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

NCT00699270 | Withdrawn

• 1 other identifier: Biomet 12380-76
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis; Humeral Fractures

Keywords

Total Shoulder Arthroplasty; Total Shoulder Replacement; Shoulder Arthritis

Outcome Measures

Primary Outcomes (2)

• UCLA End Result Score

  3 months, 6 months, 1 year, 3 years, 5 years

• X-rays

  3 month, 1 year, 3 years, 5 years

Secondary Outcomes (1)

• Incidence of revisions and removals

  Any time

Study Arms (1)

Biomet Humeral Stems

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid Arthritis
• Correction of functional deformity

You may not qualify if:

• 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

Sponsors & Collaborators

• Biomet Orthopedics, LLC: lead

MeSH Terms

Conditions

Osteoarthritis; Osteonecrosis; Arthritis, Rheumatoid; Humeral Fractures

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Kenneth J Beres, MD

  Clinical Research, Biomet Orthopedics, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2008
• First Posted: June 17, 2008
• Study Start: August 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 21, 2017

Record last verified: 2017-06