Dynamic Cervical Implant (DCI) Versus Anterior Cervical Discectomy And Fusion(ACDF) For The Treatment Of Single-Level Cervical Degenerative Disc Disease (DDD): An RCT

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

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

Conditions
-----------------
Cervical Degenerative Disc Disease

Intervention / Treatment
-----------------
* Procedure: Cervical spine surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
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: ossification of posterior longitudinal ligament facet arthritis lack of motion or instability at the level of surgery fracture infection tumors osteoprosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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%
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group (1) (ACDF)<br>All patients on this group will undergo Anterior Cervical Discectomy And Fusion | Procedure: Cervical spine surgery<br>* 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<br>|
| Active Comparator: Group (2) (DCI)<br>All patients on this group will undergo Dynamic Cervical Implant | Procedure: Cervical spine surgery<br>* 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<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological outcome | MRI grading for the degree of ASD (Mario Matsumato grading) | At 1 year follow up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 . | 
| 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. | 
| Radiological outcome (MSCT) | 1-implant fusion | At 1 year . | 
| clinical outcome | Visual analogue scale (VAS) scores for neck and arm from 0 to 10 score , the higher score is worse | At 3 month . | 
| radiological outcome | 2- Range of motion (ROM) using Cobb method for cervical spine and functional spine unit of treated segment | at 6 month . | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervical Degenerative Disc Disease, Dynamic Cervical Implant, Anterior Cervical Discectomy And Fusion