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临床试验/NCT05522010
NCT05522010Unknown不适用

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 University0 个研究点目标入组 50 人开始时间: 2022年8月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
Radiological outcome

研究概览

简要总结

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

详细描述

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 .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Single or multiple symptomatic cervical DDD with radiculopathy and\or mylopathy not responding to non-surgical management
  • Age older than 18 years

排除标准

  • ossification of posterior longitudinal ligament
  • facet arthritis
  • lack of motion or instability at the level of surgery
  • osteoprosis

结局指标

主要结局

Radiological outcome

时间窗: At 1 year follow up.

MRI grading for the degree of ASD (Mario Matsumato grading)

次要结局

  • Radiological outcome (Plain x-ray)(at 6 month.)
  • radiological outcome(at 6 month .)
  • Clinical outcome(At 3 month .)
  • Radiological outcome (MSCT)(At 1 year .)
  • clinical outcome(At 3 month .)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Abdelrahman Saleh El Attar

principal investigator

Assiut University

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