Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-25 @ 4:53 AM
NCT ID:
NCT03409718
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.
Study:
NCT03409718
Study Brief:
Protocol Section:
NCT03409718