Other Articles

Using DNA to Predict Scoliosis
Six million people (estimate from the National Scoliosis Foundation) have scoliosis in one form or another. The primary age for onset of idiopathic scoliosis is 10-15 years old. Finally, there is a test which can reliably predict scoliosis. Fewer X-rays. Lower cost. Better outcomes.

New Capital, New Science for Cartilage Repair
$36 million invested in the last couple of months. TiGenix has more than that in the bank to fund market penetration. Then a new paper last week finds molecular cause of OA. Cartilage repair momentum is building.

Should I Become a Physician-Employee?
Large healthcare institutions are increasingly purchasing orthopedic practices. What does this mean for patient referrals? How beneficial can it be for orthopedists? The upside is more stability, among other things…and one of the downsides is loss of freedom.

Outrageous Whistleblower Lawsuit Challenged
Spine surgeons sued by whistleblowers in Boston are fighting back. Their lawyer is outraged and says the claimants are just shopping an old and settled case to another judge. Is this the proverbial lipstick on a pig? Find out.

Medical Education Under the Microscope – Is It Up to Today’s Challenges?
Where is the line drawn between what medical schools, residencies, and professors should provide to students and what doctors-in-training should reach for themselves? Here are the results of interviews with three senior surgeons, who opine on things such as attitudes, how people learn, and the possible effects on the field.

The Underlying Meaning of Zimmer’s Purchase of Abbott Spine
From the price paid to the timing, this transaction held an underlying meaning for the entire spinal implant industry. Zimmer, the $4.2 billion (revenue) diversified orthopedic company is now #5 in spine. More to come?

Resurging Lumbar and Cervical Total Disc Replacement Markets! New PearlDiver Estimates
Rumors of the TDA market’s demise were premature. Increasingly positive long term patient data is at the core of a resurging lumbar and cervical TDR market. Senior analyst Matt Menze tackles the TDA market and interviews one of the fathers of TDR, Dr. Scott Blumenthal from the Texas Back Institute. Where is this market actually heading? We think to the $2 billion range by 2015. All details here.

Six Days in June – Biomet and Zimmer Battle for Distributors in Kentucky
Documents filed recently in a Kentucky lawsuit pull the curtain back on an epic battle between Biomet and Zimmer. For six fevered days in June 2007, Biomet CEO Jeff Binder and founder Dane Miller went into the trenches to save one of their own. For all the details, read on.

Multicenter Clinical Trials: Do They Get the Respect They Deserve?
They’re not fast or sexy, but they are critical…large trials, that is. With multiple sites and principal investigators who donate their time, large trials are more complex—and normally yield more actionable data—than smaller, quicker studies. But large trials don’t always get the respect they deserve. And, says at least one physician-researcher, this could affect the future of the field.

Patent Wars: Medtronic Attacks NuVasive
MSD’s lawsuit came amid a period of declining spinal implant market share – from a peak of 60% in late 1998 (just prior to being acquired by Medtronic) to, we estimate, 36% currently – and a growing sense that MSD’s reign as the king of spine was coming to a close. What’s really behind Medtronic’s attack on its former senior exec? Read on.

Spine Gainsharing Through the Looking Glass
The feds have issued their first opinion allowing a spine gainsharing proposal. In Alice in Wonderland style, Through-the-Looking-Glass logic, they said the proposal was improper but would not impose sanctions. Who is the author of such a plan and what’s her secret? Read here.

PearlDiver Data Raises New Questions About Synovial Injections
Synovial injections for painful knees have been approved for use since 1997. If the goal is to improve the quality of life for the patient, is that being accomplished? The latest numbers from the PearlDiver Patient Records Database cast doubt.

Plantar Fascia: The Annual 3 Million Patient Market
“Plantar Fascial Fibromatosis (ICD-9-D-728.71) is right up there in frequency with pain in the shoulder joint, degeneration of lumbar intervertebral discs, pain in the lower leg joint, and carpal tunnel syndrome. As usual, PearlDiver has this market mapped out.

