Primary or Secondary Omarthrosis of the Shoulder Joint Clinical Trial
Official title:
Patient Benefit From the New Modular Shoulder Prosthesis PROMOS - a Multicentre Cohort Study
Overall study design:
This study is a prospective, non-randomized, multicenter postmarket clinical follow-up study
with two study arms using the two shoulder prosthesis PROMOS™ STANDARD (group A) and PROMOS
REVERSE™ (group B). The study will collect efficacy and safety data over 10 years.
Primary objective of the study:
The primary objective is to quantify patient benefit after primary total shoulder
arthroplasty with the modular PROMOS™ shoulder system in a multicenter cohort study (real
world approach). Patient benefit will be quantified using objective and validated subjective
measures of function, activities of daily living (ADL) and quality of life (QoL).
Secondary objectives:
- Rate of implant related findings like radiological loosening of the glenoid and
complications like intraoperative stem fissures
- Prosthesis survival at common time points, e.g. 5 and 10 years
;