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

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.

Study Overview

• Status: Unknown
• Conditions: Cervical Spondylosis
• Intervention / Treatment: Procedure: TDR

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 Type: Observational
• Enrollment (Anticipated): 150

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TDR with Prodisc-C; participant underwent total disc replacement with Prodisc-C artificial disc	Procedure: TDR; total artificial disc replacement
TDR with Mobi-C; participant underwent total disc replacement with Mobi-C artificial disc	Procedure: TDR; total artificial disc replacement
TDR with Prestige-LP; participant underwent total disc replacement with Prestige-LP artificial disc	Procedure: TDR; total artificial disc replacement

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: Zhenqi Zhu, Department of spinal surgery

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2018
• Primary Completion (ANTICIPATED): December 31, 2018
• Study Completion (ANTICIPATED): December 31, 2018

Study Registration Dates

• First Submitted: November 25, 2017
• First Submitted That Met QC Criteria: December 1, 2017
• First Posted (ACTUAL): December 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 7, 2017
• Last Update Submitted That Met QC Criteria: December 1, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: complications; cervical spondylosis; artificial disc replacement; photographic indicators; functional efficacy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylosis
• Other Study ID Numbers: TDR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No