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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Osteoarthritis Avascular Necrosis Rheumatoid Arthritis Humeral Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Biomet Humeral Stems

Biomet Humeral Stems: Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems

No interventions assigned to this group

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No