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Clinical and Radiological Outcomes: Two-level Cervical ProDisc-C Vivo Versus Hybrid Construct.

NCT ID: NCT03367052

Last Updated: 2017-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

542 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2025-12-01

Brief Summary

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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

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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.

Conditions

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Cervical Disc Disease

Keywords

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ProDisc-C vivo Hybrid Cervical degenerative disc disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Two level Prodisc-C vivo

Two level Prodisc-C vivo cervical artificial disc replacement.

Group Type EXPERIMENTAL

Two level Prodisc-C vivo

Intervention Type PROCEDURE

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

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).

Group Type ACTIVE_COMPARATOR

Hybrid

Intervention Type PROCEDURE

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

Interventions

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Two level Prodisc-C vivo

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

Intervention Type PROCEDURE

Hybrid

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Any prior cervical spine surgery.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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guochen

Department of Spine Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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chen guo, Master

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Central Contacts

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Weiwei Xia, Ph.D.

Role: CONTACT

Phone: 008613260001978

Email: [email protected]

chen guo, Master

Role: CONTACT

Phone: 008618811792718

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 23080427 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24010901 (View on PubMed)

Other Identifiers

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twolevelprodiscC

Identifier Type: -

Identifier Source: org_study_id