Sandvik Materials Technology return to home page
For Today's Orthopaedic Professional
visits:  this month all time total site hits
  5,383 536,682 44,382,042

Calling Time on the Debate…
Author: Joanna Wood

Arthroscopy
Author: Satish Kale, FRCS.ED

The Role of the Customer in Developing A New Medical Device
Author: Guy Sellek, Summit Medical Ltd

Bone Cement, its History, its Properties
and Developments in its Use
Authors: Paul Fenton MRCS, Ashok Rampurada MRCS Ed &
Ford Qureshi FRCS (Tr and Ortho) - www.shoulderelbowsolutions.com




Calling Time on the Debate…
Author: Joanna Wood

The Great Debate – Early Intervention in the Hip and Knee was held over the 19th and 20th of January in the IMAX Theatre at the heart of the Science Museum in South Kensington, London. The meeting, which was sponsored and organised by Finsbury Orthopaedics, was designed to encourage an atmosphere that would allow the 33-strong faculty to explore the technologies that enable them to manage the early symptoms of osteo-arthritis in the hip and knee. The numerous sessions were also careful to take into particular account the high demand that healthy adults place on their bodies today.

The meeting attracted over 220 delegates from all over the globe, including Germany, Iceland, Spain and the US, making it the second largest orthopaedic event to be held in Britain. This impressive level of attendance was particularly poignant for the organisers of the meeting, for whom panic had set in, when the rather inclement weather conditions threatened to close motorways, airports and rail lines. Despite these minor set backs the meeting ran smoothly and Professor Cobb, the Chair of the meeting, seemed to be incredibly happy with the outcome stating: “The Great Debate certainly lived up to its name and succeeded in stimulating us all to reflect on our current practice and the direction we wish to take, whether it be conservative or invasive.”

Delegates of varying seniority were evenly split between trainees and consultants, this mixture made for interesting and surprising results especially when delving into the more controversial technologies such as navigation and arthroscopy. The knee sessions kicked off the debate on Friday morning with issues on opening wedge versus closing wedge osteotomy expounded as well as their impact on the ACL deficient knee. Interestingly delegates registered they would like to learn more about what has seemingly become a lost art in British orthopaedics. The place of uni-compartmental knee arthroscopy was debated with Medial UKA’s revealing themselves as the most popular choice for the future. Specialist subjects such as joint biomechanics and arthroplasty were also dissected.

The hip sessions which began on Friday afternoon focused on a variety of different topics such as the advantages of navigation in hip arthroplasty, by the end of the session a surprisingly high number of delegates said they would like to use navigation during hip resurfacing admitting that it would improve levels of accuracy. Unsurprisingly the resurfacing versus replacement issue was perhaps the most heated, with parties ranged on both sides of the argument.

The most rewarding aspect of the meeting was arguably the interactive element. On arrival at the venue, each delegate was given a handset which allowed them to vote on numerous issues throughout each of the sessions. This anonymous system allowed everybody to air their views and to feel a part of the proceedings despite varying levels of seniority. Mike Tuke, Managing Director of Finsbury Orthopaedics commented: “The result of this Old English style of debate was that the audience got the chance to learn from the experts, who invariably don’t all agree, and to form a broad opinion. We felt that the meeting offered a unique and exciting opportunity to teach people in an informative and interesting way.”

Although it has not yet been announced whether or not the meeting will be repeated, with such tremendous feedback, there seems to be no doubt that it would be a great shame to cut the Great Debate off in its prime. For more information on this event or to read more about the issues discussed, log on to
www.thegreatdebate.uk.com.

top  | next
Arthroscopy
Author: Satish Kale, FRCS.ED

Introduction
Arthroscope is a term that comes from two Greek words, arthro- meaning joint, and -skopein, meaning to examine. Arthroscopy refers to examination of the inside of a joint with an arthroscope.

Not long ago, before arthroscopy came into its own, orthopaedic surgery involved major incisions to expose and treat joint pathology, followed by a prolonged and painful rehabilitation needed to recover from the trauma due to pathology compounded by the pain from the surgical procedure itself. Smaller incisions, contrary to popular belief may be minimally invasive but are not necessarily minimally traumatic. Arthroscopy is the exception, a minimally access surgical procedure, not only allowing excellent visualization with minimal soft tissue trauma but also giving the surgeon the advantage of tackling almost everything through camera. The real winner is the patient.

Historical Aspects
Arthroscopy has a most interesting history of evolution. Medical endoscopy has been described as early as the 1800s. Bozzini, in 1806, presented his “Lichtleiter” to the Rome Academy of Medicine. Unfortunately, it was scorned by that scientific body and very little progress was made until 1853 when A.I. Désormaux developed the “gazogene endocystoscope”. This instrument used turpentine burned in a combustion chamber to transmit the light into the bladder by mirrors. In 1918, Prof Kenji Takagi of Tokyo University did the first arthroscopy in a cadaveric knee using a cystoscope! Dr. Eugene Bircher is the first to be credited for performing and publishing the first ever arthroscopy on live patients.

Watanabe was the first to develop the concept of triangulation, bringing instruments into the knee from different directions to treat the pathology that was seen. In 1955, he performed the first recorded operative procedure under arthroscopic control, which was the removal of a solitary giant cell tumor from a knee joint. In 1961, he removed a loose body and in 1962 he performed the first partial meniscectomy under endoscopic control. Robert W. Jackson, MD from Canada, was the first foreign doctor to visit Watanabe in 1964. He also gave the first instructional course on arthroscopy at the American Academy of Orthopaedic Surgeons in 1968 and wrote the first textbook (in English) on “Arthroscopy of the Knee” in 1976, with Mr. David Dandy.

