FDA Clears Two New Clavicle Repair Technologies

The FDA has granted 510(k) clearance for two products designed to aid in the repair of the shoulder made by Arnold, Maryland-based Suspension Orthopaedic Solutions, Inc. One product is the Distal Clavicle Fracture Fixation System and the second is the Mid-Shaft Clavicle Plate.

The two devices, made of stainless steel, “can be used in combination for the repair of distal-clavicle fractures,” company CEO Robert S. Collins told OTW. “These two new FDA clearances will expand the availability of our confidence-inspiring solutions for orthopaedic surgeons who treat difficult shoulder injuries, and reflect Suspension’s core mission of bringing meaningful innovation to challenging orthopaedic injuries.”

The Distal Clavicle Fracture Fixation System features Suspension’s patent-pending T-Loc Technology which enables knotless, protected and precisely controlled tension for secure fixation of multiple soft-tissue injuries.

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Tabby Cat Gets Knee Replacement

It is not just humans who are getting knee replacements. A ten-year-old tabby cat named Cyrano, in a medical first, received a new knee last week. Veterinary doctors believe this to be the first feline total knee replacement performed in the U.S.

Doctors from Texas and Washington D.C. were present in the operating theater to assist the three orthopedic surgeons from the North Carolina State University College (NCSU) of Veterinary Medicine in the six hour surgery. The implant, designed and fabricated by an international team of collaborators, was made from dense plastic and a cobalt chromium alloy, using a laser process that hardens metal powder to replicate bones.

"The surgery was kind of a bit difficult, but it went very smoothly," said Dr. Denis Marcellin-Little of NCSU, who led the surgical team, in the January 28 news release.

The cat had previously been treated successfully for bone cancer. But the treatment had left the animal with a painfully damaged knee. The cat’s owner, Sandy Lerner of Upperville, Virginia, sought the knee replacement in an effort to avoid having to amputate the cat's rear left leg. In 2005, Marcellin-Little had performed the world's first surgery to fuse leg implants with a cat's bone tissue, so Cyrano's owner turned to him for help.

Marcellin-Little said the 20-pound tabby's big bones were a plus. "He's already able to stand," he said. "His foot is in the right place, and he can put his foot on the ground. So far, so good. Now we have to be very patient with letting his tissues reattach, and it has to heal slowly."

DePuy Announces Several Advancements In Orthopedic Treatment

DePuy Orthopaedics, Inc. (DePuy) announced the launch of several new advancements in orthopaedics spanning joint replacement, shoulder reconstruction and hip revision surgery, each designed to optimize or streamline procedures, personalize care and provide clinical and economic value.

The announcement was made here at the 79th Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS).

New treatment options include AOX Antioxidant Polyethylene, RECLAIM Modular Revision Hip System, GRIPTION TF Acetabular Augment System, GLOBAL UNITE Platform Shoulder Arthroplasty System and GLOBAL STEPTECH Anchor Peg Glenoid (APG). DePuy is also introducing the latest generation of TRUMATCH Personalized Solutions technology for use with its SIGMA Fixed-Bearing Knee System, one of the most widely used knee systems in the world.

'Our ever expanding portfolio enables us to offer solutions to most of the orthopaedic challenges a surgeon or patient may face,' said Andrew Ekdahl, President, DePuy Orthopaedics. 'Our goal is to provide surgeons and health care institutions with more choices that help fill clinical needs, streamline procedures and personalize treatment. We believe that products that focus on these areas will help enhance care while reducing health care costs.'

Last year, DePuy received several FDA product approvals and clearances, including premarket approval (PMA) for AOX Polyethylene, an antioxidant polyethylene designed for optimal wear resistance and long-term oxidative stability, and the PINNACLE COMPLETE Acetabular Hip System, the industry's first and only ceramic-on-metal hip bearing approved for sale in the United States.

The PINNACLE Cup System, which has more than 10 years of documented clinical success and has been provided for more than one million patients, is the only acetabular cup system on the market with PMA approvals for both ceramic-on-ceramic and ceramic-on-metal bearing options. The PINNACLE Ceramax Ceramic Total Hip System, featuring a new generation of ceramic material, received its PMA approval in 2010. The all ceramic implant is the only device in the U.S. with BIOLOX delta, the fourth generation of BIOLOX ceramic. Its three previous versions have been used in millions of implants throughout the world.[i] The PINNACLE System is now the only acetabular cup system with five bearing options, providing surgeons with a full range of options to meet the clinical needs of their patients.

