CClinicalTrials.gg
Sign In
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verified this record recently (last verified Dec 2017), so the status shown — last known as Not yet recruiting — may be out of date.
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

Browse trials for

Keywords

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

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.

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.
04

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

05

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

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03364816
Lead sponsor
Peking University People's Hospital
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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Spondylosis→

Other studies from this sponsor

Peking University People's Hospital

Start the discussion