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

Verified by: Biomet, Inc., January 2012
First Received: June 13, 2008 | Last Updated: January 25, 2012 | Phase: N/A | Start Date: August 2007
Overall Status: Withdrawn | Estimated Enrollment: 0
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The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of Biomet Humeral...

Brief Summary

Official Title: “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

  • Study Type: Observational
  • Study Design: Observational Model: Cohort, Time Perspective: Prospective
  • Study Primary Completion Date: August 2008

Arms, Groups and Cohorts in this Clinical Trial

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

Outcome Measures for this Clinical Trial

Primary Measures

  • UCLA End Result Score
    • Time Frame: 3 months, 6 months, 1 year, 3 years, 5 years
      Safety Issue?: No
  • X-rays
    • Time Frame: 3 month, 1 year, 3 years, 5 years
      Safety Issue?: No

Secondary Measures

  • Incidence of revisions and removals
    • Time Frame: Any time
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Biomet Orthopedics, LLC Industry

Overall Clinical Trial Officials and Contacts

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

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00699270

Study ID Number: Biomet 12380-76

ClinicalTrials.gov Identifier: NCT00699270

Health Authority: United States: Institutional Review Board

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00699270