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

This study has been withdrawn prior to enrollment.
(Business need changed.)
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:
NCT00699270
First received: June 13, 2008
Last updated: January 25, 2012
Last verified: January 2012
History of Changes

June 13, 2008
January 25, 2012
August 2007
August 2008   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00699270 on ClinicalTrials.gov Archive Site
Incidence of revisions and removals [ Time Frame: Any time ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of Biomet Humeral Stems
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients that have already made the decision to undergo shoulder replacement surgery and will receive a Biomet humeral stem.
  • Osteoarthritis
  • Avascular Necrosis
  • Rheumatoid Arthritis
  • Humeral Fractures
Not Provided
Biomet Humeral Stems
Biomet Humeral Stems: Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00699270
Biomet 12380-76
No
Biomet, Inc. ( Biomet Orthopedics, LLC )
Biomet Orthopedics, LLC
Not Provided
Study Director: Kenneth J Beres, MD Clinical Research, Biomet Orthopedics, LLC
Biomet, Inc.
January 2012

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