Hip Resurfacing News

Pseudotumours Risk For Hip Resurfacing Highlights Need For Regular Clinical Follow-up For New Devices

Link  http://www.medicalnewstoday.com/articles/114601.php

July 11, 2008

As the incidence of metal-on-metal hip resurfacing has increased in recent years, especially in younger patients, research published in the Journal of Bone and Joint Surgery - British Volume (JBJS-Br) discusses occurrences of "pseudotumours" as a result.

The researchers estimate that approximately 1% of patients who have metal-on-metal hip resurfacings develop pseudotumours within five years of treatment. A pseudotumour is 'a soft-tissue mass associated with the implant…neither malignant nor infective in nature', but that causes pain and discomfort to the patient.

Most worryingly for patients and doctors is that the causes of the tumours are unknown. The research discusses possible causes including 'toxic reaction to an excess of particulate metal wear debris.' The article stresses the need for further research to be done into the incidence of pseudotumours in patients who have had this treatment.

The paper concludes that the incidence of pseudotumours must be related to metal-on-metal hip resurfacing highlighting 'the need for regular clinical follow-up for new devices'. Such follow-up would follow NICE recommendations, but the current NHS climate makes this difficult, if not impossible, to achieve.

Read the research abstract

Notes

- The Journal of Bone and Joint Surgery - British Volume is a world leading orthopaedics journal with an Impact Factor of 1.868

- JBJS-Br publishes twelve issues a year of high-quality, peer-reviewed research, overseen by an international editorial board led by Editor James Scott

- The Journal was first published in 1948 by The British Editorial Society of Bone and Joint Surgery, a registered charity (No. 209299), with the object of the advancement and improvement of education in orthopaedic surgery and allied branches of surgery and the diffusion of knowledge of new and improved methods of teaching and practicing orthopaedic surgery in all its branches

- You can find out more about the Journal at http://www.jbjs.org.uk

Journal of Bone and Joint Surgery, British Volume

Link  http://www.medicalnewstoday.com/articles/114601.php

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11, 2008

As the incidence of metal-on-metal hip resurfacing has increased in recent years, especially in younger patients, research published in the Journal of Bone and Joint Surgery - British Volume (JBJS-Br) discusses occurrences of "pseudotumours" as a result.

The researchers estimate that approximately 1% of patients who have metal-on-metal hip resurfacings develop pseudotumours within five years of treatment. A pseudotumour is 'a soft-tissue mass associated with the implant…neither malignant nor infective in nature', but that causes pain and discomfort to the patient.

Most worryingly for patients and doctors is that the causes of the tumours are unknown. The research discusses possible causes including 'toxic reaction to an excess of particulate metal wear debris.' The article stresses the need for further research to be done into the incidence of pseudotumours in patients who have had this treatment.

The paper concludes that the incidence of pseudotumours must be related to metal-on-metal hip resurfacing highlighting 'the need for regular clinical follow-up for new devices'. Such follow-up would follow NICE recommendations, but the current NHS climate makes this difficult, if not impossible, to achieve.

Read the research abstract

Notes

- The Journal of Bone and Joint Surgery - British Volume is a world leading orthopaedics journal with an Impact Factor of 1.868

- JBJS-Br publishes twelve issues a year of high-quality, peer-reviewed research, overseen by an international editorial board led by Editor James Scott

- The Journal was first published in 1948 by The British Editorial Society of Bone and Joint Surgery, a registered charity (No. 209299), with the object of the advancement and improvement of education in orthopaedic surgery and allied branches of surgery and the diffusion of knowledge of new and improved methods of teaching and practicing orthopaedic surgery in all its branches

- You can find out more about the Journal at http://www.jbjs.org.uk

Journal of Bone and Joint Surgery, British Volume

Link  http://www.orthosupersite.com/view.asp?rid=29416

By Gina Brockenbrough
July 2008

DENVER — Patients with foot and/or ankle surgical wounds who are taking COX-2 inhibitors may have a significantly higher incidence of delayed wound healing than those not taking the medication, according to new research presented here.

To evaluate the potential impact of COX-2 inhibitors on surgical wound healing, Chad Lamoreaux, MD, and colleagues performed a retrospective study of all foot and ankle patients operated on by a single surgeon using the same wound care plan during a 3-year period. The investigators excluded patients with pre-existing foot and ankle wounds and those with a history of chronic ulcers.

The results were presented at the American Orthopaedic Foot and Ankle Society 24th Annual Summer Meeting.

Of the 175 patients included in the study, 12.6% had delayed wound healing, which the investigators defined as a postoperative delay, infection, wound sloth or lesion that was followed for a period in the wound care clinic. Of the total study group, 18 patients were on preoperative standing doses of COX-2 medications, which included either celecoxib or rofecoxib.

The investigators discovered that nine of the 18 patients taking a COX-2 inhibitor had delayed wound complications compared to only 13 of the 157 non-COX-2 patients. While the groups were similar regarding demographics such as age and gender, a closer examination revealed a non-equal distribution of patients with diabetes and tobacco use.

After excluding patients with these risk factors, the investigators found that only six of the remaining 150 non-COX-2 patients had wound-healing complications (4%) compared to four out of the 13 remaining COX-2 patients (31%).

"[We] did make several assumptions to do this paper," Lamoreaux said during his presentation. "The distribution of Celebrex (celecoxib, Pfizer) vs. Bextra (valdecoxib, Pfizer) was not looked at. Also, the usage of the nonspecific anti-inflammatories was not looked at. But with the normal patients, our findings still showed a very significant impact of COX-2s on their ability to heal their surgical wounds."

For more information:

Lamoreaux C, Santrock RD and Deemer J. COX-2 inhibitors and wound healing complications. Presented at the American Orthopaedic Foot and Ankle Society 24th Annual Summer Meeting. June 26-28, 2008. Denver.
 

Link  http://www.newsweek.com/id/46170

July 2006

At 42, Sally Seeley was barely able to walk. Diagnosed with osteoarthritis in her late 20s, she tried a range of treatments from water aerobics to Vioxx. But her condition only got worse. Finally, an orthopedic surgeon recommended total hip replacement. She worried that she was too young for such surgery, but she just couldn't stand the discomfort any longer. "The pain was gone immediately," says Seeley, now 49. Three months ago, she had her right hip done; she's already back at work.

Joint replacement was once considered a last resort for elderly patients who were immobilized. Now, thanks to improved artificial joints made from longer-lasting materials like titanium, patients in their 50s and younger are signing up in growing numbers. More than 600,000 hip and knee replacements were performed in the United States last year. While the average patient was well over 60 years old, the number of people younger than 65 getting the surgery has grown by 20 percent over the past five years. "Maybe 10 or 15 years ago, the threshold was the ability to walk or do errands," says Dr. Edwin Su, an orthopedic surgeon at the Hospital for Special Surgery in New York. "Now it's continuing to ski, golf or windsurf."

Doctors compare joint replacement to replacing tires on a car that's out of alignment. Over the decades, your weight can wear down your bones. This is especially true for patients with arthritis, where inflammation destroys the cartilage surrounding the joint, causing the bones to grind together painfully. In knee replacements, the most common joint-replacement procedure, doctors cut into the joint and remove the damaged portions of the tibia (the lower leg bone), patella (kneecap) and femur (thigh bone). They are replaced with metal and plastic components. The surgery lasts at least two hours and requires general anesthesia. Artificial knees generally last from 10 to 15 years. Hips are the second most commonly replaced joints, followed by shoulders...

 

June 2008

Link http://www.nbc11.com/msnbchealth/16748813/detail.html

Timmi Ryerson, a San Diego stock market analyst, says her left hip actually works again, thanks to an orthopedic specialist in India.

...What's new about these procedures is not the exotic locales the three chose, but the way they paid for their far-flung surgeries.

While at least 150,000 Americans travel abroad for medical care every year, according to the American Medical Association, Ryerson, Mason and Davies represent a small but growing category of medical tourist: patients whose insurance companies have agreed to foot at least part of the bill.

"I think that's the solution to our health care crisis," said Davies, 53, whose company plan, Delta Dental, maxed out his dental benefit, about $2,500, toward the $30,000 he spent to repair damage caused by years of grinding his teeth, a procedure that would have cost an estimated $80,000 in the United States.

Increasingly, some of the nation's larger employers and leading health insurers agree.

Once the province of the poor and uninsured, medical tourism is gaining attention of industry giants such as CIGNA, Aetna and Blue Cross/Blue Shield, who say they either have begun or are considering pilot programs that provide limited coverage for foreign care. One Montana firm, Employee Benefit Management Services Inc., recently began offering medial tourism plans to its 120 self-insured clients in the Northwest...
 

"I just think that others need to be aware that they are able to have a safe procedure done out of the country for a price at a third the cost," she said.

Ryerson, 61, said her private Blue Cross plan paid 80 percent of a $7,000 hip resurfacing surgery in Chennai, India, that would have been about $55,000 in the U.S. - if she could get it at all.

In 2006, the hip resurfacing device necessary for her surgery had just been approved for U.S. use by the federal Food and Drug Administration and not many domestic doctors had experience with it. Dr. Vijay Bose, her U.K.-certified surgeon in India, had performed the surgery more than 1,100 times.

"Doctors here didn't know what they didn't know and I didn't want to be a guinea pig," she said.

While she was there, Ryerson also had cosmetic surgery and dental work done at her own expense...
 

 

I am honored that some of my overseas patients have got together and made a plaque in appreciation of our hip surgery team and a donation for the Jay Coulter fund.

Gary Klein has come back to Chennai to get his second hip done. He brought the plaque and the donation.

I have attached a picture of the plaque.

With best regards

Vijay bose
chennai
Asian Regional Center for Hip Resurfacing (ARCH) Website
 

AAOS SAN FRANCISCO, March 7, 2008 - Some of the purported advantages of hip resurfacing over standard arthroplasty, though not all, seem to be real, researchers found in a randomized trial.

But other pluses in activity and function can probably be chalked up to patient selection bias and expectations, reported Martin Lavigne, M.D., of the University of Montreal, and colleagues, at the American Academy of Orthopaedic Surgeons meeting here.

In the randomized trial, patients who had hip resurfacing were significantly more likely to return to work and sports and had better step and hop test scores than standard arthroplasty patients did.

But functional scores and range of motion were no better than with hip replacement, the investigators found.

Hip resurfacing gained popularity with patients and some orthopedic surgeons on the basis of assumptions about better clinical function and ability to return to a high level of activity.

While retrospective cohort studies reinforced this perceived benefit, Dr. Lavigne said, "obviously there was a bias in the patient selection for hip resurfacing." Patients who sought hip resurfacing tended to be younger, more active, healthier, and expected a more active life after surgery, he said.

The newer procedure is still controversial among orthopedic surgeons despite rapid increases, commented Tom Schmalzried, M.D., of the Orthopaedic Hospital in Los Angeles, in a press conference where there was debate over the two approaches.

"The results of good, modern total hip replacement are really, really good," he said. "So for resurfacing to have a favorable risk-to-benefit ratio, you have to show you are getting something you don't get with total hip replacement."

For a more objective answer to this issue, Dr. Lavigne's group randomized 210 patients who were candidates for either procedure to undergo either uncemented 28-mm metal-on-metal total hip arthroplasty or hybrid metal-on-metal hip resurfacing.

All procedures were done by the same three surgeons with a posterior approach. Patients were informed which surgery they underwent only afterward.

Patients had a mean age around 50. Body mass index was higher in the total hip arthroplasty group.

Functional scores were slightly worse in the hip replacement group at six months (17 versus 11 on the WOMAC scale) but identical by two years (5 for both).

At six months after surgery, hopping on the affected leg was significantly easier for resurfacing group patients ("easy" or "very easy" 91.7% versus 78.9% and "difficult" or "impossible" 8.3% versus 21.1%, P=0.023).

