Contract issues

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.

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.

Adult subject with clinical indication for total shoulder or hemi replacement due to primary diagnosis of osteoarthritis.