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

Withdrawn

• Conditions: Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis; Humeral Fractures

• Registration Number: NCT00699270
• Lead Sponsor: Biomet Orthopedics, LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-06-13
• Study First Submitted QC: 2008-06-13
• Study First Posted: 2008-06-17
• Primary Completion: 2008-08
• Study Completion: 2008-12
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
X-rays	3 month, 1 year, 3 years, 5 years
UCLA End Result Score	3 months, 6 months, 1 year, 3 years, 5 years

Secondary Outcome Measures

Name	Time	Method
Incidence of revisions and removals	Any time