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

P

Peking University

Status

Unknown

Conditions

Cervical Spondylosis

Treatments

Procedure: cervical artificial disc replacement
Procedure: hybrid surgery
Procedure: anterior cervical discectomy and fusion

Study type

Observational

Funder types

Other

Identifiers

NCT03358225
Hybrid007

Details and patient eligibility

About

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.

Full 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.

Enrollment

198 estimated patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

198 participants in 3 patient groups

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

Trial contacts and locations

0

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Central trial contact

YU Guanjie, bachelor

Data sourced from clinicaltrials.gov

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