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 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.

Study Overview

• Status: Terminated
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Device: TIDAL Cervical Interbody Fusion implant

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 Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Paducah, Kentucky, United States, 42001
      • Orthopaedic Institute of Western Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with degenerative disc disease of the cervical spine, and being surgically treated for degenerative cervical disc disease using a 3D printed titanium interbody cage

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; Patients being treated for degenerative disc disease	Device: TIDAL Cervical Interbody Fusion implant; Cervical interbody fusion device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Rate of Successful Fusion Based on Radiological Assessment at 1 Year Post-op	Assessment of fusion	1 year

Collaborators and Investigators

• Sponsor: Restor3D

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2021
• Primary Completion (Actual): May 22, 2024
• Study Completion (Actual): May 22, 2024

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: November 1, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: restor3d-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No