ClinicalTrials.gg
Status unknownNCT03364816Updated Dec 7, 2017

Evaluation on Efficacy of Total Artificial Disc Replacement (TDR) of Cervical Spondylosis

An observational study in Cervical Spondylosis, sponsored by Peking University People's Hospital. Status unknown. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-12-07.

Sponsored by Peking University People's Hospital · Observational

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Not yet recruiting — may be out of date.

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
150
Ages
20 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Cervical Spondylosis

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Keywords

  • cervical spondylosis
  • artificial disc replacement
  • complications
  • photographic indicators
  • functional efficacy
03

In context

Spondylosis

142 studies on the registry are indexed under Spondylosis; 41 are open to participants now.

This study's planned enrollment of 150 is above the median of 100 across 36 observational studies indexed under Spondylosis.

Browse Spondylosis studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 610 studies on the registry; 248 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients was diagnosed as cervical spondylosis based on imaging and symptomology;
  2. patients were purely underwent TDR within the three kinds of prosthesis;
  3. the range of participants is from 20-65 years;
  4. conservative treatment of 6 months is invalid;
  5. never had cervical operations.

Exclusion criteria

Exclusion Criteria:

  1. Patients suffered from cervical trauma or congenital malformations;
  2. non-artificial cervical disc replacement or hybrid surgery;
  3. ones who refused to be followed up.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • TDR with Prodisc-C

    participant underwent total disc replacement with Prodisc-C artificial disc

    Procedure: TDR

  • TDR with Mobi-C

    participant underwent total disc replacement with Mobi-C artificial disc

    Procedure: TDR

  • TDR with Prestige-LP

    participant underwent total disc replacement with Prestige-LP artificial disc

    Procedure: TDR

Interventions

  • ProcedureTDR

    total artificial disc replacement

06

What researchers measure

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.

    Time frame: 5 years

Secondary outcomes

  1. prosthesis sinking

    prosthesis sinking is defined by a sink of 2mm about the artificial disk postoperatively.

    Time frame: 5 years

  2. range of motion (ROM)

    range of motion

    Time frame: 5 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2018; primary completion for Dec 2018, 10 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 25, 2017
First posted
Dec 7, 2017
StartEst.
Feb 1, 2018
Primary completionEst.
Dec 31, 2018
CompletionEst.
Dec 31, 2018
Last update
Dec 7, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03364816
Responsible party
Zhu Zhenqi (Clinical Professor, Peking University People's Hospital) — Principal investigator
First posted
Dec 7, 2017
Start date
Feb 1, 2018 (estimated)
Primary completion
Dec 31, 2018 (estimated)
Completion
Dec 31, 2018 (estimated)
Last update
Dec 7, 2017

Study contacts

Shuai Xu
Contact
1204649202@qq.com
(86)18811792718
Zhenqi Zhu
principal investigator · Department of spinal surgery

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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