A new theory of joint function presented in a symposium at the 71st annual meeting of the American Academy of Orthopaedic Surgeons (AAOS; Chicago, Illinois) in San Francisco, California, last month suggests that the development of osteoarthritis (OA) in the knee following an injury may be both predictable and preventable. By examining the joint at the metabolic level, physicians may be able to identify those at risk for developing OA and take measures to stop its progress, according to Scott Dye, associate clinical professor of orthopedic surgery at the University of California, San Francisco.
Post-traumatic OA of the knee joint is one of the most frequent conditions managed by orthopedic surgeons. Currently, the most common approach is based on a structural view of joint function, with MRIs (magnetic resonance imaging) and X-rays typically used to analyze the structure of the bones, cartilage and other tissues in the joint. However, Dye has proposed a "tissue homeostasis" theory stating that joints are more than mechanical structures but rather living, metabolically active systems, and, when damaged, joint tissues can begin to lose their homeostasis (the ability to maintain their metabolic equilibrium) and lead to the development of osteoarthritis. "This loss of homeostasis may already be occurring at a time when traditional imaging studies, including MRI and X-ray, would show that the joint structures are normal," he said. "If we start imaging the knee for metabolic changes through the use of a study called a bone scan, we can identify the risk of osteoarthritis at a time when something can be done to prevent the development of overt degenerative changes."
Dye has found that following orthopedic treatment, such as reconstruction of the anterior cruciate ligament (ACL), patients may still develop OA in the knee months or years later. This is because the knee's load transference capacity (or Envelope of Function) is rarely restored in an ACL reconstruction, even if seemingly normal structural and biomechanical characteristics are achieved. The principle of treatment is to maximize the Envelope of Function for a given joint or musculoskeletal system as safely and predictably as possible.
In another report focusing on treatment of damaged knees, results of a two-year study on tears of the anterior cruciate ligament revealed a high association of cartilage and meniscal injuries associated with ACL tears in a young, active population when ACL reconstruction was unnecessarily delayed. An overseas U.S. Army assignment allowed orthopedic surgeon Steven Wei, MD, to map the natural history of ACL tears in 60 individuals for an extended period of time between injury and reconstructive surgery. Because of the circumstances limited patient access to hospitals, few surgeons and a long wait for an operating room he was able to observe injuries that normally in the U.S. would have been repaired quickly.
Wei, now affiliated with the Lawrence and Memorial Hospital (New London, Connecticut), described the high association of cartilage damage and meniscal tears with chronic ACL tears. "Individuals who have an injury to the knee should be evaluated as soon as possible, not necessarily by their family physician but by a specialist who is familiar with dealing with knees. The ACL tear itself is repairable. We can reconstruct that ligament. But much of the time, the secondary damage that happens to the knee is not repairable. That's what we want to avoid."
Stationed in Germany, Wei had an opportunity to take a close look at ACL injuries over a period of two years. Patient age ranged from 13 to 45, with 27 as the average. His study was a retrospective review of the 60 ACL reconstructions that he performed along with a fellow orthopedic surgeon. A review of the intra-operative findings revealed that 20 of the 60 patients in the study had sustained lateral compartment damage. That included 12 patients with lateral meniscus tears and 16 patients with lateral cartilage damage. Surgical findings also revealed that 30 patients had medial compartment damage, including 26 patients with incidence of medial meniscus tears and 18 with incidence of medial cartilage damage.
On average, it was 30 days from the date of the injury to the first appointment with a primary care provider; 151 days from the first appointment with the primary care provider to the first appointment with an orthopedic surgeon; and 75 days from the first appointment with the orthopedic surgeon to the date of surgery. Overall, the average time from date of injury to date of surgery was about 260 days, with a range of 12 to 1,622 days.
MIS doubted in knee surgery, not for hips
Minimally invasive surgery (MIS) is considered the newest, best thing in a broad range of procedures, and it is an important trend in orthopedics touted as producing better outcomes and getting patients back on their feet more quickly. A panel of four orthopedic surgeons discussed MIS for hip and knee replacement procedures at the AAOS gathering, with only one of the four expressing skepticism about the strategy specifically, in knee replacement.