Though initially used in diagnosis and management of tuberculosis, the art and practice of arthroscopy now spans treatment of joint disease and trauma alike. During the past two decades, arthroscopic procedures have been replacing traditional, more invasive orthopaedic surgical procedures. Today arthroscopy has broken all barriers and is being used not only in the conventional areas probed hitherto but also tighter and smaller joints from the hip to the wrist, not to mention recent procedures in the treatment of the first metatarsophalyngeal joint osteoarthritis!

Current Arthroscopic Techniques
There has been a phenomenal increase in the volume and diversity of arthroscopic procedures worldwide. As the ease of working with uncomplicated equipment grows steadily, by eliminating intra-operative glitches such as camera fogging, hand fatigue, suction clogs, and awkward instrumentation, operative time and thus health care costs for such procedures have taken a nose dive.

The surgeon’s comfort has steadily increased by development of more ergonomic designs and light weight instrumentation. Autoclave sterilization has been the focus of other innovations, since sterilization costs and time elapsed between uses are both reduced when steam can be used instead of gas or chemical sterilization. Poor visibility, previously a serious drawback has now being upturned by newer camera systems. Fiber-optic bundles are being used for both lighting and viewing in some systems, and improvements in colour, brightness, and resolution has put arthroscopy at the cutting edge of orthopaedic surgery.

Recent Advances in Instrumentation and Equipment
The development of newer and better arthroscopes has enhanced our ability to see within joints and bursae. A major advantage of arthroscopic surgery is the ability to record the procedure in real time. This helps patients to better understand their injuries and their prognosis for recovery. Modern documentation systems not only allow printing of photographs, but also DVD or VHS recording.

Computerised pumps are used to regulate the water flow and thus maintain the joint pressure during the arthroscopic procedure. Shavers available now are single use and disposable and come in many different sizes and shapes. Motorised shavers allow the surgeon to remove large amounts of tissue in a short amount of time. Tissue vaporisers and underwater cautery have been instrumental in ushering in an era of bloodless arthroscopic surgery. Specialised instrumentation has been developed for specific and frequent procedures such as anterior and posterior cruciate ligament reconstruction, meniscal repair, or osteochondral transplantation.

‘Needle arthroscopes,’ which are even narrower in diameter than ordinary arthroscopes, are already being used in diagnosis and some procedures. These diagnostic scopes has an outside diameter of 1.2mm (18 gauge needle) and requires only one portal. These are designed for use in a diagnostic environment such as an office or outpatient service under local anaesthesia. This system can be used in addition to MRI or alone.This scope is primarily being used in the knee and shoulder. However, the wrist, elbow, ankle and other small joints are presently being investigated. These pilot data suggest that in knee Oosteoarthritis (OA), needle arthroscopy can accurately detect meniscal and cartilage abnormalities and also detect most synovial abnormalities but may often underestimate the severity.

New applications are in development, including studies with laser arthroscopes to ‘re-bond’ injured tissues, rather than simply remove them, and even smaller, digital imaging devices to replace and improve on current television-camera imaging.

Another new and somewhat controversial device currently used in arthroscopic fixation are bioabsorbable implants. The biggest advantage is the ability to view the surgical repair on X-ray, MRI, or a CT-scan without any metal obstruction or scatter. This is useful for standard post-op evaluations and is especially important when the patient becomes symptomatic after surgery or returns with a related injury. The downside is the current costs of bioabsorbable implants which can be 25 to 50 percent greater than that of their metal counterparts.

Another significant trend in post-arthroscopy management is the use of leave-in catheters or take-home pain pumps that automatically and continuously deliver local anesthetics directly into the surgical site for the first 48 post-op hours. The pumps are tamper resistant and feature sterile ‘closed’ integrated tubing for reducing contamination risk.

Knee Arthroscopy
Nowadays knee arthroscopy as a diagnostic procedure has evolved from an inpatient procedure to one performed as a day-care procedure under regional or even local anaesthesia.

Meniscal repair
Since the meniscus is paramount to effective shock-absorbing function of the knee joint, it is always recommended to preserve the meniscus rather than debride it. Various techniques are now available for arthroscopic meniscal repair. The Bio-absorbable Meniscal Arrows are made up of copolymers ( 96% poly-L, 4 %Poly–D Lactic acid) which provides high strength microstructure. After the tear is reduced into position with the help of a probe ,the arrow is introduced through the cannula to fix the tear.

Arthroscopic Meniscal Transplantation
The indication for this procedure is a patient with meniscectomy or a severely injured meniscus, skeletally mature with stable ligaments and a normal femorotibial alignment. This technique involves use of deep frozen cadaver allograft tissue thoroughly thawed to eliminate crystalline water content. The original meniscal remnants are debrided except for the peripheral border. With a hand gouge and burr a trough is prepared to receive the allograft bone. The allograft bone is fixed to the tibial bone trough by means of pull out sutures.

Chondral injuries
According to recent research, up to 10 to 12% of individuals present with chondral injuries. Those which are symptomatic or in the weight-bearing zone manifest as swelling and knee pain. The natural history of untreated lesions is progression and increasing disability. These are classified by the modified Outerbridge classification into grades 1 to 4 depending on the severity. In Outerbridge grades 2 and 3 lesions, with a properly tracking patella, debridement removes fibrillation and provides a stable rim of chondral tissue. Recent studies suggest that bipolar radiofrequency probes are superior to mechanical shavers for articular cartilage debridement. This procedure is a valuable technique particularly in adolescents and young adults 

Autologous chondrocyte implantation (ACI) beneath a periosteal patch covering the lesion is increasing being used across dedicated centres across the globe. The choice of procedure depends on the characteristics of the lesion, patient’s symptoms, age and activity level. Though Autologous chondrocyte transplantation is presently claimed to have a durable outcome, long term results are not yet clear.

