Shoulder implant under the microscope: 10-Year safety study launches

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation. Interlok™ finish humeral stems are intended for cemented use and the MacroBond™ coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications. \*\*\* For the specific components, Titanium (Ti) Glenospheres are intended for patients with Cobalt Alloy material sensitivity. Exclusion Criteria: * Absolute contraindications include infection, sepsis, and osteomyelitis. Relative contraindications include: 1. Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions. 2. Osteoporosis. 3. Metabolic disorders which may impair bone formation. 4. Osteomalacia. 5. Distant foci of infections which may spread to the implant site. 6. Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram. 7. Patient is a prisoner. 8. Current alcohol or drug abuser. 9. If female, patient is known to be pregnant or breastfeeding. 10. Patient has a psychiatric illness or cognitive deficit that will not allow from proper informed consent.