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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00699270
• Other study ID #: Biomet 12380-76
• Status: Withdrawn
• Phase: N/A
• First received: June 13, 2008
• Last updated: June 19, 2017
• Start date: August 2007
• Est. completion date: December 2008

Study information

• Verified date: June 2017
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Avascular Necrosis
• Humeral Fractures
• Necrosis
• Osteoarthritis
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biomet Orthopedics, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UCLA End Result Score		3 months, 6 months, 1 year, 3 years, 5 years
Primary	X-rays		3 month, 1 year, 3 years, 5 years
Secondary	Incidence of revisions and removals		Any time