Pinn-ACL® CrossPin System Welcome
Transcription
Pinn-ACL® CrossPin System Welcome
DEC | 2005 | Issue NO. 1 ConMed Linvatec Sports Medicine News and Product Information Welcome in this issue: Clinical Focus Theory of the ThRevo™ Stephen J. Snyder, MD 2 Impact™ Suture Anchor 4 The “Complete System” Soft-Tissue ACL Reconstruction 2, 3 Surgeon Testimonial: Pinn-ACL CrossPin System 3 What‘s New Pinn-ACL CrossPin System 1 3 New Advances In Sports Medicine 6 Meetings and Workshops 6 We look forward to your feedback about the premier edition of THE SPORTS MEDICINE NEWSLETTER. Please email us at: [email protected]. Customer Service Phone: 1-800-237- 0169 Fax: 1-727-399-5256 International Fax: 1-727-397- 4540 Web: www.linvatec.com e-mail: [email protected] ©2 005 Linvatec Corporation, a subsidiary of ConMed Corporation, 11/05, COS 9107 With over 40 years of experience, ConMed Linvatec is recognized as a leader in the development and manufacture of arthroscopic instrumentation. We pioneered the development of the first disposable arthroscopic shaver blade, manufactured the first bioabsorbable interference screw, introduced the first autoclavable 3-chip video camera, and we are the global market leader in fluid management systems. Additionally, our commitment to Medical Education has served to build strong relationships with our customers worldwide. Utilizing our expertise in biocomposite materials, surgical instrumentation, and implant development, ConMed Linvatec continues to provide new and innovative products, the aim of which is to reduce healthcare cost, enhance surgical efficiency and most importantly, improve clinical outcomes. With facilities in Largo, Florida, Santa Barbara and Anaheim, California, and Tampere, Finland, ConMed Linvatec is well positioned to provide these new products and technologies today, and into the future. I hope that you will find this newsletter to be educational and informative. We look forward to receiving your feedback and input into future issues. Sincerely, Gerald Woodard President, ConMed Linvatec Pinn-ACL CrossPin System ® Orthopedic Fracture Fixation Calendar It is with great pleasure that I welcome you to the premier issue of the ConMed Linvatec Sports Medicine Newsletter. The purpose of this quarterly publication is to keep you, our customers, up to date on the latest products, techniques, and technology in the area of arthroscopic surgery. In each edition of this newsletter, clinicians and medical educators from around the world will share the latest in surgical techniques, clinical pearls of wisdom, innovative technology applications, and much more. ConMed Linvatec is pleased to announce the release of the Pinn-ACL CrossPin System instruments and implants. This system is designed for transverse femoral fixation of soft tissue grafts in Anterior Cruciate Ligament reconstruction, allowing for increased pull-out strength. With the pull-out strength of the Pinn-ACL CrossPin implant at approximately 1700* Newtons, the femoral fixation greatly surpasses normal forces applied to the reconstructed ACL during the rehabilitation phase. With existing systems on the market, the concern has been the possible deforming of the femoral tunnel when using a wire to pass the graft or the damage to the collagen fibers caused by spearing the graft with pins. Lastly, the lack Features: CrossPin material (SR-PLLA) Graft Harness and CrossPin interface of confidence in a solid graft-to-pin interface may result in post-operative concern for adequate fixation of the graft. Our system passes the graft using standard techniques of graft/tunnel sizing, protects the graft using our Graft Harness system with the high strength polyethylene Dyneema fiber loop, and allows the surgeon to see the exact path of the CrossPin through the Graft Harness. Utilizing a scope in the transverse tunnel, the unique system and surgical technique allows the surgeon to visualize the exact point of femoral fixation. Precision, reproducibility and confidence are built into the Pinn-ACL CrossPin System! Benefits: –Proven bioabsorbable – Superior implant strength – Increases pull out strength –Prevents graft slippage and micro motion – Eliminates need to spear the graft Unique surgical technique – Instrument design incorporates – 3-point precision reference system High-strength fiber, – continuous loop design – Allows for scope visualization of transverse tunnel and Graft Harness to CrossPin interface Allows for consistent accuracy in transverse tunnel placement and implant cortical length selection Offers an atraumatic graft passing/fixation design 360° graft to bone contact providing more surface area contact S p orts M edicine 2 Theory of the ThRevo® Anchor Stephen J. Snyder, MD From the time of Codman, it has been recognized that the torn rotator cuff has the ability to heal to the prepared humeral tuberosity if it is securely anchored to the exposed cancellous bone without unphysiologic tension. The pioneers of shoulder surgery advocated using simple or mattress sutures passed through bone tunnels adjacent to the edge of the