Patient Benefit From the New Modular Shoulder Prosthesis PROMOS

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

Eligibility:

• Ages eligible for study: minimal age of 18 years
• Genders eligible for study: both
• Accepts healthy volunteers: no

Inclusion Criteria:

• Primary or secondary omarthrosis as an indication for primary total shoulder arthroplasty
• Massive rotator cuff rupture
• Willing an able to give written informed consent to participate in the study including follow-ups

Exclusion Criteria:

• Previous ipsilateral shoulder arthroplasty (group A and B)
• Late stage rotator cuff disease (only group A)
• Acute shoulder trauma (group A and B)
• General medical contraindication to surgery (group A and B)
• Legal incompetence (group A and B)
• Tumour / malignoma (group A and B)
• Recent history of substance abuse (group A and B)
• Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder) (group A and B)
• Known hypersensitivity to the materials used (group A and B)
• Bacterial infection at the time point of operation (group A and B)