Friday, October 25, 2013

The Steptech glenoid - is this TV Spot accurate?

This blog post was prompted by phone calls from patients who wanted to know if we "can do the Step tech for them instead of a total shoulder" after seeing the spot on TV.

Here's the text from the spot that seems to have patients with shoulder arthritis confused.  We placed some footnotes to shed some additional light on potentially confusing statements. We have removed the names of the persons from the ad. We doubt that the physicians had any intent to mislead patients.

"Osteoarthritis can lead to severe shoulder pain, wearing down the joint so much that simple movements become unbearable.

Now, a new shoulder replacement surgery is giving patients their reach back. (1) One of the developers is a local doctor.

To watch him swing, you wouldn’t know Mr. X's shoulder ever gave him trouble. He has lived with shoulder pain for years, until it become debilitating.

"One of the things that, for example, my wife and I do is cuddle at night, and I just couldn't get my arm up and around,” said Mr. X.(1)

That’s when he opted for a new shoulder replacement surgery. In Mr. X's case, there was virtually no cartilage left, just bone on bone. (2) Dr. XX says that made Mr. X an ideal candidate for the Steptech surgery.  (3) 

"I think that this will be one of those milestones that will help us address significant shoulder arthritis with bone loss," said Dr. XX, an orthopedic surgeon (3). "What we do is we make a very precise cut in the bone and then instead of implanting a slanted socket, we can implant a more orientated anatomic socket, which we believe will have better results in the long term." (4)

The surgery has put Mr. X back in the game.

"Pain?” said Mr. X. “I have no pain. I have no pain at all." (5)

One of the benefits of Steptech is that it allows surgeons to make a 90 degree cut, preserving as much bone as possible. (6)

Dr. XXX was one of the developers of the Steptech device. He's also one of the few doctors in the country who does this procedure." (7) 

Another version of this 'announcement' is titled "New shoulder replacement easier on patients" (8)

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Footnotes

(1) For decades now shoulder joint replacement  has been successfully returning patients with osteoarthritis of the shoulder to activities such as golf, tennis, swimming, and cuddling - "giving them their reach back". This not in any way 'new'. 

(2) Loss of articular cartilage is always present in osteoarthritis, as shown in these typical x-rays.

(3) Dr. XX and Dr. XXX are on the speakers' bureau and make paid presentations for the company that manufactures the Steptech. 

(4) There are no substantial clinical followup studies with the Steptech glenoid. The clinical results to date do not indicate it gives any better results than a standard total shoulder for which there are many decades of followup data showing reproducible and long lasting improvements in comfort and function.

(5) This is a typical result from a standard total shoulder.

(6) Bone can best be preserved by not making a cut at all, but rather by gently reaming the glenoid to the proper shape. The clinical value of special glenoid components, bone grafting and excessive reaming has not been demonstrated.

(7)  The Steptech glenoid is commercially available glenoid prosthesis that has more plastic on its posterior aspect. Shoulder joint replacement with a Stephtech is still a "total shoulder" and not something else. Its use is not restricted to 'a few doctors in the country'.

(8) No data are presented to support this claim. For example, the video states that patients are able to start moving their shoulders 24 hours after the procedure. The standard practice in many centers with a standard total shoulder is to move the shoulder the evening of the shoulder replacement.

Note that for individuals with bone loss desiring a higher than average level of function, a ream and run procedure may be a consideration as shown here .

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