Database Retrieval for the Comprehensive Shoulder

Zimmer Biomet

Status: Active, not recruiting

Conditions: Prior Failed Revision; Osteoarthritis of the Shoulder; Correction of Functional Deformity; Cuff Tear Arthropathy; Avascular Necrosis; Fracture of Proximal End of Humerus; Rheumatoid Arthritis

Treatments: Device: Biomet Comprehensive Shoulder System

Study type: Observational

Funder types: Industry

Identifiers

NCT03409718

ORTHO.CR.EX003

Details and patient eligibility

About

This study is a retrieval of database information regarding survivorship of the Comprehensive Shoulder System family of products. The primary objective of the retrieval is to collect data that will contribute to the post market surveillance requirements for this product and will provide feedback to design engineers, support marketing efforts and publications, and answer potential questions form reimbursement agencies.

Full description

The Comprehensive Shoulder System has been cleared by the FDA via premarket notifications. No experimental or investigational surgical techniques or devices will be used in this study. All devices and products will be used in accordance with their instructions for use and/or approved labeling. The aim of the Comprehensive Shoulder System is to improve shoulder function and reduce pain.

One site will be used for this database retrieval. The number of patients involved will depend upon the size of the Comprehensive database available at Acromion, LLC.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must have one of the following indications:
• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis
• Revision where other devices or treatments have failed.
• Correction of functional deformity.
• Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
• Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
• Need to obtain pain relief and improve function
• Ability and willingness of the patient to follow instructions, including control of weight and activity level
• A good nutritional state of the patient
• The patient must have reached full skeletal maturity

Exclusion criteria

• Absolute contraindications include infection, sepsis, and osteomyelitis.
• Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
• Osteoporosis.
• Metabolic disorders which may impair bone formation.
• Osteomalacia.
• Distant foci of infections which may spread to the implant site.
• Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.

Trial design

160 participants in 1 patient group

Biomet Comprehensive Shoulder System

Description:

Subjects in need of a total shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Shoulder System.

Treatment:

Device: Biomet Comprehensive Shoulder System