David Hungerford, MD, professor, department of orthopedic surgery at Johns Hopkins School of Medicine (Baltimore, Maryland), reported reviewing 275 revision standard total knee replacements performed at the medical center between 1987 and 1997 and came away skeptical. He said there was no convincing evidence that patients will benefit meaningfully as a result of MIS total knee replacements. "During this 10-year period, the surgeons involved in the study performed approximately 3,000 total knee replacements, of which about 275 were re-operations," Hungerford said. Based on a review of the pre- operative X-rays of the 275 knees, he reported that 75% had technical failures, meaning they were malaligned.
"If the surgeon, with full exposure, cannot reproducibly and reliably align the knee, what will the outcome be with limited exposure? If MIS becomes widespread in total knee replacement, there will be a significant and predictable increase in the number of technical failures," Hungerford predicted.
As opposed to Hungerford, Peter Bonutti, MD, of St. Anthony's Memorial Hospital (Effingham, Illinois), said his personal experience has given him confidence in the MIS approach. Since 1999, he has performed successful MIS procedures with incisions as small as 6 cm (about 2 "). Bonutti said that with standard surgery of knee replacement, total knee replacement patients always have a disability. "There is permanent functional deterioration because the muscles have been cut." The result, he said, is often an inability to do very simple everyday activities, such as walking downhill or kneeling to pick something up.
Allowing full functionality "is what minimally invasive surgery on knees is all about," Bonutti said. Bonutti reported that his patients leave the hospital within three days, as opposed to five days for standard surgery, and they are doing well four years later.
The AAOS reports about 325,000 knee replacement in the U.S. annually, with a dramatic growth in that number.
There was no disagreement among panelists concerning hip replacement via MIS, a procedure taking place about 300,000 times a year in the U.S., the association says.
Thomas Sculco, MD, surgeon-in-chief at the Hospital for Special Surgery and professor of orthopedic surgery, Weill Medical College of Cornell University (both New York), reported beginning the MIS strategy on hip replacement in 1996 and now using it for 95% of his cases. "I have used this less-invasive technique in more than 1,500 patients," he said, adding that they "recover more quickly and lose their limp and need for a cane more quickly than with the standard approach. There has been no increase in complications in my experience with this approach in terms of wound problems, dislocation of the implant or inferior results when valuated by X-rays."
Extending this confidence even further, Richard Berger, MD, assistant professor of orthopedic surgery at Rush-Presbyterian-St. Luke's Medical Center (Chicago, Illinois), said that outpatient surgery for hip replacement "is feasible" with an MIS approach. Berger said that his patients meet rigorous criteria for discharge, including walking the hospital hallways four or five hours after surgery.
The first surgeon in the world to offer MIS for this application on an outpatient basic, Berger reported using the approach for almost all of his patients. He noted that in 2003 "every patient ... has gone home the same day" and that, on average they resume daily living activities within 10 days and can walk a half mile within 16 days. "This is an order of magnitude faster than has ever been done in hip replacement," he said.
Among other studies presented at the conference:
"Female recreational athletes have a probability of NC (non-contact)-ACL injuries 7.3 times greater than that of male recreational athletes," said Bing Yu, PhD, associate professor and director of the Center for Human Movement Science at the University of North Carolina (Chapel Hill, North Carolina), a member of a panel discussing the injury and strategies for prevention.
New research presented by Yu and William Garrett Jr., MD, PhD, professor in the department of surgery at Duke University Medical Center (Durham, North Carolina), offered data on a controlled study of 30 male and 30 female recreational athletes between 18 and 30 years of age. "The most important aspect of the findings in our study is that we provide evidence that altered movement patterns are responsible for the elevated risk for NC-ACL injuries in women," said Yu. "Specifically, we found that people who land hard with excessive movements at the knee joint in athletic tasks are at higher risk for NC-ACL injuries."