articular cartilage to secure the fixation. The assumption was that securely attaching the torn tendon to bone with the least possible tension was the best way to insure that it would heal. The most important factor was the security of the attachment sight and not the vaunted “footprint”. Never before in the history of shoulder surgery has a respected shoulder surgeon deemed it necessary to pull the tendon out to an unnatural length in order to reestablish a “footprint” on the tuberosity. If that were the case, shouldn’t present-day shoulder surgeons be reporting unacceptable failures in their arthroscopic cuff repair cases? The ThRevo anchor was developed to augment the strength of the suture fixation of the torn rotator cuff tendon to bone using the theory of a single medial row. By using three, rather that two sutures per anchor the number of balanced fixation points in the cuff can be increased using the minimal number of anchors. The ThRevo eyelet has been designed in a horizontal orientation so that each of the three sutures will slide independently of the other two allowing use of secure sliding locking knots. The sutures may be passed in various patterns: as three simple sutures, a central mattress with two outside simple sutures or as a Castagna stitch having the central suture function as a horizontal rip-stop or “Mac”stitch and the outside simple sutures passing medial to it. Recently there has been an incredible flood of reports and podium presentations extolling the potential benefits of using an additional row of suture anchors. The suggestion is that by having one row of sutures at the edge of the cartilage and another further lateral on the tuberosity, cuff healing will somehow be enhanced. Without any proof of this theory, the proponents have speculated that this practice of applying an additional percentage of the cuff tendon to the bone over the native footprint will improve the healing of the tendon to bone. There is no doubt that adding additional sutures to hold the cuff stump will increase the pullout resistance and should thereby promote more secure fixation to bone. But the methods suggested to increase the holding power by using additional anchors to make available more sutures seems unnecessary. A damaging consequence that may ultimately arise from lateral placement for “double row” surgeon testimonial: Pinn-ACL CrossPin System “…my initial feeling is that the reconstructed knees feel more solid with less laxity compared to my previous techniques,” said Dr. Haw Chong Chang of Changi General Hospital, Singapore. “It is exciting! The ability for me to visualize and confirm the positioning of the pin through the harness hole provides a lot of confidence during femoral fixation.” Dr. Haw Chong Chang Changi General Hospital, Singapore repair may be that as a shortened tendon and it’s contracted muscle are subjected to unnatural stress causing the muscle to stretch beyond the natural Starling muscle-tension curve. This stress in a chronic situation may lead to either overstrain injuring the muscle or the eventual stretching and failure of the cuff repair as it reverts back to the normal resting tension or “tension overload”. (Ref.1) The “theory of the ThRevo anchor” is simply to employ an inexpensive method to maximize the fixation of the torn tendon to bone using three rather than two sutures from each anchor. It has been proven by Morley and Barber (Ref 2.) that this ThRevo method increases the holding power of the fixation system by approximately 50% per anchor (compared to two sutures per anchor) without requiring extra anchors or increasing the tension on the repair. Unless and until honest and respected shoulder surgeons demonstrate that using additional suture anchors to form a lateral row actually promotes better healing of the torn rotator cuff it makes no sense to add additional cost, time and difficulty to the rotator cuff repair operation for no proven benefit. Ref. 1 Burkhart SS, Diaz Pagan JL, Wirth MA, Athanasiou KA. Related Articles, Links Cyclic loading of anchor-based rotator cuff repairs: confirmation of the tension overload phenomenon and comparison of suture anchor fixation with transosseous fixation. Arthroscopy. 1997 Dec;13(6):720-4. Ref. 2 Barber F, Herbert M, Coons D. ThRevo Anchor Study. Spring AANA 2005; Poster Exhibit. S p orts M edicine 3 The “Complete System” Soft-Tissue ACL Reconstruction ConMed Linvatec strives to produce the best products available for use in arthroscopy. Our latest combination of products for soft tissue ACL reconstruction offers the surgeon a “Complete System” approach to obtaining a reproducible and balanced repair. By combining the Pinn-ACL® Femoral CrossPin system, which boasts a pullout strength of approximately 1700* N (Newtons), with the BioScrew® Xtralok® interference screw's tibial pull-out strength of approximately 1400*N, we approach the boundaries of a balanced repair. Using the SE (Stress Equalization) Graft Tensioning System, allows the surgeon to reproducibly distribute the load placed on the graft construct calculated