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

Cervical Spondylosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03364816
• Other study ID #: TDR
• Status: Not yet recruiting
• Phase: N/A
• First received: November 25, 2017
• Last updated: December 1, 2017
• Start date: February 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: December 2017
• Source: Peking University People's Hospital
• Contact: Shuai Xu
• Phone: (86)18811792718
• Email: 1204649202[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Spondylosis
• Spondylosis

Intervention

Procedure:
• TDR
total artificial disc replacement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Outcome

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