compare washing the knee joint to washing and scraping in patients with arthritis.

Dr. Wray had a bolder idea.

"She said, `How do you know that what you are seeing is not a placebo effect?' " Dr. Moseley recalled and Dr. Wray confirmed. "My response was, `This is surgery.' She said, `I hate to tell you this, but surgery may have the biggest placebo effect of all.' "

But placebo studies of surgery are almost never done. Many doctors consider them unethical because patients could undergo risks with no benefits. Working with Dr. Brody, the ethicist, the group attempted to make the placebo treatment no more dangerous than daily life.

At the V.A. center, patients could not get the knee operation outside of the clinical trial. But, of course, they could go elsewhere and since most were elderly, Medicare would pay. To be sure that they understood what they were agreeing to, the patients in the study were required to write, by hand, that they knew that they may get placebo surgery. Out of 344 consecutive patients who were asked, 144 declined, a 44 percent refusal rate.

For those who agreed to participate, the day of surgery meant being wheeled into an operating room while neither they nor any of the medical staff knew what their treatment would be. When they were on the operating table, Dr. Moseley, who did all the operations, opened a sealed envelope telling him whether the patient was to have his knee flushed, flushed and scraped, or whether he was part of the placebo group.

Those in the placebo group were given a valium-like drug that put them to sleep to the point of snoring but unlike those who had the real operation, they did not have general anesthesia.

Dr. Moseley made small cuts in their knee so it would look like he had done an operation. He bent and straightened the knee and asked for surgical instruments, just in case the patient was partly conscious. There even was an assistant in the room who sloshed water in a bucket so it would sound like the knee was being flushed clean. And when they woke up, Dr. Wray said, virtually every one of these patients thought they had had a real operation.

The paper on the study is accompanied by two editorials. One, by Sam Horng and Dr. Franklin G. Miller of the National Institutes of Health, asked if it is unethical to do placebo surgery. The controversy, they wrote, comes because doctors assume that patients in clinical research should not be put at risk if they cannot benefit and placebo surgery would seem to involve risk.

But, they explain, clinical research is different from medical therapy — it is a tool to decide whether treatments are effective and its aim is not to help those in the study but to help future patients. To be ethical, a study with placebo surgery must not place patients at undue risks, the benefits of finding out whether the surgery works must be worth any potential risk to the patients, and the patients must give informed consent. In this case, they wrote, all those objectives were met and the study "exemplifies the ethically justified use of placebo surgery."

In the second editorial, Dr. David T. Felson of Boston University and Dr. Joseph Buckwalter of the University of Iowa, note that if there were large beneficial effects from the surgery, the study should have found them. "Although the study may not have been large enough to permit the detection of any small effects, the data presented do not suggest that there were any," they wrote.

In a telephone interview this week, Dr. Felson, a professor of medicine and a rheumatologist by training, praised the research. "I think it is a wonderful study," he said, adding that he was surprised by the absolute lack of benefit from the operation. But, he said, it remains to be seen whether doctors and patients really will abandon the procedure.

"There's a pretty good-sized industry out there that is performing this surgery," Dr. Felton said. "It constitutes a good part of the livelihood of some orthopedic surgeons. That is a reality."

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