Cervical SpondylosisNCT03364816
Evaluation on Efficacy of Total Artificial Disc Replacement (TDR) of Cervical Spondylosis
An observational study of Cervical Spondylosis, run by Peking University People's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Cervical Spondylosis
- What is being tested?
- TDR
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2018to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Patients suffered from cervical trauma or congenital malformations;
- non-artificial cervical disc replacement or hybrid surgery;
- ones who refused to be followed up.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cervical Spondylosis
- Being tested
- TDR
- Keywords
- cervical spondylosis, artificial disc replacement, complications, photographic indicators, functional efficacy
- Medical subject headings
- Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDRProcedure or surgery
total artificial disc replacement
| Study group | Role | What they receive |
|---|---|---|
| TDR with Prodisc-C | participant underwent total disc replacement with Prodisc-C artificial disc Receives: Procedure: TDR | |
| TDR with Mobi-C | participant underwent total disc replacement with Mobi-C artificial disc Receives: Procedure: TDR | |
| TDR with Prestige-LP | participant underwent total disc replacement with Prestige-LP artificial disc Receives: Procedure: TDR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (2)
prosthesis sinking
prosthesis sinking is defined by a sink of 2mm about the artificial disk postoperatively.
Measured: 5 years
range of motion (ROM)
range of motion
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start1 Feb 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical SpondylosisStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Zhenqi, Peking University People's Hospital
- Investigators
- Zhenqi Zhu, Principal investigator, Department of spinal surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364816
- Sponsor's protocol ID
- TDR
- Status last verified
- Dec 2017
- First submitted
- 25 Nov 2017
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation on Efficacy of Total Artificial Disc Replacement (TDR) of Cervical Spondylosis: a Cohort Prospective Follow-up for 5 Years
- ClinicalTrials.gov ID
- NCT03364816
- Acronym / sponsor ID
- TDR
- Conditions
- Cervical Spondylosis
- Keywords
- cervical spondylosis, artificial disc replacement, complications, photographic indicators, functional efficacy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TDR with Prodisc-C | – | Procedure: TDRparticipant underwent total disc replacement with Prodisc-C artificial disc |
| TDR with Mobi-C | – | Procedure: TDRparticipant underwent total disc replacement with Mobi-C artificial disc |
| TDR with Prestige-LP | – | Procedure: TDRparticipant underwent total disc replacement with Prestige-LP artificial disc |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients suffered from cervical trauma or congenital malformations;
- non-artificial cervical disc replacement or hybrid surgery;
- ones who refused to be followed up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TDRtotal artificial disc replacement | Procedure or surgery | TDR with Mobi-C, TDR with Prestige-LP, TDR with Prodisc-C |
Primary outcome
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.
2 secondary outcomes
prosthesis sinking
Time frame: 5 years
range of motion (ROM)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenqi Zhu principal investigator
Department of spinal surgery
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Spondylosis, run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuai Xu ((86)18811792718, 1204649202@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
JOA score (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2017.