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News in Brief - July 2008
Brief items of the latest industry news...

Readers Comments
Unedited readers comments about Orthopaedic Product News ...

Dissolvable Glass May Help Natural Bone Regrowth - July 2008
Scientists are developing a new type of glass that can...

Titanium Implant Coating Aids Bone Growth And Tissue Repair - July 2008
Research has shown that coating a titanium implant with a new biologically...

No Link Between Joint Surgery And Dentistry - July 2008
Research shows that there is “no evidence to link prosthetic joint...

Aspirin Helps In Prevention of Osteoporosis - July 2008
Aspirin can help in the fight against osteoporosis, according to...

Nanoparticles ‘Grow Denser Bone’ - Study - July 2008
Scientists have shown they can grow denser bone tissue by sprinkling...

Heel Ultrasound May Help To Predict Osteoporosis Risk - July 2008
A heel ultrasound may be able to predict if a woman is at heightened...

Cartilage Study Aids Natural Regeneration - July 2008
A nanotechnology specialist has found a way to regenerate cartilage naturally by...

Agfa Incorporate Orthoview™ Into IMPAX™ System - July 2008
Agfa HealthCare and Meridian Technique have signed an agreement to integrate...

Alphatec Spine Enjoy Europe Launch - July 2008
A U.S. jury has found Arthrex guilty of infringing...

OrthoRehab Gets Rebrand - July 2008
Otto Bock Healthcare is discontinuing use of the OrthoRehab name...

News In Brief
The Arthritis Society is offering a free book, All About Arthritis plus a free natural supplement based on the latest science detailed in the book by nutritionist Ben Ong.

The Society guarantees that both the information in the book and the supplement, ‘Arthritis Comfort’ works, recommending using the information in the book and the supplement for three months. The Society will offer a full refund for the supplements if there is no improvement.

The book explains in detail in an easy-to-understand way what to eat, what not eat and why. It explains why some food categories encourage inflammation and why others heal inflammation, and also uses the research to illustrate and explain why organic produce is nutritionally richer.

Ben Ong also examines the prescription drugs usually prescribed for Arthritis and details their effects, how they work, and their side-effects. He also details the research into a range of nutrients, including Glucosamine, which he says are more effective at dealing with the underlying disease - not just the symptoms - and are safer.

The book can be received by calling 0800 077 6369 or email contact@yoag.com.

NHS Supply Chain’s diagnostic imaging contract has brought benefits to the NHS in four months.

In some cases medical imaging and radiology procurement times have been reduced by up to 75%, and delivered savings of up to 12% because of the contract between DHL and the Department of Health.

The medical imaging team at NHS Supply Chain enables Trusts to buy a broad range of equipment, at competitive rates and faster than has previously been available.

The NHS spends over £360m per annum on imaging equipment and NHS Supply Chain’s strategy is to create an effective procurement framework for this.

So far, over 150 individual Official Journal of European Union (OJEU) adverts have been avoided, simplifying an otherwise lengthy and complicated procedure, taking each trust up to nine months to complete. Around £45m of imaging and diagnostic equipment has been purchased in four months for trusts, comprising 400 individual pieces of equipment, from MRI and CT scanners to X-Ray machines.

Alan Kaye, Radiology Services Manager at Chelsea and Westminster Hospital Foundation Trust, said: “By spending less time on the procurement process we can provide patients with access to modern medical equipment much quicker. We were pleasantly surprised at the speed of the process and the advice on offer – we wouldn’t now return to the previous way of doing things.”

Just 18 months into its 10 year contract, NHS Supply Chain is on its way to fulfilling its commitment to saving the NHS £1bn, having saved £9m in the first year alone.

A controversial website has been set up to let patients rate every doctor who has treated them.

www.iwantgreatcare.org has been set up by Dr Neil Bacon, who created doctors.net.uk. He said that letting patients review medics will bring about higher standards. Patients have to answer three questions: ‘Do you trust them?’, ‘Did they listen to you?’ and ‘Would you recommend them?’, and can also post a review of the doctor, which will not be censored.

Dr Richard Vautrey of the BMA’s GPs committee, said: “There’s a significant possibility of it being used in a malicious way, leading to doctors finding themselves under incredible stress and worry, and leaving them open to potential abuse from individuals with a vendetta. It would be of great concern if any doctor was put in jeopardy through a malicious campaign, maybe through viral email, to attack or undermine a doctor at a hospital or GP’s practice, which could easily happen.”

