Safety and Effectiveness of the Tornier Simpliciti™ Shoulder System in Shoulder Arthroplasty

Stryker Trauma and Extremities

Status: Withdrawn

Conditions: Shoulder Osteoarthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT02452957

1206-T-SIMPLICITI-RM

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 1 patient group

Device: Simpliciti™ System

Description:

The Simpliciti™ nucleus is a humeral prosthesis intended for total and hemi shoulder arthroplasty in patients with a severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis. The implant is sized to match and replicate the anatomy of the proximal humerus, while maintaining a bone conserving approach. It does not extend beyond the metaphysis, leaving the humeral canal untouched. Fixation is enhanced through a porous coating with a high coefficient of friction; resulting in a solid initial fit and long term fixation. The Simpliciti™ nucleus is designed to receive a humeral head. The Simpliciti™ system is authorized to bear the CE mark and will be investigated within this clinical study in accordance with its intended use.