Multicenter Clinical Observation PROMOS®

Study Overview
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Brief Summary
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Overall study design: This study is a prospective, multicenter, postmarket clinical observation to validate the PROMOS™ Standard Shoulder System as state-of-the-art implant system for total shoulder arthroplasty in terms of radiographic and clinical performance as well as long-term survivorship over 10 years.

Detailed Description
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Primary objective: Radiological and clinical loosening rates of the glenoid and humeral components must be comparable or below the rates of other well documented state-of-the-art shoulder systems with cemented glenoid components. Complications occurring intra- or postoperatively will be assessed and sub-classified in their relation to the implant. At the end of the observation, a long-term survival rate will be calculated according to Kaplan-Meier with revision due to aseptic loosening as the end-point. Secondary objectives: The Constant Murley score and the ASES clinical evaluation are used for documenting the improvement in pain, function and range of motion. For the patient's subjective view of improvement in function a patient self-assessment form is used.

Official Title
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Multicenter Clinical Observation PROMOS®

Conditions
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Primary and Secondary Omarthrosis

Intervention / Treatment
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* Device: standard PROMOS prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient has no general medical contraindication to surgery informed consent to participate in the observation signed by the patient routine radiographic assessment is possible patient is likely to comply with study follow-up requirements primary total- or hemi-shoulder-arthroplasty to the affected side, unilateral or bilateral Exclusion Criteria: acute shoulder trauma tumor / malignoma avascular necrosis late stage rotator cuff disease Charcot joint disease or other severe neurosensory deficits high comorbidity previously failed shoulder arthroplasty fracture sequelae of proximal humerus hypersensitivity to the implant materials used addictive disorders such as alcohol or drug abuse severe spinal disorders bacterial infections

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

| Intervention/Treatment |
| --- |
|Device: standard PROMOS prosthesis|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological and Clinical Loosening Rates of the Glenoid and Humeral Components | The long-term survival rate of the Promos™ Standard shoulder system was calculated with revision due to aseptic loosening as endpoint using a Kaplan-Meier Analysis. | up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant Murley Score | The Constant Murley Score is a shoulder outcome score to determine the functionality of the shoulder after the treatment of a shoulder injury. The score ranges from 0 to 100 with a higher score indicating better shoulder function. | 10 Years | 
| ASES Shoulder Score Index | The American Shoulder and Elbow Surgeon's (ASES) evaluation is used to document the improvement in pain, function and range of motion after shoulder injury. The ASES Shoulder Score Index is calculated from the ASES patient related questionnaire and ranges from 0-100 with a higher score indicating improvement in pain and function. | 10Years |