But consultant orthopaedic surgeon, Chris Bulstrode, said: ‘This website is a great idea and will put the cat among the pigeons with the medical profession, which is just what’s needed. Doctors will feel threatened, and rightly, as one or two will find their trousers round their ankles.”

New research out of the University of Delaware (UD) indicates that patients who have undergone TKA need to re-learn the proper techniques of moving from a sitting to standing position.

“Because most patients with knee replacement have lived with debilitating pain for years, they work around the pain by adopting different strategies to avoid using their weakened quadriceps femoris muscle (muscle in front of the thigh) when going from a sit-to-a-stand position,” says Lynn Snyder-Mackler, at UD’s Department of Physical Therapy and a certified sports physical therapist and athletic trainer who was one of the study investigators.

The study evaluated 12 patients three months and one year following TKR, showing that the patients relied on a larger hip extensor movement to perform the sit-to-stand task. “What is interesting about the study is that it shows that, even following surgery, this strategy continued as patients’ muscle strength improved.”

The strategy, although dangerous because of the risk of falling, had become second-nature to them, said Snyder-Mackler. “Simply put, it was a learned movement pattern that could not be resolved without retraining by a physical therapist, usually beginning 4-6 weeks after surgery when weight can be put equally on both legs,” she said.

Data released at the 9th Annual Congress of EFORT showed that the oral, once-daily, anticoagulant rivaroxaban (Xarelto®) is more effective in preventing blood clots following TKR than twice-daily injectable enoxaparin, (the standard treatment regimen in the U.S.), whilst maintaining low major bleeding rates.

The RECORD4 study (REgulation of Coagulation in major Orthopaedic surgery reducing the Risk of DVT and PE) has shown that rivaroxaban provided TKR surgery patients with a statistically significant reduction of total venous thromboembolism (VTE) event rates over twice daily injectable enoxaparin, corresponding to a 31% relative risk reduction (RRR) over enoxaparin. The rate of major bleeding in the rivaroxaban-treated patients was low and not statistically different to the rate of major bleeding in the enoxaparin-treated patients.

“The superior efficacy and similar adverse event profile of rivaroxaban demonstrated in RECORD4 are in line with the outstanding results of the earlier RECORD studies,” said Dr. A.G.G. Turpie, Professor of Medicine, McMaster University, Canada and Principal Investigator for the RECORD program.

“The success of this trial strengthens my belief that direct Factor Xa inhibition with rivaroxaban has the potential to revolutionise the way we prevent the formation of dangerous blood clots.”

Dissolvable Glass May Help Natural Bone Regrowth

Scientists are developing a new type of glass that can dissolve and release calcium into the body, with the possibility of enabling patients to regrow bones.

The porous glass, originally developed at Imperial College, London is capable of acting as an active template for new bone growth, dissolving in the body without leaving any trace of itself or any toxic chemicals. As it dissolves, it releases calcium and other elements such as silicon into the adjacent body fluids, stimulating bone growth.

Microscopic image of bone cells grown on bioactive glass after two weeks of activity. Credit: Imperial College
Partners at the Universities of Kent and Warwick have been carrying out experiments at the Science and Technology Facilities Council’s ISIS neutron source. Research shows exactly how the calcium is held in the glass and then released into the body. Professor Bob Newport at the University of Kent explains that it was when the material was studied at ISIS that the process became clear.

“Using ISIS to study the relationship between these atoms and the host silicate glass via techniques unique to neutron diffraction has enabled us to move forward with the programme. The key outcome of our experiments has been a full understanding, at the level of atomic arrangements, of why it is that calcium is able so easily to leave the glass at the rate required to generate the desired response.”

By comparing samples made with natural calcium and with a calcium isotope it was possible for the first time to isolate the complex and subtle contribution of the calcium from that of all the other atoms present.

Further research is planned at the ISIS Second Target Station when it opens later this year. This will investigate glass/polymer hybrids and could be instrumental in developing mechanically stronger versions of the glass that would be load bearing and available for medical use in the context of joint replacement. If the extensive research goes as expected, clinical trials could be in place in the next five years.
Titanium Implant Coating Aids Bone Growth And Tissue Repair

Research has shown that coating a titanium implant with a new biologically inspired material enhances tissue healing, improves bone growth around the implant and strengthens the attachment and integration of the implant to the bone.

