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

April 3, 2020 updated by: Smith & Nephew Orthopaedics AG

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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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.
Time Frame: Preop / 6M / 1Y / 2Y / 5Y / 10Y
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
Time Frame: Preop / 6M / 1Y / 2Y / 5Y / 10Y
Preop / 6M / 1Y / 2Y / 5Y / 10Y

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smith & Nephew Orthopaedics AG

Investigators

  • Principal Investigator: Hans-Kaspar Schwyzer, Dr. med., Schulthess Klinik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • D10054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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