Novum Vitrium® Cervical Cage in Anterior Cervical Discectomy and Fusion (NCT03828136) | Clinical Trial Compass
TerminatedNot Applicable
Novum Vitrium® Cervical Cage in Anterior Cervical Discectomy and Fusion
Stopped: Sponsor business decision
United States25 participantsStarted 2019-04-24
Plain-language summary
A prospective, multicenter, randomized, concurrently controlled, noninferiority clinical trial to compare the safety and effectiveness of instrumented Bio2 Vitrium Cervical Interbody Device in anterior cervical discectomy and fusion (ACDF) with structural allograft bone and local autologous bone graft in treating patients with a symptomatic degenerative cervical disc disease at one level from C3/C4 to C7/T1.
Who can participate
Age range
22 Years – 70 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
. Symptomatic cervical disc disease (SCDD) in the one vertebral level between C3/C4 to C7/T1, defined as neck or arm (radicular) pain, or functional or neurological deficit and correlated with radiculopathy or myelopathy or radiographic confirmation (by CT, MRI, x-ray, etc.) of any of the following:
. Requires only one cervical vertebral level to be surgically treated, confirmed radiologically by Xray, CT, or MRI and correlated with neurologic examination prior to enrollment;
. Age between 22 and 70 years (inclusive);
. Skeletally mature patients;
. Failed at least 6 weeks of conservative treatment (e.g. medication, physical therapy), or exhibit progressive symptoms or signs of spinal cord/nerve root compression with continued non-operative care;
. Neck Disability Index (NDI) Questionnaire score of at least 30 (on a scale from 0 to 100);
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.
What they're measuring
1
Number of participants who have achieved of radiologic fusion assessed by roentgenographic examination.
Timeframe: 12 months
2
Change in Neck Disability Index (NDI) with a response greater than or equal to 15 from baseline.
Timeframe: 12 months
3
Number of participants with neurological success.
Timeframe: 12 months
4
Number of participants who have completed follow-up up to month 12 without Secondary Surgical Intervention (SSI).
. Able to read and Understand all documents used in this study, including the Informed Consent and patient-reported outcome questionnaires;
. Understand and read English at elementary level;
Exclusion criteria
. More than one vertebral level requiring treatment, confirmed radiologically by X-ray, CT, or MRI
. Cervical instability;
. Prior fusion surgery at any cervical vertebral level;
. Prior surgery at the level to be treated with the exception of surgery that does not require the use of hardware and/or the treatment of facet disease;
. Severe facet disease;
. Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma
. Neck or arm pain of unknown etiology;
. Osteoporosis, osteopenia, Paget's disease, osteomalacia or any other metabolic bone disease;