Patient Benefit From the New Modular Shoulder Prosthesis PROMOS

Primary or Secondary Omarthrosis of the Shoulder Joint Clinical Trial

— Promos  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00925496
• Other study ID #: D10054
• Status: Completed
• Start date: June 2009
• Est. completion date: December 2019

Study information

• Verified date: April 2020
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Eligibility:

• Ages eligible for study: minimal age of 18 years

• Genders eligible for study: both

• Accepts healthy volunteers: no

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)

Related Conditions & MeSH terms

• Primary or Secondary Omarthrosis of the Shoulder Joint

Locations

Country	Name	City	State
Germany	Orthopaedische Praxis / Praxisklinik	Münster
Switzerland	Schulthess Klinik	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew Orthopaedics AG

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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