A Prospective, Randomized, Controlled, Multi-center, (Pilot) Study of Osigraft® in Instrumented Posterolateral Fusions
- Conditions
- Subjects qualifying for decompression and fusion of one spinal level (L3-S1) with the use of autograft will be recruited through the medical institutions of participating investigators. All subjects will have undergone non-operative treatment for at least six months prior to study enrollment.
- Registration Number
- EUCTR2004-000675-34-ES
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 150
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method