Clinical trial NCT05114356: Cervical Interbody Fusion Device Patient Registry
Official title: Cervical Interbody Fusion Device Patient Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Degenerative Disc Disease
Lead sponsor: Restor3D
Sponsor class: INDUSTRY
First posted: 2021-11-10
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50 at 1 year post-operative from a pre-operative baseline
timeFrame: 1 year
measure: Change in VAS Pain at 1 year post-operative from a pre-operative baseline
timeFrame: 1 year
Secondary outcomes:
measure: Improvement in patient reported short-form 36 (SF36) scores at 1 year post-operative from a pre-operative baseline
timeFrame: 1 year
measure: Rate of Successful Fusion Based on Radiological Assessment at 1 Year Post-op
timeFrame: 1 year
Other outcomes:
Locations:
city: Paducah
country: United States
facility: Orthopaedic Institute of Western Kentucky
state: Kentucky
Study officials:
References: