NL-OMON32769尚未招募2 期
A MultiCenter Prospective Randomized Phase II Clinical Trial to Evaluate Safety and Efficacy of Hyalospine® in Lumbar Laminectomy or Laminotomy. - Efficacy and safety of Hyalospine®
Fidia Advanced Biopolymers (FAB) S.r.l.0 个研究点目标入组 32 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
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
- •Age 18 * 75 years;
- •Scheduled for elective single or two*level lumbar laminectomy or laminotomy procedure for treatment of spinal stenosis or disk herniation.
- •Subjects who have failed conservative care for at least 6 weeks.
- •At least 25% narrowing of the central, lateral or foraminal spinal canal compared to the adjacent levels.
- •Radiographic confirmation of any one of the following:
- •o Evidence of the tecal sac and/or cauda equina compression
- •o Evidence of nerve root impingement (displacement or compression) by either osseous or non*osseous elements
- •o Evidence of hypertrophic facets with canal encroachment
- •Skeletally mature.
- •Able to understand this clinical study and willing and able to participate in the study follow*up according to the protocol.
- •Understand and read country national language at elementary level.
- •Signed informed consent.
- •Women must be one of the following:
- •o Postmenopausal defined as amenorrhea for at least 6 months before screening and a serum follicle stimulating hormone (FSH) level consistent with postmenopausal status
- •o Surgically sterile, (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy)
- •o Abstinent (at the discretion of the investigator) or,
- •o If sexually active, be practicing an effective method of birth control such as hormonal prescription oral contraceptives, progesterone implants or injections, intrauterine device (IUD), a double*barrier method such as condoms, diaphragms or cervical caps with spermicidal foam, cream or gel, or male partner with a vasectomy.
- •Women of childbearing potential must have a negative serum β*human chorionic gonadotropin (β*hCG) pregnancy test at screening, or a negative urine pregnancy test at baseline or screening.
排除标准
- •Systemic infection such as AIDS, HIV, and active hepatitis.
- •Systemic Lupus erythematosus.
- •Contraindication to MRI (e.g. any electrically, magnetically or mechanically activated implants).
- •Known allergic reaction to MRI contrast.
- •Instrumented fusion (Exception: non*instrumented fusion permissible).
- •Postoperative wound treatment planned with suction drainage device (Exception: treatment with gravity drainage device allowed).
- •Patient has post traumatic vertebral body compromise or fracture at surgery level.
- •Prior lumbar spine surgery at surgery level.
- •Undergoing treatment for tumor or bony traumatic injury to the lumbar spine.
- •Cauda equina syndrome (defined as neural compression causing neurogenic bowel or bladder dysfunction).
- •Significant symptomatic peripheral vascular disease (at the discretion of the investigator).
- •Active malignancy defined as history of invasive malignancy, except if the patient has received a treatment and has displayed no clinical signs and symptoms for at least 5 years (excludes basal cell carcinoma).
- •Infection in the disc or spine, past or present.
- •Evidence of active (systemic or local) infection at time of surgery.
- •Has a disease process that would preclude accurate evaluation (e.g., neuromuscular disease, significant psychiatric disease).
- •Paget*s disease, osteomalacia or any other metabolic bone disease.
- •Taking immunosuppressants or steroids which have the potential to interfere with bone/soft tissue healing.
- •Morbid obesity (BMI >= 40).
- •Is a prisoner.
- •A recent history (less than 3 years) of chemical substance dependency or significant psychosocial disturbance that may impact study outcome or participation.
- •Participation in a clinical trial of another investigational drug or device within
- •the past 30 days.
- •Known allergies to any of the components of the investigational device.
- •Intraoperative exclusion criteria
- •Dural entry during the surgical procedure.
- •Newfound intraspinal tumor.
- •Involvement of more than two vertebrae levels.
- •Epidural fat placement.
- •Use of steroid solution.
- •Intraoperative decision to use a suction instead of a gravity drainage device.
- •Intraoperative decision to leave a hemostatic agent at the surgery site.
研究者
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