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Trial record 10 of 12465 for:    cervical

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

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ClinicalTrials.gov Identifier: NCT03358225
Recruitment Status : Not yet recruiting
First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Liu Haiying, Peking University People's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Cervical Spondylosis Procedure: anterior cervical discectomy and fusion Procedure: cervical artificial disc replacement Procedure: hybrid surgery

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.

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Study Type : Observational
Estimated Enrollment : 198 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Muti-Center Study Comparing 3 Procedures for Bi-level Cervical Spondylosis
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 1, 2018

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with bi-level cervical spondylosis
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358225


Contacts
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Contact: YU Guanjie, bachelor 18500234005 yuguanjieok@163.com

Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: LIU Haiying department of spinal surgery,PekingUPH

Publications:
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Responsible Party: Liu Haiying, department of spinal surgery, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03358225     History of Changes
Other Study ID Numbers: Hybrid007
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Liu Haiying, Peking University People's Hospital:
Hybrid surgery,ACDF,C-ADR,bi-level cervical spondylosis

Additional relevant MeSH terms:
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Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases