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临床试验/NCT07739979
NCT07739979已完成不适用

Radiological Outcome of Bony Fusion After Single Level Anterior Cervical Discectomy and Fusion Using Iliac Crest Graft vs. Polyetheretherketone Cage in Cervical Spondylosis

Services Hospital, Lahore1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
1
主要终点
Trabecular Bone Formation and Bridging Bone Formation

研究概览

简要总结

The cervical spine is the most mobile portion of the spine and is more prone to degenerative spine changes like cervical disc herniation, cervical spine stenosis, ossified posterior longitudinal ligament and osteophyte formation. Cervical spondylosis describes a variety of progressive degenerative changes that affect all components of the cervical spine (i.e., intervertebral discs, facet joints, Luschka joints, ligamentum flavum, and lamina). This is a normal aging process that affects most people in their 50's. Due to its stability, ACDF (anterior cervical discectomy and fusion) employing an iliac crest auto-graft is regarded as best, but it carries significant donor-site morbidity, hematoma formation, infection and pain etc. These morbidities leads to development of newer techniques, such as a PEEK cage. This technique lacks donor site morbidity but it is not cost-effective. The purpose of this study is to compare bony fusion between two of the most common fusion grafts: iliac crest auto-graft and PEEK(Polyetheretherketone) cage allograft, among patients undergoing ACDF in the Neurosurgical facility of Services Hospital, Lahore.

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
Single (Participant)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • In our study, patients were included with an age of 20- 60 years, both male and female, and having one level of disc disorder between C3-C7 with radiculopathy/myelopathy, no previous ACDF Surgery, and Cervical Spine traumatic injury.

排除标准

  • Patients who had previous cervical spine surgery, having more than one level of pathology, patients who needed posterior instrumentation, having infection/Caries Spine/Osteomyelitis etc. and having malignancy

结局指标

主要结局

Trabecular Bone Formation and Bridging Bone Formation

时间窗: 6 Months

Trabecular bone is the formation of bone between graft and end plates of superior and inferior vertebrae.It was noted at 1, 3 and 6th Month.

Motion on Flexion-Extension X-rays

时间窗: 6 Months

Motion of the spinous process of \<2mm is marked as fused, while a distance of \> 2 mm between spinous processes on flexion and extension X-rays is marked as unfused.

Disc Height Score

时间窗: 6 Months

Disc height was observed as distance between endplates and \>25% reduction in disc height from postoperative X-rays were noted as unfused

次要结局

未报告次要终点

研究者

发起方
Services Hospital, Lahore
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sohaib Ashraf

Principal Investigator

Services Hospital, Lahore

研究点 (1)

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