Multicenter Clinical Observation PROMOS®

Smith & Nephew Orthopaedics AG87 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Primary and Secondary Omarthrosis

Interventions

standard PROMOS prosthesisDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: up to 10 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: 10Years

Data from ClinicalTrials.gov

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