A novel procedure that helps some patients with amputated legs regain much of their lost function and mobility is at the centre of a debate over whether provinces should fund the treatment.
Osseointegration involves hollowing out the bone in an individual’s residual limb and inserting a titanium implant that attaches directly to a prosthetic leg. The results, according to prosthetic experts and patients who have undergone the treatment, can be life-changing. Many people who have had it can go back to work, walk long distances and recover many of the functions they lost when their leg was amputated.
But the procedure comes with risks – notably infection – and some experts say it hasn’t been studied enough to fully understand the potential downsides. In Ontario, those concerns have prompted a provincial agency to publish draft recommendations against supporting it. At the same time, Quebec plans to start funding a limited number of osseointegrated prosthetic implant surgeries starting this year. The funding will cover up to about 50 patients a year, said Robert Turcotte, an orthopedic surgeon at the McGill University Health Centre who has performed several of these procedures.
The divergent responses show how provinces are grappling with challenging issues over which treatments merit coverage.
“There’s no doubt these are difficult decisions,” said Irfan Dhalla, vice-president of evidence development and standards at Health Quality Ontario (HQO), which provides advice to the government on funding for new treatments and medical devices.
Options for people with an amputated leg have traditionally been limited to a socket prosthetic that is suctioned or strapped to their residual limb. It’s an imperfect solution that causes many to experience pain, skin problems and limited mobility.
In the case of osseointegration, Dr. Dhalla highlighted the fact that osseointegrated prosthetic implants for lower limbs haven’t been approved by Health Canada and that the procedure is not widely available in other countries. For instance, the U.S. Food and Drug Administration granted osseointegrated prosthetic implants for lower leg amputations a humanitarian device exemption in 2015, meaning it can be used in a limited number of patients.
He added that while anecdotal evidence suggests these implants work well, there needs to be more research done to figure out who may be prone to risks such as infections that can be difficult to treat.
Orthotics Prosthetics Canada, which represents clinicians, is hoping HQO changes its mind before the agency publishes final recommendations, expected this summer. Dan Mead, president of the association and a prosthetist and orthotist in Sudbury, said keeping this treatment out of reach will rob some individuals of their mobility by forcing them to use ill-fitting prosthetics or rely on a wheelchair.
For years, Canadian patients have been travelling out of the country – mainly to Australia, where the surgery was pioneered – to get their implants. Mr. Mead noted that Ontario used to provide funding for these out-of-country procedures on a case-by-case basis, but stopped once the number of patients requesting it grew. Ontario’s Ministry of Health and Long-Term Care did not respond to questions about the current status of funding.
Jerzy Sredniawski, who lives just outside of Sudbury, Ont., travelled to Australia to have an osseointegrated prosthetic implant in 2016. He lost his leg after a motorcycle accident in 2013. Mr. Sredniawski said he hasn’t suffered any infections or other problems since the surgery and that he’s been able to regain his mobility and independence. Now, he can easily go on walks, drive a car and do every day tasks such as grocery shopping with ease.
“It did change my life forever,” Mr. Sredniawski said.