With bony defects co-existing with chondral injuries, osteochondral autograft transplant is used in which a bone cone graft capped with healthy hyaline cartilage is harvested from the non weight bearing region of the intercondylar notch and transplanted into the defect. This can effectively delay total knee replacement in the relatively young patient. For larger defects the technique of “mosaicplasty” is used involving insertion of multiple plugs of osteochondral grafts into the defect.

PCL Reconstructions
Though anterior cruciate ligament reconstruction has been widely practiced using the arthroscope. Increasingly posterior cruciate reconstruction is being attempted rather successfully by the new genre of knee surgeons and arthroscopic reduction and retrograde fixation is being done for large fractured bony fragments which get avulsed with the posterior cruciate ligament.

Intra-articular Fractures
Tibial plateau fractures needing condylar elevation techniques to reconstruct the joint congruity and patellar fractures without major separation and comminution can be reduced under arthroscopic guidance and fixed percutaneously with cannulated screw. It allows clear visualization of the reduction and facilitates early mobilization of the knee.

Hip Arthroscopy
Inspite of recent advances the application of hip arthroscopy in its scope as a routine procedure remains small. Of particular application in athletes, the current indications for hip arthroscopy include symptomatic acetabular labral tears, intra-articular loose bodies, femoroacetabular impingement, chondral lesions and osteochondritis dissecans. It can be used in pelvic and acetabular fixation to assess the congruity of reduction of the fracture surfaces and avoid metalwork from impinging onto articular surfaces. In rare cases, hip arthroscopy can be used to “buy time”in patients with mild-to-moderate hip osteoarthritis with associated mechanical symptoms. The procedure is presently not widely available as it requires specialist equipment and has a steep learning curve. Complications are not uncommon occurring in slightly less than 5% of patients.

Ankle Arthroscopy
In selected patients with advanced and symptomatic ankle arthritis, arthroscopic debridement and arthrodesis is rapidly become the procedure of choice amongst arthroscopic surgeons. Selected patients though, include those with only mild angular deformity and avascular necrosis not greater than 30% of the talus. The advantages of the arthroscopic technique include a high fusion rate, decreased time to fusion and good wound healing without the need for external fixation devices.

Arthroscopic curettage and drilling are being increasingly performed for both, primary and revision treatment of an osteochondral defect in the dome of the talus. Autologous chondrocyte implantation (ACI) is also being used in the ankle for osteochondritis dissecans though the long term benefits and results are still unclear.

Ankle fractures have a high incidence of concomitant occult intra-articular injury with syndesmosis disruption and a high risk of articular surface injury to the talar dome. Arthroscopy is a valuable tool in identifying and treating such lesions following ankle trauma. These that would otherwise remain unrecognised are being increasingly diagnosed and treated. This procedure also helps to prognosticate the functional outcome of these injuries. Arthroscopy is an acceptable modality to obtain accurate reduction and fixation of a juvenile Tillaux fracture.

Recent studies suggest that, with the patient in the prone position, arthroscopic equipment may be introduced into the posterior aspect of the ankle without gross injury to the posterior neurovascular structures.

Shoulder Arthroscopy
In arthroscopic trans-humeral rotator cuff repair, the results now being achieved are comparable to a standard open procedure. Many sophisticated instrument systems and techniques have been developed for performing arthroscopic Bankart repair. Thermal modification of the joint capsule and ligamentous tissues, is a recent introduction. Arthroscopic thermal capsulorrhaphy is one such procedure for treating joint instability. This helps to avoid large incisions and iatrogenic shoulder joint trauma. Relatively low-temperature heat is directed to the supportive structures tightening a previously stretched and attenuated shoulder capsule. Beside electro-thermic procedures, several suture-anchor system for labrum fixation have been developed in the last years. Compared to open procedures the arthroscopic shoulder stabilization has many advantages.

Newer techniques use Surtec – a bioabsorbable fixation device which has spikes with concentric ribs contributing to its high pullout strength. After the preparation of the glenoid neck the guide wire is introduced to shift the capsule superiorly. Over the guide wire the Surtech is passed and impacted into place. Knotless suture anchor fixation can be achieved by use of a suture anchor made of a titanium body with two nitinol arcs which prevent anchor pullout. Bioknotless suture is bioabsorbable anchor made of poly-L- Lactic acid.

There are very few studies that directly compare the arthroscopic versus open treatment of particular disorders. However, the benefits of arthroscopy have been well studied for the surgical repair of Bankart lesions. In 1993, Green and Christensen were able to show that arthroscopic repair of Bankart lesions was associated with a significant decrease in operative time, blood loss, and postoperative narcotic use compared with the open procedure. In addition, the use of arthroscopic Bankart repair significantly decreased the length of hospital stay and the time lost from work. In a prospective randomised study, Fabbriciani et al compared the outcomes of patients undergoing open versus arthroscopic treatment of Bankart lesions. While there was no difference in the general outcome, the arthroscopic group demonstrated a significantly better range of motion of the shoulder.

Elbow Arthroscopy
Arthroscopic synovectomy is a reliable procedure to alleviate pain in rheumatoid arthritis. A preoperative radiographic Grade of 1 or 2 is a good indication. The fundamental of arthroscopy is visualization and access. Visualization and access to the ulnohumeral and radiocapitellar articulation is rather difficult presently. Recent modifications have included use of a joint jack or a distractor to widen the ulnohumeral joint space for enhanced visualization.

Wrist Arthroscopy
Acute nondisplaced scaphoid fractures have traditionally been managed with cast immobilization. Prolonged casting has been implicated in post-fracture muscle atrophy, joint stiffness and disuse osteopenia. Arthroscopic assisted fixation offers an advantageous compromise between traditional cast immobilization and open reduction for scaphoid fractures with minimal soft tissue dissection, a lower risk of damaging the bone’s already tenuous blood supply, avoids division of the stabilizing important radioscaphocapitate ligament and allows adequate visualization of the fracture and stable fixation. This technique allows for faster and early rehabilitation and an earlier return to work. Nondisplaced fractures presenting with delayed or fibrous union without evidence of avascular necrosis, cyst formation, or bony sclerosis may also be considerations for this technique.

Imaging techniques may offer a pointer for diagnosing occult fractures and distal radioulnar subluxation, but are unsatisfactory for diagnosing dynamic ulnocarpal impingement, tears of the triangular fibrocartilagenous complex (TFCC) and lunotriquetral ligament and joint mice. Therefore, prior to surgical intervention arthroscopy is recommended for patients with persistent ulnar wrist pain that interferes with their daily activity. Triangular fibrocartilagenous complex (TFCC) tears can be eminently treated via the arthroscope. Carpal detachment injury should be considered when no abnormalities of the TFCC and ligaments are observed with ongoing wrist symptoms. Arthroscopic findings suggested that a portion of TFCC that was originally attached to the ulnar side of the triquetrum may get detached. Resection of meniscus homologue-like tissue which arose from TFCC with a shaver, may improve symptoms

Injuries to the scapholunate complex present the surgeon with both diagnostic and treatment dilemmas. Arthroscopy is considered the gold standard for complete evaluation of scapholunate interosseous ligament injury and often is performed as a first step before repair or reconstruction.

Several reports have shown the superiority of endoscopic carpal tunnel release over open surgery, in particular relating to earlier recovery of hand strength and return to work. A significant reduction in scar tenderness (pillar pain) contracture and symptoms of stiffness is of particular importance for those who do heavy manual work.

Arthroscopy of the Temporomandibular joint
Temporomandibular joint (TMJ) arthroscopy is an effective therapeutic modality for patients with TMJ  internal derangements, with reoperation required for only 20% of patients. It is effective in reducing pain and increasing mandibular motion in patients with anterior unreduced disc displacement especially in patients the duration of symptoms being less then 6 months. It is recommended as a simple alternative to more invasive TMJ procedures. 

Conclusion
In conclusion, Arthroscopy has introduced some potential advantages compared with open procedures. These include shorter surgery times, less morbidity, less postoperative pain, shorter hospital stays, less blood loss, and a decreased risk of complications. In addition, the ever widening uses of arthroscopic procedures contribute to the overall reduction in healthcare costs.

top  | next
The Role of the Customer in Developing A New Medical Device
Author: Guy Sellek, Summit Medical Ltd

Introduction
In today’s challenging medical device market, the introduction of a new product is becoming increasingly difficult. Clinicians are looking for effective products that meet their needs and which are comprehensively supported by the company supplying them. Procurement teams in both the NHS and Private hospital groups have to balance the wishes of the clinicians with their responsibility to rationalise and standardise the range of products purchased.

Medical device manufacturers invest heavily in bringing new and innovative products to the market and in offering training and product support to users. In order for the needs of both the clinicians and the manufacturer to be met, it is vital that the process of launching a new product involves all stakeholders.

This article will examine the role of the customer in a typical medical device development process and will feature the development and recent launch of the Summit HiVac™ 7 bone cement mixing system as a case study to illustrate this discussion.

Understanding the Customer
Understanding the needs of the marketplace is a key starting point for the development of a new product and input from relevant stakeholders should be sought at this early stage. In the case of the HiVac™ 7 bone cement mixing device, consultations with Theatre Staff, Surgeons and Procurement personnel were critical in the formation of the Product Design Brief. With this product, initial focus groups were held with Theatre Nurses to gain feedback on their experiences of mixing bone cement and clinical practice. The focus groups consisted of scrub staff, some of whom currently used Summit mixing devices and some who used competitor systems. The discussions were centred on current techniques, the strengths and weaknesses of the mixing devices currently used and trends in surgical technique.

Focus groups can be invaluable in setting the requirements for a new product design, highlighting areas of concern to the users rather than the manufacturers. For example, with the HiVac™ 7 focus groups some significant limitations were highlighted with many of the bone cement mixing devices currently being used. In particular, reliability issues with devices where a mixing rod has to be snapped after mixing, the potential for unmixed powder to be generated in devices that are opaque and the physical effort required to use some devices, were amongst the identified problems. Simple to use designs were also favoured by the group as this has a significant influence on ease of use and the training requirement for a new product.

At this early stage of the development process surgeons were also interviewed with regard to their needs from a bone cement mixing & delivery device. Although theatre staff do the mixing, surgeons identified key requirements which were also added to the design brief. In particular, surgeons highlighted the need for good mix quality and a requirement for good feel and pressure generation from the cement delivery gun.

In many of today’s medical device markets Procurement personnel are having an increasing role in deciding which medical devices are used by clinicians. With the HiVac™ 7 project, Procurement professionals were consulted and their needs added to the Product Design Brief. Cost effectiveness was highlighted as the key issue to this particular group. Discussions highlighted that the product price, the surgical benefits of the product, being able to buy a range of mixing devices from one supplier and training / product support were important elements in the cost effectiveness calculation.

Once all the stakeholders have been consulted, market share and projected return on investment calculated, the decision can then be made on how to progress with the Product Design Brief, based on the market research results.

