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

Evaluation on Efficacy of Total Artificial Disc Replacement (TDR) of Cervical Spondylosis: a Cohort Prospective Follow-up for 5 Years

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03364816

Enrollment

150

Registered

2017-12-07

Start date

2018-02-01

Completion date

2018-12-31

Last updated

2017-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Spondylosis

Keywords

cervical spondylosis, artificial disc replacement, complications, photographic indicators, functional efficacy

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.

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.

Interventions

PROCEDURETDR

total artificial disc replacement

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

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

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.

Design outcomes

Primary

Measure	Time frame	Description
JOA score	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.

Secondary

Measure	Time frame	Description
prosthesis sinking	5 years	prosthesis sinking is defined by a sink of 2mm about the artificial disk postoperatively.
range of motion (ROM)	5 years	range of motion

Contacts

Primary ContactShuai Xu

1204649202@qq.com(86)18811792718

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026