A Clinical Investigation of the Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis; Humeral Fractures
Phase: N/A
Status: Enrolling by invitation
Sponsored by: Biomet Orthopedics, Inc. Official(s) and/or principal investigator(s):
Kenneth J Beres, MD, Study Director, Affiliation: Clinical Research, Biomet Orthopedics, Inc
Summary
The purpose of this prospective clinical data collection is to document the performance and
clinical outcomes of Biomet Humeral Stems
Clinical Details
Official title: A Prospective, Non-Controlled, Clinical Investigation of the Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems
Study design: Cohort, Prospective
Primary outcome: UCLA End Result ScoreX-rays
Secondary outcome: Incidence of revisions and removals
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: August 2007
Ending date: July 2015
Last updated: June 13, 2008
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