Cervical Interbody Fusion Device Patient Registry

Terminated

• Conditions: Degenerative Disc Disease
• Interventions: Device: TIDAL Cervical Interbody Fusion implant

• Registration Number: NCT05114356
• Lead Sponsor: Restor3D

Brief 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.

Study Timeline

• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-11-01
• Study Start: 2021-11-08
• Study First Posted: 2021-11-10
• Primary Completion: 2024-05-22
• Study Completion: 2024-05-22
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• Neck and arm pain for a minimum of 6 weeks before surgery that is recalcitrant to nonoperative treatment modalities, such as physical therapy, reduced activities, and anti-inflammatory medications.
• Radiographic evidence of cervical disc disease that is documented on dynamic radiographs and magnetic resonance imaging (MRI).

Exclusion Criteria

• Medical condition that required medication, such as steroids or nonsteroidal anti-inflammatory medications, that could interfere with fusion.

There are no restrictions on sex or ethnicity.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	TIDAL Cervical Interbody Fusion implant	Patients being treated for degenerative disc disease

Primary Outcome Measures

Name	Time	Method
Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50 at 1 year post-operative from a pre-operative baseline	1 year	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
Change in VAS Pain at 1 year post-operative from a pre-operative baseline	1 year	VAS PAIN SEVERITY SCALE ranges from 0-10. A score of zero (0) means 'no pain' and a ten (10) means 'worst imaginable pain'

Secondary Outcome Measures

Name	Time	Method
Improvement in patient reported short-form 36 (SF36) scores at 1 year post-operative from a pre-operative baseline	1 year	Questionnaire of generic, coherent, and easily administered quality-of-life measures.
Rate of Successful Fusion Based on Radiological Assessment at 1 Year Post-op	1 year	Assessment of fusion

Trial Locations

Locations (1)

Orthopaedic Institute of Western Kentucky; 🇺🇸 Paducah, Kentucky, United States