Cervical Interbody Implant Study (NCT04689854) | Clinical Trial Compass
By InvitationNot Applicable
Cervical Interbody Implant Study
United States150 participantsStarted 2020-07-07
Plain-language summary
The primary objective of this study is to evaluate the safety and performance of cervical spine surgery using interbody implants as measured by reported complications, radiographic outcomes, and patient-reported outcomes (PROs).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients who are ≥18 years of age at the time of consent
. Have a planned spine surgery using interbody implants at one or more cervical levels (C2-T1) for degenerative disc disease and/or cervical spinal instability
. Using one of the following implants (NuVasive, Inc., San Diego, CA):
. Cohere Cervical
. Modulus Cervical
. With interbody fusion using autograft and/or allograft (i.e., cancellous and/or corticocancellous allograft bone) and NuVasive supplemental internal fixation cleared by the applicable regulatory body for use in the cervical spine
. Able to undergo surgery based on physical exam, medical history, and surgeon judgment
. Understands the conditions of enrollment, is willing to follow medical advice including postoperative activity restrictions per the surgeon's standard of care, and is willing to sign an informed consent form to participate in the study
Exclusion criteria
. Use of any bone graft that is not cleared by the applicable regulatory body for use within interbody implants. Examples of these include:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Demineralized bone matrices (DBM) regulated as medical devices by the FDA (e.g., Grafton Putty/Gel (Medtronic), DBX (MTF/Depuy Synthes), Accell Evo3 (IsoTis), and Propel Putty/Gel (NuVasive))
. Peptide enhanced bone graft (e.g., iFactor (Cerapedics))
. Previous cervical fusion surgery at the level(s) to be treated (adjacent level surgery is acceptable; prior decompression is acceptable)
. Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)