Clinical and Radiological Outcomes of a 7-year Follow-up, Multi-center, Prospective, Randomized, Controlled Trial: Two-level Cervical ProDisc-C Vivo Versus Hybrid Construct.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 542
- Primary Endpoint
- Change of overall success rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •A diagnosis of degenerative disc disease with radiculopathy or myeloradiculopathy at 2 contiguous levels from C-3 to C-
- •The symptom is unresponsive to nonoperative treatment for at least 6 weeks.
- •The patient demonstrates progressive symptoms calling for immediate surgery.
Exclusion Criteria
- •Any prior cervical spine surgery.
Arms & Interventions
Two level Prodisc-C vivo
Two level Prodisc-C vivo cervical artificial disc replacement.
Intervention: Two level Prodisc-C vivo (Procedure)
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).
Intervention: Hybrid (Procedure)
Outcomes
Primary Outcomes
Change of overall success rate
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).
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 Outcomes
- 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).)
- 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).)
- 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).)
Investigators
guochen
Department of Spine Surgery
Peking University People's Hospital