NCT00925496

Patient Benefit From the New Modular Shoulder Prosthesis PROMOS

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 155 (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, 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

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

Conditions

• Primary or Secondary Omarthrosis of the Shoulder Joint

Timeline

• Start date: 2009-06-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2009-06-22
• Last updated: 2020-04-06

Locations

2 sites across 2 countries: Germany, Switzerland