Patient Benefit From the New Modular Shoulder Prosthesis PROMOS

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Patient Benefit From the New Modular Shoulder Prosthesis PROMOS - a Multicentre Cohort Study

Conditions
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Primary or Secondary Omarthrosis of the Shoulder Joint

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard PROMOS prosthesis<br>Patients receiving a standard PROMOS prosthesis | |
| Reverse PROMOS prosthesis<br>Patients receiving a reverse PROMOS prosthesis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome measures: Patient benefit will be measured with the SPADI and Constant Murley score at the joint level, with the QuickDASH for the upper extremity and the SF-36 mental score as a generic tool. |  | Preop / 6M / 1Y / 2Y / 5Y / 10Y | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Active and passive ROM and strength / Rate of implant related complications / Rate of implant related findings like radiological loosening of the glenoid / Prosthesis survival at common time points, e.g. 5 and 10 years |  | Preop / 6M / 1Y / 2Y / 5Y / 10Y | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omarthrosis shoulder joint