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A Multi-center Prospective Randomized Controlled Study on Clinical and Radiographic Analysis of ProDisc-C Vivo

NCT ID: NCT03367039

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

648 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2025-03-01

Brief Summary

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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.

Detailed Description

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This is a prospective, randomized, multicenter trial at 7 years of follow-up comparing ProDisc-C vivo artificial cervical disc replacement and ACDF (Anterior cervical discectomy fusion) to treat degenerative disc disease (DDD). 648 DDD patients (age from 20 to 70) from several hospitals matching the inclusion criteria will be randomly assigned to two groups (324 patients in each group). One group will be treated with ProDisc-C vivo disc replacement. The other group will be treated with ACDF. The clinical outcomes and radiographic measurements will be compared between two groups at 1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments.

Conditions

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Disk Degeneration Cervical Disc Disease

Keywords

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ProDisc-C vivo ACDF Cervical degenerative disc disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

648 DDD patients (age from 20 to 70) from several hospitals matching the inclusion criteria will be randomly assigned to two groups (324 patients in each group). One group will be treated with ProDisc-C vivo disc replacement. The other groups will be treated with ACDF.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ProDisc-C vivo

This group of patients will be treated with ProDisc-C vivo disc replacement (single segment).

Group Type EXPERIMENTAL

ProDisc-C vivo

Intervention Type PROCEDURE

Total Disc Replacement using ProDisc-C vivo.

Anterior cervical discectomy fusion

This group of patients will be treated with anterior cervical discectomy fusion (ACDF) procedure (single segment).

Group Type ACTIVE_COMPARATOR

Anterior cervical discectomy fusion

Intervention Type PROCEDURE

Anterior Cervical Discectomy and Fusion

Interventions

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ProDisc-C vivo

Total Disc Replacement using ProDisc-C vivo.

Intervention Type PROCEDURE

Anterior cervical discectomy fusion

Anterior Cervical Discectomy and Fusion

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
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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Zhu Zhenqi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhenqi Zhu, 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]

Zhenqi Zhu, Master

Role: CONTACT

Phone: 008618811792718

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 21938372 (View on PubMed)

Steinmetz 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.

Reference Type BACKGROUND
PMID: 18981885 (View on PubMed)

Mummaneni 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.

Reference Type BACKGROUND
PMID: 17355018 (View on PubMed)

Other Identifiers

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Prodisc-C vivo

Identifier Type: -

Identifier Source: org_study_id