Likewise, climbing stairs in a step test was easier at six months in the resurfacing group compared with the replacement group ("easy" or "very easy" 94.4% versus 76.3% and "difficult" or "impossible" 5.6% versus 23.7%, P=0.015).

Hip resurfacing group patients were also more likely to return to their prior work (96% versus 83%, P=0.02).

The young age of the patients made this an important outcome, Dr. Lavigne said.

Among the patients, 152 had data on activity level pre- and post-procedure.

Despite similar activity levels before surgery (P=0.22), more hip resurfacing than hip replacement patients returned to sports activities by one year after surgery (15% versus 7% high impact and 38% versus 28% moderate impact activity, P=0.022).

On a scale that included activities of daily living as well as sports, the difference tended to favor hip resurfacing but was not significant at one year (P=0.074).

"Both groups returned to a high level of activity," Dr. Lavigne said. "Hip resurfacing patients seem to be more active, but not as much as expected."

Type of surgery had no significant impact on what factors patients reported as limiting their return to sports activities, including implant protection, discomfort, fear of instability, and thigh pain.

Hip range of motion -- including total arc, arc of rotation, flexion-extension arc, and abduction-adduction arc -- was also similar for both groups among the 122 patients with data on this outcome (P>0.05).

Satisfaction with the procedure was uniformly high over time and across treatments.

While resurfacing is a more aggressive technique, Dr. Lavigne said, the rate of complications was similar between groups.

Long-term follow-up will be important to determine whether there are differences in need for revision between the procedures, he concluded.

Dr. Lavigne reported receiving research or institutional support from Zimmer, Stryker Howmedica, Biomet, DePuy, and Smith & Nephew and consulting for Zimmer.

Dr. Schmalzried reported receiving research or institutional support from Stryker, DePuy, Johnson & Johnson, Corin, and Wright Medical Technology; receiving miscellaneous funding from Stryker, DePuy, Johnson & Johnson, Corin, Wright Medical Technology, Zimmer, and Smith & Nephew; receiving royalties from Stryker, DePuy, Johnson & Johnson, Corin, and Wright Medical Technology; holding stock options in Stryker, DePuy, Johnson & Johnson, Corin, Wright Medical Technology, Zimmer, Biomet, Bristol-Myers Squib, and Pfizer; and being a consultant for Stryker.

Primary source: American Academy of Orthopaedic Surgeons meeting
Source reference:
Lavigne M, et al "Range of motion after hip resurfacing and THA: A single-blind randomized clinical study" AAOS meeting 2008; Abstract 058.

Additional source: American Academy of Orthopaedic Surgeons meeting
Source reference:
Lavigne M, et al "A randomized study comparing surface replacement arthroplasty to total hip arthroplasty" AAOS meeting 2008; Abstract 056.

Additional source: American Academy of Orthopaedic Surgeons meeting
Source reference:
Lavigne M, et al "Return to sports after hip resurfacing and total hip arthroplasty: A randomized clinical trial" AAOS meeting 2008; Abstract 053.

Link
http://www.argusleader.com/apps/pbcs.dll/article?AID=/20080616/LIFE/806160306/1004/life

Ken Kuipers' hip pain started in 2006. At first, the 51-year-old Platte farmer tried to tough it out.

Even though a couple doctors recommended hip replacement, Kuipers wasn't ready to give in.

"I wanted to keep my own joint as long as possible," he says.

Doctors told him he could try cortisone injections, but Kuipers ruled that out because the shots were expensive and provided temporary relief. He needed to keep up with his animals and field work, so when the pain didn't ease up, Dr. Matthew McKenzie, orthopedic surgeon at the Orthopedic Institute, offered another option.

Kuipers was a perfect candidate for hip resurfacing, McKenzie says. People who are active, younger than 65 and have normal bone tissues have the best chance for success with the procedure, he says.

