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

Primary Purpose

Disk Degeneration, Cervical Disc Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ProDisc-C vivo
Anterior cervical discectomy fusion
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disk Degeneration focused on measuring ProDisc-C vivo, ACDF, Cervical degenerative disc disease

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ProDisc-C vivo

    Anterior cervical discectomy fusion

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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".

    Secondary Outcome Measures

    Change of sagittal angular motion
    Neutral anteroposterior and lateral radiographs and dynamic flexion-extension lateral radiographs will be measured.
    Change of neck disability index scores
    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.
    Change of Arm and Neck pain intensity
    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".

    Full Information

    First Posted
    November 29, 2017
    Last Updated
    December 4, 2017
    Sponsor
    Peking University People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03367039
    Brief Title
    A Multi-center Prospective Randomized Controlled Study on Clinical and Radiographic Analysis of ProDisc-C Vivo
    Official Title
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2018 (Anticipated)
    Primary Completion Date
    March 1, 2025 (Anticipated)
    Study Completion Date
    March 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University People's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Disk Degeneration, Cervical Disc Disease
    Keywords
    ProDisc-C vivo, ACDF, Cervical degenerative disc disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    648 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ProDisc-C vivo
    Arm Type
    Experimental
    Arm Description
    This group of patients will be treated with ProDisc-C vivo disc replacement (single segment).
    Arm Title
    Anterior cervical discectomy fusion
    Arm Type
    Active Comparator
    Arm Description
    This group of patients will be treated with anterior cervical discectomy fusion (ACDF) procedure (single segment).
    Intervention Type
    Procedure
    Intervention Name(s)
    ProDisc-C vivo
    Intervention Description
    Total Disc Replacement using ProDisc-C vivo.
    Intervention Type
    Procedure
    Intervention Name(s)
    Anterior cervical discectomy fusion
    Intervention Description
    Anterior Cervical Discectomy and Fusion
    Primary Outcome Measure Information:
    Title
    Change of overall success rate
    Description
    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".
    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).
    Secondary Outcome Measure Information:
    Title
    Change of sagittal angular motion
    Description
    Neutral anteroposterior and lateral radiographs and dynamic flexion-extension lateral radiographs will be measured.
    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).
    Title
    Change of neck disability index scores
    Description
    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.
    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).
    Title
    Change of Arm and Neck pain intensity
    Description
    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".
    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).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Weiwei Xia, Ph.D.
    Phone
    008613260001978
    Email
    weiweixia2016@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhenqi Zhu, Master
    Phone
    008618811792718
    Email
    523526767@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zhenqi Zhu, Master
    Organizational Affiliation
    Peking University People's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21938372
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    18981885
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17355018
    Citation
    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.
    Results Reference
    background

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

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