- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03364816
Evaluation on Efficacy of Total Artificial Disc Replacement (TDR) of Cervical Spondylosis
December 1, 2017 updated by: Zhu Zhenqi, Peking University People's Hospital
Evaluation on Efficacy of Total Artificial Disc Replacement (TDR) of Cervical Spondylosis: a Cohort Prospective Follow-up for 5 Years
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.
Study Overview
Detailed Description
A cohort, retrospective analysis will be performed of 150 patients who were in implementation of artificial disc replacement in our department from 2008 to 2012 and accepted a regular postoperatively follow-up up to 5 years, the sample will be divided into 3 groups according to prosthesis and 50 people in each group.
The outcome will be measured among 3 groups respectively on the operation (such as operation time, intraoperative bleeding.),
postoperative complications (such as prosthesis sinking, displacement and prolapse, adjacent segments degeneration and heterotopic ossification), photographic indicators and functional efficacy analysis and then a comparison for self-contrast pre- and post-operatively.
Study Type
Observational
Enrollment (Anticipated)
150
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 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
- The range of participants is from 20-65 years;
- conservative treatment of 6 months is invalid;
- never had cervical operations;
- operation on one to three segments.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients suffered from cervical trauma or congenital malformations;
- non-artificial cervical disc replacement or hybrid surgery;
- ones who refused to be followed up.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
TDR with Prodisc-C
participant underwent total disc replacement with Prodisc-C artificial disc
|
total artificial disc replacement
|
TDR with Mobi-C
participant underwent total disc replacement with Mobi-C artificial disc
|
total artificial disc replacement
|
TDR with Prestige-LP
participant underwent total disc replacement with Prestige-LP artificial disc
|
total artificial disc replacement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
JOA score
Time Frame: 5 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prosthesis sinking
Time Frame: 5 years
|
prosthesis sinking is defined by a sink of 2mm about the artificial disk postoperatively.
|
5 years
|
range of motion (ROM)
Time Frame: 5 years
|
range of motion
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Zhenqi Zhu, Department of spinal surgery
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)
February 1, 2018
Primary Completion (ANTICIPATED)
December 31, 2018
Study Completion (ANTICIPATED)
December 31, 2018
Study Registration Dates
First Submitted
November 25, 2017
First Submitted That Met QC Criteria
December 1, 2017
First Posted (ACTUAL)
December 7, 2017
Study Record Updates
Last Update Posted (ACTUAL)
December 7, 2017
Last Update Submitted That Met QC Criteria
December 1, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TDR
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
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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