跳至主要内容
临床试验/NL-OMON39490
NL-OMON39490招募中4 期

A multi center, prospective, randomized controlled trial comparing cervical arthroplasty to anterior cervical discectomy and fusion (ACDF) for the treatment of cervical degenerative disc disease. - Discover Artificial cervical disc IDE

Johnson & Johnson0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症

试验速览

阶段
4 期
状态
招募中
入组人数
50

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • Key Inclusion Criteria:;- Objective evidence of cervical disc disease in 1 vertebral level between C3-C7 defined as
  • (a) shoulder and/or arm pain in a documented radicular distribution resulting from herniated disc or bony osteophytes or
  • (b)myeloradiculopathy resulting from mild spinal cord compression and nerve root impingement
  • - Unresponsiveness to documented non-surgical management for greater than or equal to 6 weeks and/or presentation with progressive symptoms of nerve root or spinal cord compression in the face of continued non-surgical management
  • - Moderate Neck Disability Index (NDI) score
  • - Able to give informed consent for study participation
  • - Able and willing to return for all follow-up visits

排除标准

  • Key Exclusion Criteria:;- Significant cervical degenerative disc disease
  • - Prior fusion procedure at any level(s) (C1-T1)
  • - Marked cervical instability on lateral or flexion/extension radiographs
  • - Presence of systemic infection or infection at the surgical site
  • - Diagnosis of a condition, or requires postoperative medication(s), which may interfere with bony/soft tissue healing
  • - History of alcohol and/or drug abuse
  • - Any known allergy to a metal alloy or polyethylene
  • - Morbid obesity
  • - Any significant general illness (e.g., metastatic cancer, HIV)

研究者

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