NCT02280499

Multicenter Clinical Observation PROMOS®

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 87 (actual)
• Sponsor: Smith & Nephew Orthopaedics AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary and Secondary Omarthrosis

Interventions

Type	Name	Description
DEVICE	standard PROMOS prosthesis

Timeline

• Start date: 2003-11-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2014-10-31
• Last updated: 2016-03-21
• Results posted: 2016-03-21