The standard “PI-19 Sliding nail fatigue test” developed by PI Medical Implants describes a procedure for fatigue testing sliding nails. The test setup is based on the standard “ISO 7206-4 Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of durability characteristics and performance of femoral components with stems” developed by the International Organization for Standardization (ISO).
During the test, the sliding mechanism of the nail is blocked by an axial support to enable axial load bearing without bone tissue. Six implants are tested to determine the working load of the system.
Proximal femur fractures are a typical injury condition that is generally seen in old age and exhibits many different biomechanical characteristics. The sliding nail was first developed in 1992 as a universal implant for indications ranging from medial femoral neck fracture to root fracture.
The sliding nail has an extended surface and absolute rotational stability of the blade in relation to the nail and also to the bone itself, and the risk of shearing is minimized. Extensive experimental and clinical studies have led to the design of the sliding nail with the possibility of impact of the double T-blade in the direction of the femoral neck and the distal long holes in the direction of the femoral shaft. Special attention was paid to the implantation technical features in order to make the application as simple as possible and therefore with low complications. The selected and patented double T-profile has the same cross-sectional area and can withstand much higher loads than a U-profile or a circular profile.
Long sliding nails have an antecurvation relative to the curvature of the femoral shaft and are therefore designed as right and left variants. A wide range of products is available, with total lengths from 180 mm to 440 mm, diameters of 17/11 mm and 19/12 mm, and angles of 125 degrees (standard) and 135 degrees (CCD angle). Depending on the width of the medullary space, the nail can also be inserted without drilling. A 6-degree nail curvature in the frontal plane corresponds to the anatomical axis ratios between the trochanteric axis and the extension of the femoral shaft axis. Therefore, the nail entry point is precisely at the tip of the trochanter, which is much easier from a surgical technique standpoint than opening the piriformis fossa. Furthermore, the risk of circulatory disorders of the femoral head is lower.
Distal locking can be axial, static, or dynamic. When locking pins are placed dynamically, axial compression in the direction of the femoral shaft is possible.
This technique is a simple and safe surgical technique with few instruments, simple targeting procedures and consequently short fluoroscopy times. Distal locking is possible with a radiotranslucent targeting device up to a standard sliding nail length of 220 mm.
In short, the sliding nail system was developed for fractures and provides optimum fixation and stability when the implant is placed in osteoporotic bone. The main feature of the implant is the use of a single blade with a large surface area and the placement of the blade compresses the cancellous bone.
Among the numerous testing, measurement, analysis and evaluation studies that our organization has carried out for businesses in various sectors, it also provides testing services defined in the “PI-19 Sliding claw fatigue test” standard with its trained and expert staff and advanced technological equipment.
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