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

Peking University People's Hospital198 enrolled

Overview

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.

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

198

Conditions

Cervical Spondylosis

Interventions

anterior cervical discectomy and fusionPROCEDURE

The patients undergoing anterior cervical discectomy and fusion sugery

cervical artificial disc replacementPROCEDURE

The patients undergoing cervical artificial disc replacement surgery

hybrid surgeryPROCEDURE

The patients undergoing 1-level C-ADR plus 1-level ACDF surgery

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

range of the motion of operative segments and adjacent segments

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.

Time frame: preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively

Secondary Outcomes

scores of the Japanese Orthopedic Association

Clinical effects were evaluated based on scores of the Japanese Orthopedic Association (JOA)

Time frame: preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively

scores of the Neck Disability Index

Clinical effects were evaluated based on scores of the Neck Disability Index(NDI)

Time frame: preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively

scores of the visual analog scale

Clinical effects were evaluated based on scores of the visual analog scale(VAS)

Time frame: preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively

Central Contacts

YU Guanjie, bachelor

CONTACT

18500234005 yuguanjieok@163.com

Data from ClinicalTrials.gov

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