“We designed a coating that specifically communicates with cells and we’re telling the cells to grow bone around the implant,” said Andrés García, professor Georgia Institute of Technology (right).

In collaboration with professor David Collard, García coated the titanium with a thin, dense polymer. “Our coating consists of a high density of polymer strands, akin to the bristles on a toothbrush, that we can then modify to present our bio-inspired, bioactive protein,” said García.

The polymer had controlled amounts of an engineered protein that mimics fibronectin, a protein in the body that acts as a binding site for integrins. The binding to the titanium implant provides signals that direct bone formation, so controlling integrin binding to the titanium will result in targeted signals that enhance bone formation around the implant.

“It has been common to mimic only very small sections of fibronectin, but when you take a small section and ignore the rest of the molecule you lose specificity and activity, and therefore signaling is impaired,” said García.

So he engineered a much longer region of the same type of fibronectin as well as new sections also known to have sites that participate in integrin binding.

Analysis revealed extensive and contiguous bone matrix and a 70% enhancement in the amount of contact between the implant and bone with the titanium implants coated with the engineered fibronectin fragment.

García tested the fixation of the implants by measuring the amount of force required to pull the implants out of the bone. The study showed significantly higher mechanical fixation of the implants coated with the fibronectin fragment.
No Link Between Joint Surgery And Dentistry

Research shows that there is “no evidence to link prosthetic joint infections to dental procedures” and that the money currently being spent on preventative antibiotics would be better spent on “high-quality dental care”.

The JBJS published the research that, for the first time, proves there is no evidence of a link between infections in joint replacements and dental infections. This shows that the use of preventative antibiotic prophylaxis is unnecessary for dental patients who have had joint replacement surgery.

The annotation conducted a thorough review of relevant literature published in English, German and French from the PubMed database and concluded that “prophylactic antibiotics are not required before a dental intervention in patients with artificial joints”. The Editorial published alongside the paper sets out what change in medical policy is needed:

“The continued use of antibiotics would be expensive, contribute to an increase in antibacterial resistance, lead to increased morbidity as a result of adverse side-effects…and increase the risk of death. It is clear that better oral hygiene is the answer rather than the administration of antibiotics.”
Aspirin Helps In Prevention of Osteoporosis

Aspirin can help in the fight against osteoporosis, according to U.S. Researchers.

The study, at the University of Southern California, School of Dentistry, showed that an aspirin regimen appears to help mice recover from osteoporosis in two ways, striking a balance between bone formation and resorption, according to Professor Songtao Shi and Research Associate Takayoshi Yamaza.

According to Shi, the removal of the ovaries and the resulting decrease in estrogen induces osteoporosis in mice, much like the onset of the disease in post-menopausal women. It is commonly thought that T-lymphocytes, a type of immune system cell, play a pivotal part in this process by over-activating osteoclasts, which reabsorb bone material from the skeleton.

However, there seems to be another side to ‘T-cells’, in osteoporosis, Yamaza says. While the immune cells typically attack disease cells and other foreign entities, the T-cells can mistakenly attack healthy stem cells.

“After infusing the mice with T-cells, the T-cells impaired the function of bone marrow mesenchymal stem cells as well as caused osteoclast numbers to increase,” he said.

The bone marrow mesenchymal stem cells (BMMSC), differentiate to become many different cells including osteoblasts. If this process is impaired by T-cells, bone formation cannot keep up with bone resorption caused by osteoclasts, and bone mineral density decreases.

Aspirin has been linked in earlier epidemiological studies to better bone mineral density, but the mechanisms of its interactions in regards to bone health had not yet been studied extensively, Shi said. “We’ve shown how aspirin both inhibits bone resorption and promotes osteoblast formation.”

The dose administered to the mice in order to increase their bone mineral density is the same as that of a typical human aspirin regimen when adjusted for body weight differences, he added. While the species difference is still a factor, the results are promising.

“When we gave a large amount of aspirin to the mouse by injection, it did not work,” Shi says, “but when we gave a low dose in the mice’s water for a long period of time, similar to a human dosage, the bone mineral density increased.”

Shi and Yamaza hope that their work will translate into new clinical strategies for osteoporosis.

“We have opened a door,” Shi said. “We hope other scientists can confirm what we’ve found and move the treatment forward.”

