Patient Benefit From the New Modular Shoulder Prosthesis PROMOS

Completed

• Conditions: Primary or Secondary Omarthrosis of the Shoulder Joint

• Registration Number: NCT00925496
• Lead Sponsor: Smith & Nephew Orthopaedics AG

Brief 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

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-19
• Study First Submitted QC: 2009-06-19
• Study First Posted: 2009-06-22
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-03
• Last Update Posted: 2020-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

• Primary or secondary omarthrosis as an indication for primary total shoulder arthroplasty
• Massive rotator cuff rupture
• Willing an able to give written informed consent to participate in the study including follow-ups

Exclusion Criteria

• Previous ipsilateral shoulder arthroplasty (group A and B)
• Late stage rotator cuff disease (only group A)
• Acute shoulder trauma (group A and B)
• General medical contraindication to surgery (group A and B)
• Legal incompetence (group A and B)
• Tumour / malignoma (group A and B)
• Recent history of substance abuse (group A and B)
• Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder) (group A and B)
• Known hypersensitivity to the materials used (group A and B)
• Bacterial infection at the time point of operation (group A and B)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome measures: Patient benefit will be measured with the SPADI and Constant Murley score at the joint level, with the QuickDASH for the upper extremity and the SF-36 mental score as a generic tool.	Preop / 6M / 1Y / 2Y / 5Y / 10Y

Secondary Outcome Measures

Name	Time	Method
Active and passive ROM and strength / Rate of implant related complications / Rate of implant related findings like radiological loosening of the glenoid / Prosthesis survival at common time points, e.g. 5 and 10 years	Preop / 6M / 1Y / 2Y / 5Y / 10Y

Trial Locations

Locations (2)

Schulthess Klinik; 🇨🇭 Zurich, Switzerland

Orthopaedische Praxis / Praxisklinik; 🇩🇪 Münster, Germany