Femur (or thighbone) fracture is the most commonly occurring orthopedic trauma injury requiring hospitalization in children, according to orthopedic surgeons who analyzed data from a national pediatric inpatient database reported on the top 10 traumatic orthopedic injuries requiring hospitalization in children, as well as variations in pediatric care of traumatic orthopedic injuries. Pediatric trauma is a leading cause of death and disability in children, with the study focusing on the variability in care of children's injuries and identifying trends in pediatric trauma. The researchers concluded that orthopedic surgeons can be instrumental in prevention of recreational orthopedic injuries by participating in patient education, research and programs that promote safe play.
"It was important that we conduct this study to explore how these injuries are treated in order to guide policies that promote pediatric trauma prevention," said Michael Vitale, MD, lead author. While femur (thighbone) fractures represent 21.7% of hospitalized traumatic orthopedic injuries, the number of tibia/fibula, or lower leg fractures was not far behind, accounting for 21.5%. Other conditions, such as fractured humerus (upper arm), radius or ulna fracture (lower arm), and vertebral, or spinal fracture, were reported at 17%, 14.7% and 5.2%, respectively. The remaining list of hospitalized pediatric traumatic orthopedic injuries consists of bony pelvis fractures (4%), sprain or strain of the knee or leg (4%), hand or finger fractures (2.6%), toe or foot fractures (2.3%) and strain or sprain of the back (1.2%).
The researchers also reviewed gender disparities by types of injuries, to find that adolescent males were more likely to sustain the types of orthopedic injuries found in the study, due to participation in high-risk contact sports. But because vertebral and pelvic fractures often are attributed to motor vehicle and pedestrian accidents, the gender distribution for these two injuries was fairly even.
The population for the study was taken from the Healthcare Cost and Utilization Project Kids Inpatient Database, which provides data on all pediatric discharges.
DePuy unveils 'Intelligent Orthopaedics'
DePuy Orthopaedics (Warsaw, Indiana), a unit of Johnson & Johnson (New Brunswick, New Jersey), used the opening day of the AAOS conference to roll out a business program titled "Intelligent Orthopaedics" (or iOrthopaedics). Its activities were highlighted by a major product introduction and an early look at an expansion of DePuy's traditional developmental strategy. The new product is the Ci System, an integrated hardware, software and instrumentation technology that produces advanced visualization for minimally invasive knee joint replacement. Gordon van Ummersen, vice president of marketing, highlighted the iOrthopaedics program as "a change in strategy" and a "transformational effort" by the company.
The Ci System, along with other future iOrthopaedics products, was unveiled in DePuy's exhibit floor "iOrthopaedics Operating Room (OR) of the Future," an operating theater showcasing the company's development of "computer-assisted aspects of orthopedic procedures," van Ummersen told The BBI Newsletter. The Ci System is the first output from DePuy's collaboration with Brainlab (Munich, Germany), specifically developed via R&D work on the Brainlab campus, he said. "We partnered with who we feel is the most forward-thinking and the best navigation and image-guided company in the business we've been deep into this [R&D effort] for two years."
The Ci System enables the orthopedic surgeon to view, through the skin, the actual bony anatomy of the patient's knee in what van Ummersen described as a "morphing" process, similar to that used by filmmakers, and to display that anatomical image on a computer screen during the procedure. That is a feature especially beneficial as the incision points for minimally invasive procedures in orthopedics become ever smaller, he noted. "The system's software is far advanced beyond what is [already] out there," he said. "[By displaying] the actual anatomy of the knee, the surgeon can go in and do very, very precise cuts and this offers strong precision around placement of the implant."
van Ummersen explained that the system works with an infrared camera and "trackers placed on the patient's anatomy." The camera "bounces signals picked up by the trackers and registers the anatomy for the computer system." The computerized model provides real-time feedback and visualization "not fully seen in the traditional procedure," he said.
Bill Barrett, MD, an orthopedic surgeon with Valley Orthopaedic Associates (Renton, Washington), emphasized the increased procedural success and better outcomes enabled by the Ci System. "The technological advancements made possible by iOrthopaedics ... will ultimately allow surgeons to align joints with much more accuracy using much less invasive procedures," he said. "In my experience, the potential benefits seen with these technologies include reduced incision size and scarring, minimized soft tissue damage and decreased risk of malalignment."
Moving into the computer-assisted, advanced visualization and robotics arenas, van Ummersen said, "is really looking at a way to create optimal value for surgeon and patients." He called the Ci System "a fully integrated package, with the software made to work specifically with our instrumentation. This isn't a case of making a computer system and software used with already existing systems."
He further described the system as "the first tangible output of what we hope to be many in significant product launches over the next few years."
Referring to the "paradigm-shifting" potential of the iOrthopaedics strategy, Kevin Sidow, worldwide president of DePuy, said the effort will change "how people think about our industry more positive changes will occur over the next four years than the last 40."
The Ci System will require considerable physician training, so the product will be rolled out over the next few months with a "no train, no use" approach, van Ummersen said. He said this is intended to guarantee the "appropriate level of education on the system and product "adoption at a precise pace." He said the Ci System would cost between $100,000 and $300,000 a fraction of the cost of a magnetic resonance imaging system. The technology will pay for itself, he added, both through superior patient outcomes and also as a large marketing advantage. "Orthopedic surgeons are looking for an edge on their competition," van Ummersen said. "They are really reaching out to embrace the concept of breakthrough technology, and they'll find this a much more successful and efficient procedure."
DePuy also reported at AAOS the creation of its new Trauma & Extremities Group, also to be based in Warsaw. Because many surgeons who treat trauma patients also operate on non-emergency cases of the extremities, DePuy has combined its trauma and extremities operations, the company said in a statement. Its product offerings include reconstructive extremity products, as well as trauma products previously marketed by the former DePuy ACE business unit.
Chris Lee, vice president of the new Orthopaedics Trauma & Extremities Group, said, "This organizational improvement is designed to help orthopedic surgeons and their patients gain better access to technology used in treating accident victims and patients with severe joint problems." The new group, Lee said, "matches the way many surgeons approach their practice. Many of the surgeons who treat traumatic injuries are the same ones who operate on non-emergency cases and deformities of the extremities. Combining these two operations improves the surgeon's options." He added: "By representing both of these intertwined product lines, our group can solve more problems, more quickly, for our surgeon customers." The Trauma & Extremities Group will be focused on providing surgeons with better access to treatment options for fractures of the hip, foot, ankle, long bones of the leg and upper extremities.
George Haidukewych, MD, an orthopedic surgeon specializing in traumatology and adult reconstructive surgery at the Florida Orthopaedic Institute (Tampa, Florida), said,"Manufacturers have typically treated trauma and reconstructive products as separate entities, even though they fit together. It is not unusual for patients treated with fractures to later require joint replacements or other reconstructive procedures. Pooling the talent and brainpower of these two areas will hopefully result in faster and better development of products."
DePuy also reported the development of a New Technology concept team that will identify future technologies and applications. Billing itself as the worldwide market leader for artificial joints for extremities, the company says it also provides surgeons with a broad array of options for reconstructive surgery for the shoulder, elbow, ankle, wrist and fingers. The company's hip and knee replacement products are managed separately.
BioniCare device can delay TKA surgery
BioniCare (Sparks, Maryland) reported on a new study indicating that its Model BIO-1000 System, a pulsed electrical stimulation technology, may enable postponement of total knee replacement (or total knee arthroplasty, TKA) for as much as four years for those with moderate to severe osteoarthritis (OA) this in addition to the device's already demonstrated capacity to reduce OA knee pain, an especially important benefit for patients unable to undergone TKA. Importantly, TKA is usually considered a procedure of last resort, can often come with misalignment and, for younger patients, frequently must be repeated 10 to 15 years later.
