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
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
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
NCT ID
NCT03367039
First Posted
November 29, 2017
Last Updated
December 4, 2017
Sponsor
Peking University People's Hospital
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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