Product Design & Development
The design and development of a new product is a dynamic process balancing innovative ideas and market feedback with practical issues such as manufacturing the product robustly and to a consistently high quality. The next phase of this process usually involves the creation of prototype product designs. Development engineers will use the Product Design Brief to guide the development of prototype devices. With the HiVac™ 7 product the intent was not only to produce a device that was as good as the other products in the market place but also to overcome the weaknesses that were apparent in some of these devices, as highlighted in the market research.

Once prototype designs are created they are converted into product models which should then be shown to clinicians. In the case of HiVac™ 7 a number of different design ideas were shown to nurses, surgeons and Procurement Personnel to guide the development programme. During this stage some ideas were rejected but others were highlighted as significant improvements over products currently being used.

For example, the HiVac™ 7 product is made from a transparent material. This allows clinicians to view the mix quality during mixing but is also strong enough to reliably resist the high levels of force that it would be subjected to during cement delivery. When shown to clinicians, this feature was viewed as being beneficial as clarity allows the user to maintain control over the mix and ensure consistent cement quality for the patient.

Whenever possible, it is useful to allow the various groups to use the prototype models. For example, to ensure that HiVac™ 7 was easy and simple to use, a number of different designs were evaluated by users. Different mixing handles, bases and paddle ideas were assessed to produce a final design that most Theatre Staff agreed was significantly easier to use than many existing products. Ease of use was highlighted as being a key element for new products as it gave confidence to those that operate the product, made training of new staff easier and should result in more consistent results for the patient.

Features to enhance product reliability should also be tested at this stage of the development programme. For example, positive feedback was given by users on the coloured snap point of the HiVac™ 7 mixing rod. This new idea was viewed by users as improving a significant area of weakness and product failure that occurs with a number of existing mixing devices.

Health & Safety related product features were also discussed at this stage. The HiVac™ 7 prototypes were of a closed design reducing the potential for users to be exposed to polymethylmethacrylate fumes during mixing. Even though all modern vacuum mixing systems reduce fumes to below Health & Safety guidelines 1 the closed system concept was well received by users.

Prototype designs were also shown to surgeons. Mix quality and cement strength were highlighted as being a key concern with this group. To enhance the mechanical properties of cement the HiVac™ 7 device was designed to operate at 550mmHg. The application of a vacuum during mixing reduces the air content in bone cement which up to a point makes the cement stronger and more likely to survive the extreme loading that it is subjected to post implantation. The vacuum level of 550mmHg was chosen due to previous test work 2 conducted by Queens University Belfast which demonstrates that this vacuum level is optimum. This paper demonstrates that the higher vacuum levels used by many existing mixing devices produce cement with very low levels of porosity leading to the cement suffering from excessive shrinkage. This has been shown to produce micro cracks in the cement mantle which can weaken the fatigue life of the cement. In addition excessive shrinkage has been shown to produce voids at the cement stem interface 3 which could increase the chance of aseptic loosening.

In addition to mix quality a number of surgeons were interested in the feel of the cement delivery gun and the pressure that it could generate during cement delivery. To enhance gun performance the HiVac™ 7 prototypes were designed with a narrow bore mixing & delivery tube. Surgeons suggested that this design feature would allow them to generate enough pressure in the cement delivered to the femur to create effective micro interlock which is important for secure fixation of the implant. In addition surgeons liked the lightweight manoeuvrable gun which contrasts favourably with the bulkier caged guns used with some existing mixing systems.

Prototype product designs were also discussed with Procurement personnel. This group of customers were keen to purchase all mixing devices from one company which helps to streamline the purchasing process. With this in mind a triple mix version of HiVac™ 7 was proposed which would cover the requirement for up to 120g of mixed cement for revision hip procedures. Although the demand for a triple mix was suggested to be modest, Procurement staff were keen to have this option to cover all surgical requirements.

Final Design Stage and Testing
Once feedback on prototypes has been gathered from all relevant stakeholders a final design is chosen. This design is fine tuned and tested by the development engineers to ensure that certain key criteria are met. Many of these criteria are regulatory requirements which have to be adhered to.

Functionality testing is critical to ensure that the product is going to perform as intended. For HiVac™ 7 this included destructive testing on components to ensure that the device is robust enough to function without failure. This also has to include the testing of components that have been sterilised as the sterilisation process can affect the strength of individual components. In addition, materials had to be tested to ensure that the components of the device were compatible with the aggressive characteristics of bone cement.

Mechanical testing of cement mixed in the new system was also an important step in the HiVac™ 7 project. The cement has to be tested to ensure that when delivered to the patient it is at least equal to the criteria set out in the international standard for bone cement ISO5833. In addition cement fatigue testing is conducted as this is viewed as a key performance indicator for long term cement survival. The importance of this was illustrated by the launch of the Boneloc bone cement in the early 1990’s. This cement was sold on a number of key benefits and passed the basic ISO requirements. However later test work revealed that it suffered from poor fatigue properties 4. Had Boneloc been tested for fatigue failure prior to launch, the large amount of early implant failures 4 reported as a result of the Boneloc failure could have been avoided.

In addition packaging has to be assessed to ensure that during transit the sterility of the product is not compromised and that the product is not damaged. Also the product has to be aged tested to ensure that when launched the shelf life marked on the product is reliable.

During the final stages of initial product development the packaging design also needs to conform to the regulatory requirements of the markets that the product will be sold into. For example the information on the packaging for the HiVac™ 7 product had to be translated into 21 languages to reflect the regulatory requirements of those particular markets.

