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Clinical Trials/NCT00699270
NCT00699270
Withdrawn
N/A

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

Biomet Orthopedics, LLC0 sitesAugust 2007
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ConditionsOsteoarthritisAvascular NecrosisRheumatoid ArthritisHumeral Fractures

Overview

Phase
N/A
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
Biomet Orthopedics, LLC
Primary Endpoint
X-rays
Status
Withdrawn
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
August 2007
End Date
December 2008
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

X-rays

Time Frame: 3 month, 1 year, 3 years, 5 years

UCLA End Result Score

Time Frame: 3 months, 6 months, 1 year, 3 years, 5 years

Secondary Outcomes

  • Incidence of revisions and removals(Any time)

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