Treatment of One and/or Two Level Cervical Degenerative Disc Disease (NCT05812092) | Clinical Trial Compass
By InvitationNot Applicable
Treatment of One and/or Two Level Cervical Degenerative Disc Disease
United States50 participantsStarted 2021-05-01
Plain-language summary
The objective of this study is to collect clinical and radiographic outcomes using the CONDUIT™ Interbody Cervical System with supplemental fixation using a DePuy Synthes Cervical Plating System.
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
. Male or female subject; at least 18 years of age
. Diagnosis of radiculopathy or myelopathy with radiculopathy of the cervical spine, with pain, paresthesias or paralysis in a specific nerve root distribution C2 through T1, including at least one of the following:
. Neck and/or arm pain of at least 30/100 mm on the visual analogue scale (VAS) scale
. Decreased muscle strength of at least one level on the clinical evaluation (0 to 5) scale
. Abnormal sensation including hyperesthesia or hypoesthesia; and/or
. Abnormal reflexes
. Symptomatic cervical disc disease, facet arthropathy, or cervical spinal stenosis at 1 or 2 levels between C2 and T1, suitable for treatment with anterior discectomy, decompression, and fusion
. Radiographically determined pathology at the level to be treated correlating to primary symptoms including at least one of the following:
Exclusion criteria
. Have an active systemic infection or infection at the operative site.
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.
. Have a history of or anticipated treatment for active systemic infection, including HIV or Hepatitis C.
. Have previous trauma to the C2 to T1 levels resulting in significant bony or disco- ligamentous cervical spine injury.
. Have had any prior spine surgery at the operative level(s).
. Have osteoporosis
. Have Paget's disease of bone, osteomalacia or any other metabolic bone disease other than osteoporosis (addressed above).
. Have active malignancy that included a history of any invasive malignancy (except non- melanoma skin cancer),unless the subject had been treated with curative intent and there had been no clinical signs or symptoms of the malignancy for at least five years.
. Have symptomatic cervical disc disease or significant cervical spondylosis at more than 2 levels.