Cervical Interbody Fusion Device Patient Registry

Degenerative Disc Disease Clinical Trial

Official title:

Cervical Interbody Fusion Device Patient Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05114356
• Other study ID #: restor3d-001
• Status: Active, not recruiting
• Start date: November 8, 2021
• Est. completion date: October 31, 2024

Study information

• Verified date: March 2024
• Source: Restor3D
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 73
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Device:
• TIDAL Cervical Interbody Fusion implant
Cervical interbody fusion device

Locations

Country	Name	City	State
United States	Orthopaedic Institute of Western Kentucky	Paducah	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Restor3D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50 at 1 year post-operative from a pre-operative baseline	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	1 year
Primary	Change in VAS Pain at 1 year post-operative from a pre-operative baseline	VAS PAIN SEVERITY SCALE ranges from 0-10. A score of zero (0) means 'no pain' and a ten (10) means 'worst imaginable pain'	1 year
Secondary	Improvement in patient reported short-form 36 (SF36) scores at 1 year post-operative from a pre-operative baseline	Questionnaire of generic, coherent, and easily administered quality-of-life measures.	1 year
Secondary	Rate of Successful Fusion Based on Radiological Assessment at 1 Year Post-op	Assessment of fusion	1 year