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van CCT (UK)

van CCT (UK)

Osigraft Study.

- candidate number1383
- NTR NumberNTR217
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR5-sep-2005
- Secondary IDsEU 101 
- Public TitleOsigraft Study.
- Scientific TitleA Prospective, Randomized, Controlled, Multi-center, (Pilot) Study of Osigraft® in Instrumented Posterolateral Fusions.
- hypothesisIt is postulated that the use of Osigraft will prove beneficial in the treatment of patients requiring decompression and instrumented lumbar spinal fusion while eliminating the pain and morbidity associated with harvesting of autograft bone from the iliac crest.
- Healt Condition(s) or Problem(s) studiedDegenerative Disc Disease (DDD), Spondylolisthesis
- Inclusion criteria1.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;
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.
- Exclusion criteria1. 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, Appendix B);
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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 14-jul-2004
- planned closingdate16-okt-2006
- Target number of participants150
- InterventionsAll subjects will receive decompression and posterolateral spinal fusion via instrumented pedicle fixation. There will be two arms: a treatment arm with Osigraft® and local autograft and a control arm using autogenous bone graft from the iliac crest.
- Primary outcomeIn order for a patient to be classified as a success, the patients has to meet all of the criteria mentioned below:

1. Radiographic demonstration of spinal fusion;
2. Oswestry Disability Index improvement of at least 20% from the pre-treatment visit;
3. No revisions, removals or supplemental fixations may occur;
4. Absence of a serious investigational-produc -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;
6. No decreases in neurological status at the final examination from the preoperative evaluation.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Department of Orthopaedics
- Funding
(Source(s) of Monetary or Material Support)
Styker Biotech
- PublicationsN/A
- Brief summaryInstrumented posterolateral fusion of the lumbar spine is a commonly performed procedure for a variety of spinal disorders. The classical technique for achieving spinal fusion involves placing autologous bone graft between the spinal surfaces.The bone graft stimulates new bone formation. However, harvesting of bone from the posterior iliac crest is associated with significant complications.
Osigraft contains rhBMP-7 and has shown to be capable of bone formations. The purpose of the study is to establish Osigraft® as a safe alternative to autograft for instrumented posterolateral fusion of the lumbar spine and thereby avoiding the pain and morbidity associated with iliac crest bone harvesting.
- Main changes (audit trail)
- RECORD5-sep-2005 - 30-aug-2011

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