Data is collected as part of the Surgical Site Infection Surveillance Service (SSISS), which has supported voluntary surveillance in several categories of surgical procedure since 1997.

The requirements of the mandatory surveillance are that all NHS Trusts where orthopaedic surgical procedures are performed are expected to carry out a minimum of three months surveillance in at least one of the four orthopaedic categories.

• Total hip replacements
• Knee replacements
• Hip hemiarthroplasties
• Open reduction of long bone fractures

Some Trusts that have more than one acute hospital may have chosen to collect data at one hospital only. Some Trusts, in particular paediatric specialist hospitals, only carry out procedures in the open reduction of long bone fracture category and the throughput was too small to enable them to participate in the surveillance.

The surveillance to detect SSI therefore requires active monitoring of patients from the time of their operation until they are discharged from hospital. To ensure that as far as possible data collected in different Trusts are comparable they are expected to adhere to the standard method of collecting and reporting data described in the SSI surveillance protocol. Currently there is no requirement to continue surveillance once the patient has been discharged from hospital.

Trusts participate in the surveillance for minimum three-month periods although they can choose to collect data for more than one period. Each patient undergoing a procedure within a defined category is included in the surveillance and monitored for subsequent signs of SSI.

Trusts participating in the surveillance receive an individual report at the end of each surveillance period that contains their results compared to the data aggregated from all participating hospitals. They use this data to monitor local practice and initiate further investigation and action should the results indicate that rates are unusual.

The rates of SSI in orthopaedics were generally low and three-quarters of infections affected the superficial layers of the wound only.

More information about the data collected in this first year of mandatory surveillance of SSI in orthopaedics is contained in a separate report available from the Centre of Infections at the Health Protection Agency website.

The number of procedures on which rates are based varies according to the throughput of the given type of surgical procedure at the Trust and the number of surveillance periods they have chosen to participate in.

Confidence limits are shown in order to give a guide as to how precise a particular estimate is. The confidence limits for a Trust rate in a given category represent the range of rates between which their true rate could feasibly lie. The confidence limits will be wider for those Trusts with rates based on fewer operations and narrower for those Trusts with higher numbers of operations.

Very low, or very high rates that are based on a small number of procedures should therefore not be taken at face value but should be interpreted in conjunction with the confidence limits. The conventional method of calculating confidence limits could be misleading for rates based on less than 50 operations, as they will overestimate the true upper 95% limit. Confidence limits have therefore not been shown for rates based on less than 50 operations.

The possibility that an SSI will be detected depends on the length of time that the patient spends in hospital post-operatively. Some variation in rates may therefore be explained by differences in length of post-operative follow-up. In addition, the rates included in these tables have not been adjusted for underlying risk factors related to the patient or their operation that could affect the risk of developing an SSI, for example age, underlying illness, complexity of the operation.

The effect of these risk factors and longer post-operative follow-up contributes to the generally higher rates of SSI seen in patients undergoing hip hemiarthroplasty. Data on the effect of some of these factors is contained in the report of the first year of mandatory SSI surveillance in orthopaedics.

Making data entry as quick and efficient as possible has been a key element of the NJR’s progress. Allowing hospital data managers and surgeons to easily and quickly input their data has been aided by three major NJR developments.

From 1 April 2005 the types of default techniques that can be recorded on the NJR was expanded to reflect more closely the type of patient procedure used.

Originally, the NJR Data Entry System only allowed surgeons to create their default techniques via their own NJR user accounts. However, not all surgeons completed their default technique on-line, which resulted in incomplete records that could not be submitted to the NJR. To help remedy this situation the ability to create the surgeon’s default technique on-line was opened up to Hospital Data Managers.

This means that a Hospital Data Manager (HDM) can also enter the default techniques on the behalf of those surgeons associated with their hospital via their own HDM account (where they have surgeon agreement).

The XML schema and instance files have now been released and are available on the NJR website. This will enable interested parties to generate the required file that is required to use the Bulk Upload facility. A test version of the system will be made available so that the facility can be tested in full and also to allow interested parties to test their systems can create the required bulk upload XML file.

