NL-OMON47404已完成4 期
Prospective longitudinal outcome study assessing the use of REGENOSS for attaining spinal fusion in patients requiring single level Posterior Interbody Fusion (PLIF) in the lumbar spine. - REGENOSS posterior interbody fusion, pilot study
Finceramica0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Patients who signed the ethics committee approved specific informed consent prior to surgery.
- •2. Male and non-pregnant female patients between 18-70 years of age.
- •3. Patients with a BMI <<= 35 Kg/m2
- •4. Patients with low-grade spondylolisthesis requiring single-level or 2 level posterior interbody fusion at level L3-L4 L4-L5 or L5-S1.
- •5. Patients who are physically and mentally willing and able to comply with postoperative functional evaluation.
- •6. Patient can read and understand the Dutch language.
- •7. If intra-operatively the surgeons decided to fuse an additional level for spinal stability this is not an exclusion criteria however the primary level for surgical indication will be measured.
排除标准
- •1. Patients who are unwilling to cooperate with the study protocol and follow-up schedule.
- •2. Patients who, as judged by the surgeon, are mentally incompetent or are likely to be non-compliant with the prescribed post-operative routine and follow-up evaluation schedule.
- •3. Patients with bleeding history, hemophelia or systemic blood diseases
- •4. Female patients that are pregnant or planning a pregnancy during the course of the study
- •5. Obese patients where obesity is severe enough to affect subject*s ability to perform activities of daily living (body mass index, kg/m2 > 35)
- •6. Patients with active or suspected infection
- •7. Patients with malignancy * active malignancy within last 5 years
- •8. Patients known with a diagnosed systemic disease that would affect the subject*s welfare or overall outcome of the study (severe osteoporosis requiring medication, Paget*s disease, renal osteodystrophy,hypercalcemia ) or is immunologically suppressed, or receiving steroids in excess of physiologic dose.
- •9. Patients with a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient*s ability to limit weight bearing or places an extreme load on the implant during the healing period.
- •10. Patients with systemic or metabolic disorders leading to progressive bone deterioration
- •11. Patients with other concurrent illnesses that are likely to affect their outcome such as all autoimmune diseases (including RA), sickle cell anaemia, systemic lupus erythematosus, psoriasis, not controlled type 1/2 diabetes or renal disease requiring dialysis.
- •12. Patients with a known sensitivity to device materials
- •13. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse
- •14. Has received drugs that may interfere with bone metabolism within two weeks prior to the planned surgery date (e.g., steroids or methotrexate) excluding routine perioperative, non-steroidal anti-inflammatory drugs.
- •15. Any prior surgical treatment at the surgical level in the lower lumbar spine
- •16. Has chronic or acute renal and/or hepatic failure or prior history of renal or hepatic disease.
- •17. Below 18 and over 70 years of age.
- •18. Known allergies to collagen of equine origin and to calcium phosphate salts
- •19. If per *operative fusion of 2 levels is necessary, this will not be a reason for exclusion
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