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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00699270
Recruitment Status : Withdrawn (Business need changed.)
First Posted : June 17, 2008
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of Biomet Humeral Stems

Condition or disease
Osteoarthritis Avascular Necrosis Rheumatoid Arthritis Humeral Fractures

Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-Controlled, Clinical Investigation of the Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems
Study Start Date : August 2007
Primary Completion Date : August 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699270


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

Responsible Party: Biomet Orthopedics, LLC
ClinicalTrials.gov Identifier: NCT00699270     History of Changes
Other Study ID Numbers: Biomet 12380-76
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017

Keywords provided by Zimmer Biomet ( Biomet Orthopedics, LLC ):
Total Shoulder Arthroplasty
Total Shoulder Replacement
Shoulder Arthritis

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Necrosis
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