Simpliciti IDE Trial; Replacing the Humeral Head in Total Shoulder Arthroplasty
Condition: Primary Generalized (Osteo)Arthritis; Post-traumatic Arthrosis of Other Joints, Upper Arm
MeSH terms: Osteoarthritis
Intervention: Simpliciti™ Shoulder System
Intervention description: Total shoulder arthroplasty system
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 157.0
Sex: All
Minimum age: 22 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to demonstrate safety and efficacy of the Simpliciti Shoulder
      System in total shoulder arthroplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subject 22 years or older

          -  Clinical indication for total shoulder replacement due to primary diagnosis of
             arthritis. Primary arthritis for this study includes osteoarthritis, and/or traumatic
             arthritis.

          -  Scapula and proximal humerus must have reached skeletal maturity

          -  Subject with a Constant Score ≥ 20

          -  Willing and able to comply with the protocol

          -  Willing and able to sign the informed consent (or the Legally Authorized
             Representative will sign for the subject)

        Exclusion Criteria:

          -  Lack of sufficient sound bone to seat and support the implant such as:

               1. Rapid joint destruction, marked bone loss or bone resorption;

               2. Destruction of the proximal humerus that precludes rigid fixation of the humeral
                  component; and

               3. Osteomalacia

          -  Metal allergies or sensitivity, including a known allergic reaction to implant metals
             (e.g., nickel) or polyethylene

          -  Infection at or near the site of implantation, including:

               1. Glenohumeral joint infection

               2. Osteomyelitis

          -  Distant or systemic infection

          -  Medical conditions or balance impairments that could lead to falls

          -  Prior open shoulder surgery on the shoulder to be treated in the study including
             failed rotator cuff surgery, but excluding successful shoulder arthroscopy

          -  Any full thickness rotator cuff tear at the time of surgery or a nonfunctional rotator
             cuff

          -  Excessive glenoid bone loss defined by preoperative computed tomography (CT) scans of
             the shoulder which show insufficient glenoid bone, or insufficient bone identified at
             the time of surgery

          -  Metabolic disorders which may impair bone function

          -  Nonfunctional deltoid muscle

          -  Neuromuscular compromise condition of the shoulder (e.g., neuropathic joints or
             brachioplexus injury with a flail shoulder joint)

          -  Known active metastatic or neoplastic diseases, Paget's disease or Charcot's disease

          -  Currently, or within the last 6 months, or planning to be on chemotherapy or radiation

          -  Currently taking > 5mg/day corticosteroids (e.g. prednisone) excluding inhalers,
             within 3 months prior to surgery

          -  Female subjects who are pregnant or planning to become pregnant within the study
             period

          -  In the surgeon's opinion, the subject is unable to understand the study or be
             compliant with the follow up or have a history of non-compliance with medical advice

          -  History of any cognitive or mental health status that would interfere with study
             participation

          -  Alcohol or drug abuse

          -  Engages in manual labor or sports activities that could affect shoulder outcome

          -  Currently enrolled in any clinical research study that might interfere with the
             current study endpoints