A Prospective, Randomized, Controlled, Multi-center, (Pilot) Study of Osigraft® in Instrumented Posterolateral Fusions

niversity Medical Center Utrecht0 个研究点目标入组 150 人开始时间: 2005年11月2日最近更新: 2012年3月19日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: niversity Medical Center Utrecht
入组人数: 150

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1) Diagnosis of Degenerative and/or Isthmic Spondylolisthesis and/or Degenerative Disc Disease (DDD) at the levels of L3-S1 with (a) Lumbar instability of at least 2 to 3 mm translation in standing standard radiographs or (b) at least 2 to 3 mm translation in flexion extension radiograms29,30 and/or angulation motion defined as >15° at L3-L4 level, >18° at L4-L5 level, and >17° at L5-S1 spine level.
•2) Leg and/or back pain with one or more of the following phenomena: radiculopathy, sensory deficit, motor weakness, reflex pathology, neurogenic claudication;
•3) The subject has been non-responsive to at least 6 months of non-operative treatment prior to study enrollment;
•4) The subject has a preoperative Oswestry Disability Index of 30-100;
•5) Fusion of only one lumbar level in the L-3 to S-1 region is indicated;
•6) The subject has no history of previous fusion attempt(s) to the affected spinal level;
•7) The subject is willing and able to understand, sign and date the study specific Patient Informed Consent, which has been approved by the Institutional Review Board;
•8) The subject agrees to comply with post-operative clinical and radiographic evaluations and required rehabilitation regimen;
•9) Age: the subject is skeletally mature between 18 and 80 years of age;
•10) Gender: both males and females can be included in the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•1) The subject has gross instability as a result of Degenerative and/or Isthmic Spondylolisthesis and/or DDD that requires multiple levels fusion (an example would be exclusion of Grade IV Spondylolisthesis);
•2) The subject is severely osteoporotic/osteopenic as manifested by the presence of a history of osteoporotic spine fractures and/or medical treatment for osteoporosis and/or such changes on the AP/lateral radiographs that will make the surgeon decide to exclude this patient from any form of pedicle fixation;
•3) The subject has an active spinal and/or systemic infection;
•4) The subject has a systemic disease or condition, which would affect his/her ability to participate in the study requirements or the ability to evaluate the efficacy of the investigational product (i.e., active malignancy, neuropathy);
•5) The subject is a prisoner, a transient or has been treated for alcohol and/or drug abuse in an inpatient substance abuse program within six months prior to proposed study enrollment;
•6) The subject has participated in clinical trials evaluating investigational devices, pharmaceuticals or biologics within 3 months of enrollment in the study;
•7) The subject is a woman who intends to bear children within 1 year of enrolling in the study (e.g. is not post-menopausal, has not had a hysterectomy, is not on long term oral contraception);
•8) The subject is morbidly obese (defined as weight >60 percent over the recommended ideal weight as described in the 1996 Metropolitan Height and Weight Tables for Men and Women;
•9)The subject has a known sensitivity to any component of Osigraft®;
•10) The subject is known to require at the time of treatment, additional surgery to the lumbar spinal region within the next six months;
•11) Patients who have in the last year been prescribed systemic corticosteroids.

研究者

发起方

niversity Medical Center Utrecht

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