Elbow is a complex joint and a crucial part for forearm function. It has a unique anatomy comprising limited ball-and-socket joint and a hinge type of synovial joint, which allows for hand movement and control. Though radial head fractures are usually not too complicated in nature, various devices and radial head resection implants are available in the market that help address any issues related to the same. Products used in radial head resection are approved and are widely used by orthopedic surgeon and few of the techniques are under section of limited study. However, there are couple of medical procedures that are executed in case of radial head fractures such as closed reduction with casting or early motion and open reduction with internal fixation or resection in which radial head resection implants are mainly used.
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According to National Center for Biotechnology Information, radial head fractures are common worldwide with around 2.5 to 2.8 per 10,000 of incidence per year. Also, due to the patient benefits in terms of no deformity and regaining normal functionality after a relatively short period following the surgery, the radial head resection therapy is gaining wide acceptance across the globe. The use of radial head resection implants are strictly recommended by the orthopedic surgeon by looking at the severity of type III and type IV fractures.
Limited data available regarding the upper extremity limb discrepancy under radial head resection implants market:
Although the location of the fracture is very crucial in the upper extremity, data regarding the same is limited, which shortens the horizon for market growth in the radial head resection implants segment. However, rise in awareness among the population about consequences of limb deformity if not treated using appropriate implant is projected to support growth of the radial implants market. Furthermore, the concern is more on the altering length of the limb. However, lower extremity is more susceptible in terms of limb-length discrepancies, including abnormal body posture and various other problems. Deformity is a common phenomenon in upper limb fractures as compared to the limb length discrepancies. Furthermore, studies related to radial head fractures further highlight the importance of the radial head resection by the help of prosthesis and implants. Some such studies are short- to medium-term outcomes of radial head replacement arthroplasty in posttraumatic unstable elbows mentioned in Chang Gung Med Journal in 2010 and resection of the radial head after mason type-III fractures of the elbow mentioned in The Journal of Bone and Joint Surgery published in 1998.
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Weakening of bones is a continuous process with the progression of age, which is further catalyzed by inappropriate healthcare infrastructure and unhealthy lifestyle, especially in emerging economies. Most economies are not balanced with either of the above mentioned criteria. For instance, most economies with a sound healthcare infrastructure have an unhealthy lifestyle and vice versa. In 2015, according to the Department of Orthopedic and Trauma Surgery, University of Freiburg Medical Centre, Freiburg, Germany, the radial head fractures contributes to around 4% of all types of fractures, and within all elbow fractures the radial fractures constitutes to around 30%. It is also diagnosed in around 75% of all proximal lower-arm fractures, securing an incidence of around 25 to 30 cases per 100,000 patients among the adult population. Rapidly aging population in the U.S., Japan, and China are projected position these as major markets for radial head resection in the near future. Incidence rate of radial head resection is especially high among people aged above 44 years.
The global radial head resection implants market is less fragmented as major players account for major share of the market. High entry barriers and stringent regulations such as Medical Device Amendments of 1976 requires mandatory FDA approval to obtain “reasonable assurance of safety and effectiveness” before marketing may hamper the entry of new players as only the well-established players can focus and invest on improving their existing radial head resection implants products, which further brings accuracy in the device.
Furthermore, in 2013, there was a product recall for DePuy Synthes Companies, a Johnson & Johnson Company. The reason for recall as cited by the manufacturer was loosening trial head from the implant stem during manipulation of the arm during surgery. However, this incidence has not adversely impacted demand for radial head resection implants. However, it highlights the important checkpoints during production that need to be considered by market players in order to ensure sustainable growth. Major players involved in the radial head resection implants market include Biomet, Inc., Wright Medical Technology, Inc., Smith & Nephew Plc, and Stryker.
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