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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Spondylosis

Intervention / Treatment
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* Procedure: TDR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients was diagnosed as cervical spondylosis based on imaging and symptomology; patients were purely underwent TDR within the three kinds of prosthesis; the range of participants is from 20-65 years; conservative treatment of 6 months is invalid; never had cervical operations. Exclusion Criteria: Patients suffered from cervical trauma or congenital malformations; non-artificial cervical disc replacement or hybrid surgery; ones who refused to be followed up.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TDR with Prodisc-C<br>participant underwent total disc replacement with Prodisc-C artificial disc | Procedure: TDR<br>* total artificial disc replacement<br>|
| TDR with Mobi-C<br>participant underwent total disc replacement with Mobi-C artificial disc | Procedure: TDR<br>* total artificial disc replacement<br>|
| TDR with Prestige-LP<br>participant underwent total disc replacement with Prestige-LP artificial disc | Procedure: TDR<br>* total artificial disc replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical spondylosis, artificial disc replacement, complications, photographic indicators, functional efficacy