Simpliciti IDE Trial; Replacing the Humeral Head in Total Shoulder Arthroplasty

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:

• Rapid joint destruction, marked bone loss or bone resorption;
• Destruction of the proximal humerus that precludes rigid fixation of the humeral component; and
• 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:

• Glenohumeral joint infection
• 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