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NCT05114356 · ClinicalTrials.gov registry record
Cervical Interbody Fusion Device Patient Registry
A clinical trial, sponsored by Restor3D.
- Terminated
- Registry status
- 73
- Enrollment target
NCT05114356: Clinical Trial study, sponsored by Restor3D.
NCT05114356 is a clinical trial that was terminated before completion, run by Restor3D. The registered enrollment target is 73 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05114356 was terminated before completion, sponsored by Restor3D.
- TERMINATED
- Registry status
- 73 participants
- Enrollment target
Study Summary
The registry has been designed as a prospective, observational program for patients undergoing anterior cervical discectomy and fusion (ACDF) procedures treated with TIDAL cervical interbody fusion device. The ultimate goal of the study is to aid in the development of treatment pathways and improved patient care. All patients who agree to participate in the registry will sign an informed consent form and subsequently be treated by their surgeon with the device in either an inpatient or outpatient facility.
Primary Outcome
ODI/NDI Score Range: 0-50 0-4 No disability 5-14 Mild disability 15-24 Moderate disability 25-34 Severe disability \>34 Complete disability
Interventions
- DEVICE TIDAL Cervical Interbody Fusion implant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2021-11-08 |
| Est. Completion | 2024-05-22 |
Why NCT05114356 stopped before completion
NCT05114356 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 73 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which TIDAL Cervical Interbody Fusion implant is the first listed.
NCT05114356 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05114356 about?
NCT05114356 is a clinical study titled "Cervical Interbody Fusion Device Patient Registry". The registry has been designed as a prospective, observational program for patients undergoing anterior cervical discectomy and fusion (ACDF) procedures treated with TIDAL cervical interbody fusion device. The ultimate goal of the study is to aid in the development of treatment pathways and improved...
What is the current status of trial NCT05114356?
This trial is currently terminated. The enrollment target is 73 participants. The study started on 2021-11-08. Estimated completion is 2024-05-22.
What interventions are being tested in trial NCT05114356?
The interventions under investigation include: TIDAL Cervical Interbody Fusion implant (DEVICE).
Who is sponsoring clinical trial NCT05114356?
This trial is sponsored by Restor3D, which has 20 total clinical trials registered on ClinicalTrials.gov.
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