The aim of this observationnal post-marketing study is to provide additional information on the safety and effectiveness of Simpliciti™ system at 24 months post-shoulder arthroplasty , in usual surgical practice.
Study Type
OBSERVATIONAL
Krankenhaus Agatharied
Hausham, Germany
Number of patients with device related adverse events as a measure of safety
All adverse events will be summarized by the number and percentage of patients with each type of event. The following will be summarized separately: procedure related adverse events, device related adverse events, anticipated adverse events. Additionally, the incidence of serious device associated adverse events will be summarized.
Time frame: 24 months
Change in the Range of Motions (ROM) as a measure of effectiveness
Changes in ROM variables from the pre-implant visit to each follow-up visit will be calculated and sumarized until 24-month visit.
Time frame: 24 months
Change in the Constant Score as a measure of effectiveness
Changes in the Constant Score from the pre-implant visit to each follow-up visits will be calculated and summarized until 24-month visit.
Time frame: 24 months
Change in the DASH Score as a measure of improvement in the patients' Quality of Life
Changes in the DASH Score from the pre-implant visit to each follow-up visits will be calculated and summarised until 24-month visit.
Time frame: 24 months
Change in humeral cortical thickness as an evaluation of Stress Shielding
Changes in humeral cortical thickness from the pre-implant to 24-month visit will be mesured according to the modified method of Tingart \& Al.
Time frame: 24 months
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