Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two… (NCT00637156) | Clinical Trial Compass
CompletedNot Applicable
Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels
United States397 participantsStarted 2006-06
Plain-language summary
The purpose of this clinical investigation is to assess the safety and effectiveness of using the PRESTIGE-LP device in the treatment of patients with symptomatic degenerative disc disease at two adjacent levels of the cervical spine, with overall success being the primary endpoint of the clinical trial. The primary objective is to show non-inferiority of the investigational device to the control treatment. If non-inferiority is established, superiority will also be examined as the secondary objective.
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:
* Has cervical DDD at 2 adjacent cervical levels (C3-C7) requiring surgical treatment \& involving intractable radiculopathy, myelopathy, or both
* Has a herniated disc and/or osteophyte formation at each level to be treated that is producing symptomatic nerve root and/or spinal cord compression. The condition is documented by patient history, and the requirement for surgical treatment is evidenced by radiographic studies
* Unresponsive to non-operative treatment for approximately 6 weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management
* Has no previous surgical intervention at the involved levels or any subsequent planned/staged surgical procedure at the involved or adjacent level(s)
* Must be ≥ 18 years; skeletally mature at time of surgery
* Preoperative NDI score ≥ 30
* Preoperative neck pain score ≥ 8 based on the preoperative Neck and Arm Pain Questionnaire
* If a female of childbearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant during the study period
* Is willing to comply with the study plan and sign Patient Informed Consent Form
Exclusion Criteria:
* Has a cervical spinal condition other than symptomatic cervical DDD requiring surgical treatment at the involved levels
* Has documented or diagnosed cervical instability relative to adjacent segments at either level, defined by dynamic (flexion/extension) radiograph…
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.