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Sponsored by: |
Biomet Orthopedics, LLC |
Information provided by: | Biomet, Inc. |
ClinicalTrials.gov Identifier: | NCT00699270 |
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of Biomet Humeral Stems
Condition |
Osteoarthritis Avascular Necrosis Rheumatoid Arthritis Humeral Fractures |
MedlinePlus related topics: | Fractures Osteoarthritis Osteonecrosis Rheumatoid Arthritis |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | A Prospective, Non-Controlled, Clinical Investigation of the Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems |
Estimated Enrollment: | 200 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | July 2015 |
Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
Biomet Humeral Stems
Biomet Humeral Stems: Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients that have already made the decision to undergo shoulder replacement surgery and will receive a Biomet humeral stem.
Inclusion Criteria:
Exclusion Criteria:
Absolute contraindications:
- Infection, Sepsis, and Osteomyelitis
Relative contraindications:
Responsible Party: | Biomet Orthopedics, LLC ( Kenneth Beres, MD Director Clinical Research ) |
Study ID Numbers: | Biomet 12380-76 |
First Received: | June 13, 2008 |
Last Updated: | July 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00699270 |
Health Authority: | United States: Institutional Review Board |
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