Variable Angle LCP Medial Column Fusion Plating System ®

VALUE ANALYSIS BRIEF Value Summary

Introduction

• The goal of medial column fusion is to decrease pain and improve function in patients with a multitude of etiologies including pes planus or flat foot deformities, Charcot arthropathy, trauma, post-traumatic degenerative joint disease, and rheumatoid arthritis.1,2 • Each patient presents with characteristic deformities across the involved joints. Early stages may respond well to aggressive conservative management, yet more severe deformity necessitates prompt surgical therapy to halt the progression of the disease. Later disease stages require more complex procedures or amputation.3 • Early complications of surgical treatment include wound problems, malunion, and nonunion.4,5 This is due to the fact that many standard operative techniques and implants often lack stability and subsequently fail.5 • The Variable Angle Locking Compression Plate (LCP®) Medial Column Fusion Plating System is designed for complex fusion applications, specifically Charcot foot, severe arthritis, and advanced deformities: – The three plates and screws in the system are optimized for strength, durability, and anatomic fit to address different deformities and anatomies. – Compression instrumentation was designed to aid in joint compression and promote procedural efficiency of the surgical technique. – The Variable Angle LCP Medial Column Fusion Plating System is designed for ease of use and to streamline hospital inventory. This system provides surgeons with the choices they need while promoting hospital standardization strategies.

This value brief presents information on the potential clinical, patient, and economic benefits of using the 3.5 mm Variable Angle LCP Medial Column Fusion Plating System for a variety of medial column fusion applications. The referenced data were obtained through a MEDLINE search for clinical and economic studies published from 2004–2014 and resulted in a total of 213 papers. Papers were selected for use in this value brief based on the rigor and relevance of the clinical and economic data. Recently completed biomechanical studies were also included to support the design features underlying the value propositions for the system.

Background Burden of Illness and Unmet Need Adult acquired flatfoot deformity (AAFD) embraces a wide spectrum of deformities.3 Each patient requires individualized treatment due to characteristic deformities across the involved joints. Early stages may respond well to aggressive conservative management; however, more severe AAFD necessitates prompt surgical therapy to halt the progression of the disease to stages requiring more complex procedures.3 • The foot can be divided into two major parts: the medial column and the lateral column. • The talus, navicular, cuneiforms, and the first three rays comprise the medial column. • The medial column has an adaptive function during the weight-bearing stage and acts as a stabilizer during the propulsive phase.

VA LCP Medial Column Fusion Plating System  Value Analysis Brief  DePuy Synthes Companies    1

Variable Angle LCP Medial Column Fusion Plating System

Clinical and Economic Burden Medial column fusion may be performed for a multitude of etiologies including Pes planus or flat foot deformities, Charcot arthropathy, trauma, post-traumatic degenerative joint disease, and rheumatoid arthritis.1 The most common reason for midfoot fusion is pain in the midfoot joints that has not improved with nonsurgical treatment. Other common reasons to do a midfoot fusion include too much motion of one or more of the midfoot joints or deformity of the midfoot.6 Diabetic arch deformity is typically a more severe etiology because diabetic patients do not feel pain as the arch collapses.7 The worldwide incidence and prevalence of diabetes and its complications are increasing, including secondary neuropathy and development of Charcot arthropathy, leading to a higher risk for foot ulcers and very poor function of the foot.6 The progressive character of instability due to arthropathy is associated with serious impairment of quality of life and an estimated 49% risk of recurrent ulceration with high risk for further infectious complications and eventually amputation.8,9 Melior Bold 10/13 Melior Bold 10/13 Charcot foot arthropathy creates a severe negative impact Melior Bold 10/13 on health-related quality of life for affected individuals, Melior Bold 10/13 leading to both substantial disability and resource Melior Bold Successful 10/13 consumption. deformity correction in patients Melior Bold foot 10/13 with Charcot can greatly improve quality of life, foster greater walking independence, and improve longevity. A recent retrospective observational study of patients with Charcot foot suggested that the cost of surgical care for Charcot foot is not that different from limb amputation during the first year ($56,712 vs. $49,251, respectively).10 Considering the possible quality of life gains with surgery, the poor survival rate following amputation in the diabetic population,11 and the considerable cost of amputation, it is not surprising that the trend among experts favors surgical correction of the deformity.10

The Future of Medial Column Fusion Care Experts continue to work to improve the outcomes of medial column fusion. New technologies in the development of plates and screws are evolving. Such technologies look to optimize the recovery of patients with medial column fusion12 and may result in better patient-centered (e.g., patient satisfaction and quality of life) care and economic outcomes. The use of better designed and stronger plating systems and enhanced compression techniques could also possibly decrease surgical time, anesthesia, and risk of infection.

