A Clinical Investigation of the Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems

Biomet Orthopedics, LLC

Overview

The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of Biomet Humeral Stems

Study Type

OBSERVATIONAL

Conditions

Osteoarthritis Avascular Necrosis Rheumatoid Arthritis Humeral Fractures

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis * Rheumatoid Arthritis * Correction of functional deformity Exclusion Criteria: Absolute contraindications: \- Infection, Sepsis, and Osteomyelitis Relative contraindications: * Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions * Osteoporosis * Metabolic disorders which may impair bone function * Osteomalacia * Distant foci of infections which may spread to the implant site * Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram

Outcomes

Primary Outcomes

UCLA End Result Score

Time frame: 3 months, 6 months, 1 year, 3 years, 5 years

X-rays

Time frame: 3 month, 1 year, 3 years, 5 years

Secondary Outcomes

Incidence of revisions and removals

Time frame: Any time

Data from ClinicalTrials.gov

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