ACTRN12619000307101招募中未知
Genipin Microinvasive Device for Treatment of Low Back Pain from Degenerative Disc Disease- CE Marking Safety and Efficacy Study
Intralink-Spine Australia Pty. Ltd.0 个研究点目标入组 50 人开始时间: 2019年2月28日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 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
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •1. Adults 18-60 years old
- •2. Degenerative Disc Disease at 1 or 2 levels between L2 and S1, with clinical presentation of discogenic pain where the central back pain is greater than radicular pain (leg, hips, or buttocks), confirmed by:
- •a. MRI correlative to the affected segment, and/or
- •b. discography with concordant pain within 6 months- If imaging and examination can
- •not conclusively determine which disc is the source of the pain, a discogram is
- •mandated for confirmation.
- •3. Failed non-operative treatment which may include injections or radiofrequency
- •denervation of medial lumbar and lateral sacral branches (failed response is considered
- •when pain relief lasted less than or equal to 3 months)
- •4. Preoperative Numeric Rating Scale (NRS) score for back pain greater than or equal to 4 or Visual Analog Score for back pain greater than or equal to 40 mm.
- •5. Preoperative Oswestry Disability Index (ODI) score greater than or equal to 30%
- •6. Documented symptoms for a cumulative minimum of 3 months
- •7. Participant is competent to sign the informed consent
- •8. Participant voluntarily signs the participant informed consent form and agrees to the
- •release of medical information for purposes of this study
排除标准
- •1. Symptomatic DDD at more than 2 levels
- •2. Less than 3 months of back pain
- •3. Previous diagnosed Paget's disease, osteomalacia, other metabolic bone disease or insulin-dependent diabetes
- •4. Evidence of spinal osteopenia or osteoporosis (radiographic or DEXA)
- •5. Active systemic or spine infection
- •6. Previous device or therapeutic interventions on the target disc (excluding those listed in the Inclusion Criteria)
- •7. Any surgery at the index level and any extensive surgery (fusion, laminectomy, artificial disc) at any level
- •8. Chronic steroid use (except for inhaled steroids)
- •9. Other diagnosed causes of back pain or neuropathy such as vertebral fracture, facet joint or vertebral arch (spondylolysis) generated pain, rheumatoid arthritis, cauda equine syndrome, spinal fracture within last 6 months, and sacroiliac joint pain
- •10. Previous treatment of target disc level with steroid injection in past 3 months
- •11. Active malignancy
- •12. Spinal tumor
- •13. Immune compromised participants
- •14. Lumbar scoliosis > 15 degrees
- •15. Evidence of disc herniation or large penetrating fissure including current diagnosis of sciatica, disc bulge > 5mm with radicular pain, or abnormal neurological examination (excluding diminished pin prick test), or in the case of previous sciatica (not current) presence of penetrating disc tear confirmed by observation of Dallas 5 disc tear (Dallas Discogram Classification System) during (mandatory) pressure-controlled discography using an automated injection device.
- •16. Symptomatic spinal stenosis
- •17. Congenital or degenerative spondylolisthesis (grade 2 and 3)
- •18. Psychological comorbidities that could contribute to the need for seeking medical treatment (e.g., depression, anxiety,cPTSD, borderline PD, schizophrenia, substance abuse)
- •19. Anticipated compliance problems (e.g., transportation, dementia, computercilliteracy)
- •20. Currently participating in another investigational study that could interfere with the outcome measurements of this study
- •21. Known anaphylactic reaction to contrast dye
- •22. Opioid daily intake > 90 MEQ
- •23. Not able to communicate with study center staff sufficiently to complete study questionnaires
- •24. Positive urine pregnancy test
- •25. History of unexplained, easy or persistent bruising or bleeding, bleeding from the gums, or bleeding problems experienced in previous surgical procedures
- •26. Congenital or acquired coagulopathy or thrombocytopenia; or currently taking anticoagulant, antineoplastic, antiplatelet, or thrombocytopenia-inducing medications, or undergoing radiation therapy
- •27. Annular rim tear suspected by posterolateral located high intensity zone or a focal disc protrusion on MRI, confirmed by observation of Dallas 5 disc tear (Dallas Discogram Classification System) during (mandatory) pressure-controlled discography using an automated injection device.
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