While the BIO-1000 would seemingly threaten the turf of surgeons doing TKA, Thomas Zizic, MD, president, chief executive officer and co-founder of BioniCare, told BBI that the patient benefit of the company's device, and word-of-mouth testimony of that benefit, is likely to bring the orthopedic surgeon additional patients and procedures. The orthopedist "may lose some surgeries," he said, "but the person helped by the Model BIO-1000 might refer five or six other people. The surgeon might end up doing three times as many surgeries by saving some patients [from TKA]."
The device is comprised of a soft Velcro wrap placed around the knee and a system for delivering electrical stimulus to the joint, working, according to BioniCare, to retard the degeneration of bone, cartilage and other connective tissue and support healthy movement of the joint. The study reported at AAOS involved 157 patients, 48 men and 109 women, ranging in age from 31 to 88, at 23 centers in the U.S. These patients were diagnosed with moderate-to-severe OA of the knee, aggravated by activity and relieved by rest, with most of the patients wearing the BIO-1000 from six to 10 hours daily. Data on these patients was compared to a control group of 101 patients who previously had a TKA on one knee and who reported moderate-to-severe pain in the other knee.
"In this study, 62% of severe OA patients deferred TKA for four years vs. 7% in the control group," said lead author Michael Mont, MD, director of the Center for Joint Preservation and Reconstruction of the Rubin Institute for Advanced Orthopedics at Sinai Hospital (Baltimore, Maryland). Additional data showed that at the end of one year, 85% of patients treated with the BIO-1000 System deferred total knee replacement surgery vs. 67% of untreated patients. At year two, 75% of treated patients deferred TKA surgery vs. 51% of those in the control group. And at the third year, 65% of study patients deferred surgery vs. 46% in the untreated group.
The device is FDA-cleared for reducing the level of pain and symptoms associated with OA of the knee and for overall improvement as assessed by a physician's global evaluation. And it is cleared for treatment of rheumatoid arthritis of the hand.
Zizic said that the company would seek added labeling for the deferring of TKA, supported by the new study. Additionally, he said that BioniCare is in a Phase III study using the BIO-1000 for treatment of OA of the hip and has plans for researching the treatment of the foot, ankle, elbow and shoulder, those studies likely to be launched next year. "We think we'll have one or two product launches per year for the next three or four years minimum," he said, adding that additional studies would examine the different "dosages" that the BIO-1000 can deliver, in terms of wearing the device for longer periods and altering the electrical frequencies.
The device can be used only by prescription and requires some expertise in placement, Zizic said. The BIO-1000 "has to be strapped on in precisely the right place with precisely the right electrodes." This is done with an applicator that determines the proper position on the knee, with voltage then adjusted to what he termed "sub-threshold levels."
At a price of $4,425, the device is not cheap. But it is significantly less costly than TKA, which Zizic said ranges to more than $30,000, on average. The therapy already is being covered by some carriers and managed care networks, he said, and the company is actively working with Medicare to acquire a new coverage code. Zizic said the response to the product at the AAOS gathering was "very significant," with another 50 centers indicating an interest in participating in clinical trials, joining 50 already involved in such studies.
ArthroCare plans spine surgery push
ArthroCare (Sunnyvale, California) rolled out a new business strategy one designed as expansion into the spinal surgery market at the AAOS conference. David Applegate, the new vice president and general manager of ArthroCare's spine division, said that the company has "until today almost exclusively focused on the interventional side of the spine market interventional spine physicians, interventional radiologists, anesthesiologists and physiatrists," via its Coblation technology, a low-temperature radio frequency system to gently and precisely dissolve rather than burn soft tissue, minimizing damage to healthy tissue.
