Comprehensive SRS Regenerex Tissue Attachment

Eligibility Criteria

• * Patient must be 18 years of age or older.
• * Patient must be willing and able to follow directions.
• * The Comprehensive Segmental Revision System was used in cases of:
• 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Revision where other devices or treatments have failed.
• 3. Correction of functional deformity.
• 4. Oncology applications including bone loss due to tumor resection.
• * Proximal or total humeral replacement, for: Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.
• * Distal or total humeral replacement for: Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.
• * Biomet Comprehensive Segmental Revision System was used in a reverse application 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 for proximal humeral replacement. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
• * The Comprehensive Segmental Revision System was used with bone cement in distal humeral and total humeral applications.
• * Regenerex Tissue Attachment Augments were used in combination with the Comprehensive Segmental Revision System
• * Absolute contraindications:
• * Infection
• * Sepsis
• * Osteomyelitis
• * Patient is a prisoner
• * Patient is a current alcohol or drug abuser
• * Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
• * Patient is unwilling to consent
• * Relative contraindications:
• * Uncooperative patient or patient with neurologic disorders who is incapable of following directions
• * Osteoporosis
• * Metabolic disorders which may impair bone formation
• * Osteomalacia
• * Distant foci of infections which may spread to the implant site
• * Vascular insufficiency, muscular atrophy, or neuromuscular disease
• * The Comprehensive Segmental Revision System was used in a reverse shoulder application in patients receiving radiation therapy
• * The Comprehensive Segmental Revision System was used without bone cement in distal humeral and total humeral applications.
• * Regenerex Tissue Attachment Augments weren't used during the patient's surgery