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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00699270

Enrollment

Registered

2008-06-17

Start date

2007-08-31

Completion date

2008-12-31

Last updated

2017-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Avascular Necrosis, Humeral Fractures, Osteoarthritis, Rheumatoid Arthritis

Keywords

Total Shoulder Arthroplasty, Total Shoulder Replacement, Shoulder Arthritis

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
UCLA End Result Score	3 months, 6 months, 1 year, 3 years, 5 years
X-rays	3 month, 1 year, 3 years, 5 years

Secondary

Measure	Time frame
Incidence of revisions and removals	Any time

Outcome results