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

December 4, 2017 updated by: Zhu Zhenqi, Peking University People's Hospital

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

648

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Zhenqi Zhu, Master
  • Phone Number: 008618811792718
  • Email: 523526767@qq.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ProDisc-C vivo
This group of patients will be treated with ProDisc-C vivo disc replacement (single segment).
Procedure: ProDisc-C vivo
Total Disc Replacement using ProDisc-C vivo.
Active Comparator: Anterior cervical discectomy fusion
This group of patients will be treated with anterior cervical discectomy fusion (ACDF) procedure (single segment).
Procedure: Anterior cervical discectomy fusion
Anterior Cervical Discectomy and Fusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of sagittal angular motion
Time Frame: 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).
Neutral anteroposterior and lateral radiographs and dynamic flexion-extension lateral radiographs will be measured.
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
Time Frame: 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).
The neck disability index(NDI) questionnaire measures the level of pain and disability associated with various activities. The NDI is a 10-item, 50-point index that assesses different aspects of daily functioning in patients with neck pain. Each item is scored 0 to 5. The NDI score is a sum of the scores of the10-item. Clinical effects will be evaluated based on scores of the NDI. Higher values represent a better outcome.
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
Time Frame: 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).
Neck and arm pain scores will be measured using a visual analogue scale (VAS) from "0' (no sensation) to '100"(the most intense pain imaginable) where 30 means "pain threshold".
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Principal Investigator: Zhenqi Zhu, Master, Peking University People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2018

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

November 29, 2017

First Submitted That Met QC Criteria

December 4, 2017

First Posted (Actual)

December 8, 2017

Study Record Updates

Last Update Posted (Actual)

December 8, 2017

Last Update Submitted That Met QC Criteria

December 4, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prodisc-C vivo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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