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 range18 Years
SexALL
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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);
✓. 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;