Study Stopped
Sponsor decision
Cervical Interbody Fusion Device Patient Registry
1 other identifier
observational
73
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2021
CompletedStudy Start
First participant enrolled
November 8, 2021
CompletedFirst Posted
Study publicly available on registry
November 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2024
CompletedJuly 3, 2024
July 1, 2024
2.5 years
October 20, 2021
July 1, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Improvement in patient reported short-form 36 (SF36) scores at 1 year post-operative from a pre-operative baseline
1 year
Rate of Successful Fusion Based on Radiological Assessment at 1 Year Post-op
1 year
Study Arms (1)
Study group
Patients being treated for degenerative disc disease
Interventions
Eligibility Criteria
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
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Restor3Dlead
Study Sites (1)
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, 42001, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2021
First Posted
November 10, 2021
Study Start
November 8, 2021
Primary Completion
May 22, 2024
Study Completion
May 22, 2024
Last Updated
July 3, 2024
Record last verified: 2024-07