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Trial record 20 of 368 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Diseases"

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

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ClinicalTrials.gov Identifier: NCT03367039
Recruitment Status : Not yet recruiting
First Posted : December 8, 2017
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Zhu Zhenqi, Peking University People's Hospital

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.

Condition or disease Intervention/treatment Phase
Disk Degeneration Cervical Disc Disease Procedure: ProDisc-C vivo Procedure: Anterior cervical discectomy fusion Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 648 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
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.
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 1, 2025
Estimated Study Completion Date : March 1, 2025

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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".


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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".



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367039


Contacts
Contact: Weiwei Xia, Ph.D. 008613260001978 weiweixia2016@163.com
Contact: Zhenqi Zhu, Master 008618811792718 523526767@qq.com

Sponsors and Collaborators
Peking University People's Hospital
Investigators
Principal Investigator: Zhenqi Zhu, Master Peking University People's Hospital

Publications:
Responsible Party: Zhu Zhenqi, Principal Investigator, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03367039     History of Changes
Other Study ID Numbers: Prodisc-C vivo
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhu Zhenqi, Peking University People's Hospital:
ProDisc-C vivo
ACDF
Cervical degenerative disc disease

Additional relevant MeSH terms:
Spinal Diseases
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases