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.
Conditions
Interventions
Trade Name: Osigraft
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: EPTOTERMIN ALFA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
University Medical Center Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary end point of this study is the 12 (+/- 45 days) months follow-up overall success rate. The success criteria are defined below. If the patient fails to achieve any of the succes criteria mentioned below, the patients will be classified as a failure. 1. Radiographic demonstration of spinal fusion: - CT-scans indicating fusion defined as continuous intertransverse bony bridges at one of the two sides indicated the presence of fusion at that location. 2. Oswestry Disability Index improvement of at least 20% from the pre-treatment visit. 3. No revisions, removals or supplemental fixations. All re-operations that are intended to promote fusion at the treated level result in the patient being considered failure. Re-operations that are not intended to promote fusion, such as drain removal will not be considered failures. Revision, removals, supplemental fixations and re-operations are defined: - A revision is a procedure that adjusts or in any way modifies or removes part of the original implant configuration (hardware and/or bone graft procedure), with or without replacement of a component. A revision may also include adjusting the position of the original configuration; - A removal is a procedure where the entire original system configuration is removed with or without replacement; - A reoperation is any surgical procedure at the involved level(s) that does not remove, modify or add any components to the system; - A supplemental fixation is a procedure in which additional instrumentation not under study in the protocol is implanted (e.g., supplemental placement of a rod/screw system or a plate/screw system). 4. Absence of a serious investigational-product -related adverse event during the course of the study. 5. No unresolved neurological deficits at the final examination that were not present prior to study treatment, unless the deficit is due to a concurrent medical condition. Unresolved neurological deficits due to a concurrent medica | — |
Countries
Spain
Outcome results
None listed