This week, McMaster University and a prominent orthopedic researcher announced what is believed to be Hamilton's first study involving placebo surgery.

Only hours later, Hamilton Health Sciences and a surgeon leading the research denied placebo operations are taking place.

The contradictory accounts by the two principal investigators of the FIRST trial raise serious questions about a study involving 54 patients to date put under general anesthetic at McMaster University Medical Centre.

The two investigators provide conflicting accounts on almost every major aspect of the study released Thursday at 10 a.m.

One says the aim is to test a hip procedure growing in popularity. The other says it is evaluating two different methods of doing the surgery.

Their descriptions of what is being done to half of the patients during the minimally invasive procedure differ. One says repairs take place, while the other maintains the hip joint is simply washed with normal saline.

The biggest divide is whether the operation provided to one of the two groups in the study is an accepted treatment or a placebo meant to test if the idea of surgery has as much healing power as repairs done by the surgeons themselves.

"It's not at all unreasonable for one surgeon to view a particular therapy closer to a 'placebo' while another has strong beliefs that the same therapy has a strong biological effect and is far from such a 'label,'" reads a statement on behalf of the university, the hospital network, researcher Dr. Mohit Bhandari and surgeon Dr. Olufemi Ayeni.

"These are simply opinions that are part of the scientific debates that occur daily in research trials."

Only one of the two opinions appears on the patient consent form.

The form does not state that one principal investigator believes washing out the hip joint with normal saline is a placebo while the other sees it as an accepted approach to treating patients with femoroacetabular hip impingement (FAI). The painful condition is caused by a bony abnormality of the hip joint and/or tears in the ring of cartilage on the outside rim of the socket called the labrum.

Instead, patients are told they will get one of two "treatments."

"While some may consider the treatment in question a 'placebo' approach, there is no evidence to support this belief, hence the need for further research," said the Friday statement.

Statistics provided by HHS show none of its surgeons have simply washed out the joint with normal saline when treating FAI in the last five years. All of the 534 procedures done outside of the study since 2009 at HHS have also involved repairing tears and/or shaving the bone.

The study funded by the Canadian Institutes of Health Research is taking place in seven sites in Canada, Denmark and Finland. It's expected to enrol about 220 patients — 50 per cent of them from Hamilton.

McMaster, HHS and the researchers have refused to provide the study protocol, the information provided to the Hamilton Integrated Research Ethics Board or the minutes of the July 17, 2012, meeting when the board approved the study. All were said to be "proprietary and confidential." It has left numerous unanswered questions.

McMaster's original press release described the study as testing FAI surgery, which Bhandari describes as shaving bone and fixing tears.

"Is hip arthroscopic surgery a sham?" reads the headline in the original release provided to media Wednesday.

"At the end of the day, we believe this is the most robust design to determine whether or not this procedure works," Bhandari said in an interview.

But Ayeni says the study actually compares adding bone shaving on the ball and socket of the hip with the traditional method of repairing torn tissue.

"The study question really evaluates if the new additional bone shaving (extra intervention) helps patients comparing to what was always done," he said in an email.

There are also conflicting accounts of what procedure FAI surgery is being compared against. In one version, the hip joint is washed out with normal saline and torn tissue repaired. In another, repairs are done "very rarely" when significant damage is found.

The patient consent form itself states the surgery involves "treating obvious hip damage of the hip joint such as labral tears." But further down on the same page the wording changes to "treating any significant labral damage."

McMaster's original press release called it "a placebo surgery that skips the step of actual repair and tests whether patients feel relief." It was changed one day later to "a simpler accepted treatment."

Bhandari describes the procedure in an interview as "going in with a scope, putting fluid in the joint, looking around and pulling it out. We won't be going in and doing any sort of other procedures beyond that — that are typical of the FAI surgical procedure."

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He said surgeons only repair tears if they are so serious they can't ethically leave them untouched.

"Patients know if there is something really terrible, the surgeon knowingly will not leave it there," he said. "They will do something. That being said that has happened very rarely in the trial."

Ayeni said: "All surgeons lavage the joint with saline AND repair torn labral tissues."

Bhandari has a PhD and an MD. He is the Canada research chair in musculoskeletal trauma and surgical outcomes, a professor of surgery and the academic division head of orthopedic surgery. He left no doubt he views the procedure as a placebo.

"The trial will aim to carefully test the effect of hip arthroscopy against a placebo procedure and determine, once and for all, whether the exponential rise in hip scope procedures has a scientific basis and true benefit to patients," he says in the original McMaster release.

He elaborated on the use of placebo surgery in the FIRST trial in a series of emails to The Spectator and during a 26-minute phone interview Wednesday. He said it was the first time placebo surgeries were being done in orthopedics in Hamilton.

"Placebo surgery studies are uncommon currently," he said in an email. "We need to do more, actually. Within the Division of Orthopedic Surgery, this is indeed the FIRST (to pardon the pun on the acronym of the trial). However, many others have been done in our field."

Ayeni has an opposite view.

"I've been told this may have been called a placebo or sham operation, but that would be incorrect," said the associate professor of orthopedic surgery. "Rather, this is a comparison of different approaches to treating a condition."

He said to be considered placebo surgery: "Such a trial would require no treatment (such as no lavage and no suturing to repair torn tissue)."

Despite the many contradictions, the statement from all the parties reads: "To be clear there is absolutely no disagreement in the way either approach the conduct of the FIRST trial. Dr. Ayeni and Bhandari agree on the design and the null hypotheses.'"

A leading medical ethicist suggests the root of the problem is how placebo is being defined.

"It's an assumption placebo means you've done nothing," said Margaret Somerville, founding director of the Centre for Medicine, Ethics and Law at McGill University. "In a way, both of them are right. They are doing something … That doesn't mean it's not placebo surgery."

She says the classic view that placebo surgery is "wrong," "a fake" and "a deception" is not accurate. It's only an issue ethically if patients aren't informed they could undergo a placebo procedure or doctors already know the treatment works.

"Sometimes the people who get the treatment end up much worse off," she said. "That is what they're trying to find out. If you don't do anything, does the patient get better anyway? Once you know the nonactive treatment is as good as the active one, then in the future you won't be doing the surgery."

Patients involved in the FIRST trial can contact 905-526-3349 or jfrketich@thespec.com