A Prospective Multi-Center Study of the Safety and Effectiveness of the Tornier Simpliciti™ Shoulder System in Shoulder Arthroplasty

Stryker Trauma and Extremities1 site in 1 countryJanuary 2020

ConditionsShoulder Osteoarthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Shoulder Osteoarthritis
Sponsor: Stryker Trauma and Extremities
Locations: 1
Primary Endpoint: Number of patients with device related adverse events as a measure of safety
Status: Withdrawn
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this observationnal post-marketing study is to provide additional information on the safety and effectiveness of Simpliciti™ system at 24 months post-shoulder arthroplasty , in usual surgical practice.

Registry

clinicaltrials.gov

Start Date

January 2020

End Date

January 2022

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Stryker Trauma and Extremities

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A subject must meet all of the following inclusion criteria in order to enter the study:
•Adult subject 18 years or older,
•Clinical indication for total shoulder or hemi replacement due to primary diagnosis of osteoarthritis,
•Scapula and proximal humerus must have reached skeletal maturity,
•Willing and able to comply with the protocol,
•Willing and able to personally sign the informed consent form,
•Subject is legally competent, understands the nature, significance and implications of the clinical investigation, and is able to form a rational intention in the light of these facts.

Exclusion Criteria

•A subject will not be eligible to participate in the study if any of the following conditions is present:
•lack of sufficient sound bone to seat and support the implant, including that resulting from skeletal immaturity, osteoporosis or erosive arthritis,
•Severe Walch grade B2 glenoid defined as \>60% posterior head displacement and \>20% posterior glenoid bone loss,
•metal allergies or sensitivity,
•infection at or near the site of implantation,
•distant or systemic infection.

Outcomes

Primary Outcomes

Number of patients with device related adverse events as a measure of safety

Time Frame: 24 months

All adverse events will be summarized by the number and percentage of patients with each type of event. The following will be summarized separately: procedure related adverse events, device related adverse events, anticipated adverse events. Additionally, the incidence of serious device associated adverse events will be summarized.

Secondary Outcomes

Change in the DASH Score as a measure of improvement in the patients' Quality of Life(24 months)
Change in the Range of Motions (ROM) as a measure of effectiveness(24 months)
Change in humeral cortical thickness as an evaluation of Stress Shielding(24 months)
Change in the Constant Score as a measure of effectiveness(24 months)