NEWS - Climate change in knee and hip surgery, and pressure from patients

[Guest guest]

Climate change in knee and hip surgery, and pressure from patients

Rheumawire

Mar 1, 2005

Zosia Chustecka

Washington DC - There's been a climate change in both knee and hip surgery

in recent years, with moves toward less-invasive and minimally invasive

procedures, new techniques as well as new components, and the introduction

of sophisticated computer-aided navigation tools. But another marked

changenot an altogether welcome onehas been increasing demands from patients

for particular types of surgery or prosthesis, driven to a large extent by

direct-to-consumer advertising by both manufacturers and surgeons

themselves.

This direct-to-consumer marketing is " unethical and should be made illegal, "

says Dr Maloney (Stanford University, CA). " Patients are coming in

to see us with information from the internet or from television or other

advertising and are asking for a particular type of implant or a specific

surgical procedure, " Maloney said at a press briefing during the American

Academy of Orthopaedic Surgeons (AAOS) 2005 meeting. He cited the case of a

hip prosthesis being promoted by a famous golfer and numerous websites on

which orthopedic surgeons themselves promote new techniques and report

glowing success rates. It creates real problems, he said, as often what

patients come in demanding is inappropriate for their particular case, and

they are preempting decisions that should be made by the surgeon after

careful evaluation of each patient's case history.

" Gone are the days when doctor knew best, " says Dr Branovacki

(Scripps Clinic, La Jolla, CA). " Over the past 5 years, we've seen a real

change in attitudes, " he tells rheumawire. " In the past, patients would ask,

'What would you recommend, doctor?' but now some patients are coming in and

demanding a particular implant or a certain type of incision, and sometimes

they are quite insistent, even when you advise them that it's not suitable. "

When faced with such a patient, Branovacki says he tells them they are

welcome to go and find a surgeon who will agree to do what they want, but he

won't. " Unfortunately, these patient demands are increasing, and some

surgeons are pressured into attempting surgery that is beyond their

experience. "

At the AAOS meeting, Branovacki presented a history of the evolution of hip

and knee arthroplasty, which he hopes to publish in some format in the near

future. Hip replacement was successful early on, from its very beginning in

the 1940s and 1950s, whereas knee replacement took longer to perfect and

really took off during the 1970s. He traced 285 hip implants and 149 knee

systems that have been used to the present day. At the moment, there are

around 120 hip systems available in the US, and the market for implants is

divided fairly equally among 6 major companiesBiomet, DePuy/ &

, & Nephew, Stryker, Medical, and Zimmer. In Europe, the

market is more fragmented and there are more than 600 different systems

available, he commented.

So how does a surgeon choose? " It depends to a large extent on what they

trained with and what they have clinical experience with, but also it's

influenced by the success of marketing by the manufacturers, " he says.

Knee replacement soars in popularity

Knee replacement is now one of the most common orthopedic procedures carried

out in elderly people, and the latest statistics show that this surgery

increased almost 8-fold in the period from 1979 to 2002.

" Knee replacement is a very successful operation, " says Dr Mont

(Sinai Hospital, Baltimore, MD). " I would class it as one of the best

medical advances of this century, " he declared, adding that " rheumatologists

view it as a major advance. " But patients are sometimes not so happy, he

said. The typical patient profile has changed, from sedentary individuals in

their 60s and 70s to active 50-year-olds who want to return to playing

tennis or golf, even to running marathons and skiing, Mont says. But with

standard procedures, only about 35% of patients end up with no limitations

to their knee movement, he pointed out.

That's why there's such a huge interest in minimally invasive surgery (MIS),

because the smaller incisions (about 3 to 4 inches as compared with the

traditional 8 to 12 inches) spare the muscles. At the AAOS meeting, Mont

described a new lateral approach, which avoids any splitting of the muscles.

" We've seen some incredible results, " he says. " Some patients can walk with

a normal gait within 3 weeks of the operation, whereas with standard

procedures some never get back to normal. " And 23 of 26 patients he operated

on with this new technique managed to raise their leg in a straight

horizontal line within hours of surgery " This is something I've never seen

before, and it makes me believe that this approach has tremendous

potential. "

But Mont also warned that the technique is not yet ready for prime time.

" Although we have seen some of the best results in the world with this

technique, as well as with other minimally invasive procedures, we have also

encountered problems. " The lateral technique has a high complication rateof

30 patients so far, 2 have returned with loosening of the prosthesis, which

has needed revision surgery, and there was 1 case of nerve palsy and I

patient with a wound-infection problem.

" This is pretty hard to swallow, " says Dr Dennis (Rocky Mountain

Musculoskeletal Research Laboratory, Denver, CO), pointing out that he would

be disappointed with a rate of 2 per 1000 for loosening of the prosthesis

requiring revision surgery. He suggested that Mont was irresponsible in

describing his results as " incredible, " especially at a media briefing,

commenting: " This is exactly the sensationalist type of marketing, more

focused on results at 15 days than those at 15 years, that we should be

avoiding. " Dennis is concerned that many of the newer techniques have no

long-term data yet, and he has been particularly alarmed at some of the

catastrophic complications he has observed from minimally invasive surgery

that he has not performed. These include a lacerated popliteal artery, cut

ligaments leading to knee dislocation, and even skin necrosis resulting from

excessive pulling of the delicate skin around the knee, because the small

incision limits visibility.