The goal of the medial column fusion is to get the bones to heal together to decrease pain and improve function.2 Arthrodesis has proven to be reliable and reproducible in obtaining successful deformity correction and good clinical results.2,5 Early complications may include wound problems, malunion, or nonunion. These complications generally require further surgery to try and correct the problems. Optimization of surgical technique and instrumentation is the key to successful surgical outcomes.

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Variable Angle LCP Medial Column Fusion Plating System

3.5 mm Variable Angle LCP Medial Column Fusion Plating System* Three Plates Available for Complex Fusion Applications • The 3.5 mm Variable Angle LCP Medial Column Fusion plates are designed for complex fusion applications, specifically Charcot foot, severe arthritis, or advanced deformities. • This plating system consists of three plates designed to treat the following: – Dorsomedial or medial arthrodesis of the first naviculocuneiform and tarsometatarsal joints (Figure 1) – Dorsomedial or medial arthrodesis of the first naviculocuneiform and tarsometatarsal joints extending up to the talonavicular joint (Figure 2) – Plantar arthrodesis of the first naviculocuneiform and tarsometatarsal joints (Figure 3) • Variable Angle Locking screws are designed to sit flush in the plate holes to reduce the likelihood of soft-tissue irritation. • Precontoured plates are designed to promote procedural efficiency and potentially save time in the operating room by reducing the need for extensive intraoperative contouring of the plate to address the deformity.

Figure 1. Medial Column Fusion Plate for arthrodesis of the first naviculocuneiform and tarsometatarsal joints

Figure 2. Medial Column Fusion Plate, Talus Extension for arthrodesis of the talonavicular, first naviculocuneiform, and tarsometatarsal joints

Figure 3. Medial Column Fusion Plantar Plate for plantar arthrodesis of the first naviculocuneiform and tarsometatarsal joints

*For a complete list of indications for use, warnings, and precautions, please see the package insert or surgical technique.

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Variable angle lCP Medial Column Fusion Plating system

Evidence-Based Design: Plates Optimized for Anatomic Fit • the design of the Variable angle lCP Medial Column Fusion Plating system was based on a thorough analysis of cadaveric bones (n=31) from the university of tennessee bone bank:13 – the tennessee bone bank study assessed the overall footprint and shape of the medial column plates to ensure that the three plate types would fit the majority of the population. – the study included a wide range of specimens with varying height, ethnicity, age, and gender to account for different anatomies and patient types. – Critical measurements to confirm plate sizing included the following: - l ength of the medial column was evaluated by adding the average lengths of the first metatarsal, medial cuneiform, and navicular bone - W idth of the medial column, for dorsomedial placement, was assessed using the average heights of the first cuneiform, the first tMt joint, the proximal first metatarsal, and the distal first metatarsal - Width of the medial column, for plantar placement, was examined based on the average width of the medial cuneiform – screw lengths were confirmed using the following medial to lateral measurements: - a verage width of the navicular, width at 10 mm distal to the first tMt joint, and width 10 mm proximal to the first MtP joint • results of this analysis show the design of the Variable angle lCP Medial Column Plating system optimizes fit in up to 93.7% of the patient population.

