Patient Benefit From the New Modular Shoulder Prosthesis PROMOS (Promos)

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

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.

Study Overview

• Status: Completed
• Conditions: Primary or Secondary Omarthrosis of the Shoulder Joint

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 Type: Observational
• Enrollment (Actual): 155

Contacts and Locations

Study Locations

• Germany
  • Münster, Germany
    • Orthopaedische Praxis / Praxisklinik
• Switzerland
  • Zurich, Switzerland, 8008
    • Schulthess Klinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Standard PROMOS prosthesis; Patients receiving a standard PROMOS prosthesis
Reverse PROMOS prosthesis; Patients receiving a reverse PROMOS prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Smith & Nephew Orthopaedics AG
• Investigators: Principal Investigator: Hans-Kaspar Schwyzer, Dr. med., Schulthess Klinik

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ACTUAL): December 1, 2019
• Study Completion (ACTUAL): December 1, 2019

Study Registration Dates

• First Submitted: June 19, 2009
• First Submitted That Met QC Criteria: June 19, 2009
• First Posted (ESTIMATE): June 22, 2009

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2020
• Last Update Submitted That Met QC Criteria: April 3, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Omarthrosis shoulder joint
• Other Study ID Numbers: D10054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED