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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This study has been withdrawn prior to enrollment.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
  Purpose

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


Condition
Osteoarthritis
Avascular Necrosis
Rheumatoid Arthritis
Humeral Fractures

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-Controlled, Clinical Investigation of the Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 0
Study Start Date: August 2007
Study Completion Date: December 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Biomet Humeral Stems
Biomet Humeral Stems: Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients that have already made the decision to undergo shoulder replacement surgery and will receive a Biomet humeral stem.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699270

Sponsors and Collaborators
Biomet Orthopedics, LLC
Investigators
Study Director: Kenneth J Beres, MD Clinical Research, Biomet Orthopedics, LLC
  More Information

No publications provided

Responsible Party: Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier: NCT00699270     History of Changes
Other Study ID Numbers: Biomet 12380-76
Study First Received: June 13, 2008
Last Updated: January 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Biomet, Inc.:
Total Shoulder Arthroplasty
Total Shoulder Replacement
Shoulder Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Humeral Fractures
Necrosis
Osteonecrosis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
 Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Arm Injuries
Wounds and Injuries
Fractures, Bone
Pathologic Processes
Bone Diseases

ClinicalTrials.gov processed this record on June 18, 2013