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

NCT ID: NCT03364816

Last Updated: 2017-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-01

Study Completion Date

2018-12-31

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.

Conditions

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Cervical Spondylosis

Keywords

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cervical spondylosis artificial disc replacement complications photographic indicators functional efficacy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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TDR with Prodisc-C

participant underwent total disc replacement with Prodisc-C artificial disc

TDR

Intervention Type PROCEDURE

total artificial disc replacement

TDR with Mobi-C

participant underwent total disc replacement with Mobi-C artificial disc

TDR

Intervention Type PROCEDURE

total artificial disc replacement

TDR with Prestige-LP

participant underwent total disc replacement with Prestige-LP artificial disc

TDR

Intervention Type PROCEDURE

total artificial disc replacement

Interventions

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TDR

total artificial disc replacement

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhu Zhenqi

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhenqi Zhu

Role: PRINCIPAL_INVESTIGATOR

Department of spinal surgery

Central Contacts

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Shuai Xu

Role: CONTACT

Phone: (86)18811792718

Email: [email protected]

Other Identifiers

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TDR

Identifier Type: -

Identifier Source: org_study_id