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

• Conditions: Cervical Spondylosis
• Interventions: Procedure: anterior cervical discectomy and fusion; Procedure: cervical artificial disc replacement; Procedure: hybrid surgery

• Registration Number: NCT03358225
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-26
• Study First Submitted QC: 2017-11-26
• Last Update Submitted: 2017-11-26
• Study First Posted: 2017-11-30
• Last Update Posted: 2017-11-30
• Study Start: 2018-01-01
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 198

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
range of the motion of operative segments and adjacent segments	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

Name	Time	Method
scores of the Neck Disability Index	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)
scores of the visual analog scale	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)
scores of the Japanese Orthopedic Association	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)