NCT03367052

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
542

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 8, 2017

Completed
24 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 8, 2017

Status Verified

December 1, 2017

Enrollment Period

7.9 years

First QC Date

November 29, 2017

Last Update Submit

December 4, 2017

Conditions

Cervical Disc Disease

Keywords

ProDisc-C vivoHybridCervical degenerative disc disease

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 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).

Study Arms (2)

Two level Prodisc-C vivo

EXPERIMENTAL

Two level Prodisc-C vivo cervical artificial disc replacement.

Procedure: Two level Prodisc-C vivo

Hybrid

ACTIVE COMPARATOR

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).

Procedure: Hybrid

Interventions

Two level Prodisc-C vivoPROCEDURE

Two level of Prodisc-C vivo artificial disc replacement will be done in one group of patients.

Two level Prodisc-C vivo
HybridPROCEDURE

The hybrid method will be used in one group of patients.

Hybrid

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Any prior cervical spine surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Zigler JE, Delamarter R, Murrey D, Spivak J, Janssen M. ProDisc-C and anterior cervical discectomy and fusion as surgical treatment for single-level cervical symptomatic degenerative disc disease: five-year results of a Food and Drug Administration study. Spine (Phila Pa 1976). 2013 Feb 1;38(3):203-9. doi: 10.1097/BRS.0b013e318278eb38.

    PMID: 23080427BACKGROUND

  • Davis RJ, Kim KD, Hisey MS, Hoffman GA, Bae HW, Gaede SE, Rashbaum RF, Nunley PD, Peterson DL, Stokes JK. Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled multicenter clinical trial: clinical article. J Neurosurg Spine. 2013 Nov;19(5):532-45. doi: 10.3171/2013.6.SPINE12527. Epub 2013 Sep 6.

    PMID: 24010901BACKGROUND

Study Officials

  • chen guo, Master

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiwei Xia, Ph.D.

CONTACT

008613260001978523526767@qq.com

chen guo, Master

CONTACT

008618811792718weiweixia2016@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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 compared between the two groups at 1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Spine Surgery

Study Record Dates

First Submitted

November 29, 2017

First Posted

December 8, 2017

Study Start

January 1, 2018

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

December 8, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share