AAOS 2012 Launches

AOX Polyethylene

Approved for use with the SIGMA Rotating Platform Knee System and LCS COMPLETE Mobile Bearing Knee System, the new AOX Polyethylene delivers an advanced blend of polyethylene resin and a unique antioxidant, COVERNOX, to create a new polyethylene material that is highly efficient in trapping free radicals and scavenging oxygen. By eliminating the annealing or remelting process, AOX Polyethylene delivers oxidative stability and optimum wear resistance without compromising the mechanical properties or strength of the polyethylene.[ii], [iii], [iv] By introducing COVERNOX Antioxidant into the base resin before the polyethylene is consolidated, the process enables the antioxidant to be uniformly dispersed and remain blended, eliminating the risk of outward migration.

Hip Revision Solutions

The RECLAIM Modular Revision Hip System is engineered to deliver a high level of implant strength. This system has been studied extensively through analytic techniques and rigorous laboratory testing and has demonstrated promising capabilities, particularly with respect to construct fatigue strength and torsional stability. The modular design of the RECLAIM Revision Hip System features novel instrument technology that may improve intraoperative handling, flexibility and efficiency. The modularity of the system offers surgeons numerous options to treat a patient's unique pathology while simplifying the instrumentation required in surgery.

DePuy's GRIPTION TF Acetabular Augment System addresses bone defects in moderate to complex acetabular revision surgery using a highly porous structure made from commercially pure titanium; a strong, corrosion-resistant metal that has high surface roughness and a similar elasticity to bone. The GRIPTION TF System offers a wide range of options and configurations for the patient at the time of surgery and is designed to work in conjunction with the full range of PINNACLE Acetabular Cup options.

Procedural Efficiency in Knee Replacement

TRUMATCH Personalized Solutions 2.5i provides enhanced capabilities that aid implant positioning and procedural efficiency. TRUMATCH, which reduces procedure time by up to 35 minutes, [v] is the first system to utilize CT scans and computer software to guide the development and production of femoral and tibial cutting blocks that are individually prepared to match the actual bone surfaces of each patient. The use of CT scans, rather than MRIs, results in improved bone imaging, less scanning time and lower costs. [vi]

Advanced Shoulder Solutions

DePuy is launching two new shoulder solutions. The GLOBAL UNITE Platform System, which treats fractures of the proximal humerus, helps improve tuberosity healing and is the only system that can later be easily converted to a reverse shoulder arthroplasty for treatment of arthritis with a torn rotator cuff. The GLOBAL STEPTECH APG System, has been designed to correct excessive retroversion caused by posterior glenoid bone loss, closely recreate the original glenohumeral joint line, and minimize the removal of healthy bone. The prosthesis incorporates a proprietary step design with an anterior backside surface that is spherical and a posterior backside surface that is conical. This unique dual surface design effectively counteracts posterior loading.

Important Safety Information

The performance of joint reconstruction and replacement products depends on a patient's age, weight, activity level and other factors. There are potential risks, and recovery takes time. People with conditions limiting rehabilitation should not have these surgeries. Patients should consult with an orthopaedic surgeon to determine if joint reconstruction and replacement surgery is appropriate for them.

About DePuy Orthopaedics

DePuy Orthopaedics, Inc., a Johnson & Johnson company, is a leading global provider of orthopaedic devices for hip, knee, trauma and extremities, as well as bone cement and operating room products. It is part of the DePuy Family of Companies, which has a rich heritage of pioneering a broad range of products and solutions across the continuum of orthopaedic and neurological care. These companies are unified under one vision - Never Stop Moving - to express their commitment to bring meaningful innovation, shared knowledge and quality care to patients throughout the world. Visit www.depuy.com for more information.

i] CeramTec. 'BIOLOX delta - Nanocomposite for Arthroplasty: The Fourth Generation of Ceramics.' p. 4.

[ii] Data on File at DePuy Orthopaedics, Inc. WR070300.

[iii] Data on File at DePuy Orthopaedics, Inc. WR070248.

[iv] Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants. ASTM Designation: F648-00

[v] Data on file at DePuy. Operating room time includes preparation, operating room, and turnover time.

[vi] D. White, K. L. Chelule, B. B. Seedhom. Accuracy of MRI vs CT imaging with particular reference to patient specific templates for total knee replacement surgery. Int J Med Robotics Comput Assist Surg 2008; 4: 224-231.