ArthroCare now will expand into the broader surgical side of the spine market, Applegate told BBI, an initiative made possible through its recent purchase of Parallax Medical (Scotts Valley, California), a manufacturer of products for bone access, percutaneous injection of bone cement and bone augmentation in the spine. ArthroCare acquired Parallax for $28 million in cash and future milestone payments. The new product set includes the Parallax Spinal Fracture Reduction/Fixation Set for open spine surgeries: the Parallax Vertebral Compression Fracture Kit, enhanced to increase its adoption by spine surgeons; the Coblation-based Cavity SpineWand device, designed to dissolve tissue growths in the spine; and the next-generation Micro Discoblator device for performing the Coblation Assisted Microdiscectomy (CAM) surgical procedure. As some of the names indicate, these instruments are used in conjunction with Coblation.
Applegate said that the new rollouts enable a new "three-pronged strategy" for ArthroCare. First, Parallax technology in combination with the Cavity wand can be used for vertebralplasty, or the removal of soft tissue within the vertebral body, to create a space for injection of bone cement. Secondly, this system can be used to remove vertebral tumors the product of metastasis from other parts of the body that occur in about 10% of vertebralplasty patients. And third, the CAM system provides "a different way of doing a microdiscectomy, [which is] taking tissue out of the nucleus of the disc," Applegate said. That difference, he said, is avoidance of damage to the annulus, the sheath holding the nucleus in place. "You can enter into the nucleus through the annulus with a very small, 15-gauge needle and not affect the integrity of the annulus."
As described by James Rappaport, MD, assistant clinical professor of orthopedic surgery at the University of California, San Francisco, with CAM, "the Micro Discoblator enables precise removal of disc tissue with easier disc access, which may result in minimal nerve root retraction and less scarring. Its major advantage is avoiding the damaging annulotomy, which is associated with re-herniations and accelerated disc degeneration."
The new offerings in vertebralplasty will allow ArthroCare to compete with Kyphon (Sunnyvale, California), which Applegate said "dominates with spine surgeons today" in this procedure. He said that in terms of the removal of vertebral tumors and the CAM procedure for microdiscectomy, ArthroCare essentially is building ground-floor entry to applications with little or no competition. "These are going to be very exciting growth areas over the next two years."
Michael Baker, president and chief executive officer of ArthroCare, also emphasized the new opportunities that will grow from the AAOS product launches. "By offering a product suite designed specifically for spine surgeons and establishing a dedicated spine surgery distribution channel, ArthroCare is positioned to become a leader in spinal treatments across a full spectrum of procedures, from outpatient, interventional treatments to complex open fracture reduction and fixation surgeries."
ArthroCare also reported the availability of two new SpineWands using Coblation and designed for use in disc nucleoplasty for the treatment of contained herniated discs in obese and overweight patients and for tissue ablation in larger discs of the spine. According to the American Obesity Association (AOA; Washington), more than 60% of the U.S. population is overweight or obese, and many of these individuals often deterred from physical activity because of back pain caused by herniated discs become even more sedentary. ArthroCare said it designed the Perc-DXL SpineWand to meet the needs of the growing number of these patients requiring treatment for contained disc herniation by offering a longer needle to access their disc. The company also introduced the Perc-D X SpineWand, capable of removing more tissue than previously available devices. The Perc-D X can be used to treat patients with larger contained herniations who were previously not candidates for percutaneous disc decompression.
ArthroCare additionally reported expansion of its Sports Medicine product lines for knee and shoulder surgeries. It will market and distribute Biocomposites' (Staffordshire, England) BiLok ST screw for ACL reconstruction. This agreement is part of a previously announced partnership with Biocomposites, which manufactures devices for bone grafting and sports medicine. ArthroCare is the global distributor of the company's BiLok family of ACL products.
It also introduced the ParaLOK anchor for shoulder surgery, which will be available in 2Q04. It is designed for the 400,000 patients in the U.S. who each year undergo shoulder surgery for torn rotator cuffs or procedures to treat shoulder instability, including Bankart repairs.