Once the product has passed all of its testing and conforms to the regulatory requirements of the market place it is ready for production. The launch stock of a new product faces rigorous Quality testing before being released, ready for sale.

Product Launch and Beyond
As part of a new product launch, detailed briefing and product training will need to be given to the relevant sales team. Product training needs to be comprehensive as new products often involve different techniques and methods which need to be fully understood before being passed on to users. In addition comprehensive product support programmes need to be in place to give users confidence and to ensure that the products are used correctly. In the case of the HiVac™ 7 the product support package included;
  • In-service training programme
  • Train the Trainer programme
  • Principles of Bone Cement Mixing & Application educational programme
  • Competency testing user assessment material
It is not enough for products to be sold and for the salesperson to walk away. Users now require comprehensive support especially during the early stages of adopting a new medical device.

The launch of a new medical device is not the end of the product development process. It is important that post launch feedback is gathered from users to indicate areas for future improvement. Many products evolve over time with minor changes helping to enhance the product offering. With the HiVac™ 7 product, as with all Summit Medical devices, a regular review of post market surveillance is conducted to ensure that products are performing as desired and to highlight areas for improvement where relevant.

The HiVac™ 7 example demonstrates the benefit of involving clinicians and Procurement staff in every stage of the product development process. Due to significant input from Theatre Staff, Surgeons and Procurement personnel the product has built on the strengths of existing bone cement mixing devices and has overcome some of the weaknesses.

In addition to customer feedback guiding the development of a new product it can also be used to help formulate the programme of activities that support the product once introduced. In the case of HiVac™ 7 this has resulted in a comprehensive support programme which is already a valued part of the HiVac™ 7 package. For a new medical device to survive in the long term it may need to evolve. Customer feedback is critical for this process to be successful and for the product to continue to meet the needs of the marketplace.

References
  1. Cary R, Morris L, Cocker J, Groves J and Ogunbiyi A, 1995. Methylmethacrylate Criteria document an occupational exposure limit: Health and Safety Executive.
  2. Dunne N J, Orr J F, Mushipe M T, Eveleigh R J, 2002. The relationship between porosity and fatigue characteristics of bone cement. Biomaterials 24 (2003) 238-245
  3. Bishop NE, Ferguson S and Tepic S, 1996. Porosity reduction in bone cement at the cement stem interface. J Bone Joint Surgery, 78B (3): 349-356
  4. Harper E.J, Bonfield W, 2000. Tensile characteristics of ten commercial acrylic bone cements. J Biomedical Material Research, V53, Issue 5:605-616
  5. Furnes O N, 2002, The Norwegian Arthroplasty Register 1987-2000


top  | next
Introduction
The use of bone cement is become important in many orthopaedic procedures, especially in joint arthroplasty. Polymethyl methacrylate was first used as a cement in dentistry. John Charnley popularised its use in orthopaedics whilst developing his low friction joint arthroplasty. Despite attempts to find alternative means of implant fixation, bone cement still has a common place in orthopaedic surgery. In this article, we review the history of the development of bone cement, discuss the properties of polymethyl methacrylate particularly in relation to the fixation of total hip arthroplasty prostheses and finally we review some potential future developments.

The History of Bone Cement
The history of modern cements began in the early 20th century with Otto Rohm synthesising polymethylmethacrylate [or bone cement] and was first used in dental institutions in the 1930’s. In 1936, the Kulzer company discovered that by mixing liquid methylmethacrylate monomer with a polymethylmethacrylate powder and an initiating agent, a mouldable ‘dough’ was produced. During the Second World War, it was shown that this ‘dough’ could be polymerized at room temperature and it became useful in cranioplasties [to fill skull defects] and securing the Judet femoral head prosthesis 10.

The late John Charnley popularised the use of bone cement in orthopaedic surgery and by the late 1950’s he was searching for ways to fix the femoral component as part of the development of his low friction arthroplasty. He sought a material that was resistant to body fluids, viscous with a low toxicity, could be easily manipulated and would set within a reasonable time. Charnley worked at Manchester University and after experimenting with various materials eventually settled on polymethylmethacrylate: a viscous dough which he formed by mixing the powder with the liquid monomer 20. In 1958, he performed his first case in Manchester. Charnley was the first to realise that it could be easily used to fill the medullary canal and blend with the bone morphology 3. The cement acted to increase the biomechanical stability and decrease the stress on the implant and he settled on the idea of using cement as a ‘grout’ for the hip implants. Despite all the early scepticism, polymethylmethacrylate is being used as bone cement for implant fixation to this day.

Properties of Bone Cement
Bone cement is supplied as two separate components, a polymer powder and a monomer, which is a colourless and inflammable liquid. The liquid also contains a stabiliser (hydroquinone) to prevent polymerisation, an activator (dimethyl-para-toluidine) and may contain a green dye (chlorophyll). The powder consists of a spherical polymer, an initiator (dibenzoyl peroxide), a radiopacifier (zirconium oxide or Barium sulphate) and often an antibiotic.

As the powdered polymer and liquid monomer are mixed, a viscous dough is formed. The initiator and activator react together to produce an initiation reaction creating free radicals that cause the polymerisation of the monomer molecules. When two polymer molecules meet, they combine to form an unreactive molecule 12. This process is exothermic, with a maximum in vivo temperature of 40° to 47°C and this thermal energy is dissipated into the circulating blood, the prosthesis and the surrounding tissue 18 as the cement cures.

Cement viscosity determines the handling and working properties of the cement. The chemical composition, the powder to liquid ratio and the cement temperature in turn determine the viscosity. There are high viscosity and low viscosity cement types. High viscosity bone cements have a short wetting phase and a longer working phase. Low viscosity cements have a longer wetting phase and a shorter working phase. Clinical experience has shown that the high viscosity cements produce better clinical results, as compared with low viscosity cements.

