The objectives of this study are to confirm safety and performance of the Anatomical Shoulder Domelock System when used in hemi or total shoulder arthroplasty by analysis of standard scoring systems, radiographs and adverse event records.
This study is a multicenter, prospective and retrospective, non-controlled PMCF study involving orthopaedic surgeons skilled in hemi and total shoulder arthroplasty procedures. A minimum of six study centers will be involved and a total number of 73 implants will be included into the study.
Study Type
OBSERVATIONAL
Enrollment
73
Hemi or Total Shoulder Arthroplasty
Universitaire Ziekenhuizen Leuven
Leuven, Belgium
Krankenhaus Maria Hilf
Daun, Germany
HELIOS ENDO-Klinik Hamburg
Hamburg, Germany
Univeritätklinik Bagrist
Zurich, Canton of Zurich, Switzerland
Implant Survivorship
The primary endpoint of this study is defined by the survival of the implant at 10 years which is based on removal or intended removal of the prosthesis and will be determined using Kaplan Meier method.
Time frame: 10 Years
Clinical Performance
The secondary endpoint is defined by the performance of the Anatomical Shoulder Domelock System at 5 years, which is assessed by the Constant and Murley score. The Constant and Murley score is a 100-point functional shoulder assessment tool in which higher scores reflect increased function. The subjective variables are pain (15 points) and function (activities of daily living - sleep, work, recreation/sport; 20 points), for a total of 35 points. The objective variables are active range of motion (clinician assessment; 40 points) and strength (25 points), for a total of 65 points.
Time frame: 5 Years
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Universitätsspital Basel
Basel, Switzerland
Royal Derby Hospital
Derby, United Kingdom