Jarrod Shapiro, DPM
Practice Perfect Editor
Assistant Professor,
Dept. of Podiatric Medicine,
Surgery & Biomechanics
College of Podiatric Medicine
Western University of
Health Sciences,
St. Pomona, CA

Should We Remove All Hardware?

The other day, I did a simple hardware removal procedure. After performing a Lapidus/Akin procedure on a patient a year ago, she started having hardware irritation (2 crossed screws in the Lapidus and an Arthrex Plapel® for the Akin). The hardware removal is a procedure I don’t tend to perform very often. For my years in practice so far, I’ve gone by the principle that I won’t remove any hardware unless either the patient wants it out (some people just don’t like the fact of having the hardware in their bodies), it becomes symptomatic, or causes some other problem.

At the same time, I had been having a conversation with one of my partners about hardware removal. We were discussing the fact that many orthopedists seem to routinely remove hardware. For some time, I felt this was more of a business practice than a medically necessary one, and my suspicions were heightened when my partner asked me about transfixion screws for ankle fractures.

"Why," he asked, "do we take these screws out at twelve weeks? Is there something special about twelve weeks?"

He argued – convincingly I’ll add – that if ligaments heal around the one month time period (even pushing it to six weeks to be cautious), why keep the screws in so long? Funny coincidence, he pointed out, that this is remarkably close to the 90 day global period for the original ankle open reduction internal fixation (84 days to be precise).

Hmmm.

Now, sometimes I can be naïve, as I had never actually considered this possibility. I felt a bit foolish, but then started thinking, what does the literature say? Is there actual scientific evidence that removing implanted hardware is beneficial in some way other than our wallets?

Tonight's Premier Lecture is
Nutrition and Neuropathy
Allen Jacobs, DPM

Off to PubMed I went, and here’s what I found.

First, there are quite a few issues related to retained hardware beyond the "symptomatic hardware" question. An interesting review article from the Journal of the American Academy of Orthopedic Surgeons reports studies that show an increased risk of refracture after removal of plate fixation. This is due to both stress shielding and stress risers from the weakened hole where the screws used to be and advocate for the following:¹

Allow complete fracture union and remodeling before removing the hardware to reduce the risk of refracture.
Avoid unnecessary vascular disruption of the bone (ie, maintain as much periosteum as possible).
Screw holes may remain as stress risers for up to 4 months.

So far that all sounds pretty unsurprising and consistent with what we do in practice: let the fracture heal, don’t destroy the tissue, and be careful with any screw holes.

So, what about the hardware itself? Can it cause symptoms just by being there?

Brown and colleagues tried to provide some perspective on this with their 2001 study in the Journal of Orthopedic Trauma.² These folks retrospectively reviewed 126 patients who underwent ORIF of ankle fractures using pain scores and functional assessments. Thirty-nine of the 126 (31%) patients had pain overlying their hardware. Twenty-two patients actually had their hardware removed, and of these only 11 (50%) had improvement in their pain. When comparing the surveys, there was no significant difference (regarding pain) between survey results in patients who had their hardware removed and those who didn’t. The authors concluded that lower functional outcome scores were independent of whether the hardware was removed and did not recommend or condemn the routine removal of fixation after ankle fracture ORIF. This makes sense, since this is a traumatic injury with a strong chance for late arthritis and other joint problems.

An earlier study by Jacobsen and colleagues³ found better results in a similar type of patient group. These researchers retrospectively evaluated 66 patients who underwent ORIF of ankle fractures using a similar but less scientific method as the Brown study (pain scale and questionnaire). They found 75% of patients noted significant improvement in pain and/or function after hardware removal.

Any studies of podiatric foot surgery and hardware removal (elective or not)? None that I could find. If you know of one please let me know.

Can we answer my title question? Should we routinely remove all hardware? Both of these studies have significant methodological problems, but it seems safe to say that patients who have symptomatic hardware may reasonably benefit from removal, but have a strong chance of having continued pain . I would recommend for any podiatric surgeons who do a lot of ankle fracture repairs to consider a prospective trial that randomizes patients to one of two groups: automatic hardware removal versus no removal. You’d then track these patients over X number of years and see how they do. I’m not sure if this study would get past an institutional review board, but it sure would be interesting to see the results.

What do you think? Do you routinely remove hardware? Do you reserve this procedure for the painful patient? Write in with your thoughts. Best wishes.

Best wishes.

Jarrod Shapiro, DPM
PRESENT Practice Perfect Editor
[email protected]

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References:

Busam M, et al. Hardware removal: indications and expectations. J Am Acad Orthop Surg.2006:14:113-120.
Brown O. Incidence of Hardware-Related Pain and Its Effect on Functional Outcomes After Open Reduction and Internal Fixation of Ankle Fractures. J Orthop Trauma. 2001;15(4):271-274.
Jacobsen S, et al. Removal of Internal Fixation -- the Effect on Patients' Complaints: a Study of 66 Cases of Removal of Internal Fixation After Malleolar Fractures. Foot and Ankle Int.1994;15(4):170-171.