Did patients in study get promised treatment?

Specialists say procedure in Hamilton Health Sciences and McMaster initiative on hip condition treatment is little more than a ‘placebo’

Questions are mounting about whether patients in a Hamilton study got a treatment that is “acceptable and within the current standards of care” for a painful hip condition, as promised in the consent form.

A number of orthopedic specialists say a procedure that is supposed to be done on 50 per cent of the patients is neither acceptable nor within the current standards of care for the condition where there is a mismatch of the ball and socket in the hip joint. Some go as far as calling it a placebo, which means it leaves out the key therapeutic element of the treatment.

However, it appears surgeons involved in the Femoroacetabular Impingement RandomiSed Controlled Trial (FIRST) are not doing what they said they would be in numerous published reports of the ongoing study done by Hamilton Health Sciences and McMaster University.

Contradictory accounts between principal investigators Dr. Olufemi Ayeni and Dr. Mohit Bhandari have left questions about the aim of the study and how it is being done.

All that is clear is that the 54 patients to date were guaranteed treatment when they went under general anesthetic at McMaster University Medical Centre.

“Participants in this study will all receive treatment for femoracetabular impingement (FAI) in a manner which is considered acceptable and within the current standards of care,” states the consent form.

But a simple saline wash of the hip joint is all half of them were supposed to get. What procedure they actually received is unclear.

Bhandari called it a placebo while Ayeni said it was treatment.

No surgeon at HHS in the last five years has simply performed a saline wash — also known as arthroscopic lavage — to treat FAI in the 534 procedures done outside of the study.

Two specialists in FAI surgery say they don’t consider it a treatment.

“It doesn’t make sense to me,” said Dr. Nikolaj Wolfson, who practises at Sutter Health California Pacific Medical Center in San Francisco. “The reason for surgery is to remove the cause of the condition. What is the problem? The problem is an impingement. You want to remove the impingement. Doing a la- vage addresses the symptoms. It does not address a cause.”

Dr. Derek Ochiai at the Nirschl Orthopedic Center in Arlington, Virginia, goes one step further calling it “sham surgery.” Sham surgery is a medical term for a placebo surgery.

“That is like a placebo,” said the specialist in FAI surgery. “Lavage is basically pumping a bunch of water into a joint. You are not actually treating the hip like you would in hip arthroscopy surgery.”

Evidence-based medicine group Cochrane also calls what FIRST is supposed to be doing “sham surgery” in a report published in 2014 on FAI research done by five professionals associated with hospital orthopedic departments and a sixth connected to epidemiology.

Ayeni and HHS have denied placebo surgery is taking place at MUMC and McMaster removed the word from an amended news release.

“The treatment of FAI of the hip has a spectrum of available therapies all of which are used in practice, and many of which have little high quality evidence to support their routine use,” says a statement on behalf of McMaster, HHS and the two researchers. “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.”

Ayeni says he repairs tissue as well as washes the joint in every surgery. Another surgeon taking part in the study, which is recruiting 220 patients at multiple sites in Canada, Finland and Denmark, says the same.

“Both groups get the soft tissue repairs,” says Dr. Daniel Whelan from St. Michael’s Hospital.

But that contradicts a number of published accounts of the study, including a listing in the Canadian Research Information System which reports on grants given by the Canadian Institutes of Health Research, the main funder of the trial.

“We propose a randomized controlled trial (RCT) to investigate whether surgical correction of the impingement (arthroscopic osteochondroplasty, or shaving down the bone) provides improved clinical results (decreased pain and increased function) at 12 months compared to arthroscopic lavage (washing out of painful inflammation debris) of the hip joint,” states the abstract on the listing.

Tears are only supposed to be repaired when it is considered to be medically necessary, meaning the surgeon could not ethically leave them alone, said Bhandari, backed up by a number of sources including ClincalTrials.gov run by the U.S. National Institutes of Health.

The pilot study published a year ago in the journal BMC Musculoskeletal Disorders states tear repairs were done for one of 22 patients randomly assigned to the group getting the wash.

The distinction is significant considering the study is supposed to determine whether the popular surgery works. Its rate doubled between 2008 and 2014 in the U.S. despite a lack of evidence.

Whelan called Ayeni “courageous” for investigating the surgery “in the f ace of adversity from U.S. centers.”

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