Cervical Interbody Fusion Device Patient Registry

Stopped early

Conditions studied: Degenerative Disc Disease

In brief

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.

Key facts

Study ID

NCT05114356

Run by

Restor3D

People needed

73

Starts

2021-11-08

Expected to finish

2024-05-22

Last updated by the study team

2024-07-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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