To use the Bulk Upload facility the hospital will need to request access via the Helpline. The reason for this is that the hospital system must be compatible with the NJR system for data transfer to take place. The hospitals IT department will need to test the hospital system’s compatibility to ensure data integrity.

The system is one of many time saving devices developed by the NJR for use within all orthopaedic hospitals. The barcode system will also reduce any data entry errors that can occur when component information is manually entered.

Paul Allen Theatre Data Entry Manager for the NJR from Royal Berks Hospital piloted The NJR barcode reader system and said, “It’s a welcome development as it easy to use and saves data entry time. Piloting the system was made easy by help and advice provided by the NJR team.”

Menisci after suture repair without RF Treatment

Menisci after RF Treatment and suture repair

The purpose of the current study was to utilize radiofrequency (RF) in the treatment of the avascular meniscal injury/repair and investigate the healing response.

The degree of healing for the RF-treated menisci was higher at the later time points i.e. 28 and 84 days. Cellular proliferation was higher in RF-treated compared to suture-only menisci at 9 days post-repair as was mRNA expression of IGF-1, bFGF and VEGF. No differences were detected at 84 days.

Histology of Menisci after RF Treatment and suture repair

Histology of Menisci after suture repair without RF Treatment

This study has demonstrated the ability of Radiofrequency to stimulate a healing response in the avascular region of the meniscus following injury and suture repair. We believe these results suggest that RF treatment is a viable treatment option for avascular meniscal injuries.

Modern airliners fly with an operating cabin pressure equivalent to an altitude of around 7,500 feet. This equates to a barometric pressure of around 80% that of sea level, which represents a 20-30% volume increase to any compressible substance (such as trapped air). The resultant fall in molecular oxygen concentration leads to a desaturation of blood oxygen of approximately 1% in the healthy subject. Because of the nature of the oxygen dissociation curve most patients will be able to tolerate this decreased partial pressure without detriment.

Patients with only the upper limb in cast will only require one seat to travel. If the lower limb is in plaster below the knee, then one seat is sufficient. If the lower limb is in plaster above the knee, it will be necessary to purchase an additional two seats in order to obtain the necessary legroom to elevate the limb. Fractures of the hip or femur will almost certainly require a stretcher, and this will need to be discussed with the relevant airline.

Absolute contra-indications to flying are recent craniotomy, recent abdominal surgery, pneumothorax without a chest drain, and facial injuries with intrasinusal haemorrhage. In the case of a resolved pneumothorax, flying should be avoided for at least 14 days following removal of the chest drain. Any disease with an ischaemic component will deteriorate in the conditions of hypobaric hypoxia that are encountered during air travel.

Patients with pre-existing cardiorespiratory disease may require supplementary oxygen. The risk of deep venous thrombosis (DVT) associated with air travel is well publicised. Many airlines promote in-flight lower limb exercise and encourage mobility within the cabin. This, of course, may not be possible for a patient in a cast. Furthermore, passengers having undergone recent surgery or trauma will be at increased risk of DVT and consideration should be given to the use of compression stockings, aspirin or anticoagulants in those with additional risk factors for thromboembolic disease.

The senior author (CWO) has never heard of an aircraft ever having to be landed in an emergency due to problems with an overtight cast. We would be interested to hear from anybody who has ever been involved in such an incident. Flying with a cast in isolated limb trauma is safe. If fitted for less than 48 hours, the cast should be split. If the patient has a long leg cast, additional seats will be required to facilitate elevation of the limb.

Although innovation in arthroscopy has been evolutionary over the past few years, improvements continue to emerge in visualization equipment (e.g. higher-quality digital cameras, systems for access to hard-to-reach areas, autoclavable cameras, flat screen monitors, etc.), diagnostic arthroscopy and thermal energy technologies.

