Avascular Necrosis, Correction of Functional Deformity, Cuff Tear Arthropathy, Fracture of Proximal End of Humerus, Osteoarthritis of the Shoulder, Prior Failed Revision, Rheumatoid Arthritis
Conditions
Keywords
Total Shoulder Arthroplasty, Medical Device, Performance, Safety, Shoulder Prosthesis
Brief summary
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.
Detailed 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.
Interventions
DEVICEBiomet Comprehensive Shoulder System
Total shoulder system designed to provide intraoperative flexibility for surgeons with unmatched humeral stem options, and infinite humeral head offset possibilities while meeting the growing demand for ease of glenoid preparation through a streamlined, low-profile, cannulated instrument platform
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant survivorship is assessed counting the number of implant revisions | 10 years | Implant survivorship will be documented by assessing the number of implant revisions occurring throughout the course of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Constant Shoulder Score | 10 years | The Constant-Murley Shoulder Score is a scoring method used by clinicians to assess function of the shoulder. The standard score is on a scale of 0 to 100, with 0 being no shoulder function and 100 being excellent function. |
| Clinical Safety | 10 years | Clinical safety is assessed through documentation of complications occurring during the course of the study. |
| Clinical Safety - Device Related | 10 years | Clinical safety is assessed through documentation of device-related events occurring during the course of the study. |
Countries
United States
Contacts
STUDY_DIRECTORErin D Osborn
Zimmer Biomet
Outcome results
None listed