NCT05522010

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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 .

Conditions

• Cervical Degenerative Disc Disease

Interventions

Type	Name	Description
PROCEDURE	Cervical 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

Timeline

• Start date: 2022-08-25
• Primary completion: 2023-08-01
• Completion: 2024-08-01
• First posted: 2022-08-30
• Last updated: 2022-08-30