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| Smarter Supply - Supply chain management in the orthopaedic devices market |
| Author: Eric J. Lewis, CEO, Doncasters Group |
| Endoscopic Spinal Surgery |
| Authors: Mr. Satish Kale, FRCS.Ed, Trauma Fellowship (NY, USA), Assistant Professor and Consultant; Dr.Samir Pilankar, Lecturer,
Department of Trauma and Orthopaedics, Dr. R.N.Cooper Hospital, University of Mumbai, India |
| The Use of the Arthroscopic Tightrope in Shoulder Injuries |
| Authors: Ford Qureshi FRCS (Tr & Ortho) - www.shoulderelbowsolutions.com and David Potter FRCS (Tr & Ortho) Shoulder & Elbow Unit, Department of Orthopaedics and Trauma, Northern General Hospital, Herries Road, Sheffield |
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Smarter Supply - Supply chain management in the orthopaedic devices market
Author: Eric J. Lewis, CEO, Doncasters Group 
Growth in the global orthopaedic devices market is being driven by favourable demographic trends. Longer life expectancies and lifestyle factors such as obesity are contributing to an increase in the incidence of osteoarthritis and osteoporosis worldwide.
To tackle these increasingly common ailments, surgeons are now recognizing the justification for paying more for newer products which provide better clinical outcomes and increased implant longevity. Meanwhile “generic” implants are still seen as reliable and efficient for older and less active patients in particular. Over 175,000 generic endosprostheses for example are implanted every year. With advances in surgery and technology, the list of generic products within the orthopaedic market is growing and now includes other related components such as compression plates used in trauma procedures.
These trends, combined with increased patient awareness, growing expenditure on health in many economies and higher procedural volumes, mean that the market for orthopaedic devices continues to expand.
As a result, the orthopaedics devices market is a dynamic one and traditional roles are changing. OEMs are now demanding more than just product from their parts suppliers. With limited manufacturing capacity, OEMs need and want to invest in R&D and marketing to target new and potential customers. OEMs are looking to their parts suppliers for improved service levels, a more integrated approach to projects and the ability to step up to the plate with supply chain partnership and management of risk. Cost-efficiency is of course paramount for OEMs, but not at the sacrifice of service or product quality. In fact, poor quality could cost more down the road in terms of increased finishing costs and liability concerns. So, highly efficient and quality low cost manufacturing options from parts suppliers is also a prerequisite.
This shift is putting suppliers under extra pressure to not only deliver quality parts at a competitive price, but also to bring advanced supply chain management skills to the mix. The drive now is for parts suppliers to add value for both existing products working in partnership with customers and offering new technologies to enable customers to enhance their products in the marketplace.
In light of this, innovation from parts suppliers is not just coming from new manufacturing techniques but also from new approaches to service delivery and supply chain solutions. In fact, these new demands provide an opportunity for parts suppliers to add real value with ‘end-to-end’ solutions incorporating supply chain management and additional services such as surface engineering, surface metallurgy, machining and finishing.
 End-to-end solutions
‘End-to-end solutions’ means the ability from parts suppliers to offer excellence in service delivery to OEMs – from drawing through to finished product. This long term approach can help OEMs to simplify their supply chain and accelerate time to market, reduce design and development costs and enable them to focus on strategic strengths such as sales and marketing.
 Smarter Solutions: an example from the field
Clearly, innovation in the orthopaedic parts market is coming from service delivery and supply chain solutions. For example, Doncasters Medical Technologies has developed an expert understanding of the challenges faced by OEMs in the manufacture of “generics” and is able to offer supply chain solutions which offer cost efficiencies without compromising on quality. Doncasters has closely examined both the market demands and the needs of its OEM customer base for generics. It has responded by structuring its supply chain to combine the expertise of Western manufacturing techniques with the efficiencies offered by manufacturing in low cost economies in order to offer OEMs a commercially competitive quality product.
Doncasters has opened a low cost manufacturing facility in Monterrey, Mexico, which operates to ‘Western’ standards (ISO 9001:2000 registered) and already offers the labour intensive machining and polishing of bespoke customer products such as build to print knees or hips. Backed by the ‘Western’ higher quality raw material supply from Doncasters’ European and North American operations and quality procedures, this supply chain system offers the quality and cost-effectiveness required by the OEM for generic products.
Final word
It is clear that the future of the orthopaedic products market will increasingly demand the ability from parts suppliers to offer OEMs the depth and breadth of capability efficiently and competitively with low cost manufacturing options. Smarter supply with ‘end-to-end solutions’ relies on mutual trust, partnership and a ‘one-team’ ethos between the OEM and the parts supplier. By seizing this opportunity, parts suppliers and EMs will both benefit from more integrated and efficient working relationships.
