NL-OMON32568招募中4 期
A MULTI-CENTER, POST MARKETING SURVEILLANCE STUDYTO MONITOR THE SAFETY AND PERFORMANCEOF THE BARRICAID® ARD IN THE TREATMENT OF BACK ANDRADICULAR PAIN CAUSED BY PRIMARY LUMBAR DISCHERNIATION - BARRICAID
Canisius Wilhelmina Ziekenhuis0 个研究点目标入组 30 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
- 发起方
- 入组人数
- 30
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
- •Any subject meeting all of the following criteria will be considered acceptable for inclusion in this trial.1. Age 18 to 75 years old (male or female).2. Patients with posterior or posterolateral disc herniations at one or two levels between L1 andS1 with radiographic confirmation of neural compression using CT and/or MRI.3. At least six (6) weeks of failed, conservative treatment prior to surgery, including physicaltherapy, use of anti-inflammatory medications at maximum specified dosage and/oradministration of epidural/facet injections.;4. Minimum posterior disc height of 3mm at the index level(s).5. Lower back pain and/or sciatica with or without spinal claudication.6. Oswestry Questionnaire score of at least 40/100 at baseline.7. VAS leg pain of at least 40/100 at baseline.8. Psychosocially, mentally and physically able to fully comply with the clinical protocol and willingto adhere to follow-up schedule and requirements.
排除标准
- •3.1.2 EXCLUSION CRITERIAAny subject meeting any one of the following criteria will be excluded from enrollment into the trial:1. Spondylolisthesis Grade II or higher2. Subject requires uni or bilateral facetectomy to treat leg/back pain3. Subject has back or non-radicular leg pain of unknown etiology.4. Prior fusion (with or without instrumentation), motion preservation, facetectomy or IDETsurgery at the index lumbar vertebral level5. Subject*s requiring a spine DEXA (i.e., patients with SCORE of = 6) with a T Score lessthan -2.0 at the index level.6. Subject has clinically compromised vertebral bodies at the index level(s) due to any traumatic,neoplastic, metabolic, or infectious pathology.7. Subject has sustained pathologic fractures of the vertebra or multiple fractures of the vertebraor hip.8. Subject has scoliosis of greater than ten (10) degrees (both angular and rotational).9. Any metabolic disease bone disease that has not been stabilized for at least three months
研究者
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