Status:
WITHDRAWN
A Clinical Investigation of the Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems
Lead Sponsor:
Biomet Orthopedics, LLC
Conditions:
Osteoarthritis
Avascular Necrosis
Eligibility:
All Genders
Brief Summary
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of Biomet Humeral Stems
Eligibility Criteria
Inclusion
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid Arthritis
- Correction of functional deformity
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00699270
Start Date
August 1 2007
End Date
December 1 2008
Last Update
June 21 2017
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