 Endoscopic Spinal Surgery
Low back pain is probably, the most common disease after common cold. By a conservative estimate, 90% of the population will at some point in life encounter low back pain. Of the many aetiologies of low back pain degenerative disc disease is the commonest.
Traditionally prolapsed intervertebral disc has been treated by open laminectomy and discectomy. Over the last 10 years many endoscopic techniques have been advanced through which discectomy is accomplished by a much smaller and thus a more cosmetic scar. Since muscle retraction and bone excision is also minimal there is reduced post-operative pain with early return to activity.
Authors: Mr. Satish Kale, FRCS.Ed, Trauma Fellowship (NY, USA), Assistant Professor and Consultant; Dr.Samir Pilankar, Lecturer, Department of Trauma and Orthopaedics, Dr. R.N.Cooper Hospital, University of Mumbai, India Historical background
Ottolenghi and Argentina in 1955 performed the first posterolateral biopsy of the spine. In 1983, Kambin and Gellman performed modified arthroscopic lumbar discectomy using a working sheath of 6.5 mm outer diameter. In 1993, Mayer and Brock discussed the use of endoscope for percutaneous discectomy and in the same year, Dr. Jean Destandau performed endoscopic discectomy by the posterior approach. Subsequently Smith et al designed instruments and dedicated endoscopy equipment for a microendoscopic approach to the lumbar spine.
Mack et al in 1993 published the results from the first thoracoscopic spine series, which led to development of equipment capable of performing biopsies and drainage of paravertebral abscesses. Around the same time use of laparoscopic techniques to approach the lumbar spine also gained popularity. Thoracoscopic and laparoscopic intervertebral fusion and instrumentation are now, routinely performed at specialized centres worldwide.
The difference between Microdiscectomy and Endoscopic discectomy
Microdiscectomy is the procedure of disc excision with the aid of loupe magnification or a surgical microscope through an open yet limited “smaller” incision.
Endoscopic discectomy is performed with the aid of the endoscope and only uses “stab” incisions, enough to allow insertion of narrow instruments. The operation is monitored on video-TV unit. More importantly the endoscopic techniques approach the anatomical structures from without the spinal canal.
Indications for Endoscopic Spine Surgery
Disc prolapse and spinal stenosis Presently these are the main indications for posterior endoscopic lumbar surgery. Lumbar canal stenosis can be decompressed by either the uniportal or biportal technique. With conventional surgery, the surgical management of the lateral disk is technically difficult. Open procedures require extensive muscle dissection and may have a destabilizing effect on the spinal architecture. Excessive facet resection can complicate about 2% of decompressions for spinal stenosis and cause recurrent leg and back symptoms. With endoscopic discectomy, stripping of the paraspinal musculature and soft tissue trauma are minimized thus causing minimal morbidity and complications. The risks of causing post-operative iatrogenic instability is also low. Contraindications There are no absolute contraindications for these techniques as a trained endoscopic spine surgeon can tackle most if not all disc problems endoscopically. Relative contraindications are extreme instability and epidural scaring at the operative site. Instability warrants instrumentation and fusion, while in epidural scaring the risk of dural tear and neural injury is high in endoscopic techniques. Another relative contraindication is inexperience of the operative surgeon. Techniques Three major techniques are in vogue to tackle spinal symptoms: (A) Posterior endoscopic approaches (B) Thoracoscopic surgery (C) Laproscopic surgery (A) Posterior Endoscopic Lumbar Surgery 1. Triangular Working Zone: This procedure involves placing a needle in the “triangular working zone”. This triangular working zone, defined by Kamin and Gellman, is bordered superiorly by the exiting nerve root, medially by the proximal articular process and dural sac and inferiorly by the endplate of the inferior vertebra. The sinu- vertebral nerve and the vertebro-medullary branch of the segmental artery lie superior to the triangular working zone and are not usually at risk. Several venous structures often cross the working zone and need to be carefully retracted or coagulated. 2. Portals: 2a. Postero-lateral portal is the classic endoscopic approach, which allows easy access to the annulus, disk, lateral recess, foramen and the far lateral spine. 2b. Posterior Paramedian Portal This portal is a supplement to the postero-lateral portal. The skin stab incision is made on the contralateral side to the postero-lateral portal, approximately one centimeter from the midline. The needle is inserted through the interspinous ligament and ligamentum flava, just medial to the inferior articular facet. 2c. Posterior Midline Portal This portal establishes entry into the posterior or lateral epidural space and provides access to the central and paracentral portions of the intervertebral disk. It is possible to advance the endoscope into the lateral recess from this portal for addressing pathology directly under the pars. 2d. Transforaminal Portal In this technique, an endoscope can be passed into or through the neuroforamen and provides access not only to the epidural and intra-discac lesions but can also access pathology from the axilla of the nerve root to the lateral pedicle. 3. Technique of Posterior endoscopic discectomy: With the patient prone the disc level is localized on image intensifier and the incision taken slightly paramedian. Following this the outer tube with obturator is introduced so that the outer tube rests on the lower half of the lamina & the upper half on the ligamentum flavum. Now the ligamentum flavum is cut & excised cranio-caudally. The medial facet is undercut. The nerve root is identified & retracted with a special nerve root retractor incorporated in the system. This presents the disc to vision which is now excised with disc forceps. If lumbar canal stenosis is evident on the MRI the undersurface of the spinous process and contralateral lamina can be nibbled at.