Novel two-incision approach to hip surgery

Another proponent of MIS, and the first to perform both knee and hip

replacements as an outpatient procedure, is Dr Berger (Rush

University Medical Center, Chicago, IL). He spoke enthusiastically about a

new approach to hip replacement involving 2 small incisions, 1 for inserting

the acetabular component, the other for the femoral stem (a technique

supported by instruments and components from Zimmer), instead of the

traditional single long incision that opens up the hip joint. Dr Sonny Bal

(University of Missouri, Columbia) also uses this 2-incision approach, and

he says it is easier for the surgeon to perform and leads to much quicker

recovery rates for the patient. " The recovery at 1 month is profound, and

patients say they don't want to see me again there is much less pain and

blood loss with this technique, and the patients don't look as toxic as they

used to. "

Both Berger and Bal claim to have very low complication rates with this

2-incision technique, but other surgeons who have tried it report much

higher rates. Dr Mark Pagnano (Mayo Clinic, Rochester, MN) reported on a

series of 80 patients, of whom 69 had no complications, but 4 patients (5%)

had major problems, with 3 fractured femurs and 1 dislocation, and 7

patients (19%) had minor complications. " Patient and surgeon enthusiasm must

be tempered against the risk of major complications, " he concluded.

" Sometimes new techniques get a lot of hype, " says Dr Sculco

(Hospital for Special Surgery, New York, NY). He's all for MIS, which he

began doing 7 years ago, but he uses 1 incision for the hip and says the

2-incision method has the disadvantage of limited visibility. " Although you

may be able to see the socket of the hip joint, you have to view the femur

through fluoroscopy guidance. " He added: " I'm not saying that we shouldn't

push the envelope, and it's good that we have people like Berger and Bal

advancing new techniques, but for me personally, I don't like the 2-incision

approach because I can't see both surfaces. "

Other surgeons also made this point about lack of visibility and were

concerned about reports of fractured femurswith standard surgery, the

fracture rate is less than 1%. Some also suggested that there has been

patient selection bias, and 1 surgeon joked that the " boutique " approach to

surgery on an outpatient basis attracts a certain type of person. " These are

very highly motivated individuals, most are Type A personalitiesthe sort of

person that would be the chief executive officer of their own company. "

Bal estimated that probably less than 5% of all hip replacements in the US

are currently carried out using the 2-incision method, but he expects it to

grow, as there is a lot of interest in it, both from patients and other

surgeons. However, Sculco suggested that interest in this technique has

already peaked. At an informal poll of the audience at a session debating

various approaches to hip replacement, about 40 surgeons said they had been

trained in this technique, but only 2 of them said they were still using it.

About 50% of the audience said they favored a posterior approach to hip

surgery, while about 30% said they preferred the anterior approach. And only

a single surgeon in the audience said that he was currently using

computer-assisted navigational tools.

" What you have to remember is that many of the speakers at this meeting are

top experts in their field, and they are doing maybe 300 hips or knees each

year, whereas the average orthopedic surgeon may do only 15 or 20 cases, "

Maloney commented. " But there's a danger that hype about these new

techniques and patient demand for them will pressure surgeons into trying

them. "

Maloney also described advertising by manufacturers as " mostly garbage. . .

Even in the promotion to professionals, there are claims that aren't

substantiated by the literature that is cited, and we have a hard time

separating the facts from the hype, never mind the public. " He said

direct-to-consumer marketing should not be allowed, nor should surgeons

advertise their clinics and their performance rates over the internet or in

other media. " It's unethical, " he says.

Lack of data

Amid the hype and claims, there is also a lack of hard data, Maloney says.

He estimates that, at present, about 5% of all knee replacements are done

using MIS techniques, and he highlighted a new, controlled study comparing

this new approach with standard surgery. It's an important study, he said,

because it's 1 of the only comparisons to date in which only the surgical

approach has been changed. In many other comparisons there are also other

differences between the groups, eg, in the anesthetic used, the

rehabilitation procedures, pain management, etc.

The study, conducted by Dr Bonutti (St 's Memorial Hospital,

Effingham, IL), involved 80 patients and 6 surgeons at different medical

centers. At 12 weeks of follow-up, there were no statistically significant

differences in traditional knee measures between the patients who had

undergone MIS and those who had traditional surgery. " We did see subtle

differences, with slightly fewer complications and a slightly faster

recovery in the MIS group, but they weren't significant, " Bonutti said. He

says the study is " important . . . because our first responsibility is to

prove the safety and efficacy of an MIS approach. "

" We can now focus on studies that measure patient satisfaction improvements

as we evolve the technique, " Bonutti says. Although he is 1 of the pioneers

of MIS for knee surgery, he urges caution: " Only experienced surgeons should

be trying these new techniques, " he says. " The standard procedure has a

solid long-term success rate, and while the recovery rates do seem much

faster with the MIS approach, there are little data so far on long-term

outcome. " He also criticized manufacturer promotion, saying, " Some companies

have jumped on the bandwagon, and direct-to-consumer advertising is putting

pressure on surgeons to try procedures they're not experienced in. " He

warns: " Buyer bewarethere are significant downsides. "

Maloney emphasized the point about evolving, saying surgery should " evolve

rather than radically change. . . . We should move ahead slowly, changing 1

variable at a time, like did in his study, and not rush in and embrace

new techniques and new implants and be pressured into making radical

changes. "

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org