Viewing Study NCT02403453



Ignite Creation Date: 2024-05-06 @ 3:54 AM
Last Modification Date: 2024-10-26 @ 11:40 AM
Study NCT ID: NCT02403453
Status: TERMINATED
Last Update Posted: 2023-10-25
First Post: 2015-03-19

Brief Title: RHINE Cervical Disc Clinical Study A Prospective Observational Study for Patients Requiring 1-2 Level C-spine Surgery
Sponsor: K2M Inc
Organization: K2M Inc

Study Overview

Official Title: RHINE Cervical Disc Clinical Study
Status: TERMINATED
Status Verified Date: 2023-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Stryker has made the decision to remove the Rhine Cervical Disc Replacement from their product portfolio Stryker is not aware of any safety or effectiveness concerns and this decision is not related to poor patient outcomes or known device failures
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: A Prospective open label multi-center observational study of patients requiring surgical treatment at one or two contiguous cervical spine levels The primary objectives of the RHINE Cervical Disc study are to obtain operative data and feedback on surgical instruments and surgical technique confirm device performance in terms of clinical and radiographic outcomes confirm device performance in terms of safety and to collect original data to be compared to published reports of the performance of comparable motion-sparing devices as well as clinical outcomes of fusion devices
Detailed Description: A Prospective open label multi-center observational study of patients requiring surgical treatment at one or two contiguous cervical spine levels C3-C7 The primary objectives of the RHINE Cervical Disc study are to obtain operative data and feedback on surgical instruments and surgical technique confirm device performance in terms of clinical and radiographic outcomes confirm device performance in terms of safety and to collect original data to be compared to published reports of the performance of comparable motion-sparing devices as well as clinical outcomes of fusion devices Device- and procedure-related adverse events serious adverse events and secondary surgeries will be monitored throughout AEs will be characterized by severity seriousness and relationship to device Investigator reports of serious adverse events and any AE trends will be reviewed by a medical monitor

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None