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.
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.
Study Type
OBSERVATIONAL
Enrollment
160
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
Acromion LLC
Towson, Maryland, United States
Implant survivorship is assessed counting the number of implant revisions
Implant survivorship will be documented by assessing the number of implant revisions occurring throughout the course of the study.
Time frame: 10 years
Constant Shoulder Score
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.
Time frame: 10 years
Clinical Safety
Clinical safety is assessed through documentation of complications occurring during the course of the study.
Time frame: 10 years
Clinical Safety - Device Related
Clinical safety is assessed through documentation of device-related events occurring during the course of the study.
Time frame: 10 years
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