The process of polymerization of cement can be divided into four different phases. The mixing phase lasts up to one minute as the powder and liquid are homogenised. The waiting phase can last several minutes as the cement reaches a non-sticky state. The working phase lasts two to four minutes as the cement is applied, at this point viscosity must be enough to withstand bleeding pressure otherwise cement strength will be reduced. Finally, the hardening phase occurs whilst the final setting takes place. As the temperature increases [cement, body or theatre], the time of each of the phase is shortened. 12

Bone cement acts as an elastic buffer between the prosthesis and bone and distributes the physiological load evenly. In static mechanical testing the compressive strength of acrylic bone cement is greatest followed by the flexural strength and then by the tensile strength. The addition of radiopacifiers and antibiotics slightly decrease the strength of cement. Cement is subjected to both static and dynamically alternating loads in-vivo.Loading is complex and is a combination of different loading types 13.

The fatigue properties of cement are measured using cyclical loading and are assessed by four point bending, tensile or compression-tensile testing. A major cause of fatigue failure with cement are the pores or inclusions. These can concentrate stress and then lead to cracks and subsequent cement failure. Air can also be trapped within the cement mantle, when the powder is wetted, as the cement is mixed or when the cement is transferred to the application device. Developments in the mixing and application of cement have served to reduce the porosity 13.

During the first 4-8 weeks after implantation, there is a small amount of water uptake by bone cement, this results in a reduction of stiffness and modulus of elasticity. Lowering the stiffness of cement may actually increase the fracture resistance. Water resorption can also cause the cement to expand.

Polymethyl methacrylate is a visco-elastic material. When subjected to a constant load there is an initial elastic deformation. There is then a delayed continuous deformation, part of which recovers when the load is removed (primary creep) and part of which does not recover (secondary creep). Creep is a possible cause of loosening in cemented prostheses although the subsidence of prostheses secondary to creep is small 22.

One of the major drawbacks of bone cement in joint replacement is cement fragmentation and foreign body reaction to wear debris, resulting in prosthetic loosening and periprosthetic osteolysis 5. Histologically, a layer of synovial like cells which line the bone cement interface supported by a stroma containing macrophages and wear particles, is described in loose prostheses. A third of dense fibrous tissue contains polymethylmethacrylate, polyethylene and metallic debris 4. More recently, the importance of polyethylene debris in prosthetic loosening and osteolysis has been identified 23. Wear particles induce a chronic inflammatory response. Activated macrophages express cytokines including interleukin-1, interleukin-6 and tumour necrosis factor alpha, which mediate periprosthetic osteolysis 6. Cement debris can be generated by incomplete mixing, abrasion, fatigue fracture and third body wear. It has been shown that cement particles can activate the pro-inflammatory cascade implicated in osteolysis 17.

As well as cement fracture and a role in particulate disease there are several other disadvantages with the use of cement. Acrylic cement is chemically dissimilar to bone. It generates heat as it cures and contracts and later expands due to water absorption. It is neither osteoinductive nor osteoconductive and does not remodel. The monomer is toxic and there is a potential for allergic reactions to cement constituents 5. In addition to this, there is the potential for cardiovascular compromise on application of cement, particularly with pressurisation, with possible fatal consequences. In elderly patients or those with pre-existing cardio respiratory disease the decision to use cement must be made carefully. In all patients who are receiving cement, close attention must be paid to washing the medullary cavity out to remove all marrow, fat, blood and bone debris. The patient must have a good circulating volume and be closely monitored as the cement is applied.

Evolution in Cementing Techniques
Since Charnley first began using acrylic bone cement in hip arthroplasty, there have been a number of developments in the preparation and application of bone cement. First generation cementing techniques involved the hand mixing of cement in bowls. There was only a minimal preparation of the femoral canal and cancellous bone was left in-situ. The canal was irrigated and suctioned prior to the digital application of cement. The prosthesis was then inserted into the femoral canal.

During the 1980’s these techniques were refined. Steps were taken to reduce the porosity of the cement and thereby increase the fatigue life. Pressurization of the cement was introduced to improve osseo-integration of the cement and the importance of a good cement mantle around the prosthesis was more clearly understood. Thus, second generation cementing techniques removed all cancellous bone as near to the endosteal surface and a distal cement restrictor was also used. There was pulsatile irrigation, packing and drying of the femoral canal followed by retrograde insertion of cement with a cement gun. The prosthesis was again positioned manually 14, 7.

Further improvement lead to the development of third generation cementing techniques. Cement is now prepared using a vacuum-centrifugation, which further reduces porosity. The femoral canal is irrigated with pulsatile lavage and then packed with adrenaline soaked swabs. After insertion of the cement in a retrograde fashion, the cement is pressurised. Finally the prosthesis is inserted using distal and proximal centralizers to ensure an even cement mantle 8.

The recognition of the importance of the cement mantle in femoral component loosening has resulted in a grading system of the mantle: Grade A representing a complete cement mantle on all views with cement at least 1mm thick containing no voids, defects or bubbles. Cement should extend 10mm beyond the prosthesis and it should not be possible to distinguish cement from cortical bone in the diaphyseal region. Conversely, in grade D cementing, the cement does not extend below the tip of the stem, there are deficiencies in the cement mantle, voids and bubbles may be present 15.

