Clinical and Radiological Outcomes: Two-level Cervical ProDisc-C Vivo Versus Hybrid Construct.
- Conditions
- Cervical Disc Disease
- Interventions
- Procedure: Two level Prodisc-C vivoProcedure: Hybrid
- Registration Number
- NCT03367052
- Lead Sponsor
- Peking University People's Hospital
- Brief Summary
The objective of this study is to investigate the clinical and radiological results of two-level cervical ProDisc-C vivo versus hybrid construct.
- Detailed Description
This is a prospective, randomized, multicenter trial at 7 years of follow-up comparing two level ProDisc-C vivo artificial cervical disc replacement and hybrid construct, i.e., combining ACDF (Anterior cervical discectomy fusion) and ProDisc-C vivo to treat degenerative disc disease (DDD). 542 DDD patients (age from 20 to 70) from several hospitals matching the inclusion criteria will be randomly assigned to two groups (271 patients in each group). One group will be treated with two level ProDisc-C vivo disc replacement. The other group will be treated with hybrid construct. Clinical outcomes and radiological analysis will be done at 1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 542
- A diagnosis of degenerative disc disease with radiculopathy or myeloradiculopathy at 2 contiguous levels from C-3 to C-7.
- The symptom is unresponsive to nonoperative treatment for at least 6 weeks.
- The patient demonstrates progressive symptoms calling for immediate surgery.
- Any prior cervical spine surgery.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Two level Prodisc-C vivo Two level Prodisc-C vivo Two level Prodisc-C vivo cervical artificial disc replacement. Hybrid Hybrid This group of patients will be treated with hybrid construct, i.e., one level of Prodisc-C vivo and one level of anterior cervical discectomy fusion (ACDF).
- Primary Outcome Measures
Name Time Method Change of overall success rate 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). 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".
- Secondary Outcome Measures
Name Time Method Change of sagittal angular motion The radiographs will be obtained at each study point (before surgery,1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments). Neutral anteroposterior and lateral radiographs and dynamic flexion-extension lateral radiographs.
Change of NDI Scores The NDI scores will be assessed at each study point (before surgery,1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments). 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.
Change of Arm and Neck pain 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). 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".