ISRCTN47205504已完成未知
A study to evaluate the safety and effectiveness of TOPS™ System: a non-randomized single centre study
Premia Spine Ltd (Israel)0 个研究点目标入组 10 人开始时间: 2013年8月2日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 10
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
- 性别
- All
入选标准
- •The study population will be comprised of patients suffering from lower back and leg pain which results from degenerative spondylolisthesis and/or spinal stenosis who meet the eligibility criteria as follows
- •1. Patients with one or both of the following conditions at a single spinal level between L3 and L5 are eligible for the TOPS™ System implant:
- •1.1. Symptomatic monosegmental lumbar spinal stenosis
- •1.2. Degenerative Spondylolisthesis up to and including grade 1 (see radiographic protocol)
- •2. Patients with one or more of the following conditions at one or two levels adjacent to the TOPS System between L4 and S1 are eligible for the Versalink™ Fixation System implant:
- •2.1. Symptomatic monosegmental lumbar spinal stenosis
- •2.2. Degenerative Spondylolisthesis up to and including grade 1 (see radiographic protocol)
- •2.3. Discogenic pathology
- •3. At least three (3) months of failed, conservative treatment prior to surgery, including use of anti-inflammatory medications at maximum specified dosage; administration of epidural/facet injections, unless deemed inadvisable due to progressive motor weakness or other evidence of rapidly deteriorating condition; rest, heat, electrotherapy/physical therapy
- •4. Narrowing of the lumbar spinal canal classified as moderate to severe using CT scans/MRI
- •5. Age 40-85 years old (male or female)
- •6. Lower back pain and sciatica with or without spinal claudication
- •7. Psychosocially, mentally and physically able to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.
- •8. Leg pain of at least 40/100 at baseline as per visual analogue scale (VAS)
- •9. Oswestry Questionnaire score of at least 40/100 at baseline
排除标准
- •Patients who have any of the following conditions or meet any of the following criteria are excluded from participating in this study:
- •1. Primary diagnosis of discogenic back pain at the TOPS System level
- •2. Back or non-radicular leg pain of unknown etiology at the TOPS System level
- •3. Lytic spondylolisthesis at the TOPS System level
- •4. More than one (1) motion segment involved in the degenerative pathology to the extent that justifies its inclusion in the surgical procedure, unless a decompression alone can be done at that level without compromising stability or the Versalink System is implanted.
- •5. Known allergy to titanium and/or polyurethane
- •6. Prior surgery at any lumbar vertebral level
- •7. Supplemental interbody support required (e.g., bone graft, spacers, VBRs, or fusion cages) at the TOPS System level
- •8. Clinically compromised vertebral bodies at the affected level(s) due to any traumatic, neoplastic, metabolic or infectious pathology.
- •9. Deformity of the spine that would compromise the implant, e.g. scoliosis of greater than ten (10) degrees
- •10. Morbid obesity defined as a body mass index > 40 or a weight more than 100 lbs. over ideal body weight
- •11. DEXA bone density measured T score equal to or lower than ? 2.0
- •12. Paget's disease, osteomalacia, osteogenesis imperfecta, thyroid and/or parathyroid gland disorder and/or any other metabolic bone disease
- •13. Active infection - systemic or local
- •14. AIDS, HIV, or active hepatitis
- •15. Rheumatoid arthritis or other autoimmune disease
- •16. Tuberculosis active or in the past 3 years
- •17. Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years
- •18. Medical conditions requiring treatment with any drugs known to potentially interfere with bone/soft tissue healing
- •19. Pregnant or interested in becoming pregnant in the next 3 years
- •20. Current chemical/alcohol dependency or significant psychosocial disturbance
- •21. Subject is currently involved in another investigational study
- •22. Cauda equina syndrome or neurogenic bowel/bladder dysfunction
- •23. Severe arterial insufficiency of the legs, peripheral vascular disease
- •24. Sustained pathologic fractures of the vertebra or multiple fractures of the vertebra or hip
- •25. Unremitting pain in any spinal position
- •26. Significant peripheral neuropathy
- •27. Immunologically suppressed, received steroids > 1 month out of the past year
- •28. Insulin-dependent diabetes mellitus
- •29. Currently taking anticoagulants other than aspirin (e.g., Plavix)
- •30. Life expectancy less than 3 years
- •31. Waddell signs > 3
- •32. Currently involved in active spinal litigation
- •33. Subject is incarcerated
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