Fracture not healing. Second ORIF. Doctor prescribed device. Seeking advice.

I fractured my clavicle twice, [2011-11-29, pre-op & post-op x-rays](http://imgur.com/a/yzeFi), and again on ~[2013-08-13 pre-op x-ray](http://imgur.com/a/Dqtmy) (both times cycling [e.g.](http://www.strava.com/activities/74664240)).

All follow up x-rays from 2011 through to re-break in 2013 show the gap never healed. While the 2013 surgery grafted bone from my hip and post op x-rays showed all surfaces were touching. No gaps.

Well now it's 2013-10-09 and I've just had my third round of follow up x-rays. And they show not only has the bone not fused, but a gap has appeared. Now I trust both surgeons. They did excellent work. I have a full range of motion and no complications.

But today I was prescribed a device to stimulate bone growth. The surgeon described it as a ultrasound device called Exogen. After mentioning the device he stepped out and got a prescription pad. When he came back he corrected himself and said that they're now using a device called CMF OL1000. This all sounded reasonable.

Now I'm home, and upon searching the net for the efficacy of the device, I find out that this particular device isn't using ultrasound (which at least strikes me as vaguely plausible). Instead the CMF in the product name stands for "Combined Magnetic Field", [manufacturer's website FAQ/pdf](http://www.djoglobal.com/sites/default/files/2012-2164_CMF_OL1000_FAQ_BONE_GROWTH%20r8.pdf).

This is quackery right? Magnetic Fields? Really? Google lead me to the following..

* [.edu summary report](http://www.ohsu.edu/xd/research/centers-institutes/evidence-based-policy-center/med/upload/Bone-Growth-Stimulators_PUBLIC_RR_Final_08_09.pdf). It covers lots of different tech (ultrasound aka LIPUS) and different electric (PEMF and CMF). I'm prescribed CMF but I find the evidence very weak (a study by Hayes which is a Manufacturer).
* [.gov Health Technology Assessment. Bone Growth Stimulators](http://www.hta.hca.wa.gov/documents/bgs__comments_responses_080309.pdf). Unfortunately it's just the comments not the conclusions / findings. But the response to the "76.6Hz" quote is just golden.
* [cms.gov](http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=24&IsPopup=y&NCDId=65&NcaName=Electrical+Stimulation+for+Fracture+Healing&ncdver=2&bc=AAAAAAAACAAAAA%3D%3D&) Mostly about time frame definitions, but mentions related devices.
* [stanford.edu re: class action suit on one of the devices from previous link](http://securities.stanford.edu/1005/OLGC96/)
* [US govt suing DJO inc manufacturers of the device I've been prescribed](http://www.fcaalert.com/uploads/file/09513748181.pdf). The lawsuit is damning but it's about medical billing fraud, not about device efficacy.
* [Last 4 paragraphs of this article sound right to me, but I'm unfamiliar with the source](http://www.healio.com/orthopedics/sports-medicine/news/print/orthopedics-today/%7B2e35434b-98de-453d-a9db-56e93b926159%7D/new-studies-offer-no-final-word-on-bone-growth-stimulators)

Sigh.. I'm trying to convince myself that it's a wise decision (esp since my insurance is only covering 18% of the cost). Frankly I'll probably end up getting it because it's prescribed and he's the expert. Sigh.. Help?

**TL;DR** = **EMF / Magnets don't heal bones, right?**

Write Answer

Health Care

avatar
memorylane
1 Answers
Contributor
1 people found this helpful

Well I got an appointment with a doctor for Friday where I'll get a second opinion.

FWIW: today's net search turned up;

* [An actual study on CMF](http://www.ncbi.nlm.nih.gov/pubmed/9879046), but [unfortunately that study has problems. read after "the study by Hanft"](http://www.aetna.com/cpb/medical/data/300_399/0343.html)
* [Another study, but by the manufacturer](http://www.accessdata.fda.gov/cdrh_docs/pdf/P910066S011b.pdf)
* Some random site, says there's ["a paucity of literature" for CMF](http://www.medscape.com/viewarticle/778366_7)

OTOH

* [This bit of a textbook says PEMF works and compares it to CMF in later pages](http://books.google.ca/books?id=Yq-5CsC_nY4C&pg=PA81&lpg=PA81&dq=CMF+bone+growth+stimulator+studies&source=bl&ots=69TnLCEKsQ&sig=hlZp6MHqIALhiQUxCrXFXa1XwJk&hl=en&sa=X&ei=S21XUraNAYLhygG0xoGIDg&ved=0CEkQ6AEwBjhu#v=onepage&q=CMF%20bone%20growth%20stimulator%20studies&f=false) If the link doesn't work it's from a book, "Concepts and Cases in Nonunion Treatment" By René Marti, Peter Kloen. Pages 81 through 84.
* And this [doctor's blog says it works](http://www.drblakeshealingsole.com/search/label/Bone%20Stimulators%20for%20Slow%20Fractures).

Sigh.. why doesn't the manufacturer link to the damn studies (or even cite them)? Why not host them online? They made $400 million (or so the lawsuit linked above claims), they can afford a web server and copyright fees.

Edit: 2014-07-16: The device hasn't worked for me. All subsequent Xrays after staring to use the device showed the gap between the bones growing, not healing. Finally in March 2014-03-09 I broke my elbow and the force from that fall [bent the plate](http://imgur.com/koUBDW3). You can clearly see how large the gap was (right at the bend), which was 5 months after using the device. Sigh. I continue to use it for a half hour every day because I paid for it so I may as well use it, but honestly I think it is worthless.

I had an appointment a few weeks ago to discuss options from here, but the surgeon rescheduled for September. The bent plate will break eventually possibly soon. So it will be replaced, it's only a matter of time. But I don't know what else can be done. Another graft?

Was this answer helpful? Yes No
About HealthExamine
HealthExamine is a community dedicated to health care question and answers. The statements made on HealthExamine are not a substitute for medical care. If you have a medical emergency or your condition worsens, seek medical attention immediately.