The use of aspirin offers hope to patients and doctors searching for a potential alternative to bisphophonates currently being used as a means of prevention and treatment for osteoporosis. This latest study opens up the possibility that aspirin some day will not only be prescribed to ward off heart disease but also osteoporosis.
Nanoparticles ‘Grow Denser Bone’ - Study

Scientists have shown they can grow denser bone tissue by sprinkling stick-like nanoparticles throughout the porous material used to pattern the bone.

“Ideally, a scaffold should be highly porous, nontoxic and biodegradable, yet strong enough to bear the structural load of the bone that will eventually replace it,” said lead researcher Antonios Mikos from Rice University, U.S., who were partaking in the study with Radboud University in Nijmegen, the Netherlands,

“Previous research has shown that carbon nanotubes give added strength to polymer scaffolds, but this is the first study to examine the performance of these materials in an animal model.”

In the experiments, the researchers implanted two kinds of scaffolds into rabbits. One was poly(propylene fumarate, PPF), which has performed well in previous experiments. The second was made of 99.5% PPF and 0.5% single-walled carbon nanotubes, which are about 80,000th the width of a hair. While they are normally about a thousand times longer than they are wide, the researchers used shorter segments that fared well in prior cytocompatibility studies.

Half the samples were examined four weeks after implantation and half after 12 weeks. While there was no notable difference at four weeks, the nanotube composites exhibited up to threefold greater bone ingrowth after 12 weeks than the PPF. The researchers also found the composite scaffolds contained about two-thirds as much bone tissue as the nearby native bone tissue, while the PPF contained only about one-fifth as much.

Mikos said the nanocomposites performed better than anticipated and the results show that it may go beyond passive guides to take an active role in promoting bone growth.
Heel Ultrasound May Help To Predict Osteoporosis Risk

A heel ultrasound may be able to predict if a woman is at heightened risk for fractures due to osteoporosis, according to a new study.

Along with certain risk factors, radiation-free ultrasound of the heel may be used to better select women who need further bone density testing, such as a dual-energy x-ray absorptiometry (DXA) exam. “Osteoporosis is a major public health issue expected to increase in association with worldwide aging of the population,” said the study’s lead author Idris Guessous, at Lausanne University Hospital in Switzerland.

“The incidence of osteoporosis will outpace economic resources, and the development of strategies to better identify women who need to be tested is crucial.” Patients with osteoporosis are not optimally treated because of a lack of general awareness,” Dr. Guessous said.

“A simple prediction rule might be a useful clinical tool for healthcare providers to optimize osteoporosis screening.”

In the three-year multicenter study, 6,174 women age 70 to 85 with no previous formal diagnosis of osteoporosis were screened with heel-bone quantitative ultrasound (QUS), a diagnostic test used to assess bone density. QUS was used to calculate the stiffness index, which is an indicator of bone strength, at the heel. Researchers added in risk factors such as age, history of fractures or a recent fall to the results of the heel-bone ultrasound to develop a predictive rule to estimate the risk of fractures. The results showed that 1,464 women (23.7%) were considered lower risk and 4,710 (76.3%) were considered higher risk.

Participants were mailed questionnaires every six months for up to 32 months to record changes in medical conditions, including illness, changes in medications or any fracture. If a fracture had occurred, the patients were asked to specify the fracture’s precise location and trauma level and to include a medical report from the physician in charge. In the higher risk group, 290 (6.1%) developed fractures, compared to only 27 (1.8%) of the lower risk group. Among the 66 women who developed a hip fracture, 60 (90%) were in the higher risk group.

The results show that heel QUS is not only effective at identifying high-risk patients who should receive further testing, but also may be helpful in identifying patients for whom further testing can be avoided. “Heel QUS in conjunction with clinical risk factors can be used to identify a population at a very low fracture probability in which no further diagnostic evaluation may be necessary,” Dr. Guessous said.
Cartilage Study Aids Natural Regeneration

A nanotechnology specialist has found a way to regenerate cartilage naturally by creating a synthetic surface that attracts cartilage-forming cells.

“Cartilage regeneration is a big problem,” said Thomas Webster, an associate professor at Brown University. “You don’t feel pain until significant cartilage damage has occurred and it’s bone rubbing on bone. That’s why research into how to regenerate cartilage is so important.”

Webster’s work involves carbon nanotubes, which are molecular-scale tubes of graphitic carbon among the stiffest and strongest fibers known and great conductors of electrons.

