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

Study Overview
=================
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.

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

Conditions
-----------------
Cervical Spondylosis

Intervention / Treatment
-----------------
* Procedure: anterior cervical discectomy and fusion
* Procedure: cervical artificial disc replacement
* Procedure: hybrid surgery


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hybrid surgery,ACDF,C-ADR,bi-level cervical spondylosis