Doctors also consider the expected life span of the patient before deciding on the type of surgery performed. Hip replacements don't last forever.

"There is about a 20 percent failure rate in 25 years, depending on what study you're looking at," McKenzie says.

He has done the resurfacing procedure for about nine months, something that Orthopedic Institute added because patients were going out of town to have the surgery, he says.

A hip resurfacing procedure has the same goal as a standard total hip: Pain alleviation. Contrary to popular belief and Internet promises, the procedure is not less invasive or expensive nor does it mean a shorter recovery time.

With hip resurfacing, Kuipers faces six weeks of healing, the same time a total hip replacement would have taken. The newer surgery is not cheaper because new technology always costs more, McKenzie says.

The main reason to have a hip resurfacing is because it means less bone removal. "If it fails, you can revise it to a standard total hip," he says. "Anything to save bone is the right thing to do."

During a hip resurfacing procedure, the ball of the hip is machined down, a metal cap is fitted over it and a short anchoring spike is driven down the femur. The neck of the femur is preserved as well as much of the ball. The position of the implant and the patient's muscles hold the hip in place.

In a traditional hip replacement, the entire ball and joint is removed and replaced with an artificial joint, and a long rod is placed in the femur.

Kuipers' incision is 10 inches long, that compared with a hip replacement that is typically half that or less.

He was in the hospital for several days. He had the surgery on a Wednesday and went home Saturday. He had two physical therapy sessions on Thursday and Friday while in the hospital, says his wife, Donna. They taught him stretching and strengthening exercises to do at home.

He's using a walker right now.

"I'm just about ready to switch to a cane," he says.

The pain is better but different, he says. It's surgical pain from the muscles being cut. And he still needs pain pills to sleep.

At two weeks post-op, he had his first office visit where his staples were removed and his incision was looked over. Healing is progressing, and McKenzie gave permission to increase activity as tolerated.

"I was given the go ahead to get on a tractor," Kuipers says.That's exactly what he plans to do as soon as it dries out enough to get in the fields.

 

Hip, knee implant makers agree to pay $311M settlement

Link  http://blog.nj.com/ledgerupdates/2007/09/hip_knee_implant_makers_to_pay.html

Posted by John P. Martin and Jeff Whelan  September 27, 2007

The nation's largest manufacturers of hip and knee implants today agreed to pay $311 million to settle allegations that they bribed top surgeons to recommend their products.

Agents gathered evidence that orthopedic surgeons routinely accepted lavish vacations, gifts and annual "consulting fees" as high as $200,000 from medical device makers in return for endorsing their implants or using them in operations.

The 30-month investigation, headed by federal prosecutors in New Jersey, marks one of the larger settlements of its kind and follows a wave of cases to spotlight questionable ethics within the health care industry.

"With these agreements in place, we expect doctors to make decisions based on what is the best interest of their patients - not the best interest of their bank account," U.S. Attorney Christopher Christie said in a statement.

The agreements covered five firms, including DePuy Orthopaedics, a subsidiary of New Jersey-based Johnson and Johnson. Together, the companies control more than 90 percent of the U.S. market in reconstructive implants, a billion-dollar field expected to surge in coming years.

Three of the manufacturers -- DePuy, Zimmer Holdings and Biomet, Inc. -- are based in Warsaw, Ind. The others are Stryker Corp., of Kalamazoo, Mich. and Smith and Nephew PLC, of London.

The civil settlements ranged from $169 million for Zimmer to $26.9 million for Biomet, based in part on the market share of each defendant, authorities said. Stryker will not pay any money.

In criminal complaints filed in federal district court in Newark, the companies admitted paying surgeons consulting fees that violated the federal Medicare Fraud Statute. The law prohibits companies from offering inducements to doctors who participate in Medicare. About two-thirds of the 700,000 knee and hip replacement surgeries performed each year are covered by Medicare.

As part of the agreement, each will also pay for a federal monitor to supervise their practices for 18 months. The monitors include former U.S. Attorney General John Ashcroft and the former U.S. Attorneys for New York and Los Angeles.