Multicenter Clinical Observation PROMOS®

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Radiological and Clinical Loosening Rates of the Glenoid and Humeral Components	up to 10 years	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.

Secondary Outcome Measures

Name	Time	Method
Constant Murley Score	10 Years	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.
ASES Shoulder Score Index	10Years	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.