DenCT Shoulder Bone Quality Evaluation

Who can take part

• Patient must be older than 18 years and skeletally mature
• Patient must undergo the SHA, TSA, or RSA according to the Instructions for Use (IFU)
• Patient must be anatomically and structurally suited to receive shoulder arthroplasty implants
• Patient is a candidate for lateral or bi-lateral shoulder arthroplasty due to one or more of the following:
• Non-inflammatory degenerative joint disease including osteoarthritis
• Avascular necrosis of the humeral head
• Autoimmune disease including rheumatoid arthritis
• Irreparable rotator cuff tears
• Correction of functional deformity
• Patient must be able and willing to sign the IRB/EC approved informed consent
• Patient must be able to undergo a preoperative CT scan
• Patient must be willing to share their CT images with sponsor

Who cannot take part

• Revision TSA/RSA after the prior TSA/RSA
• Patient has experienced the traumatic fractures to the implant site
• Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and/or anticipated to be non- compliant)
• Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study, e.g., any neuromuscular disease compromising the affected limb
• Patient is uncooperative or patient with neurologic disorders who is incapable or unwilling to follow directions
• Patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site
• Patient is a candidate for shoulder arthroplasty due to one or more of the following:
• Fractures of the proximal humerus, where other methods of treatment are deemed inadequate
• Patient is unwilling or unable to give consent
• Patient is known to be pregnant or breastfeeding
• Patient has rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram