A Multi-center Prospective Randomized Controlled Study on Clinical and Radiographic Analysis of ProDisc-C Vivo
Clinical and Radiographic Analysis of ProDisc-C Vivo to Treat Degenerative Disc Disease: A 7-year Follow-up, Multi-center, Prospective, Randomized, Controlled Clinical Trial.
1 other identifier
interventional
648
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2018
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2017
CompletedFirst Posted
Study publicly available on registry
December 8, 2017
CompletedStudy Start
First participant enrolled
March 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedDecember 8, 2017
December 1, 2017
7 years
November 29, 2017
December 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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".
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).
Secondary Outcomes (3)
Change of sagittal angular motion
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 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 at each study point (before surgery,1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments).
Study Arms (2)
ProDisc-C vivo
EXPERIMENTALThis group of patients will be treated with ProDisc-C vivo disc replacement (single segment).
Anterior cervical discectomy fusion
ACTIVE COMPARATORThis group of patients will be treated with anterior cervical discectomy fusion (ACDF) procedure (single segment).
Interventions
Anterior Cervical Discectomy and Fusion
Eligibility Criteria
You may qualify if:
- Single-level cervical disc disease.
- At least one additional confirmatory neuroradiographic study, such as MRI or CT- enhanced myelography that showed findings consistent with clinical findings and complaints.
You may not qualify if:
- Patients have cervical spinal conditions other than single-level symptomatic degenerative disc disease or evidence of instability.
- Symptomatic disc disease at level C2 -3 or C7-T1.
- A history of discitis.
- A medical condition that required medication,such as steroids or nonsteroidal antiinflammatory medications that could interfere with fusion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
Sasso RC, Anderson PA, Riew KD, Heller JG. Results of cervical arthroplasty compared with anterior discectomy and fusion: four-year clinical outcomes in a prospective, randomized controlled trial. J Bone Joint Surg Am. 2011 Sep 21;93(18):1684-92. doi: 10.2106/JBJS.J.00476.
PMID: 21938372BACKGROUNDSteinmetz MP, Patel R, Traynelis V, Resnick DK, Anderson PA. Cervical disc arthroplasty compared with fusion in a workers' compensation population. Neurosurgery. 2008 Oct;63(4):741-7; discussion 747. doi: 10.1227/01.NEU.0000325495.79104.DB.
PMID: 18981885BACKGROUNDMummaneni PV, Burkus JK, Haid RW, Traynelis VC, Zdeblick TA. Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial. J Neurosurg Spine. 2007 Mar;6(3):198-209. doi: 10.3171/spi.2007.6.3.198.
PMID: 17355018BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhenqi Zhu, Master
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 29, 2017
First Posted
December 8, 2017
Study Start
March 1, 2018
Primary Completion
March 1, 2025
Study Completion
March 1, 2025
Last Updated
December 8, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share