The “PI-61 Reverse shoulder system wear test” standard, developed by PI Medical Implants, describes the requirements for reverse shoulder replacement systems.
Essentially , test parameters for reverse shoulder replacement systems are based on a conducted wear study. For in vitro testing, the humerus component is positioned superior to the glenosphere component, and the joint load is applied vertically. It is recommended that the angles between the component axes and the load line at the reference position be selected according to the studies conducted.
These tests use a hip joint simulator. During the test, the following movements are applied to the implant system simultaneously: abduction/adduction, flexion/extension and internal/external rotation. In the tests, a sinusoidal joint load ranging from 250 N to 1000 N is applied. The samples are assembled under laminar flow conditions and sealed with single test chambers with capsules to prevent contamination. The temperature and liquid level of the test fluid are controlled throughout the test. Wear of the components is determined gravimetrically. The wear test is performed for 5 million cycles.
Abduction and adduction are the movements of a body part towards or away from the midline of the body around the horizontal (sagittal) axis. Abduction is the movement of a body part attached to a joint away from the midline of the body. For example, the movement of the right arm towards the right in anatomical posture is abduction. Adduction is the movement of a body part attached to a joint towards the midline of the body. For example, the movement of the arm, which is moved away from the midline of the body as a result of abduction in anatomical posture, towards the midline of the body, that is, towards the torso, is adduction.
Flexion and extension; is the approaching or moving away of two different parts of the body around the transverse axis. Flexion is the decrease in the angle between two parts that make up a joint, that is, bending. For example, the forearm bends with flexion and approaches the arm, and the leg flexes and approaches the thigh. Extension is the increase in the angle between two parts that make up a joint, that is, stretching or stretching. For example, in the sitting position, the legs and thighs are in a flexed position, that is, bent. When standing up, both the thigh and the leg extend and come to their anatomical position.
The reverse shoulder system is a total semiconstrained shoulder arthroplasty. This procedure reverses the normal relationship between the scapula and humeral components, moving the center of rotation of the scapulohumeral joint medially and inferiorly.
In reverse shoulder replacement, the normal ball-and-socket structure is reversed. An artificial ball is attached to the shoulder blade. An artificial socket is attached to the top of the arm bone. The large deltoid muscle that covers the shoulder can usually move the arm.
Reverse shoulder replacement is an advanced procedure specifically designed to treat patients who are not candidates for traditional shoulder replacement surgery due to rotator cuff tear arthropathy. Rotator cuff tear arthropathy is a condition in which both shoulder arthritis and a rotator cuff tear are present. With the option of reverse shoulder replacement, people who are not candidates for traditional shoulder replacement can find relief from pain and regain shoulder function. Reverse shoulder replacement is a highly technical procedure and should be performed by an orthopedic surgeon who specializes in shoulder care.
Reverse shoulder system wear testing focuses specifically on testing the high shear forces associated with unstable conventional or hemiarthroplasty that can cause implant wear and loosening.
One way to extend the life of a shoulder prosthesis is to optimize its placement and alignment. In these tests, the shoulder prosthesis is evaluated in virtual three-dimensional form on a computer.
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-61 Reverse shoulder system wear test” standard with its trained and expert staff and advanced technological equipment.
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