Is Conservative Care Mandatory Prior To Bunion Surgery?

Allen Jacobs DPM FACFAS

A recent Cochrane Review concluded there is no evidence that non-operative management of bunion deformity, including the use of orthotics, is in any way superior to no treatment at all.1 In fact, the studies reviewed by the Cochrane database suggested that one year following initial evaluation for a bunion deformity, more people are pleased with the results of surgery than with orthotic or other non-operative management.

I recently participated as a defense expert in an alleged malpractice action. This concerned a patient scheduled for bunion surgery following her initial evaluation by her podiatric physician. She presented with specific concerns and complaints referable to her bunion. The podiatrist apprised her of the usual accommodative and palliative options available to her for this condition as well as the distal metaphyseal osteotomy for the correction of her bunion. The podiatrist reviewed the procedure, usual sequelae, recovery and risks of surgery with her. She signed a consent form.

Following surgery, the patient developed a minor, non-infected superficial wound dehiscence. For some reason, her podiatric physician made the well intended error of referral to a wound care center, where the minor wound dehiscence was blown into weeks of debridement, hyperbaric oxygen and a lot of unnecessary expense.

She healed without residual problems but her experience in the wound care center left her rather upset. She sued for malpractice.

The plaintiff's expert, who is a state podiatry board member, opined that the performance of surgery for the correction of a bunion without non-operative care such as orthotics fell below the standard of care and represented negligent care. Furthermore, the expert played the “angle game.” You know it: “This intermetatarsal angle did not warrant an osteotomy.”

A Closer Look At The Key Issues With This Malpractice Claim

Now let us get to the key points of this epistle. What concerned me about the case were at least two issues about which I believe we need some commentary.

The first issue is the concept of “conservative care” for a problematic bunion. Yes, we have an obligation to discuss accommodative and palliative efforts that we could render, but is the performance of such efforts required when there is no data to support the efficacy of such therapy?

I say no. A bunion is a deformity. If it is causing pain or creating adjacent digital deformity, a patient and podiatric physician have the right to proceed with surgery if both parties are of the opinion that this is appropriate and desirable. Yes, the patient should have a clear understanding of the procedure and potential complications. No question. But is non-operative care mandatory for a bunion?

The second issue of concern is that the plaintiff's expert in this case is a state board member. He has an absolute right to his opinion but does not have the right to ignore evidence-based medicine. What if a dissatisfied bunionectomy patient contacted the state board with a complaint that the podiatric physician corrected his or her deformity without non-operative care? In the eyes of this state board member, the care was negligent, potentially threatening the licensure of the doctor in question.

I personally witnessed this some years ago. A patient was upset with a continued lack of great toe motion following a component implant utilized for the treatment of a hallux limitus condition. The podiatric physician was accused of performing surgery with an “investigational” implant. I represented the individual at his state board hearing with regard to the standard of care. The particular implant was fully FDA approved and two retrospective studies had been published in our literature on the particular implant.

When confronted with these facts, the board chairperson (an older fellow) looked straight at me and said, “That's all nice, Dr. Jacobs but up here, we consider these implants experimental.” The practitioner in question had his license disciplined.

Suggestions For Determining The Standard Of Care

What is the “standard of care”? I will tell you an easy way to interdict many expert witnesses: Take national surveys of podiatric physicians. This would be a fantastic project for the American College of Foot and Ankle Surgeons (ACFAS) or the American Society of Podiatric Surgeons (ASPS), or an independent group.

For example, pose the question “Is non-operative management required prior to the performance of bunion surgery?” Have a national Web site. Individuals accused of malpractice could elect to pose specific questions. The answer would tell you the standard of care, namely, what the average podiatrist would do under the same or similar circumstances. The information, although certainly non-binding, just might be useful in court. Let a jury know what the average doctor actually does, not what the “experts” say the average podiatrist does. Is there a potential danger to this? I suppose. Put safeguards on the availability of the data prior to release, for example. This could be done.

Another solution is to have ACFAS or ASPS or somebody set up an independent review committee for accusations of alleged malpractice. There would likely have to be a fee associated with this. However, let the accused podiatric physician submit his or her case for an independent review. The panel would have no real authority in court as such. Then again, how could it not be helpful for a jury to hear that a national surgical organization reviewed the case and concluded there was no malpractice and the individual doctor comported with accepted standards of care?

My guess is that nobody will like the suggested solutions above. Certainly, the plaintiffs’ bar won’t care for these suggestions. Without them, there are fewer jobs for defense attorneys. Without them, there is less money for the expert witnesses.

What are your thoughts?

Reference

1. Ferrari J, Higgins JPT, Prior TD. Interventions for treating hallux valgus (abductovalgus) and bunions. Cochrane Database Syst Rev. 2009, Issue 2. Art. No.: CD000964. DOI: 10.1002/14651858.CD000964.pub3.

Comments

Interesting topic. I generally feel you should exhaust conservative care prior to surgical intervention for most foot and ankle problems. However, with painful bunions, that is a little different. I always explain the conservative options as well as the surgical options. Most women, especially younger women are not interested in conservative care and want the bunion fixed surgically right out of the gate.

