跳至主要内容
临床试验/NCT03565224
NCT03565224已完成不适用

Prospective Follow-up Study of CeSPACE XP - Titanium Coated PEEK Cages - for the Treatment of Degenerative Cervical Disc Disease

Aesculap AG1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年1月10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
Aesculap AG
入组人数
50
试验地点
1
主要终点
Neck Disability Index (NDI) during Follow-Up

研究概览

简要总结

Prospective Follow-up study of CeSPACE XP coated PEEK cages for the treatment of degenerative cervical disc disease

详细描述

Anterior cervical discectomy and fusion (ACDF) has been accepted as the standard procedure for the treatment of myelopathy and radiculopathy in the cervical spine. A tricortical iliac crest bone graft is the traditional inter-body fusion material that can show perfect bony fusion and maintain the patency of the neuroforamen. However, donor site complications were reported in fusion with an iliac bone graft, such as subcutaneous hematomas, infections, and chronic wound pain.

Currently, the titanium cage and polyetheretherketone (PEEK) cage are the two most common cages in clinical practice. The ideal cage should lead to a high fusion rate and prevent complications, such as subsidence and loss of correction.

Even though a titanium cage can provide long-term stabilization, increase lordosis, and increase foramina height compared with the iliac bone graft, some inferior clinical outcomes appeared in clinical practice. Loss of correction is a major complication of subsidence that may eventually affect cervical spinal function after the operation.

A modulus of elasticity close to cortical bone might contribute to advantages in stress distribution and load sharing, which can contribute to a lower subsidence rate and, thus, better clinical results, making PEEK cages more welcomed by surgeons.

It is supposed, that in the cervical fusion procedure, a porous coating of a PEEK cage will lead to favourable results. Therefore, the present study intends to show these results, in a larger patient cohort who received such a coated cervical cage.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • All consecutive patients who received a CeSPACE XP cage between August 2013 and January 2017

排除标准

  • Pregnancy
  • Patient consent not signed

结局指标

主要结局

Neck Disability Index (NDI) during Follow-Up

时间窗: Once between 1 to 4 years postoperative

The Neck Disability Index(NDI) is a modification of the Oswestry Low Back Pain Disability Index . It is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. The NDI has sufficient support and usefulness to retain its current status as the most commonly used self-report measure for neck pain. The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. All the points can be summed to a total score.

次要结局

  • Neck Pain at Follow-Up(Once between 1 to 4 years postoperative)
  • Patient Satisfaction at Follow-Up(Once between 1 to 4 years postoperative)
  • Arm Pain during Follow-Up(Once between 1 to 4 years postoperative)
  • Work Status at Follow-Up(Once between 1 to 4 years postoperative)
  • Radiographic Evaluation of Mobility at Follow-Up(Once between 1 to 4 years postoperative)
  • Radiographic Evaluation of Radiolucencies at Follow-Up(Once between 1 to 4 years postoperative)
  • Neurological Outcome at Follow-Up(1 to 4 years follow-up)
  • Radiographic Evaluation of Bone Bridges at Follow-Up(Once between 1 to 4 years postoperative)

研究者

发起方
Aesculap AG
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验