A Multi-center Outcomes Clinical Study of the PyroTITAN™ HRA Shoulder Implant in Humeral Head Resurfacing

You may not qualify if:

• Have destruction of the proximal humerus to preclude rigid fixation of the humeral component.
• Insufficient bone quality as determined by intra-operative evaluation.
• Have arthritis with defective rotator cuff.
• Have had a failed rotator cuff surgery.
• Have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
• Have evidence of active infection.
• Present with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachioplexis injury with a flail shoulder joint).
• Are unwilling or unable to comply with a rehabilitation program or would fail to return for the postoperative follow-up visits prescribed by the protocol.
• Are skeletally immature.
• Have a known allergic reaction to pyrocarbon.
• Have other conditions such as central nervous system disturbances, alcohol or drug addiction, etc. that may make effective evaluation of the joint replacement difficult or impossible.
• Are currently participating in another clinical study.
• Have known, active metastatic or neoplastic disease.
• Are taking \> 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery.
• Are under 21 years of age or over 75.
• +1 more criteria