The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Ce… (NCT05740176) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
United States200 participantsStarted 2023-06-01
Plain-language summary
A multicenter, prospective, non-randomized, historically controlled study. To demonstrate the Synergy Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) to treat cervical degenerative disc disease (DDD) in subjects who are symptomatic at two levels from C3 to C7 are and are unresponsive to conservative management. Patients will be evaluated preoperatively, at the time of surgery, and at 6 weeks, and 3, 6, 12, and 24 months after surgery. Follow-up will continue annually until the last patient reaches 24-month follow-up. The primary analysis will occur at 24 months.
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
. Must be at least 18 years of age and be skeletally mature at the time of surgery
. Has a preoperative neck pain score ≥ 8 (out of 20) based on the preoperative Neck and Arm Pain Questionnaire.
. Has cervical degenerative disc disease at two (2) adjacent cervical levels (from C3 - C7) requiring surgical treatment and 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 (e.g., neck pain with arm pain, functional deficit and/or neurological deficit), and the requirement for surgical treatment is evidenced by radiographic studies (e.g., CT, MRI, x-rays, etc.);
. Neck Disability Index (NDI) score ≥ 30/100 (raw score of ≥ 15/50);
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.
. Has been unresponsive to non-operative treatment for at least six 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);
. 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 the 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) radiographs showing:
. Sagittal plane translation \> 3.5 mm, or
. Sagittal plane angulation \> 20°;
. Prior attempted or completed cervical spine surgery, except (1) laminoforaminotomy (greater than 6 months prior to scheduled surgical treatment), which includes removal of disc material necessary to perform a nerve root decompression, with less than one-third facetectomy at any level, or (2) a successful single-level anterior cervical fusion (greater than 6 months prior to scheduled surgical treatment);
. Has severe pathology of the facet joints of the involved vertebral bodies;
. Axial neck pain only (no radicular or myelopathy symptoms);
. Has been previously diagnosed with osteomalacia;