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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This study has been withdrawn prior to enrollment.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.)
Information provided by (Responsible Party):
Zimmer Biomet ( Biomet Orthopedics, LLC ) Identifier:
First received: June 13, 2008
Last updated: January 25, 2012
Last verified: January 2012
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of Biomet Humeral Stems

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:

Further study details as provided by Zimmer Biomet:

Primary Outcome Measures:
  • UCLA End Result Score [ Time Frame: 3 months, 6 months, 1 year, 3 years, 5 years ]
  • X-rays [ Time Frame: 3 month, 1 year, 3 years, 5 years ]

Secondary Outcome Measures:
  • Incidence of revisions and removals [ Time Frame: Any time ]

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


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00699270

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

Responsible Party: Biomet Orthopedics, LLC Identifier: NCT00699270     History of Changes
Other Study ID Numbers: Biomet 12380-76
Study First Received: June 13, 2008
Last Updated: January 25, 2012

Keywords provided by Zimmer Biomet:
Total Shoulder Arthroplasty
Total Shoulder Replacement
Shoulder Arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Humeral Fractures
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Arm Injuries
Wounds and Injuries
Fractures, Bone processed this record on May 22, 2017