Contact information
Type
Scientific
Primary contact
Dr D Delawi
ORCID ID
Contact details
University Medical Center Utrecht
Department of Orthopaedics
G05.228
PO Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 2509001
d.delawi@chir.azu.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EU 101; NTR217
Study information
Scientific title
Osigraft Study: a prospective, randomised, controlled, multicentre, (pilot) study of Osigraft® in instrumented posterolateral fusions
Acronym
Study hypothesis
It 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.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Multicentre randomised double-blinded active-controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Degenerative disc disease (DDD), spondylolisthesis
Intervention
All 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.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
In 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-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
6. No decreases in neurological status at the final examination from the preoperative evaluation
Secondary outcome measures
Not provided at time of registration
Overall trial start date
14/07/2004
Overall trial end date
16/10/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Diagnosis of degenerative and/or isthmic spondylolisthesis and/or degenerative disc disease (DDD) at the levels of L3-S1 with:
1.1. Lumbar instability of at least 2 to 3 mm translation in standing standard radiographs, or
1.2. At least 2 to 3 mm translation in flexion extension radiograms and/or angulation motion defined as greater than 15° at L3-L4 level, greater than 18° at L4-L5 level, and greater than 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 enrolment
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant 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 enrolment
6. The subject has participated in clinical trials evaluating investigational devices, pharmaceuticals or biologics within 3 months of enrolment 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 greater than 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
Recruitment start date
14/07/2004
Recruitment end date
16/10/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Utrecht
Utrecht
3508 GA
Netherlands
Sponsor information
Organisation
University Medical Centre Utrecht (UMCU) (Netherlands)
Sponsor details
PO Box 85500
Utrecht
3508 GA
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Stryker Nederland BV (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23957727