from the individual bundle measurements, and “in-vivo” graft conditioning. By utilizing this system, the variability previously inherent in soft tissue ACL reconstruction has been greatly reduced, if not eliminated. AVAILABLE REFERENCES: Chang HC, Nyland J, Nawab A, Burden R, Caborn D. Biomechanical Comparison of the Bioabsorbable RetroScrew System, BioScrew® XtraLok® With Stress Equalization Tensioner, and 35-mm Delta Screws for Tibialis Anterior Graft – Tibial Tunnel Fixation in Porcine Tibiae. Am J Sports Med. 2005; Vol. 33, No. 7, 1057-1064. Volesky M, Pickle A, Bessette B, Wilkinson R, Dervin G, Johnson D. Comparison of XtraLok Versus Intrafix Tibial Fixation in Hamstring Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial. J Knee Surg. 2004; Vol. 17, No. 4, 249. *Pull-out data on file Orthopedic Fracture Fixation Demographically, with 6 billion people worldwide and two fractures per person per lifetime, the incidence of fractures likely will not slow over the next few decades. Couple these solid, healthy demographics with not only a more active population, but also increased industrialization and access to healthcare in certain parts of the world, and the future of fracture repair will continue to grow. Steady growth should characterize this segment of the market for decades. There is also a continued market shift towards resorbable and next generation devices. This will continue for at least the next five years. ConMed Linvatec is able to provide a patented “Self–Reinforced” bioabsorbable implant to facilitate repairs of fractures in the shoulder, elbow, wrist, knee, foot and ankle. Repairs of OCD lesions, ligaments, and corrective surgery necessary due to diseases of the bone and joints of the body are also accomplished by using our implants and repair systems. Market Drivers –Aging population –Less invasive procedures –Self-Reinforced implant design enhancements –Simplified instrumentation sets –Continued market shift towards resorbable fixation devices –Growing number of arthroscopy and open procedures The following is a list of the repair systems available for this product line: SmartScrew® SmartNail® (Bone Fixation Kit) SmartPin® SmartTack® Please contact your local Sales Representative for additional information. S p orts M edicine 4 Impact™ Suture Anchor ConMed Linvatec’s latest bioabsorbable implant, the Impact Suture Anchor, is unique – it is among few suture anchors that can be used for both instability and rotator cuff repairs. The development of the implant, instrumentation and surgical technique was done in conjunction with two world-renowned shoulder surgeons: Mark Field, M.D., of Baton Rouge, Louisiana, and Jeff Abrams, M.D., of Princeton, New Jersey. The Impact anchor's notable wing design is rotated under the cortical layer of bone and is toggled to lock it in place. This “active toggle” system is distinct compared to the other “passive toggle” anchors that may not consistently lock into the bone. The Impact Suture Anchor is made of a SelfReinforced PLA copolymer that retains 90 percent strength for approximately 20 weeks and, over time, breaks down and is eliminated from the body. The unique cone shape and wing provide a tight fit on the inserter and allow for simple and consistent deployment in the bone. This anchor is pre-threaded with two different color strands of non-absorbable, braided, polyester suture, or our highly successful Herculine™ high-strength suture. These sutures are in separate compartments of the suture handle, which means they do not tangle during insertion — a real time saver in the operating room. Additionally, the sutures are pre-threaded through separate eyelets for independent and simple suture manipulation and management. Key Product Specifications: The Impact Suture Anchor is accompanied by several reusable instruments including a Notcher for hard bone, Drill Guide, Drill Guide Obturator, 3.5mm Drill Bit and Sterilization Tray. Furthermore, due to its size and unique shape, the Impact anchor should be your top choice when another anchor has pulled out of the bone and left you with a large pilot hole to fill. This anchor toggles horizontally and therefore will fill most voids left behind by another anchor. This makes the Impact your ultimate “back-up” anchor. – Material = SR – 96L/4D PLA – Cone diameter = 3.5mm – Anchor length = 10.5mm –Pre-threaded with two strands of either #2 non-absorbable, braided, polyester suture or #2 Herculine™ High Strength Suture – Drill Bit diameter = 3.5mm Key Product Benefits: – Active toggle fixation system –Unique bioabsorbable anchor allows for quick, easy placement and setting in all bone types – Two sutures at one fixation point Mark Field, M.D. commented on his experience with the system, “the instrumentation allows me to create a consistent environment to deploy the implant in all types of bone. I have also seen a decrease in anchor pull-out with this implant compared to others I have used in the past. Finally, my OR personnel like the versatility of the implant because we can use it for multiple indications.” –Ideal system for instability and rotator cuff repair –Two separate eyelets allow the sutures to slide independently of one another –Ultimate “back-up” anchor due to size and unique wing design Impact Suture Anchor Strength Characteristics* 250 .................................................................................................................... Force (N) 200 .................................................................................................................... 