Low-Profile Plating Systems 

Plating systems have been developed by multiple manufacturers to provide stable, low-profile fixation of craniomaxillofacial, upper-, and lower-extremity fractures.

Category

Plating systems, low-profile

Device details

• Biomet Microfixation - ThinFlap Plating System
• DePuy Orthopaedics, Inc. (Johnson & Johnson Co)
• A.L.P.S. Elbow Plating System
• A.L.P.S. Distal Tibia Plating System
• Stryker - Profyle Small Bone Plating System
• Synthes - Low Profile Neuro System

The DePuy A.L.P.S. Distal Tibia Plating System combines the benefits of low-profile titanium plate metallurgy with the advantages of multiplanar locked screw technology. These features allow the formation of a 3-dimensional matrix of fixed- and variable-angle screws to create a true subchondral scaffold that can provide fixation in comminuted fractures or osteoporotic bone. The System features F.A.S.T. Guide and F.A.S.T. Tabs technology to facilitate surgical procedures and save time in the operating room. The F.A.S.T. Guide allows for accurate drilling and placement of screws. It comes preloaded and does not require intraoperative assembly, saving significant time. F.A.S.T. Tabs are distal versatile tabs with threaded screw holes to lock small distal articular fragments to the plate. Screws placed in these locking holes create an intersecting 3-dimensional scaffold to support the distal articular surface.

The DePuy A.L.P.S. Elbow Plating System addresses the challenges and complexity involved in the repair of elbow fractures. Low-profile, contoured plates mimic the anatomy of the distal humerus, olecranon, radial head, and coronoid. Since no two patients are the same, the plates are designed for in situ contouring. F.A.S.T. Guide technology allows fast accurate drilling and protects threaded screw holes in the plate during bending. Multidirectional or low-profile nonlocking screws complete the range of available screw options.

The Synthes Low Profile Neuro System is a complete line of plates, screws, and mesh designed specifically for intracranial procedures. It features a low plate and screw profile of 0.6 mm for decreased palpability, self-drilling, and self-retaining screws, with a modified cruciform recess that facilitates rapid replacement of a bone flap. There is a wide variety of low-profile plates to repair the most common types of bony defects and fractures, with modular storage options to meet specific surgeon needs.

Biomet Microfixation ThinFlap Plating System features an industry-leading 0.3-mm plate profile, resulting in minimal or no plate palpability. Biomet offers RapidFire technology, which uses preloaded ThinFlap screw cartridges, eliminating screw loading in the operating room and providing the security of factory-loaded retention. The ThinFlap plating system is available in both a conventional storage tray and SterileTrac packaged delivery system.

The Stryker Profyle Small Bone Plating System offers a comprehensive range of plates and screws to treat most phalangeal, metacarpal, and carpal fractures and disorders. Titanium plates are light, low profile, and pliable and maintain stability and shape integrity. Screws have blunt tips, a sharp threaded design, and cross-fit low-profile heads. Self-tapping cross-fit screws without cutting flutes and cross-pin screws are also available. The Lexniering Reduction Clamp maintains fracture reduction, drills and inserts the screw, and measures the depth. Modular features allow surgeons to customize their systems for appropriate use.

The use of metallic surgical appliances provides the orthopaedic surgeon a means of bone fixation and generally helps in the management of fractures and reconstructive surgeries. These implants are intended as a guide to normal healing and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing. Delayed unions or nonunions in the presence of load bearing or weight bearing might eventually cause the implant to break from metal fatigue. All metal surgical implants are subjected to repeated stress in use, which can result in metal fatigue.

The Synthes Low Profile Neuro System is intended for use in selective trauma of the midface and craniofacial skeleton, craniofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla and chin.

The Biomet ThinFlap plating system is indicated for oral and craniomaxillofacial procedures, including fractures, osteotomies, and reconstructive and revision procedures.

The Stryker Profyle Small Bone Plating System is indicated in the treatment of most phalangeal, metacarpal, and carpal fractures and disorders.

Contraindications

Screws, plates, intramedullary nails, compression hip screws, pins, and wires are contraindicated in patients with active infection, conditions that tend to retard healing such as blood supply limitations, previous infections, insufficient quantity or quality of bone to permit stabilization of the fracture complex, conditions that restrict the patient’s ability or willingness to follow postoperative instructions during the healing process, foreign body sensitivity, and in skeletally immature patients in whom the implant(s) would cross open epiphyseal plates.

Borens et al (2009) evaluated outcomes of 17 patients treated over a 2-year period with a low-profile plate for tibial fractures. They measured time to healing and complications such as delayed union, nonunion, instrument failure, loss of fixation, infection, quality of reduction, and number of reoperations. They concluded that a minimally invasive surgical technique using a low-profile plating system can decrease soft tissue complications while leading to fracture healing and obtaining results comparable to those of traditional techniques.^[1]

Frati et al (2007) identified the craniofacial area as a particularly sensitive region with regard to aesthetic concerns and therefore prospectively analyzed 65 patients undergoing neurosurgical procedures over a 2-year period. At one-year follow-up, patients were invited to undergo 3-dimensional multislice CT scanning and to complete a questionnaire with a subjective rating scale with regard to aesthetic impact of the operation. Five patients without abnormalities on CT scans reported concerns of suboptimal aesthetic outcome or psychological suffering from the aesthetic consequences of surgery. This led the authors to describe a surgical protocol to improve aesthetic outcomes in craniofacial surgery that corroborates the role of low-profile plating systems in order to achieve optimal results.^[2]

The DePuy A.L.P.S. Distal Tibia Plating System features TiMAX low-profile, anatomically contoured implants. In distal tibial surgery where soft tissue coverage is at risk, these low-profile plates are designed to minimize discomfort and soft tissue irritation, matching the anatomy of the distal tibia. Additionally, the A.L.P.S. Distal Tibia Plating System allows the use of locking, variable-angle, and standard screws. This hybrid fixation concept allows the surgeon to stabilize the fracture either by the use of lag screw techniques through the plate or by compression plating techniques. Locking screws provide stability to comminuted, unstable metaphyseal fractures or in osteopenic bone.

In craniomaxillofacial and hand surgery, thinner skin coverage and heightened concerns in aesthetically sensitive areas make low-profile plating systems desirable for fracture fixation. The Synthes Low Profile Plating System and Biomet ThinFlap Plating System (for craniomaxillofacial surgery) and the Stryker Profyle Small Bone Plating System (for hand fractures) can enhance patient satisfaction significantly owing to reduced plate palpability.

Postoperative follow-up is as advised by the individual surgeon.

The most frequent adverse events after fixation with orthopaedic screws and plates include loosening, bending, cracking, or fracture of the components or loss of fixation in bone attributable to nonunion, osteoporosis, or markedly unstable comminuted fractures; loss of anatomic position with nonunion or malunion with rotation or angulation; and infection, allergies, or adverse reactions related to the device material.

Poor bone formation, osteoporosis, osteolysis, osteomyelitis, inhibited revascularization, or infection can cause loosening, bending, cracking, or fracture of the device. Nonunion or delayed union may lead to breakage of the implant. Migration, bending, fracture, or loosening of the implant may occur. Metal sensitivity or allergic reaction to the foreign body may affect certain patients. A decrease in bone density may result from stress shielding. Pain, discomfort, abnormal sensation, or palpability due to presence of the device; increased fibrous tissue response around the fracture site and/or the implant; necrosis of the bone; and inadequate healing are also potential adverse outcomes.