Cervical Degenerative Disc Disease Clinical Trial
Official title:
Dynamic Cervical Implant (DCI) Versus Anterior Cervical Discectomy And Fusion(ACDF) For The Treatment Of Single-Level Cervical Degenerative Disc Disease (DDD): An RCT
TO Compare The Clinical And Radiographic Outcomes of DCI VS ACDF For The Treatment Of Single-Level Cervical Degenerative Disc Disease (DDD)
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | August 1, 2024 |
Est. primary completion date | August 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Single or multiple symptomatic cervical DDD with radiculopathy and\or mylopathy not responding to non-surgical management - Age older than 18 years Exclusion Criteria: 1. ossification of posterior longitudinal ligament 2. facet arthritis 3. lack of motion or instability at the level of surgery 4. fracture 5. infection 6. tumors 7. osteoprosis |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assiut University |
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Li Z, Yu S, Zhao Y, Hou S, Fu Q, Li F, Hou T, Zhong H. Clinical and radiologic comparison of dynamic cervical implant arthroplasty versus anterior cervical discectomy and fusion for the treatment of cervical degenerative disc disease. J Clin Neurosci. 2014 Jun;21(6):942-8. doi: 10.1016/j.jocn.2013.09.007. Epub 2013 Nov 4. — View Citation
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Radiological outcome | MRI grading for the degree of ASD (Mario Matsumato grading) | At 1 year follow up. | |
Secondary | Clinical outcome | 1-Neck Disability Index (NDI) : 10 item score from 0 to 5 maximum score is 50 , high score is worse | At 3 month . | |
Secondary | Radiological outcome (Plain x-ray) | 1- Cervical sagittal alignment C2 to C7 (Cobb angle)
5-implant fusion described as a less than 1-mm motion between the tips of the spinous processes in dynamic radiographs and/or the presence of bridging bony trabeculae. |
at 6 month. | |
Secondary | Radiological outcome (MSCT) | 1-implant fusion | At 1 year . | |
Secondary | clinical outcome | Visual analogue scale (VAS) scores for neck and arm from 0 to 10 score , the higher score is worse | At 3 month . | |
Secondary | radiological outcome | 2- Range of motion (ROM) using Cobb method for cervical spine and functional spine unit of treated segment | at 6 month . |
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