In the area of diagnostic arthroscopy, in 2005, Arthrotek introduced its InnerVue diagnostic scope system for use in office and outpatient surgery settings. The system not only provides immediate diagnosis (obviating the need for the patient to go elsewhere for tests), but it also allows the surgeon to determine damage and appropriate treatment modalities. InnerVue is used primarily in knee and shoulder, with application in other small joints under investigation.

On the radiofrequency (RF) front, RF electrosurgical platforms use thermal energy to manipulate (e.g. remove, cut/sculpt, coagulate, shrink, etc.) soft tissue. A key indication for RF that has arisen over the past few years involves treating soft tissue instability, particularly in the shoulder. When collagen fibers are “heated,” their molecular structure changes and they contract, leading to tighter joint spaces and purportedly more stable joints. ArthroCare, ConMed, Mitek, Smith & Nephew and Stryker dominate the RF subsegment of the market; however, unlike traditional electrosurgical systems, ArthroCare’s Coblation technology employs lower temperatures, which may minimise thermal damage to the soft tissues.

ArthroCare, too, has attained a solid patent position in the RF world, earning royalties on product sales from some of its leading competitors, some of whose products have been found to infringe ArthroCare patents. In mid-2005, the latest in ArthroCare patent infringement came to a close when the company signed a worldwide product supply agreement with Smith & Nephew Endoscopy through which it will manufacture bipolar and monopolar arthroscopy products for global sale by Smith & Nephew. A joint licensing agreement will also provide ArthroCare with royalty payments for all bipolar products sold by Smith & Nephew in the U.S. and for that company’s bipolar shaver products manufactured and sold worldwide.

Waterjet technology has been used for many years in precision cutting. Both Hydrocision and Erbe have developed ultrahigh-pressure fluidjet technology systems for use in orthopaedic procedures. Erbe’s system has application in percutaneous discectomy and synovectomy, while Hydrocision’s systems have found a place in wound debridement (TraumaJet through Smith & Nephew), cutting, ablating and shaping soft tissue, and decorticating, removing and smoothing bone in arthroscopic procedures (ExoJet through Mitek) and, through Hydrocision for spine.

Lasers, too, have use in the removal and shrinkage of tissue in arthroscopic procedures. However, despite their having been on the market for decades, lasers have not made great inroads into the segment, largely due to their cost.

With respect to soft tissue repair technologies, biologics (See Orthobiologics.) continue to grow in popularity, as do resorbables. Arthrex, Arthrotek, ConMed, Mitek, Smith & Nephew and others market full lines of implants (resorbable and metal) for most soft tissue applications in all joints. Storz, Stryker and U.S. Surgical continue to build their soft tissue repair franchises, with Stryker often partnering with smaller companies that have expertise in soft tissue repair technologies.

In 2005, faced with slower than anticipated sales by its distributors, Inion has begun discussions with new distributors for its sports medicine, dental and spinal products. Inion is also developing resorbable plating systems for spinal fusion/fracture repair and suture and tendon anchors for knee and shoulder reconstruction and will continue development of its OPTIMAPLUS technology that features small quantities of active compounds added to the polymer to promote healing.

Stryker Endoscopy also handles worldwide distribution of Biocomposites’ Biosteon interference screw technology (calcium hydroxylapatite (HA) and poly-L-lactic acid (PLLA) for ACL/PCL reconstruction using bone-tendon-bone/semitendinosus tendon and allograft. ArthroCare distributes Biocomposites’ line of resorbable composite screws including the BiLok ST (soft tissue) screw for ACL reconstruction and transverse fixation in femoral hamstrings, based on PLLA and calcium phosphate. Bilok was the first synthetic PLLA/calcium phosphate composite ACL interference screw to receive both CE Mark approval and FDA clearance.

Artimplant has worked for years to commercialise products based on developed numerous resorbable polyurethane scaffold technologies. In late 2004, the company received FDA clearance for the Artelon CMC-I Spacer for treatment of thumb base arthritis. Avanta (now part of Small Bone Innovations) distributes the Spacer (known as the TMC Spacer in Europe) outside of Scandinavia. Artimplant and Biomet signed a global development, license and supply agreement for a soft tissue repair implant product based on Artimplant’s Artelon technology. The companies’ first product under development is a tendon augmentation device which could be launched globally by the end of 2005.