Uncompromised Strength and Durability • Hardware failure is a complication that may occur after foot reconstruction.14 the standard techniques and implants often lack stability and subsequently fail.5 • the new Variable angle lCP Medial Column Fusion Plating system offers uncompromised strength and durability. – the plates and screws are optimized for strength and durability, without compromising anatomic fit. – the unique plantar application enables increased biomechanical strength, allowing the plate to be applied on the tension side of the medial column.4,15,16

Benefits of Variable Angle Locking Platform Technology • Market-leading DePuy Synthes Variable angle (Va) locking technology (Figure 4). – Variable angle locking screws provide the ability to create a fixed-angle construct while allowing the surgeon the freedom to angulate screws toward specific areas of cortical bone. – Platform technology is used for various types of Melior Bold 10/13 surgical Melior Bold procedures. 10/13 Melior Bold 10/13 Melior Bold 10/13 Melior Bold 10/13 Melior Bold 10/13

Figure 4. Variable angle locking technology allows screws to be angled anywhere within a 30° cone around the central axis of the plate hole (15° off axis in either direction)

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– Four columns of threads offer four points of locking between the Va lCP plate and the variable angle locking screw, forming a fixed-angle construct at the desired screw angle. – Va locking is achieved without the use of bushings, end caps, additional implants, or multiple steps, streamlining the procedure. – Va locking technology may be used in various types of surgeries and, therefore, may reduce hospital inventory. – 3.5 mm Variable angle locking screw holes can accommodate multiple screw types: - Variable angle locking screws - low-profile Cortex screws - locking screws - Cortex screws

DePuy Synthes Companies VA LCP Medial Column Fusion Plating System

Value Analysis Brief

Variable Angle LCP Medial Column Fusion Plating System

Instrumentation Designed to Aid in Compression and Joint Preparation May Optimize Procedural Efficiency – Compression System – Provides the ability to maintain tactile compression through the plate while inserting screws, a design feature that may facilitate procedural efficiency in the operating room (Figure 5). – Unique plate design allows for 4 mm–6 mm of compression in each joint.

– General Foot Instruments – A compact set of commonly used surgical instruments for forefoot, midfoot, and hindfoot cases (Figure 7). – New bone spreader designed to fit into tight joints and help with joint prep, along with new, smaller Hohmann retractors designed specifically for foot surgery.

Figure 7. Example of instrument included in the general instrument set

Figure 5. Compression system instrumentation

The following instrument sets offer additional options for medial column fusion procedures and are available separately: – Joint Preparation Set – A variety of chisel shapes and a cartilage remover are additionally available to facilitate proper joint preparation (Figure 6). – Silicon handles ensure optimal grip.

Figure 6. Joint preparation set

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Variable Angle LCP Medial Column Fusion Plating System

Optimized for Hospital Standardization • The Variable Angle LCP Medial Column Fusion Plating System offers the hospital a single set with three surgical options to provide surgeons with a full range of choices for a wide variety of complex fusion applications. • Standardization of physician preference items is one method for enhancing the efficiency of a hospital’s supply chain and supports improved profitability.17 • In addition to cost reduction, standardizing implants can improve efficiency and quality of care.18 • The above statements are consistent with the American Academy of Orthopedic Surgeons Information Statement on Prevention of Medical Errors that states, “Studies have suggested that the use of standard order sets have decreased hospital length of stay and improved the quality of care.”19 • In addition to the single Variable Angle LCP Medial Column Fusion Plating System with three surgical options, this system utilizes screws that may be used with multiple types of DePuy Synthes Companies Plates. This feature also facilitates hospital standardization. – Variable Angle (VA) locking screws used with this system are part of the DePuy Synthes VA Locking Platform Technology used across various trauma surgeries, and the instrumentation for VA screws is interchangeable with other plating procedures. – VA locking technology is designed to enable optimal screw positioning and offers a wide array of options to address surgeon preference for treating a full range of anatomies and types of deformities.

DePuy Synthes Trauma: Focused on Hospitals and Patients Trusted Quality and Innovation • A century of breakthroughs that create value Delivering Solutions That Help Improve Clinical Outcomes and Increase Patient Satisfaction • Industry leader in trauma • Provide a broad, high-quality product portfolio that addresses your trauma needs Advanced Technical Support and Training • Highly trained trauma focused team • Available 24 hours a day/7 days a week/365 days of the year • Access to over 750 consultants nationwide (USA) • Commitment to education and training (4 surgical training centers globally) • Online training for surgeons • Industry-leading, customizable education and training programs for entire OR staff • Reimbursement hotline for coding support (USA)

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Variable Angle LCP Medial Column Fusion Plating System

