NCT05114356

Cervical Interbody Fusion Device Patient Registry

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 73 (actual)
• Sponsor: Restor3D · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The registry is design to collect data prospectively on patients undergoing spinal fusion using the TIDAL cervical interbody fusion device. Patients will be enrolled in the registry after reviewing the protocol with their health care provider and signing the informed consent. Data will be collected at recommended time points based on the standards of care of the participating sites. The registry will serve as a database in which retrospective analysis and exploratory analysis of specific research questions will be answered. Follow up visits will be defined by the treating physicians based on their standard practice. Typical clinical follow up schedules for patients undergoing this type of surgery are pre-operative and 12 months post-operative.

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
DEVICE	TIDAL Cervical Interbody Fusion implant	Cervical interbody fusion device

Timeline

• Start date: 2021-11-08
• Primary completion: 2024-05-22
• Completion: 2024-05-22
• First posted: 2021-11-10
• Last updated: 2024-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study