Additional Artelon-based products have received CE Mark approval, including a bone scaffold, a membrane (e.g. soft tissue barrier, bone graft containment), an Augmentation Device ACL (first implanted in 1997) and a suture with application in tendon and ligament repair (also cleared in the U.S.). Future projects for Artimplant include development of Artelon for soft tissue reinforcement and as a bone void filler for orthopaedic applications.

Kensey Nash supplies a broad range of biomaterials-based sports medicine products for Arthrex. In addition, Kensey received FDA clearance to market its BioBlanket Surgical Mesh, manufactured from the company’s proprietary resorbable collagen sheet technology. Initially cleared as a patch for soft tissue reinforcement and repair, FDA granted Kensey expanded indications for the Mesh specifically for the reinforcement of soft tissue in rotator cuff repair procedures. Kensey’s orthopaedic development programs with the collagen technology include those targeting bone graft containment.

Invibio, a subsidiary of Victrex, is a leading manufacturer of polyetheretherketone (PEEK) plastics. The company provides PEEK-OPTIMA polymers to a wide range of orthopaedics companies throughout the world for such applications as finger implants, interbody fusion cages, hip stems, acetabular cup (as reinforcement) and, in sports medicine, as suture anchors, interference screws, washers, etc.

Other novelties in soft tissue repair have emerged through the efforts of Axya Medical, Bonutti Technologies and Opus Medical (now ArthroCare), all of which have commercialised technologies that obviate the need for knot tying during arthroscopic procedures. KFx Medical and MedicineLodge have also developed improved technologies for soft tissue repair.

Axya Medical introduced its AxyaWeld instrument for arthroscopic soft tissue repair in the late 1990s. The product incorporates the AxyaLoop, a suture loop that is secured with ultrasonic energy. In 2004, the company signed on ArthroCare for distribution of its bone anchors and select accessories and has since received clearance to market a resorbable bone anchor system. Axya will further develop wound closure technology and additional products for its Axya Shoulder Fixation System, which it claims is the only knotless fixation system capable of performing all shoulder repairs.

Bonutti’s Unity Ultrasonic Fixation system utilizes an absorbable “fixation seat” that is loaded with suture and introduced endoscopically. Once the seat is in place, the suture is tensioned and the seat is ultrasonically welded to the suture. Through the technology, the surgeon need not tie knots.

The AutoCuff System from ArthroCare incorporates a suturing device with a knotless fixation implant for use in rotator cuff repair, Bankart repair and SLAP lesion procedures. With both CE Mark approval and FDA clearance, the AutoCuff system has found use in more than 20,000 rotator cuff repair procedures.

Following in the footsteps of Opus, KFx Medical hopes to further improve rotator cuff repair and is developing a minimally invasive technique for shoulder surgery in which the rotator cuff is secured to the bone using improved attachment techniques. Submission of materials to FDA could come in early 2006, with potential product launch in the second half of 2006.

MedicineLodge’s ZipKnot suture fastener received clearance in the U.S. for approximation and/or ligation of soft tissues using sutures. The suture fastener obviates the need to knot tying outside the body and is deployed with a knot pusher. MedicineLodge seeks marketing/distribution partners for the product.

Ortheon Medical markets its Teno Fix system for the repair of severed or lacerated digital flexor tendons worldwide, with more than 1,000 procedures performed with the device in the U.S. since its FDA clearance in 2003. The TenoFix technology incorporates a stainless steel soft tissue anchor that attaches to the collagen fibers inside a tendon and supports significant load, thus allowing for active motion postoperatively and hence more rapid return to normal motion in the hand. Ortheon also markets the Teno Fix ACP, an arthroscopic suture cutter and knot pusher.

