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

Assiut University

Status: Not yet enrolling

Conditions: Cervical Degenerative Disc Disease

Treatments: Procedure: Cervical spine surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05522010

Cervical Degenerative Disease

Details and patient eligibility

About

TO Compare The Clinical And Radiographic Outcomes of DCI VS ACDF For The Treatment Of Single-Level Cervical Degenerative Disc Disease (DDD)

Full 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 .

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Group (1) (ACDF)

Active Comparator group

Description:

All patients on this group will undergo Anterior Cervical Discectomy And Fusion

Treatment:

Procedure: Cervical spine surgery

Group (2) (DCI)

Active Comparator group

Description:

All patients on this group will undergo Dynamic Cervical Implant

Treatment:

Procedure: Cervical spine surgery