Webster and his team found that the tubes work well for stimulating cartilage-forming cells, known scientifically as chondrocytes because of their uneven surface. “It all goes back to the fact that the nanotubes are mimicking the natural roughness of tissues in the first place,” said Webster.

The researchers also learned they could prod the cartilage cells to grow more densely by applying electrical pulses. Scientists don’t completely understand why electricity seems to trigger cartilage growth, but they think it helps calcium ions enter a cell, and calcium is known to play an integral role in growing cartilage.

The team plans to test the cartilage regeneration method procedure with animals, and if that is successful, to then conduct the research on humans.
Agfa Incorporate Orthoview™ Into IMPAX™ System

Agfa HealthCare and Meridian Technique have signed an agreement to integrate Meridian’s orthopaedic digital planning solution, OrthoView™, into Agfa HealthCare’s IMPAX™ for Orthopaedics solution.

Developed in conjunction with the orthopaedic community, OrthoView consists of five specialist modules: Joint Replacement, Fracture Management, Limb Deformity Correction, Pediatrics and Spine. Together, OrthoView and Agfa HealthCare’s own embedded Measurement tools IMPAX provide a complete set of functions for the Orthopaedic department.

OrthoView allows orthopaedic surgeons to pre-operatively plan and template surgical procedures on-screen. As hospitals throughout the world start to phase out film X-rays and introduce digital images, surgeons want a system that will let them plan surgical procedures more quickly and easily. The solution will be provided by Agfa HealthCare as part of its IMPAX Orthopaedic Suite offering.

“Integrating Meridian’s OrthoView into our IMPAX solution was a natural step for Agfa HealthCare,” said Gilbert Hersschens, Global Product Manager, Orthopaedics at Agfa HealthCare.

“We aim to meet our customer’s demands and OrthoView’s solid reputation is helping us meet these needs. The deep integration into the solution allows us to deliver the best of all worlds to our orthopaedic customers, Agfa HealthCare’s stable and reliable IMPAX solution, coupled with OrthoView’s capabilities.”

“Agfa HealthCare is a key partner of ours and a major provider of digital image solutions worldwide.” said Chris Pinner, Orthoview’s Vice President Sales and Marketing. “The close integration implemented by Agfa has created a powerful solution for orthopaedic doctors when faced by the challenges of going digital.”
Alphatec Spine Enjoy Europe Launch

A U.S. jury has found Arthrex guilty of infringing a Smith & Nephew Endoscopy patent.

Smith & Nephew and Dr. John Hayhurst sued Arthrex over three years ago, claiming that Arthrex’s Bio Suture Tak, PEEK Suture Tak and Push Lock suture anchors infringed a U.S. patent that was owned by Dr. Hayhurst and is under exclusive licence to Smith & Nephew Endoscopy. The jury awarded Smith & Nephew $14.7m for Arthrex’s past infringement.

Smith & Nephew now plans to seek an injunction prohibiting Arthrex from any further manufacturing or selling the devices in the U.S.

“We are extremely pleased with the jury’s decision,” said Mike Frazzette, president, Smith & Nephew Endoscopy.

The disputed patent covers Smith & Nephew Endoscopy’s TAG™ Wedge, TAG™ Rod, and Bioraptor™ Suture Anchors used primarily in surgical repair of the shoulder. Dr. Hayhurst, a pioneer in the field of suture anchors, developed his patented inventions over many years.

“We are aware that other competitors may continue to profit from the innovation we and our surgeon partners have developed, and we will take all appropriate measures to protect our IP,” Frazzette said.

“There’s no question there will be an appeal in the case,” said lawyer Rodger Young, who argued that the Arthrex device works differently than the one invented by Hayhurst.
OrthoRehab Gets Rebrand

Otto Bock Healthcare is discontinuing use of the OrthoRehab name for its post-surgical orthopaedic services from this month (July).

This change reflects the successful integration of the two companies’ orthopaedic rehab product lines and support services after the 2005 acquisition of OrthoRehab by Otto Bock Healthcare.

“We’ve successfully united our two organizations with one vision - providing a complete orthopaedic services solution that can support a patient from hospital to home,” said Pat Chelf, Vice President, Sales and Marketing, Otto Bock HealthCare.

“Now it’s important that our name assures our audiences they are being served by the full breadth, history and reputation of Otto Bock Healthcare.”
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