S&N unit offers bright light minus heat
Smith & Nephew Orthopedics (Memphis, Tennessee) introduced what it termed "a unique and innovative solution for one of the key challenges in minimally invasive orthopedic surgery," the SOLIS Surgical Illuminator. Noting that as incision lengths used for total knee and total hip replacements are reduced in some cases by as much as 75% S&N said surgeons can have difficulty visualizing their work inside the patient. At just half an inch wide and one-10th of an inch thick, the SOLIS provides "a bright flood of light [that] produces virtually no heat around the light source," the company said. SOLIS provides a flexible, disposable fiber optic light that attaches to any retractor and can be inserted directly into the small incision used with S&N's minimally invasive instruments. Because it produces virtually no heat, it also can be hand-held in improvised situations.
"The new SOLIS Surgical Illuminator is the newest addition to the family of tools engineered for minimally invasive surgery," said Steve Hirsch, senior vice president and general manager of S&N Orthopaedics' Reconstructive division. "This new technology provides cool light, illuminating the entire cavity as if a fluorescent light were turned on inside the patient. It is substantially brighter and easier to use than other light sources, allowing surgeons increased visibility of anatomy and proper implant placement."
The SOLIS is made by Lumitex (Strongsville, Ohio), which engineers light into sensitive applications in the medical and electronics industries. The agreement with S&N is exclusive for orthopedic trauma and joint replacement applications.
Smith & Nephew Endoscopy (Andover, Massachusetts) reported the launch of a new camera system, including the industry's first progressive scan autoclavable camera for use in endoscopic surgery. The company said that the benefits of progressive scan technology over conventional camera systems include: improvement in fine detail resolution; elimination of flicker; and reduction in fast motion artifacts, resulting in a smoother image. The camera system consists of a range of autoclave and non-autoclave options and is configured to be compatible with the recently launched S&N 640 Image Management System.
ConMed/Linvatec roll out 14 new products
Conmed (Utica, New York) and its Linvatec subsidiary may have set some sort of record with14 new product launches at the AAOS gathering. Besides the multiple rollouts, ConMed also reported a strategic co-marketing relationship with eTrauma (Deerfield Beach, Florida), a developer and manufacturer of picture archiving and communications systems (PACS) and electronic medical records software. Through this partnership, ConMed Integrated Systems will extend its Digital SMART OR integrated operating room offering to include eTrauma's OrthoPACS digital communications product.
Included in the new product rollouts were a variety of new visualization and surgical systems:
ConMed's fourth-generation Autoclavable 3-Chip Camera (3CCD) Video System, an ergonomically designed camera head for improved comfort and functionality, Linvatec's ShockFlex Prism Mounting for durability and Progressive Scan technology for high-definition image quality.
New companion product releases, including a Xenon Light Source, VP1500-Release 2.0 and Video Cart.
The 10k Pump, a new addition to the company's line of fluid management products. The new pump, designed for use in arthroscopic joint distension as well as laparoscopic irrigation, combines user friendliness with high performance, Linvatec said.
Adding to its extensive line of Advantage Shaver Blades, Linvatec introduced the UltraCut Blade and the Curved Tiger Blade, new shaver blades offering specialized solutions for arthroscopic applications such as notchplasty, acromioplasty, menisectomy and chondroplasty.
New shoulder products included Herculine, a new high-strength suture providing, according to Linvatec, "superior fixation" for soft tissue repairs and offered initially in suture packs, soon to be integrated onto a number of Linvatec's suture anchors; a new Master Shoulder Instrument Set, which provides surgeons with a suture management system specifically for shoulder arthroscopy; and the new Impact Suture Anchor is a bioresorbable SR (self-reinforced) PLLA polymer anchor specifically targeted for instability repair in the shoulder, featuring a key-lock insertion technique usable for arthroscopic, mini-open and open-shoulder reconstruction.
New knee products included the Matryx Femoral Screw, an SR biocomposite interference screw for ACL fixation; the SmartNail 2.4 mm, a SR bioresorbable nail used for cartilage repair, coupled with an expanded Arthroscopic instrumentation system.