With the patient positioned prone the level is localized with image intensifier. The skin incision for the portal is located approximately 8-12 centimetres from the midline and the path for instruments is established with a needle introduced under fluoroscopy into the triangular working area (Fig. 1). Now dilators are introduced over the guide wire and finally introduce a cannula over the dilator and is docked with the disc. Through the cannula the scope and instruments are introduced and discectomy is executed (Fig.2)
Posterolateral systems approach the disc posterolaterally and involve very little bone excision. This cannot tackle concomitant canal stenosis and also cannot excise discs which have migrated caudally or excessively. Posterior systems approach the disc through the interlaminar window. This involves slight excision of the lower edge of the lamina. The ligamentum flavum is also excised and the medial facet is undercut. Advantage with posterior systems is that any concomitant lateral canal stenosis can be tackled at the same time. Migrated discs do not pose a problem in this system. 6. Tubular Lumbar Microdiscectomy: The technique used is similar to traditional open surgery except that a tubular retractor is used, placed through a small incision centered over the lumbar pathology. By using a muscle-splitting approach and sequential dilator, a working channel is established which allows passage of instruments and use of microscope or endoscope for visualization and intervention. (B) Thoracoscopic techniques [VATS] Thoracoscopic techniques, initially introduced in 1910 have gradually developed attempting to overcome the morbidity associated with open thoracotomy procedures. These newer techniques avoid the risk of shoulder girdle dysfunction and intercostal neuralgia is low. Video Assisted Thoracoscopic Surgery (VATS) has replaced most open thoracotomy procedures. Thoracoscopic techniques are useful in midline thoracic disc herniation, for biopsy and debridement of infections and tumours and as adjuvant in managing spinal deformities. Thoracoscopic bone grafting and spinal fusion and instrumentation are now being increasingly performed at specialized centres. Technique: Thoracoscopy is performed with the patient under general anaesthesia with a double lumen endotracheal tube. With this the contralateral lung is inflated and the ipsilateral lung is actively deflated. 4 portals are required. The viewing portal is made on the anterior axillary line followed by the rest of the portals for introducing the instruments. Advantages: In properly selected patients, thoracoscopic procedures reduce incisional pains, reduce chest tube drainage, minimize respiratory difficulties and improve shoulder girdle function. (C) Laparoscopic spine surgery Laparoscopic spine procedures are generally indicated to manage anterior lumbar spine pathology (the vertebral body and the intervertebral disc). Specific applications include biopsy and debridement of tumours and infection, fusion for pseudoarthrosis, deformity or instability and discectomy for herniated or degenerative disks. Technique: Three laparoscopic techniques have been described: 1. Transperitoneal approach Carbon di-oxide gas is used to insufflate the intraperitoneal space. Instruments are then introduced through special portals for diagnosis and intervention. This is an excellent technique for approaching L5-S1 pathology. 2. Retroperitoneal approach The laparoscopic retroperitoneal approach provides the same approach as the standard retroperitoneal approach. Therefore unlike the transperitoneal approach this can be applied to the entire lumbar spine. The viewing portal is established through a small incision in the left flank just superior to iliac crest. After bluntly dissecting the retroperitoneal space with a digit the dissecting balloon is introduced and inflated under laparoscopic visualization to create a working space and allows access to the lumbar spine. A second portal is made on the anterior abdominal wall lateral to the peritoneal reflection to introduce instruments into the abdomen. 3. Endoscopically assisted mini-laparotomy This technique combines the benefit of laparoscopy and that of open surgery. The primary goal of the endoscopic portion of the procedure is to develop the retroperitoneal space while minimizing tears to the peritoneum. Pitfalls and Complications of Endoscopic Spinal Surgery
Endoscopic discectomy has a steep learning curve and poses several challenges for the aspiring surgeon; the most essential of which is mastering hand-eye co-ordination. Also working with long instruments without tactile feedback can lead to iatrogenic injury to important anatomic structures. There is lack of depth perception as 3-dimensional structures are viewed in 2-dimension. A thorough knowledge of surgical and endoscopic anatomy is essential for achieving success in endoscopic surgery.
The complications encountered are dural tears with CSF leak, neural injury, recurrent disc herniation due to inadequate disc removal and wrong level surgery. Incidence of discitis is less than that of open procedures as the incision site is smaller & the instruments for discectomy go through the outer tube and do not touch the skin prior to entry.
