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

Not Applicable

• Conditions: Cervical Degenerative Disc Disease
• Interventions: Procedure: Cervical spine surgery

• Registration Number: NCT05522010
• Lead Sponsor: Assiut University

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 .

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-19
• Study Start: 2022-08-25
• Study First Submitted QC: 2022-08-27
• Last Update Submitted: 2022-08-27
• Study First Posted: 2022-08-30
• Last Update Posted: 2022-08-30
• Primary Completion: 2023-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group (1) (ACDF)	Cervical spine surgery	All patients on this group will undergo Anterior Cervical Discectomy And Fusion
Group (2) (DCI)	Cervical spine surgery	All patients on this group will undergo Dynamic Cervical Implant

Primary Outcome Measures

Name	Time	Method
Radiological outcome	At 1 year follow up.	MRI grading for the degree of ASD (Mario Matsumato grading)

Secondary Outcome Measures

Name	Time	Method
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	at 6 month .	2- Range of motion (ROM) using Cobb method for cervical spine and functional spine unit of treated segment
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 (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