Patients are candidates for single-level Artificial Disc Replacement between C3 and C7 who suffer from cervical symptomatic degenerative disc disease. A maximum of 200 cases will be enrolled into the study. An 18-month recruitment period is planned with a 4-year postoperative follow-up period for each subject. Thus, it is anticipated that the study will require a minimum of 5.5 years. Patients will be assessed preoperatively, intraoperatively, prior to discharge and again at 6 weeks, 6 months, 1 year, 2 years and 4 years postoperatively from the date of surgery.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Symptomatic single-level cervical degenerative disc disease with neck and/or arm
* pain and/or neurological deficit, confirmed by MR scan
* Single-level surgery and single-level implantation of prosthesis between C3 and C7
* Age between 18 - 65 years at the time of surgery
* Pre-operative disc space height of the segment to be operated of at least 3mm
* Unsuccessful adequate conservative treatment
* Patient understands the conditions of the study and is willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation
* Patient signed Informed Consent
Exclusion Criteria:
* Major facet joint degeneration at the segment to be operated on
* Severe spondylosis at the segment to be operated on (bridging osteophytes, absence of motion (\<2°))
* Pre-operative disc space height of the segment to be operated on of less than 3mm
* Major cervical segmental instability at the segment to be operated on (translation ≥3,5 mm and/or ≥11° of rotational difference to that of either adjacent level)
* Previous trauma to the segment to be operated on resulting in compression or bursting
What they're measuring
1
Clinical Outcome measured by the Neck Disability Index (NDI)