The Future
The use of acrylic bone cement in total hip arthroplasty is still extensively practised in Europe. However, some of the problems with its use have prompted the search for other methods of fixation. The results of acetabular component fixation with cement are variable with some series showing up to 50% aseptic loosening rates at a long term follow up of young patients 2. This has lead to the development of cementless acetabular components utilising biological fixation with bony ingrowth. A variety of surface finishes and textures have been trialled to maximise bony ingrowth. The use of a hydroxyapatite surface finish does promote earlier and stronger fixation to the bone 16. The use of cementless acetabular components allows the exchange of worn polyethylene liners without complete component revision however, one drawback is the observation of painless pelvic osteolysis that can produce significant bone loss and complicate revision surgery 21.

Alternative methods of fixation of the femoral component have also been developed. Cementless fixation devices rely on bone ingrowth to the femoral component, this can involve proximal fixation implants where the prosthesis has a wedge fit to the metaphyseal bone or extensive porous coated prostheses, which press fit into the diaphyseal bone 21. The incidence of thigh pain with proximally fitted stems has been shown to be higher 1. Despite concerns regarding thigh pain and the proximal stress shielding associated with extensively coated femoral stems, good long-term results have been reported 11

. There has been recent interest in the development of calcium phosphate cements. These cements form one or more calcium and phosphate containing compounds when they harden and ultimately transform into apatites in vivo. Therefore, unlike polymethylmethacrylate these cements are theoretically capable of chemically bonding to bone and in some cases bony resorption and substitution by osteoconduction 9. Although calcium phosphate cements have been used successfully to fill bone defects in a trauma patients 19 their benefits in arthroplasty have yet to be demonstrated.

References
  1. Barrack RL et al . patient’s perception of pain after total hip arthroplasty. J Arthroplasty 2000;15(5): 590-6.
  2. Callaghan JJ et al. Charnley total hip arthroplasty in patients less than fifty years old. A twenty to twenty-five-year follow up note. J Bone Joint Surg 1998; 80A: 704-714.
  3. Charnley, J. Arthoplasty of the hip by low friction technique. J Bone Joint Surg 1961; 43 B: 601.
  4. Goldring SR, Schiller AL, Roelke M, Rourke CM, O’Neill DA, Harris WH. The synovial like membrane at the bone cement inter- face in loose total hip replacements and its proposed role in osteolysis. J Bone Joint Surg 1983; 65A: 575-84.
  5. Goodman S. Wear particulate and osteolysis. Orthop Clin N Am (2005) 41-48.
  6. Goodman SB, Huie P, Song Y, Schurman D, Maloney W, Woolson S et al.. Cellular profile and cytoline production at prosthetic interfaces. J Bone Joint Surg 1998;80B:531-9.
  7. Harris WH. Hybrid total hip replacement. Clin Orthop 1996. 333: 155-164.
  8. Haydon CM, Mehin R, Burnett S, Rorabeck C, Bourne R, Mccalden RW, Macdonald S. Revision total hip arthroplasty with use of a cemented femoral component. J Bone Joint Surg 2004. 86A: 1179-1186.
  9. Jansen J, Ooms E, Verdonschot N, Wolke J. Injectable calcium phosphate cement for bone repair and implant fixation. Orthop Clin N Am 36 (2005) 89-95.
  10. Kiaer S. Hip arthroplasty with acrylic prosthesis. Acta Orth 1953; XXII (2) 126-45.
  11. Kronick JL, Barba ML, Paprosky WG. Extensively coated femoral components in young patients. Clin Orthop 1997; 344: 263-74.
  12. Kuehn KD, Ege W, Gopp U. Acrylic bone cement: composition and properties. Orthop Clin N Am 36 (2005) 17-28.
  13. Kuehn, Ege, Gopp. Acrylic bone cement: mechanical and physical properties. Orthop Clin N Am (2205) 29-39.
  14. Mulroy WF, Harris WH,. Revision hip arthroplasty with the use of so-called second generation cementing techniques for aseptic loosening of the femoral component. J Bone Joint Surg 1996. 78A: 325-30.
  15. Mulroy WF, Estok Dm, Harris WH. Total hip arthroplasty with use of so called second generation cementing techniques. J Bone Joint Surg 1995; 77A: 1845-1852.
  16. Oonishi H et al. The effet of hydroxyapatite coating on bone ingrowth into porous titanium alloy implants. J Bone Joint Surg 1989; 79B: 213-6.
  17. Quinn J, Joyner C, Triffitt JT, Athanasou NA. Polymethylmethacrylate-induced inflammatory macrophages resorb bone. J Bone Joint Surg 1992;74B:652-8.
  18. Reckling FW, Dillon WL. The bone-cement interface temperature during total joint replacement. J Bone Joint Surg 1977A 80-2.
  19. Simpson D, Keating JF. Outcome of tibial plateau fractures managed with calcium phosphate cement. Injury 2004; 35: 913-918.
  20. Smith, DC. The genesis and evolution of acrylic bone cement. Orthopaedic clinics of north America 2005. 36 (1) 1-10.
  21. Sporer SM, paprosky WG. Biological fixation and bone ingrowth. Orthop Clin N Am 36 (2005): 105-111.
  22. Verdonschot N, Huiskes R. Acrylic cement creeps but does not allow much subsidence of femoral stems. J Bone Joint Surg 1997: 79B(4): 665-9.
  23. Willert HG, Bertram H, Buchhorn GH. Osteolysis in alloarthroplasty of the hip. The role of ultra-high molecular weight polyethylene wear particles. Clin Orthop 1990;258: 95-107.


top

top of page     readers comments     contact us     webmaster     legal notices     home     subscribe
Current Issue Orthopaedic Products SurgeonSpeak Future Events Articles Company Info OPNews
Copyright 2005 © Pelican Magazines Ltd  -  developed by netdirect sales

a Pelican Group Company