In 1984, bioabsorbable internal fixation devices were used at Helsinki University for the first time as a treatment for fractures and osteotomies of the extremities. Metal plates and screws remain the standard for use in internal fixation, despite the associated risks, including increased infection rates due to bacterial colony formation on the plates, bone atrophy due to stress-shielding (particularly in long bones) and the introduction of growth problems in growing patients. Metal plates and screws must often be removed, requiring a second surgery and exposing patients to the risks of surgery for a second time.
Hip fracture is a common injury that is more frequent with age and has an immediate impact on the quality of life. The approximate one-year mortality rate after a hip fracture is between 20% and 30%. A 2007 study in the American Journal of Therapy showed that fractures repaired within 48 hours of the traumatic incident had better outcomes than those repaired later. The number of annual hip fractures within the senior population alone is estimated to be over 300,000 in the United States, which is equivalent to an incidence rate of almost one per every 1,000 people. Approximately three-quarters of people affected are women, and upwards of 90% of injuries are caused by falls.
Cannulated screws are used for many different types of trauma fixation procedures. The guidewire keeps the unstable bone fragments from moving during screw insertion and allows for continuous fixation. Cannulated screws are designed to fuse multiple bone fragments together. These screws are offered in diameters ranging from under 4 mm to over 7 mm and feature a variety of shaped heads, thread lengths and designs. The analysis herein presents cannulated screws segmented first by headed or headless style and then by size, with large screws having a diameter over 6 mm, medium between 4 mm and 6 mm and small less than 4 mm. Distinctions in screw design can offer better bone purchase and easier extraction.
External fixation is a type of osseous fixation commonly used to treat bone trauma cases and other orthopedic problems. This form of reduction requires drilling holes into unaffected regions of bone around the fracture and screwing bolts or wires into the holes. External fixation is a minimally invasive procedure that is performed by placing a scaffolding frame with associated wires, pins, or both wires and pins on the outside of the damaged extremity. Small pins and wires are then used to hold the bone in its intended position.
Installation of external fixators requires general anesthesia and is usually performed in an operating room. Because the pins pierce through the skin, constant cleaning of the wound is necessary. Removal of the external device can be performed during an office visit without anesthesia.
Intramedullary (IM) hip screws are hybrid devices, incorporating aspects of intramedullary nails and conventional hip screw design. They are inserted into the femur at an angle similar to that of hip screws, but instead of being anchored by a plate external to the shaft of the bone, IM hip screws are anchored inside the medullary cavity. The screws are designed for intertrochanteric or subtrochanteric fractures of the hip. IM hip screws are also known as dynamic hip screws (DHS).
Intramedullary nails, also known as IM nails, IM rods or dynamic intramedullary rods, are solid or cannulated metal rods that are used to align and stabilize fractures. IM nails are inserted into the medullary canal of long bones of the extremities such as the femur, tibia and humerus. The most significant advantage of IM rods over other methods is that they share the weight load with the bone, rather than entirely supporting it. This allows for a more rapid recovery.
Plating devices were pioneered by the Association for the Study of Internal Fixation (AO/ASIF) in Switzerland. Early sales and marketing was done by the Straumann Group, of which the companys osteosynthesis division eventually became Synthes, which was acquired by Johnson & Johnsons Depuy in 2012 to become DePuy Synthes.
Staple fixation devices are divided into two main categories depending on the mechanism by which the compressive forces are applied across the site of fracture. Conventionally, mechanical compression staples, manufactured from either stainless steel or titanium, have been a popular form of fixation for osteotomy and arthrodesis. However, studies have shown that this type of staple provides inconsistent compression and distraction and hence does not result in optimal bone healing. This is in contrast to the second type of staple device: shape memory staples.
The very first bone stimulator device in Canada received Health Canada license in November 1999. As of 2015 there were a total of seven players in the long bone growth stimulator market, three of which also had either a separate device for spinal application or had their only device also indicated for spine. For the purpose of this report, estimated units were separated by indication and only long bone (i.e. fractures) related units were included. There is a brief discussion regarding the break-down between long bone and spinal units in the Electrical Stimulator Market section and under the competitive analysis section. For context, the long bone market is estimated to be more than seven times bigger than spine ($8.0 vs. $1.1 million, respectively) as of 2015. There is also a brief discussion on the estimated break-down between units sold and units rented under the Ultrasonic Stimulator Market section and under the competitive analysis section.
One of the market limiters for the Canadian HA market is the reimbursement structure. None of the products are covered under standard healthcare plans and must be purchased directly or through extended healthcare coverage or private insurance. Thus, some patients opt out to receiving cortisone injections; these are reimbursed by standard healthcare and are a more affordable choice.
One of the factors that contributed positively to this market is ever expanding indication. The market originally started with treating osteoarthritis (OA) of the knee, since then some products expanded into hip, shoulder, a number of small joints, as well as assisting with post-surgery joint recovery.
Bone graft substitute products are utilized by dentists/periodontitis, neurosurgeons and orthopedic surgeons. Orthopedic indications represent the most major portion of the bone graft substitute market, with spinal fusions representing the most major category of surgery within that realm. For the purpose of this report, we do not assess the dental bone graft substitute market in any way. Instead, we focus on spinal indications for bone grafts and its size relative to the bone graft substitute market (excluding dental indications).
Orthopedic image guided surgery (IGS) systems are used in procedures such as total knee arthroplasty (TKA), total hip arthroplasty (THA), anterior cruciate ligament (ACL) reconstruction, trauma and corrective surgeries. During these reconstruction procedures, the alignment of the orthopedic implant is critical and IGS systems are capable of reaching the target alignment within 3°, 95% to 98% of the time.
The market for spine navigation systems, or spinal image guided surgery (IGS) systems, is closely linked to that of neurosurgical IGS systems. There are relatively few dedicated IGS systems for spinal procedures. Most spinal IGS procedures are performed using neurosurgical IGS systems with spinal software applications. Because spinal and neurosurgical operations are often performed by the same surgeons, this arrangement has worked well so far. Certain spinal procedures may require specialized instruments; however, these disposable instruments can be used with non-specialized systems that have the appropriate software. Many spinal IGS systems can be used to assist in trauma procedures once equipped with the right software and accessories. Spinal conditions treated with IGS include fractures, metastasis, spinal slip disc and spinal curvature. Spinal imaging software allows surgeons to perform on the thoracic and lumbar regions of the spine, while many have pelvic trauma applications. Recently, there has been a push to develop more dedicated spinal IGS and robotic systems that would be better suited to strictly spinal or trauma surgeries.
Surgical robotics has tremendous potential to increase the effectiveness of existing procedures and to facilitate novel procedure types. The surgical robotics industry is, in many ways, still in its infancy, with more products in development than currently commercially available on the market. Most new surgical robotic systems are designed for highly specialized medical applications, which is a major draw-back for most facilities. The types of surgical robotic assisted systems covered in this section are: minimally invasive surgery robotic systems, orthopedic robotic systems, spinal robotic systems, neurosurgery robotic systems, robotic catheters and radiosurgery robotic systems.
Research findings included details on market sizing and trends, procedural data and competitive landscape, among other things. The research methodology and data collection for the analysis involved a multi-faceted approach which included: primary research, secondary research, utilization of iDatas proprietary in-house procedural database and an end-user physician online survey.
The elbow naturally operates as a hinge joint, with the majority of the natural range of motion occurring on one plane, although it also includes a rotational component. The joint involves the articulation of three bones: the humerus, the radius and the ulna. The articulation of the head of the radius on the ulna allows for forearm pronation and supination, resulting in the ability to rotate the wrist.