Manufacturers developing minimally invasive hip implant procedure

by Karin Lillis

A major orthopedic implant manufacturer is betting big investment dollars that a new surgical technique currently under development will give it a leg up in the lucrative hip implant market in the not-too-distant future. Led by a team of surgeons, Warsaw, IN-based Zimmer Inc., is crafting a minimally invasive approach to traditional hip replacement surgery that holds promise in cutting hospital stays and recovery time while improving patient outcomes.

The new approach – dubbed Minimally Invasive Solutions by Zimmer — allows doctors to implant the prosthesis through a pair of two-inch portals rather than the 12- to 18-inch incisions used for years in such hip procedures. The advanced technique combines existing implant products with modified instruments and procedures already in use.

“New minimally invasive techniques, used with clinically proven implants, can result in shorter recovery times, smaller scars and shorter hospital stays,” says Sheryl Conley, Zimmer’s vice president of global brand management and commercialization. “Patients have already benefited greatly from minimally invasive techniques in other areas of surgery, such as cardiology and general surgery.”

The first minimally invasive hip replacement surgery was performed earlier this year by Dr. Richard Berger at Chicago’s Rush-Presbyterian-St. Luke’s Medical Center as part of an ongoing research study. Zimmer already has in place a similar procedure for knee replacement.

The new approach has raised hopes in the investment community and the medical community alike. “There is no question that one of the biggest trends to sweep through medical products is minimally invasive surgery,” says Bruce Jacobs, an analyst for Boston-based Deutsche Banc Alex. Brown. “In almost every therapeutic category, there is some element of less-invasive procedures. It’s obvious that the procedures that are open and traumatic and have long hospital stays stand to benefit most [from minimally invasive procedures]. Hip replacement is certainly one of those.”

Hip replacement surgery is most commonly performed on patients suffering from severe, chronic pain associated with osteoarthritis that cannot be controlled either through the use of medications or physical therapy. About 300,000 hip replacements are performed in the U.S. each year, according to Zimmer, with projections for as many as 600,000 annually by 2015 as the nation’s population ages.

Jacobs says it is “fair to assume” that other players in the orthopedics market, such as DePuy, Biomet and Stryker are developing similar procedures.

“Zimmer is not alone in its efforts,” Jacobs says. “All of the major players are working on them. It will be interesting to watch this market evolve. My guess is that the company that develops the most successful approach – a combination of new instruments and technique — will lead the market.”

“Zimmer has done a better job than the others of raising the level of awareness and general excitement about the technique,” says the analyst. “Patients will also play a meaningful role in adoption of the new minimally invasive technique. What one finds is that word gets around quickly.”

Trial run

Clinical trials will ultimately involve 120 patients at Rush-Presbyterian, and facilities in Portland, OR, and Montreal, Canada.

Along with the newly emerging procedure, some variations in instruments are on the way. The instrumentation employed by physicians in traditional hip replacement surgery was slimmed down to accommodate the minimally invasive approach. Sets of new retractors were also developed to allow surgeons performing the operation to see the hip clearly through the incision.

The research study focuses solely on the techniques used to assess the hip, remove the damaged bone and insert the prosthesis. The initial study is limited to patients of average weight to systematically evaluate the effectiveness of the minimally invasive surgical approach and benefits to patients. As of early November, 41 patients had undergone the new procedure.

In September, Zimmer established a dedicated business team to maximize the potential patient benefits of applying minimally invasive surgical techniques to orthopedic surgery. The company also plans to create a medical education unit, known as the MIS Minimally Invasive Solutions Institute, to help facilitate training for surgeons and other medical professionals on the techniques required for minimally invasive procedures.

Analyst: ‘Big potential’ for hospital savings

Zimmer’s Conley anticipates that it could be several months before the company and participating hospitals know the details of the ultimate benefits to patients and potential savings for hospitals that employ the new techniques. Zimmer and the trial hospitals are still recruiting patients for the study, a process that could take another six months.

Conley is hopeful, however, that a planned economic study will “demonstrate the patient benefits and the cost trade-off. Those two factors combined are what hospitals are looking for. Where are the offsetting costs, like shorter hospital stays and [cuts in] extensive rehabilitation? Will this increase patient interest in coming to the facility?”

Although the cost of the new procedure might initially be higher than for traditional methods, minimally invasive hip surgery could ultimately pare dollars from a hospital’s costs, Deutsche Banc’s Jacobs adds. “If a hospital can cut down on length of stays, that money drops to the bottom line. There is a big potential for benefits for hospitals if they’re successful in these efforts,” he says.

The ultimate success of the new technique will hinge on persuading orthopedic surgeons that the new method is a viable alternative to traditional hip replacement surgery. “Orthopedic surgeons tend to be more conservative and it will be difficult to convince them to adopt a minimally invasive procedure like this one unless it’s proven in a significant way,” Jacobs explains.

Papers and results presented at the American Academy of Orthopaedic Surgeons annual meeting in Dallas in February could determine how soon the procedure will be accepted by the physician community.

December