Orthotics will potentially slow down the progression of the deformity, but will not reverse the deformity and often times require a change in shoes to accommodate both the device and the deformity. Most of my women patients don't want to change their shoes or have already done so prior to coming to my office.

Oral anti-inflammatories will help temporarily. I am not a proponent of injections of cortisone in the MPJ, except with severe osteoarthritis and the joint is mostly gone already, otherwise I am trying to save as much of the joint as possible.

Men are generally most apt to try some form of conservative care prior to surgery but, in general, when most patients come in, they want the pain to go away. Bump pain can be helped temporarily with wider shoes, but if they have internal joint pain with or without bump pain, surgical intervention is really the best option to achieve the patients goals and preserve and improve the joint function.

Many patients come in with the idea of having the bunion fixed, often because another family member either had surgery or had a very painful bunion, and they don't want their bunion to get to that point.

In my opinion, conservative care is not required prior to surgery for bunions. That said, question your patients well and often you will find after they have told you or your staff they have had no treatment for it, they in fact have taken Ibuprofen, Aleve, Tylenol, changed to open toed or wider shoes, and/or tried some kind of OTC insoles in their shoes.

This is so typical of podiatry, who dictates standard of care. I personally recommend a conservative option for a month or so, if not done previously, prior to any surgery. Does this make it right? Of course not but it works for me knowing that out there in cyberspace there are my peers who for a price would sell out their mother. I have personally experienced what other podiatrists will say for all the almighty buck with their holier than thou attitude. This in itself probably promotes more malpractice cases than are actually legitimate.

Any attorney will tell you it is a lot easier to defend your claim if there has been a course of conservative care. There are always exceptions to the rule. If conservative care renders the pt. asymptomatic and he or she still has a bunion, are you going to operate on it? Of course not. We would be talking cosmetic sx. and if there are complications, it would be hard to defend. You don't let your pt. dictate the course of his or her therapy or you will lose control/respect.

I personally like to use an orthotic first. By doing this, you also get to know the pt. and you might find out this is not someone to operate on. If the patient doesn't want to do it your way, let him or her walk out and be glad you didn't operate. Remember, time is always on your side! I also have a lengthy consent form that is signed days before sx. and then there is always the one signed at the hospital. I don't want someone accusing me of having the patient sign the consent form under duress and he or she saying that he or she did not realize the complications that can occur when an operation is performed.

These are interesting comments. In summary, you are all allowing the plaintiff's lawyers to drive up the cost of medical care for unnecessary treatment for self protection against lawsuits.

Where is the data that demonstrates orthotics "slow the progess of bunions?" There is none. As for NSAIDS, where is the inflammation? What about adverse sequelae to the NSAIDS? Is an ulcer, CHF exacerbation, stroke from hypertension, acute renal failure OK in using NSAIDS for a non-inflammed bunion?

How about conservative care "for a month or so"? What does that accomplish? Bunion reversal?

Sure, the defense wants conservative care no matter what. However, what if there IS NO SCIENTIFIC BASIS FOR CONSERVATIVE CARE?

This is strictly defensive medicine. Risk and cost with no benefit to the patient.

There are two insurance carriers in my area who WILL NOT pre-authorize bunion correction surgery without prior attempt at conservative management. I've gotten into verbal disputes with their peer reviewer over these requirements but these insurance companies are steadfast.

One of my dearest mentors is of the opinion that conservative care for painful bunions IS surgery. I'm of the same mind but am at the will of the insurance carriers in my region unfortunately.

Excellent article Dr. Jacobs.

Isn't this wonderful? We now have insurance companies and lawyers setting the standard of care in medicine and surgery.

When a patient signs a consent form and all options for care as well as risks and complications are included in the consent form, there is no reason for any podiatrist to be sued or for any patient to be subjected to unnecessary and unhelpful conservative care IF their goal is to wear high fashion footwear.

What was the treatment goal in this case? Was it to reduce symptoms, angle of deformity, improve range of motion or what? Non-surgical treatment would be appropriate for treating pain but would be less likely to reduce the bunion deformity, especially if severe.

An orthosis that increases the propulsive nature of gate theoretically has the potential to increase a bunion deformity due to the existing angle of hallux abduction. However, if the bunion is the result of abnormal pronation and if surgery doesn’t reduce the abnormal stj pronation, then it would seem to be very appropriate to use an orthosis postoperatively.

If a patient goes to the doctor to get treated for back pain and they have an actual knife stuck in their back, would you expect the doctor to perform conservative care by prescribing antibiotics or pain meds first? Or would you expect them to go ahead and surgically remove the knife from their back?

We all know that the conservative treatment in this situation would probably be a waste of time but the delaying of the obvious would be more hazardous to the patient as time went along. This may be a somewhat extreme example but the analogy is the same. We as physicians are being trusted to take care of problems in a competent but timely fashion. Personally, i will not delay the obvious solution just to 1) extract some extra E&Ms from a patient, and 2) appease someone else's standards when they don't accept any of the liability?