References 1. Nasser EM, LaPorta GA, Trott K. Medial column arthrodesis using an anatomic distal fibular locking plate. J Foot Ankle Surg. 2014; Jul 2. doi: 10.1053/ j.fas.2014.05.004. 2. Jordan TH, Rush SM, Hamilton GA, Ford LA. Radiographic outcomes of adult acquired flatfoot corrected by medial column arthrodesis with or without a medializing calcaneal osteotomy. J Foot Ankle Surg. 2011;50(2):176-81. 3. Vulcano E, Deland JT, Ellis SJ. Approach and treatment of the adult acquired flatfoot deformity. Curr Rev Musculoskelet Med. 2013;6(4):294-303. 4. Nadaud JP, Schon LC. Chronic Charcot midfoot reconstruction. Tech Foot Ankle Surg. 2010;9(3):123-33. 5. Agren PH. Midfoot Fusion Bolt, a new implant, and description of the technique for stabilization of severe midfoot instability including Charcot foot reconstruction. Tech Orthop 2012;27:130–4. 6. American Orthopedic Foot and Ankle Society. Midfoot Fusion. http://www.aofas.org/footcaremd/treatments/Pages/Midfoot-Fusion.aspx. Accessed Dec. 23, 2014. 7. American Academy of Orthopedic Surgeons (AAOS). Acquired adult flat foot. http://orthoinfo.aaos.org/topic.cfm?topic=a00173. Accessed Dec. 23, 2014. 8. Bevilacqua NJ, Rogers LC, Armstrong DG. Diabetic foot surgery: classifying patients to predict complications. Diabetes Metab Res Rev. 2008;24(suppl 1):S81-3. 9. Saltzman CL, Hagy ML, Zimmerman B, Estin M, Cooper R. How effective is intensive nonoperative initial treatment of patients with diabetes and Charcot arthropathy of the feet? Clin Orthop Relat Res. 2005;435:185-90. 10. Gil J, Schiff AP, Pinzur MS. Cost comparison: limb salvage versus amputation in diabetic patients with charcot foot. Foot Ankle Int. 2013;34(8):1097-9. 11. Subramaniam B, Pomposelli F, Talmor D, Park KW. Perioperative and long-term morbidity and mortality after above-knee and below-knee amputations in diabetics and nondiabetics. Anesth Analg. 2005;100(5):1241-7.

12. Ajis A, Geary N. Surgical technique, fusion rates, and planovalgus foot deformity correction with naviculocuneiform fusion. Foot Ankle Int. 2014;35(3):232-7. 13. Design Verification/Validation Report. Midfoot-hindfoot system. Report # 0000070516. Data on File, DePuy Synthes. 14. Capobianco CM, Stapleton JJ, Zgonis T. The role of an extended medial column arthrodesis for Charcot midfoot neuroarthropathy. Diabet Foot Ankle. 2010;1. doi: 10.3402/dfa.v1i0.5282. Epub 2010 Jun 1. 15. Sammarco VJ, Chevillet J. The role of internal fixation in surgery of the Charcot foot and the evolution of “super-construct” techniques. Curr Orthop Pract. 2010;21(3):233-9. 16. Shibuya N, Clawson LD, Agarwal MR. Suspension and dynamic compression of the medial column. J Foot Ankle Surg. 2011;50(4):510-3. 17. Herman B. 11 ways hospitals and health systems can increase profitability in 2013. Becker’s Hospital Review. http://www.beckershospitalreview.com/ finance/11-ways-hospitals-and-health-systems-can-increase-profitability-in2013.html. Accessed Dec. 23, 2014. 18. Rodak S. How bundled payments in orthopedics can help build the foundation for a center of excellence. Becker’s Hospital Review. Available at: http://www. beckershospitalreview.com/hospital-key-specialties/how-bundled-payments-inorthopedics-can-help-build-the-foundation-for-a-center-of-excellence.html. Accessed Dec. 23, 2014. 19. American Academy of Orthopedic Surgeons (AAOS). Information statement on prevention of medical errors. Revised December 2008. http://www.aaos. org/about/papers/advistmt/1026.asp. Accessed Dec. 23, 2014.

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