Evaluation on Efficacy of Total Artificial Disc Replacement (TDR) of Cervical Spondylosis
1 other identifier
observational
150
0 countries
N/A
Brief Summary
To evaluate the efficacy of 3 different types of cervical disc prosthesis (Prodisc-C, Mobi-C and Prestige-LP) in the treatment of cervical spondylosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2018
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2017
CompletedFirst Posted
Study publicly available on registry
December 7, 2017
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedDecember 7, 2017
December 1, 2017
11 months
November 25, 2017
December 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
JOA score
The whole name is Japanese Orthopaedic Association Scores for Assessment of Cervical spondylosis, the range of JOA is 0-17 and the full score is 17 to represent a normal function.
5 years
Secondary Outcomes (2)
prosthesis sinking
5 years
range of motion (ROM)
5 years
Study Arms (3)
TDR with Prodisc-C
participant underwent total disc replacement with Prodisc-C artificial disc
TDR with Mobi-C
participant underwent total disc replacement with Mobi-C artificial disc
TDR with Prestige-LP
participant underwent total disc replacement with Prestige-LP artificial disc
Interventions
Eligibility Criteria
1. The range of participants is from 20-65 years; 2. conservative treatment of 6 months is invalid; 3. never had cervical operations; 4. operation on one to three segments.
You may qualify if:
- Patients was diagnosed as cervical spondylosis based on imaging and symptomology;
- patients were purely underwent TDR within the three kinds of prosthesis;
- the range of participants is from 20-65 years;
- conservative treatment of 6 months is invalid;
- never had cervical operations.
You may not qualify if:
- Patients suffered from cervical trauma or congenital malformations;
- non-artificial cervical disc replacement or hybrid surgery;
- ones who refused to be followed up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhenqi Zhu
Department of spinal surgery
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
November 25, 2017
First Posted
December 7, 2017
Study Start
February 1, 2018
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
December 7, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share