The complications of thoracoscopy are much lesser as compared to open thoracotomy. Pulmonary complications, most commonly atelectasis occur in 10-15% of the patients is easily managed with chest physiotherapy. Injury to dura can occur if the pathology is adjacent or adherent to the dura. In case of such an eventuality primary repair should be done. If required open thoracotomy should be considered.
In Laparoscopic spine surgery, visceral injury can occur ( 1% of all the procedures) including intestinal, urinary tract & vascular injury with overall mortality rate of 4-8 deaths per 100,000 procedures. A constant pneumoperitoneum can result due to gas insufflation. The newer system using gasless retroperitoneum & laproscopic assisted mini open processes eliminate the risks from a constant pneumoperitoneum.
Summary
In properly selected patients endoscopic spine surgery gives excellent results with minimal complications. Apart from an aesthetic scar there is minimal postoperative pain with early return to activity. With good technique the anatomical structures are better visualized with reduced risk of dural leak or nerve root injury.
References
The Use of the Arthroscopic Tightrope in Shoulder Injuries
Fractures of the clavicle and acromio clavicular joint (ACJ) dislocations are common shoulder injuries. The ACJ is made up of two bones (the acromion and the clavicle), four ligaments (the ACJ ligaments, the conoid ligament and the trapezoid ligament) and a meniscus. The ACJ ligaments provide horizontal stability to the ACJ and the coracoclavicular ligaments (conoid and trapezoid ligaments) provide vertical stability to the ACJ.
One quarter of all clavicular fractures are of the lateral end of the clavicle1 and result from a direct fall onto the shoulder, usually from a fall with the arm adducted close to the body. If this type of clavicular fracture is treated non-operatively then 50 percent will result in an established non union2. A similar fall may cause an acromioclavicular injury which may result in a simple sprain or a complete rupture of the coracoclavicular (CC) ligaments and/or ACJ ligaments. These have been classified as follows3: a type I is a simple sprain of the ACJ, a type II injury is a disruption of the ACJ ligament with intact CC ligaments, type III sprains cause a complete displacement of the clavicle due to disruption of the ACJ and CC ligaments. Types I to III are the commonest. A Type III dislocation is usually considered if on the X-ray the distal end of the clavicle is elevated more than or equal to 75% to 100% of the width of the articular surface of the distal clavicle. A type IV injury is a type III but with posterior displacement of the distal end of the clavicle into the trapezius and a type V injury is when there is more than or equal to 125% to 200% of superior displacement of the distal end of the clavicle on the X-ray.
Neer classified fractures of the lateral end of the clavicle into three groups4.Type 1 fractures are stable undisplaced with the coracoclavicular ligaments are intact. Type 2 fractures are unstable and the coracoclavicular ligaments are detached from the medial fragment. Type 3 fractures occur distal to the coracoclavicular ligaments and have an intra-articular extension into the acromio-clavicular joint. Recently, two further fracture groups have been added.has been Type 4 fractures. Type 5 fractures are comminuted.
An ACJ sprain is a more common injury than a fracture and a concomitant meniscal tear may also occur as part of these injuries.
The increased risk of non union is well documented with lateral end of clavicle fractures, especially when the fracture is displaced and most authors propose primary fixation of this fracture type to avoid this complication5,6. Similar to any other joint in the body, if the acromioclavicular joint is injured there is an increased risk for painful arthritis to develop. Painful instability may also occur with type III ACJ dislocations.
Despite several described methods of fixation the most optimal method of fixation for these injuries remains debatable. Surgical fixation methods of fixation have included K-wire or screw fixation7, hook plates8, coraco-clavicular screw fixation9 and Dacron slings10,11.
Authors: Ford Qureshi FRCS (Tr & Ortho) - www.shoulderelbowsolutions.com and David Potter FRCS (Tr & Ortho) Shoulder & Elbow Unit, Department of Orthopaedics and Trauma, Northern General Hospital, Herries Road, Sheffield
Surgical Technique
The patient is placed into the beach chair position and administered with a general anaesthetic as well as an interscalene block. The fracture/ACJ dislocation injury is reduced by pushing down on the medial aspect of the clavicle and upwards on the elbow. The injury can be temporarily held with a transacromial transfixation K-wire inserted percutaneously, through the lateral edge of the acromion and into the medial clavicular fragment. The position is confirmed using fluoroscopy.
With an established posterior glenohumeral viewing portal, an anterior inferior portal is created in the rotator interval and debrided. The soft tissue and periosteum is then debrided from the inferior surface of the coracoid process so as to expose it, using a shaver and/or a radiofrequency probe. A small incision is then made over the clavicle 3 cm from the acromioclavicular joint in the line of Langers and the superior aspect of the clavicle is exposed.
References
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