Cervical Degenerative Disc Disease
Conditions
Keywords
Cervical Degenerative Disc Disease, Dynamic Cervical Implant, Anterior Cervical Discectomy And Fusion
Brief summary
TO Compare The Clinical And Radiographic Outcomes of DCI VS ACDF For The Treatment Of Single-Level Cervical Degenerative Disc Disease (DDD)
Detailed description
Anterior cervical discectomy and fusion (ACDF) is an effective and safe treatment for patients with radiculopathy and myelopathy. However, in the untreated levels adjacent to a fusion, increased motion and elevated intradiscal pressures have been reported. Some investigators have postulated that these changes may lead to an increased risk of adjacent segment degeneration (ASD). Limitations and problems with ACDF have led some investigators to explore the motion-preserving surgeries, such as cervical total disk replacement (TDR). Although TDR has been shown to reduce adjacent-level intra discal pressures and provide a more physiological overall cervical but also index- and adjacent-level range of motion (ROM) while maintaining sagittal alignment. Recent studies have also highlighted the potential limitations of TDR. Dynamic cervical implant (DCI) is a type of anterior decompression and cervical non-fusion implant that was initially conceived as a method to combine the potential advantages of fusion and TDR. The DCI is intended to provide controlled, limited flexion and extension-the primary motions in the sub axial cervical spine-that is greater than that seen with fusion, but less than that achieved with TDR .
Interventions
PROCEDURECervical spine surgery
A standard anterior approach was made with discectomy sparing the cartilage, and with foraminal decompression. Complete excision of the posterior longitudinal ligament was routinely performed to complete neural decompression. Trial inserters were used to identify the proper implant size. Device under sizing may lead to poor fixation and implant migration. The largest possible device that can be safely placed should be selected to maximize device- endplate contact and to gain support from the apophyseal rim. The teeth of the implant were optimally fixated to the endplate via Caspar pin compression following device insertion. The device may be replaced or changed using the same insertion instrument if final imaging demonstrated suboptimal positioning. Rinsing the implanted disc space removes rests of blood and bone dust, all potentially promoting HO
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
A calculated minimum sample of 50 patients with single or multiple symptomatic cervical DDD with radiculopathy and\\or myelopathy not responding to non-surgical management will be needed. The sample will be randomly assigned for one of two equal groups (Group I (n=25); will undergo ACDF and Group II (n=25) will undergo DCI to detect an effect size of 0.42 in the rate of adjacent segment degeneration (main clinical and radiological outcomes), with an error probability of 0.05 and 80%
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiological outcome | At 1 year follow up. | MRI grading for the degree of ASD (Mario Matsumato grading) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcome | At 3 month . | 1-Neck Disability Index (NDI) : 10 item score from 0 to 5 maximum score is 50 , high score is worse |
| Radiological outcome (Plain x-ray) | at 6 month. | 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. |
| Radiological outcome (MSCT) | At 1 year . | 1-implant fusion |
| clinical outcome | At 3 month . | Visual analogue scale (VAS) scores for neck and arm from 0 to 10 score , the higher score is worse |
| radiological outcome | at 6 month . | 2- Range of motion (ROM) using Cobb method for cervical spine and functional spine unit of treated segment |
Contacts
Primary ContactMahmoud Saleh El Attar, Master
Outcome results
None listed