Official Title: “A Prospective, Non-Controlled, Clinical Investigation of the Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems”

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

Study Type: Observational

Study Design: Cohort, Prospective

Study Primary Completion Date: July 2015

Arms, Groups and Cohorts in this Clinical Trial

• : Biomet Humeral Stems
  • Biomet Humeral Stems: Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems

Primary Measures

• UCLA End Result Score
  • Time Frame: 3 months, 6 months, 1 year, 3 years, 5 years
    Safety Issue?: No
• X-rays
  • Time Frame: 3 month, 1 year, 3 years, 5 years
    Safety Issue?: No

Secondary Measures

• Incidence of revisions and removals
  • Time Frame: Any time
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Biomet Orthopedics, LLC

Overall Clinical Trial Officials and Contacts

Kenneth J Beres, MD Study Director Clinical Research, Biomet Orthopedics, LLC  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00699270

Study ID Number: Biomet 12380-76

ClinicalTrials.gov Identifier: NCT00699270

Health Authority: United States: Institutional Review Board