150 .................................................................................................................... 100 .................................................................................................................... 50 .................................................................................................................... 227 N 133 N 188 N 0 * Data on file. #2 Suture (Ultimate Strength of Double Strand) Impact Anchor Pull-out (Anchor Pull-out Force Cadaveric Humeri study) Impact Anchor Pull-out (Anchor Pull-out Force Cadaveric Glenoid study) Call for Papers Abstract Deadline: January 16, 2006 Submit abstracts to: Laurie Hiemstra, M.D., Ph.D. and John Mehalik, M.D. Residents & Fellows Arthroscopy Conference 11311 Concept Boulevard, Largo, Florida 33773-4908 or E-mail submissions to: [email protected] For information: Contact Karen Sousa Conference Organizer (800) 325-5900, ext. 5349 The conference provides a forum for presenting original clinical and basic science research, an opportunity to exchange ideas with your peers and debate with an accomplished faculty, lead by Don Johnson, M.D., FRCS. Abstracts must represent original papers authored or co-authored by fellows or residents on subjects clinically relevant to sports medicine and arthroscopy. Abstracts should be one page in length, not to exceed two pages. Participants must be 4th or 5th year residents, fellows, or in their first year of practice to meet the eligibility requirements. First year practice participants must present papers from their residency or fellowship program the previous year. To maintain the informal atmosphere of this conference only 15 abstracts will be accepted for presentation. An educational grant is being provided by ConMed Linvatec, which includes accommodations and an airline ticket allowance. Provided through an education grant from ConMed Linvatec. S p orts M edicine New Advances In Sports Medicine Dr. Nick Sgaglione We live in exciting times as we all continue to witness with great interest several rapidly expanding and evolving trends in orthopaedics and in sports medicine – arthroscopy in particular. New developments related to the practical application of minimally invasive surgery, computer navigated techniques and biotechnology have captured our attention and our imagination and will no doubt continue to change the way in which we approach patient care. Most clinicians and basic scientists would agree that the next 5 years will most certainly yield exciting advances in the orthopaedic disciplines. bone graft substitutes and increasingly defined bioactive growth factors. In an effort to better focus our attention as clinicians on many of these rapidly changing biotechnologies, we have prepared a “state-of -the-art” symposium dedicated to “Biological Advances and Innovative Materials in Arthroscopy”. We look forward to an exciting and educational forum and interesting discussion. Up Coming Events 2006 5 – 7 January Southeastern Fracture Symposium Greensboro, NC 20 – 22 January OLC-AAOS/ASES Open and Arthroscopic Techniques in Shoulder Surgery Rosemonet, IL 27 – 29 January OLC-AANA Hip Course Rosemont, IL Most significantly, we can anticipate more practical articular cartilage biosurgery, more advanced complex biodegradable polymers, more controlled osteoconductive bioceramic You are invited to a symposium 6 3 – 5 February Ba FR g EE to X At -Ra te y nd ee s Biological Advances and Innovative Materials in Arthroscopy Faculty: Nicholas A. Sgaglione, MD F. Alan Barber, MD Self-Reinforced BioAbsorbable Implants Feature: • Increased mechanical strength • Withstand higher insertion forces • Offer selection of materials with varying degradation characteristics Proven combinations of benefits and attributes define the Material Advantage, which has allowed more than a million patients and surgeons to enjoy reproducible clinical outcomes. OCL-AAOS Advanced Techniques in Foot and Ankle Surgery Rosemont, IL 4 –7 February Arthroscopic Surgery 2006 (Metcalf) Sun Valley, ID 10 – 12 February OLC-AANA Shoulder Course Rosemont, IL 19 – 23 March AORN Washington, DC 20 – 24 March American College of Foot and Ankle Surgeons Mandalay Bay Resort, Las Vegas, NV 22 – 24 March American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting McCormick, Chicago, IL Register with your Business Card, or fill-out the form, at booth #100 30 March – 2 April Fall AANA • Desert Suite II December 2, 2005 5:30 pm to 6:30 pm OLC-AANA Resident Course Rosemont, IL Seating is limited to the first 50 registrants Exclusive gift to all registrants