Stryker Hip Suit Isn't Completely Preempted, 5th Circuit Rules

Federal law regulating medical devices doesn't completely preempt the claims of a plaintiff who alleged that a hip replacement product malfunctioned and caused him injury, the 5th Circuit has ruled.

The plaintiff underwent surgery involving the implantation of a Trident hip replacement system in his left hip. The Trident system is manufactured by Stryker Corp. The plaintiff later experienced loosening in the joint which required a surgical revision of his hip replacement.

The plaintiff filed a product liability suit, alleging that contamination of the shell of the Stryker device during the manufacturing process prevented bonding with his bone.

Stryker argued that the plaintiff's state-law claims were completely preempted by the Medical Device Amendments to the Food, Drug, and Cosmetics Act.

The court agreed that the plaintiff's breach of express warranty claims were completely preempted, as well as his claims for strict liability, design defect and negligence insofar as they were premised on failure to warn or a marketing defect.

However, the court concluded that there was no preemption of the plaintiff's strict liability and negligence claims to the extent they were based on manufacturing defects arising from a violation of Stryker's manufacturing practices or those approved by the U.S. Food and Drug Administration.

The court concluded that those claims were "parallel claims" permitted under Riegel v. Medtronic (552 U.S. 312). (See "State law claims over medical devices are preempted," Lawyers USA, March 10, 2008.)

"We ... hold that if a plaintiff pleads that a manufacturer of a Class III medical device failed to comply with either the specific processes and procedures that were approved by the FDA or the [FDA's Current Good Manufacturing Practices] themselves and that this failure caused the injury, the plaintiff will have pleaded a parallel claim," the court said.

The court similarly concluded that there was no preemption of the plaintiff's claims for breach of implied warranty.

Total Knee Replacement Can Be Deferred Using Biologic and Bionic Meniscus Replacement Procedures, Data Show

At American Academy of Orthopedic Surgeons in San Francisco, a group of renowned orthopedic surgeons from around the world gathered to discuss the latest findings for meniscus transplantations. New data on knee joint cartilage and meniscus transplantation presented at the 27th annual Meniscus Transplantation Study Group revealed that the meniscus tissue can be successfully replaced by tissue replacements such as cadaveric allografts, using artificial materials such as polyurethane scaffolds, and using polycarbonate-urethane implants. These advances bode well for all those who have developed knee pain or arthritis and want to avoid a total knee replacement.

The meniscus cartilage is the key shock absorber in the knee joint, and when injured, it is often removed. Loss of this critical structure often leads to joint pain and arthritis. Of the 1.4 million knee surgeries occurring in the United States each year, 98% of them result in the removal of meniscus tissue.

Eight investigators from five different countries presented on the science of meniscus replacement. From the United States, Kevin R. Stone, MD of the Meniscus Transplant Center at The Stone Clinic in San Francisco presented the largest and longest study of meniscus transplantation. The study spanned 16 years of data with approximately 80% success at improving patient pain and function in both pristine and arthritic knees. Many patients were able to return to a wide range of sporting activities after undergoing meniscus transplantation.

Mathew T. Provencher, MD, MC, USN of the US Navy presented data on the biomechanical changes in the knee for soldiers with a new meniscus and an osteotomy realignment procedure. The soldiers' pain was diminished and some were able to return to active duty.

Peter Verdonk, MD of Belgium unveiled a novel artificial meniscus implant made from polycarbonate-urethane. The implant is meant for patients who have a missing meniscus and knee pain, but whose knees are otherwise healthy. The data is preliminary but represents a new bionic approach to cartilage replacement. Dr. Verdonk also described the successes and failures of an artificial scaffold designed to regrow tissue called Actifit. The complication rate is still too high at 20%, but improvements are planned.

The global nature of cartilage loss and arthritis is being addressed and today offers young and old patient solutions that can be performed without removing bone or opening the joint, and permits return to sports.

SOURCE Meniscus Transplant Center

Smith & Nephew plc Announces Result Of New Study For BIRMINGHAM HIP Resurfacing (BHR) System

Smith & Nephew (NYSE:SNN; LSE:SN), the global medical technology business, today announced the results of a new study for its BIRMINGHAM HIPT Resurfacing (BHR) System. The study, carried out at the request of the FDA, followed the progress of the first 400 BHR patients in the United Kingdom and found that after 10 years, 99% were either satisfied or extremely satisfied with their BHR procedure.

