Trials / Terminated
TerminatedNCT02403453
RHINE™ Cervical Disc Clinical Study: A Prospective Observational Study for Patients Requiring 1-2 Level C-spine Surgery
RHINE™ Cervical Disc Clinical Study
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 68 (actual)
- Sponsor
- K2M, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Rhine Cervical Disc | RHINE Cervical Disc |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2023-03-01
- Completion
- 2023-03-01
- First posted
- 2015-03-31
- Last updated
- 2023-10-25
Source: ClinicalTrials.gov record NCT02403453. Inclusion in this directory is not an endorsement.