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

Tracking Information

First Received Date ^ICMJE

June 13, 2008

Last Updated Date

June 26, 2009

Start Date ^ICMJE

August 2007

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

UCLA End Result Score [ Time Frame: 3 months, 6 months, 1 year, 3 years, 5 years ] [ Designated as safety issue: No ]
X-rays [ Time Frame: 3 month, 1 year, 3 years, 5 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00699270 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence of revisions and removals [ Time Frame: Any time ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Prospective

Condition ^ICMJE

Osteoarthritis
Avascular Necrosis
Rheumatoid Arthritis
Humeral Fractures

Intervention ^ICMJE

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

200

Completion Date

December 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00699270

Responsible Party

Kenneth Beres, MD Director Clinical Research, Biomet Orthopedics, LLC

Study ID Numbers ^ICMJE

Biomet 12380-76

Study Sponsor ^ICMJE

Biomet Orthopedics, LLC

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Kenneth J Beres, MD

Clinical Research, Biomet Orthopedics, LLC

Information Provided By

Biomet, Inc.

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP