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

Peking University

Status: Unknown

Conditions: Cervical Spondylosis

Treatments: Procedure: TDR

Study type: Observational

Funder types: Other

Identifiers

NCT03364816

TDR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 3 patient groups

TDR with Prodisc-C

Description:

participant underwent total disc replacement with Prodisc-C artificial disc

Treatment:

Procedure: TDR

TDR with Mobi-C

Description:

participant underwent total disc replacement with Mobi-C artificial disc

Treatment:

Procedure: TDR

TDR with Prestige-LP

Description:

participant underwent total disc replacement with Prestige-LP artificial disc

Treatment:

Procedure: TDR