Orthopedic Incubators: Where Little Ideas Grow Up
Business incubation, also known as acceleration, can be a wild ride. Thus it’s best to approach it armed with the solid advice of experienced professionals. Who should take this ride? What can venture financiers bring to the table? These questions and more are answered by two seasoned VC professionals.

Just Say No to CMS Potential Coverage Decision List
Unless you want to be on the receiving end of a non-coverage letter, just say no to CMS’ proposed list of potential National Coverage Decisions. You’ve got until September 28 to make your case. Read what a leading industry consultant and analyst have to say.

Staking a BIG Claim
Alphatec, the company whose IPO collapse served as an object lesson for all medical device companies, has nearly completed its turnaround. The key? New management and new technology. Exhibit A: OsseoFix™—with it Alphatec stakes a claim to the next big spinal implant market.

There are lots of good things about getting older…movies are less expensive, you can laugh at yourself a bit more, and your children finally realize that you got some things right. Good knees, however, aren’t on the list. Says Dr. Giles R. Scuderi, Director and orthopedic surgeon with the Insall, Scott & Kelly Institute in Manhattan, “We have a new generation of patients who were born between 1944 and 1964 and are coming of age with arthritis. An estimated 15% – 20% of people in this country are affected by arthritis…and they don’t want to be encumbered by pain and disability. This is especially true as life expectancies continue to increase.”

Focusing on the younger baby boomers, Dr. Scuderi notes, “There is a category of baby boomers that present with knee pain and may have developed post-trauma arthritis. In fact, 10% of men and 5% of women experience knee symptoms before the age of 50. Many of these patients had prior knee surgery, were injured, and then developed more debilitating arthritis. Most of these individuals have less deformity, but their expectation is that they will be able to return to a healthy level of functioning.”

And this is often possible. “There are many options,” says Dr. Scuderi. “The process should begin with assessing a patient’s current and desired level of functioning. Fundamental to any treatment is the correct diagnosis, particularly important in complex cases. Say a patient with unicompartmental arthritis had a prior arthroscopy and meniscectomy and the joint space narrowed and collapsed. You would certainly want to take a good history, do a thorough physical exam, and order the appropriate imaging to define the pathology. When you interview patients, they will attempt to describe and/or quantify their pain, but it is important to realize that pain is subjective. What usually brings people in for treatment is daily pain that is interfering with their lifestyle. They are often experiencing recurrent mechanical symptoms like buckling and locking, and you need to decide whether they need surgery or just medical management such as anti-inflammatory medication, hyaluronic acid injections, physiotherapy and, at times, weight loss. And if they do have surgery, these young patients need to be advised that no implant lasts forever, meaning that they may require more surgeries, even revision, at a later date. It is for this reason that we like to try nonoperative treatment first.”

But for those fatigued, suffering patients who have mastered quadriceps and hamstring contractions to no avail, there is always the OR. Explains Dr. Scuderi, “The patient who is indicated for joint replacement is one for whom nonoperative treatment has failed. With a partial knee replacement we are attempting to bridge the gap between nonoperative treatment and total knee arthroplasty. The benefits are that a partial knee replacement preserves the bone and ligaments, so you are not removing the entire joint, creating less trauma, and only replacing the diseased compartment. The patient maintains his or her normal, undiseased anatomy; then when that procedure fails, either from the progression of disease, complications, or mechanical failure, the person can be revised to a total knee replacement. Unicompartmental procedures are essentially operations that allow us to buy some time for the patients.”

