A Muti-Center Study Comparing 3 Procedures for Bi-level Cervical Spondylosis

November 26, 2017 updated by: Liu Haiying, Peking University People's Hospital
A muti-center study to compare the safety and efficacy of anterior cervical discectomy and fusion, cervical artificial disc replacement and hybrid surgery for bi-level cervical spondylosis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients with bi-level cervical spondylosis undergoing anterior cervical discectomy and fusion, cervical artificial disc replacement and hybrid surgery in the muti-center hospital were retrospectively reviewed.The safety and efficacy were evaluated based on scores of the Neck Disability Index (NDI), visual analog scale (VAS), and Japanese Orthopedic Association (JOA) and the range of motion of both operative segments and adjacent segments,not only in the preoperative,but also in the 5 days,6 months,12 months and the 5 years after surgery.

Study Type

Observational

Enrollment (Anticipated)

198

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with bi-level cervical spondylosis

Description

Inclusion Criteria:

  • (1) Cervical degenerative pathology with symptomatic radiculopathy or myelopathy at two consecutive segments from C3 to C7 which not responding to conservative treatment for 6 weeks. (2) Preoperative magnetic resonance imaging (MRI), complete cervical spine radiography and computed tomography (CT) showed anterior compressive pathology. (3) None or slight osteophyte at the posterior edge of vertebrae. (4) None significant spinal stenosis or posterior compression.

Exclusion Criteria:

  • ossification of the posterior longitudinal ligament (OPLL), tumor, fracture, infection, history of cervical spine surgery, narrowing of the spinal canal, and any serious general illness. Cases with one or more than two segments requiring treatment were also excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anterior Cervical Discectomy and Fusion
The patients undergoing anterior cervical discectomy and fusion surgery
Procedure: anterior cervical discectomy and fusion
The patients undergoing anterior cervical discectomy and fusion sugery
Cervical Artificial Disc Replacement
The patients undergoing cervical artificial disc replacement surgery
Procedure: cervical artificial disc replacement
The patients undergoing cervical artificial disc replacement surgery
Hybrid surgery
The patients undergoing hybrid surgery(1-level ADR plus 1-level ACDF) surgery
Procedure: hybrid surgery
The patients undergoing 1-level C-ADR plus 1-level ACDF surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
range of the motion of operative segments and adjacent segments
Time Frame: preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively
Standard dynamic flexion and extension lateral cervical radiographs were obtained to evaluate range of motion of C2-C7 and operative segments and superior and inferior adjacent segments, cervical lordosis, and radiographic changes in adjacent segments.
preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
scores of the Japanese Orthopedic Association
Time Frame: preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively
Clinical effects were evaluated based on scores of the Japanese Orthopedic Association (JOA)
preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively
scores of the Neck Disability Index
Time Frame: preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively
Clinical effects were evaluated based on scores of the Neck Disability Index(NDI)
preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively
scores of the visual analog scale
Time Frame: preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively
Clinical effects were evaluated based on scores of the visual analog scale(VAS)
preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Principal Investigator: LIU Haiying, department of spinal surgery,PekingUPH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2018

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

November 26, 2017

First Submitted That Met QC Criteria

November 26, 2017

First Posted (Actual)

November 30, 2017

Study Record Updates

Last Update Posted (Actual)

November 30, 2017

Last Update Submitted That Met QC Criteria

November 26, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hybrid007

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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