"These results further exemplify why the BHR Hip is unlike any other metal-on-metal implant," says John Soto, Senior Vice President for Smith & Nephew's Global Hip Franchise. "Not only does the BHR Hip offer all the advantages of hip resurfacing, including bone-conservation, greater range of motion and decreased risk of dislocation, but it does so while maintaining implant survivorship rates that are on par with, or in some patient populations even better
than, traditional total hip replacement which has long been considered the most successful orthopaedic surgical procedure for relieving chronic pain."

POLARCUP™ Dual Mobility Hip System From Smith & Nephew Now Available in US

Smith & Nephew (NYSE: SNN; LSE: SN), the global medical technology business, is introducing the clinically proven POLARCUP™ Dual Mobility Hip System to orthopaedic surgeons in the US at this year's American Academy of Orthopaedic Surgeons (AAOS) annual meeting in San Francisco. The system is specifically designed to address the challenges of treating patients – in both primary and revision cases – who are susceptible to dislocation and need enhanced stability.

Backed by 10 years of clinical history in Europe and other markets outside the US, the POLARCUP System allows surgeons to implant a smaller, constrained femoral component within a larger, anatomically sized polyethylene head, thus providing greater stability by increasing range of motion and jump distance. "This stability philosophy is widely used in the European market where surgeons have extensive experience with dual mobility in elderly and less active patients," says John Soto, Senior Vice President for Smith & Nephew's Global Hip Franchise.

Anterolateral Approach for Tibial Pilon Fractures

Abstract

The anterolateral approach to the tibia has been popularized for management of tibial pilon fractures. This approach offers the benefit of improved soft tissue coverage and the potential for a lower rate of wound-healing complications by avoiding incision placement over the subcutaneous border of the tibia. Although the fracture pattern dictates specific plate use, antomically designed anterolateral plates are useful for fixation of common fracture patterns. Additional exposures may be required to address other areas of the fracture, such as the medial malleolus, which cannot be accessed through this approach.

Dr Hak is from the Department of Orthopedic Surgery, Denver Health/University of Colorado, Denver, Colorado.

Dr Hak has no relevant financial relationships to disclose.

Correspondence should be addressed to: David J. Hak, MD, MBA, Department of Orthopedic Surgery, Denver Health/University of Colorado, 777 Bannock St, MC 0188, Denver, CO 80204 (David.Hak@dhha.org).

Locking Plate Fixation for Proximal Humerus Fractures

Abstract

Locking plates are increasingly used to surgically treat proximal humerus fractures. Knowledge of the bone quality of the proximal humerus is important. Studies have shown the medial and dorsal aspects of the proximal humeral head to have the highest bone strength, and this should be exploited by fixation techniques, particularly in elderly patients with osteoporosis. The goals of surgery for proximal humeral fractures should involve minimal soft tissue dissection and achieve anatomic reduction of the head complex with sufficient stability to allow for early shoulder mobilization. This article reviews various treatment options, in particular locking plate fixation.

Locking plate fixation is associated with a high complication rate, such as avascular necrosis (7.9%), screw cutout (11.6%), and revision surgery (13.7%). These complications are frequently due to the varus deformation of the humeral head. Strategic screw placement in the humeral head would minimize the possibility of loss of fracture reduction and potential hardware complications.

Locking plate fixation is a good surgical option for the management of proximal humerus fractures. Complications can be avoided by using better bone stock and by careful screw placement in the humeral head.

Repair of Medial Collateral Ligament Injury During Total Knee Arthoplasty

Abstract

Intraoperative midsubstance lacerations of the medial collateral ligament (MCL) must be addressed during surgery, and failure to obtain coronal plane stability could affect patient outcomes and satisfaction. This article reports our results of a series of patients who sustained an intraoperative MCL injury during a primary total knee arthroplasty and were treated by direct primary repair and no change in implant constraint or postoperative protocol.

Over a 5-year period, 9 patients sustained this complication. We reviewed their subjective satisfaction and stability, as well as objective measures such as functional scores, physical examinations, and radiographs. Average patient age was 58 years, and mean patient body mass index was 43.3. All patients were satisfied with the procedure and demonstrated no instability on physical examination. Average Knee Society pain score was 91.5 and functional score was 73.3. No radiographic changes or signs of loosening were noted. This novel approach for intraoperative midsubstance lacerations of the MCL does not involve altering implants or postoperative protocols and has encouraging results.