Synthetics used in repair/replacement of ligaments find a market primarily in Europe. Companies marketing synthetic ligaments include Corin (Ligament Augmentation and Reconstruction System for PCL, ACL, ankle and shoulder repairs), Cousin Biotech (intra- and extra-articular ligaments), Ellis Development (Nottingham Hood polyester soft tissue reinforcement device for rotator cuff repair), FH (Tenolig for Achilles tendon), Fixano (acromioclavicular ligament and Achilles tendon replacements), the Neoligaments division of Xiros (Leeds-Keio Connective Tissue Prosthesis for patellar ligament and quadriceps tendon repairs and the Leeds-Keio ACL), Orthomed (Ligastic polyethylene terephthalate for medial collateral ligament reinforcement, acromioclavicular separation and trapeziectomy), Surgicraft (coracoclavicular ligament reconstruction, composite ACL ligament, other tendon/ligament augmentation), Teknimed (Achilles tendon reinforcement) and Telos Medical (synthetic ACL ligament).

To complement their lines, many arthroscopy and soft tissue repair companies also market postoperative pain pumps or other types of technologies for use in treatment of soft tissue pain. Sgarlato entered the pain pump market first with its portable pain control infusion pump, which releases analgesics continuously. Advanced Infusion, Breg/Orthofix, dj Orthopedics, I-Flow, McKinley, Sorenson, Stryker Instruments and Zimmer (through an agreement with Baxter) also sell pain pumps.

Pain management for soft tissue applications also comes in the form of ESWT. Companies and systems available outside the U.S. for use in treatment of chronic, painful soft tissue orthopaedic disorders like lateral epicondylitis, calcific tendonitis of the shoulder and plantar fasciitis include Direx Medical (Orthima), Dornier (Epos Ultra), Medical Technologies & Services (OrthoWave), Medispec (Orthospec), Orthometrix (Orbasone), SanuWave (OssaTron), Siemens Medical Solutions (Sonocur), Sonorex (representing Siemens in certain countries) and Storz Medical (MiniLTH and Masterpuls).

In the U.S., Dornier, Medispec and SanuWave market systems for plantar fasciitis, with ESWT systems from SanuWave and Siemens/Sonorex available, as well, for treating lateral epicondylitis. SanuWave acquired the orthopaedic ESWT business from HealthTronics in the fall of 2005 and will focus on non-urological shockwave therapies, while Orthometrix will pursue a PMA for the Orbasone device, which is manufactured by Kimchuk. Future indications for ESWT in the soft tissue arena may include treatment of supraspinatus tendon syndrome, medial epicondylitis, patellar tendonitis and achillodynis.

For instance, Beiersdorf and Smith & Nephew agreed to divest of their joint venture, BSN Medical, which focuses predominantly on casting, splinting, orthopaedic soft goods, fracture bracing, etc. dj Orthopedics led the way with strategic alliances, acquiring distribution rights to a new back bracing system, acquiring assets for a stock and bill soft goods/rigid bracing business; and, finally, purchasing one of its Scandinavian distributors and the orthopaedic soft goods business of Encore Medical.

Ossür, which acquired Generation II in 2003, added Royce Medical to its portfolio of companies, expanding its orthopaedic bracing and supports business and Tailwind Capital purchased Aircast, best known for its ankle and walking braces. Amid all the positive momentum, Bledsoe Brace filed for Chapter 11 bankruptcy protection following the loss of a patent infringement case brought by Generation II Orthotics.

While orthobiologics will contribute greatly to growth in the arthroscopy/soft tissue repair market into the future, so too will increased activity levels and related sports injuries worldwide, introduction of procedure-specific technologies and improved resorbables and visualization systems. The use of computer-assisted surgery, too, will find an increased role in the repair of soft tissue injuries, with particular application in ACL repair.

Excerpted from The Worldwide Orthopaedic Market –2004-2005 and used with permission of Knowledge Enterprises, Inc. The Worldwide Orthopaedic Market is published yearly by Knowledge Enterprises, Inc. and is available exclusively to Members of The Institute for Orthopaedics™.