Whatever happened to doing what is best for the PATIENT?

Hi Allen,

I looked up the Cochrane Study and this is what I read:

* Methodological quality of the trials was poor.

* Trial sizes were small with exception of one “good quality trial involving 140 participants” that showed improvement in that one study, showing all outcomes in patients receiving chevron osteotomies compared with orthoses and to no treatment.

* They also compared it to Kellers and there was no advantage or disadvantage using Kellers over other techniques except in improving the IM angle and preserving joint range of motion.

* There were differing methods of fixation, post-op rehabilitation, continuous passive range of motion after surgery or not, early weight bearing afterward, use of a crepe bandage and basically all factors.

Frankly, I am surprised that they found it to rise to the level of a Cochrane Collaboration study.

But that aside, only the abstract is available on-line, the full study having been withdrawn completely and not available because it supposedly didn’t differ significantly from the earlier one although an additional 20 studies had been added? That’s odd.

The abstract reads: “Only a few studies had considered conservative treatments. The evidence from these suggested that orthoses and night splints did not appear to be any more beneficial in improving outcomes than no treatment.”

But they did not state what the outcomes were. I would like to know.

Were the outcomes the improvement of the IM angle? Well, of course, they were not improved with orthotics!

Was it pain? I would be interested in knowing that of course. Then we would have an interesting issue at hand.

Allen, I appreciate your blog message. I get what you are saying. You make a good point. I guess I’m giving the bad guys an argument to make. Sorry. But the lawyers knew this one already. I didn't reveal any secrets.

And for the huge, bursting from the side of the shoe bunion, of course, a course of conservative care is going to do little except:

Help you to develop a relationship with your patient.

Will that make the patient less likely to sue you if something goes wrong? Maybe not? Probably not. Who knows?

Will it make a patient more comfortable revealing to you that underlying medical condition that he/she has, or drug they take that could have an impact on the surgery? Same questions here.

Will you find out that they have different expectations for the surgery as you get to know them better? "Oh, you didn't tell me you were in the National Guard?"

"You didn't tell me your favorite hobby was jumping off of 15 foot obstacle course barriers? How could you have forgotten to mention that ..."

"Thank you for telling me you are on that birth control pill, Miss Vasquez. I know you are sensitive about it because of your religion. You know what you tell me is confidential. It was important though because it can cause blood clots now that you are in your late 30s and you smoke."

A relationship with your patient that is longer than a few weeks can be a good thing.

Kathy

Dr. Adams,

I agree that we have to do what is best for the patient, but the limiting factors are circumstances beyond the patient.

If an insurance company won't pre-authorize the surgery until AFTER conservative care, this is beyond the patient/doctor relationship. You can explain to the patient all you want about the need, but if their insurance isn't going to pay for it, good luck getting that patient to do what's best for them when surgery is indicated.

There are also other factors. There was a blog here recently about patient selection. Sadly, we DO have to protect ourselves medico-legally and whether a malpractice claim is legitimate or not, the stress of dealing with something like that is something none of us need to be dealing with in today's age of reimbursement and practice management.

This topic is very interesting and underscores how pervasive the legality of medicine is with respect to the doctor-patient relationship.

That being said, let me pose the opposite question:

Should ALL bunions be treated surgically? If we can demonstrate a study that shows conservative care is just as efficacious as no therapy at all, why not schedule surgery for everyone on the first visit?

My personal opinion is that conservative care should be attempted first. We certainly don't live in a perfect world and as someone who has been involved with litigation, it is very helpful and reassuring to have as much support as possible in the defense. Having performed some type of therapy initially prior to performing surgery is helpful and something every juror can understand.

Last, if we do not believe that conservative care is helpful, what can we do for patients who are chronically ill and cannot undergo any type of elective procedure? Do we simply tell them, "Sorry, I can't help you." No, we do what we can to help alleviate the pain. In other words, we try orthotic therapy, wider shoes, injections, topical and oral NSAIDs, etc. Therefore, conservative care does play an important role in treating bunion deformities.

Dr. Jacobs,

No one suggested that orthotics "slow the progression of a bunion." I fabricate my own orthotics. They are made in stages over several weeks. Each plane of the the deformity is addressed per office visit. Since these can be made to actually post the forefoot and limit both excessive STJ and MTJ pronation, I've been very successful in rendering bunion patients asymptomatic. If my patient is asymptomatic and still has a bunion, who would operate on it? Sometimes an orthotic may reduce symptoms and allow your patient to select when they would like surgery.

Great topic.

I have patients that do not want conservative care due to work status and social life. They specifically come to our office because they want their bunions fixed.

I explain to them conservative and surgical managements in detail. I initially offer them conservative care and explain to them that most patients start with non-surgical treatment.

If they still elect to have surgery, I have them sign a waiver consent that they have been explained about conservative care, yet elect to proceed with surgery. I document it well. Next, they get the surgical consent and the rest is history.

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