The object of this study is to assess the long-term safety and efficacy of cervical disc replacement with the ProDisc-C vivo Cervical Disc in a prospective, randomized, multi-center trial with 7 years of follow-up.
This is a prospective, randomized, multicenter trial at 7 years of follow-up comparing ProDisc-C vivo artificial cervical disc replacement and ACDF (Anterior cervical discectomy fusion) to treat degenerative disc disease (DDD). 648 DDD patients (age from 20 to 70) from several hospitals matching the inclusion criteria will be randomly assigned to two groups (324 patients in each group). One group will be treated with ProDisc-C vivo disc replacement. The other group will be treated with ACDF. The clinical outcomes and radiographic measurements will be compared between two groups at 1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
648
Total Disc Replacement using ProDisc-C vivo.
Anterior Cervical Discectomy and Fusion
Change of overall success rate
A patient's outcome was considered an overall success if all of the following conditions were met: 1) postoperative (Neck Disability Index) NDI score improvement of at least a 15-point increase from preoperative score; 2) maintenance or improvement in neurological status; 3) disc height success; 4) no serious adverse event classified as implant associated or implant/surgical procedure associated; and 5) no additional surgical procedure classified as a "failure".
Time frame: The overall success will be assessed at each time point (1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments).
Change of sagittal angular motion
Neutral anteroposterior and lateral radiographs and dynamic flexion-extension lateral radiographs will be measured.
Time frame: The radiographic outcomes will be obtained at each study point (before surgery,1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments).
Change of neck disability index scores
The neck disability index(NDI) questionnaire measures the level of pain and disability associated with various activities. The NDI is a 10-item, 50-point index that assesses different aspects of daily functioning in patients with neck pain. Each item is scored 0 to 5. The NDI score is a sum of the scores of the10-item. Clinical effects will be evaluated based on scores of the NDI. Higher values represent a better outcome.
Time frame: The NDI scores will be obtained at each study point (before surgery,1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments).
Change of Arm and Neck pain intensity
Neck and arm pain scores will be measured using a visual analogue scale (VAS) from "0' (no sensation) to '100"(the most intense pain imaginable) where 30 means "pain threshold".
Time frame: Neck and arm pain scores will be measured at each study point (before surgery,1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments).
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