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

• Conditions: Cervical Spondylosis
• Interventions: Procedure: TDR

• Registration Number: NCT03364816
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Study First Submitted: 2017-11-25
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-01
• Last Update Submitted: 2017-12-01
• Study First Posted: 2017-12-07
• Last Update Posted: 2017-12-07
• Study Start: 2018-02-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TDR with Prestige-LP	TDR	participant underwent total disc replacement with Prestige-LP artificial disc
TDR with Prodisc-C	TDR	participant underwent total disc replacement with Prodisc-C artificial disc
TDR with Mobi-C	TDR	participant underwent total disc replacement with Mobi-C artificial disc

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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