Powered instruments included the PowerPro Pneumatic System, the latest addition to the company's PowerPro product line, enabling it to offer the PowerPro System in all power source options: pneumatic, battery and electric. Comprised of three new handpieces specifically designed to be small and lightweight for small-bone orthopedics (hand and foot), trauma, arthroscopy (ACL reconstruction), and maxillofacial surgery, yet powerful enough for large-bone orthopedics (hips and knees).
ConMed said the new partnership with eTrauma enhances the value of its Digital SMART OR integrated operating room offering. eTrauma's OrthoPACS product provides digital communications and storage of pre-operative, intra-operative and post-operative images, including: X-ray, computed tomography, magnetic resonance imaging and endoscopic, which document medical conditions and surgical procedures.
In other product introduction at AAOS:
Ortho Biotech Products (Bridgewater, New Jersey) officially rolled out Orthovisc (High Molecular Weight Hyaluronan), a new treatment for patients suffering from pain due to osteoarthritis (OA) of the knee. Approved by the FDA in February, Orthovisc will be available to patients through physicians' offices. It is an injectable form of ultra-pure hyaluronic acid that can be given in a series of three weekly injections into the knee joint. The hyaluronan used in Orthovisc is similar to healthy human synovial fluid, a substance that lubricates the knee joint, according to Ortho. In one clinical trial, the prescribed three-injection regimen of Orthovisc demonstrated effectiveness in reducing pain by 58%, compared to 40% for patients receiving saline injections.
According to data from the First National Health and Nutrition Examination Survey, OA of the knee affects as many as 50% of those aged 45 to 74 in the U.S. Ortho Biotech licensed the U.S. rights to Orthovisc from Anika Therapeutics (Woburn, Massachusetts) last December.
dj Orthopedics (Vista, California), specializing in rehabilitation and regeneration products for the non-operative orthopedic and spine markets, highlighted several new products for orthopedic rehabilitation. The featured products included the DonJoy Defiance III Custom rigid knee brace with a "swooping" medial thigh cuff for improved comfort and to prevent brace-to-brace contact during bilateral brace use by athletes; the new DonJoy Custom Montana(2) OA and OA Everyday braces for treating moderate-to-severe osteoarthritis of the knee; a new line of MaxTrax walker boots, a cost-effective alternative to traditional casting; and an expanded line-up of pain management products, including the new DonJoy Pain Control Device, a portable, disposable pump for dispensing local anesthetic directly into a surgical site over an extended period of time. Also showcased were regeneration products from the company's recently acquired Regentek division, including the OL1000 and SpinaLogic, which are used to stimulate bone growth in non-union fractures and spinal fusion surgery.
Exactech (Gainesville, Florida) reported that it is adding asymmetric femoral components to its Optetrak orthopedic knee system. The company said a high flexion asymmetrical system would also be introduced by mid-year. The new asymmetrical components will be available in both cruciate retaining and posterior stabilized designs as in the original Optetrak knee system. Bill Petty, MD, chairman and chief executive officer, said, "Since we launched the Optetrak knee system, it has been one of the fastest-growing orthopedic knee replacement systems in the industry. We have gained market share by producing a 20% compounded average growth rate in knee sales over the last five years."
HydroCision (Andover, Massachusetts), a provider of hydrosurgery devices, released two new handpieces as part of its SpineJet Hydrosurgery System the SpineJet Curette and the SpineJet Resector XT. The two products broaden the scope of HydroCision's product applications directed toward enabling the spine surgeon to perform fusion procedures more effectively.
The SpineJet Curette combines the mechanical advantage of a serrated edge tip with the tissue evacuation capabilities of a fluidjet. The spine surgeon can simultaneously remove soft tissue, such as disc nucleus, and scrape vertebral endplates quickly and without the repeated instrument passes near vital structures such as nerves and vessels. The SpineJet Resector XT provides access to hard-to-reach areas of the disc space, allowing the spine surgeon the opportunity to remove more of the disc nucleus in fusion procedures.