So until (or if) total knee arthroplasty is called for, the patient with unicompartmental arthritis has three options: a medial, patellofemoral, or lateral replacement. Says Dr. Scuderi, “Medial replacement is the most common of the three because medial compartment arthritis with a mild bowlegged or varus deformity is the most frequently occurring arthritic condition. Many of these patients have had a prior medial meniscectomy or chondral injury that has progressed over time to medial compartment arthritis. The results of medial unicompartmental replacement with an implant like the Miller/Galante prosthesis by Zimmer [the M/G® Unicompartment Knee System] have been rewarding. Medial unicompartmental surface replacement with minimally invasive techniques was popularized by Repicci as a ‘pre-total knee replacement’ and further stimulated interest in this procedure. Patellofemoral replacement had been less popular in prior years because many surgeons weren’t happy with the implant designs. It is now experiencing a resurgence, however, as new designs have come along. We now can reproduce the operations more consistently with improved instrumentation, can restore the femoral trochlear groove, orientation and alignment of the kneecap, and have better patellofemoral tracking. This operation has been very popular in France and other countries in Europe. Here in the U.S. it is gaining some traction as we try to change the mindset of those who are still hesitant to perform the operation.”

“Lateral unicompartmental replacement,” continues Dr. Scuderi, “is very much dependent on the implant design and stability of the knee. Particularly important in lateral replacement is an intact ACL. While you may be able to have success with this procedure on a knee that’s stable even though there is an ACL injury, there is some concern that it would be more technically demanding on the implant.”

So what hardware is available to surgeons these days? Explains Dr. Scuderi, “There are two types of implant designs, fixed and mobile bearing, the former of which is the most popular. While maintaining mobility is certainly your average patient’s goal, there are advantages to the fixed bearing models. It is a resurfacing device where all the movement is between the femoral component and the tibial polyethylene. Most research shows good success with survivorship data in the mid-90th percentile at 10 years or better. As for mobile bearing knees, the Oxford® Partial Knee from Biomet is the only one available in the U.S.; it is designed for medial replacements. Since the kinematics of the lateral compartment are different, Biomet has developed a new mobile bearing prosthesis specifically for lateral unicompartmental replacement. Looking at other devices, Smith & Nephew has a product called the JOURNEY™ DEUCE™, a bi-compartmental implant in which the medial tibiofemoral compartment and patellofemoral compartment are replaced with a single femoral component. This means that the lateral compartment is the patient’s normal joint.”

Continues Dr. Scuderi, “In Europe it has been popular with some to replace the damaged joint in a sequential fashion as the disease progresses. European surgeons would sometimes treat the patient with medial disease with a medial unicompartmental implant and years later if the person develops patellofemoral pain with arthritic changes, the surgeon would do a replacement just on the damaged patellofemoral joint. The upshot is that you’re building a knee replacement through a series of operations.”

And as always, you want to make sure you put only the most appropriate patients on the operating table. “The utility of unicompartmental replacement is limited by patient selection,” notes Dr. Scuderi. “You want patients whose disease is isolated and who have no other symptoms. This should not be a patient with inflammatory arthritis, rheumatoid arthritis, or any other inflammation or disease in other compartments. Appropriate patients for these replacements include those with osteonecrosis, degenerative arthritis, and post-trauma arthritis localizing to one compartment. Unicompartmental procedures are not meant for patients with significant deformity, so you want no more than a 5 degree varus and 10 degree valgus. And the patient should have a good range of motion, approximately 90 degree to 100 degree flexion, with flexion contraction no more than 10 degrees. With unicompartmental replacement you’re just resurfacing the damaged articular cartilage in one compartment, so there are no soft tissue releases to realign the limb. My last comment about patient appropriateness concerns body weight. There are some studies indicating that patients less than 200 pounds do better with these operations. Generally speaking, obese patients are not candidates because they are likely to experience early failure of the device, loosening, and subsidence.”

As in all ORs these days, the future is moving in and setting up shop. Dr. Scuderi: “There is some interest in placing unicompartmental devices with the aid of computer navigation and robotics. A clinical trial on medial replacement using robotics with the MAKO haptic system is now underway at several centers around the United States. With the appropriate computer navigation, software and imaging, we will be able to perform sophisticated bone resection and precise placement of the implants. This would be passive robotics, of course, where the surgeon works with the robot to ensure a quality outcome. Patients—and surgeons—wouldn’t have it any other way.”