Status:
COMPLETED
Spine Fusion Instrumented With BMP-2 vs Uninstrumented With Infuse BMP-2 Alone
Lead Sponsor:
Nova Scotia Health Authority
Conditions:
Degenerative Lumbar Disc Disease
Spondylolisthesis
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
The goal of spinal fusion is to relieve pain and/or increase stability in painful or unstable spine joints. A patient may or may not receive rods and screws with the use of bone graft materials to fac...
Detailed Description
In this study we will be using BMP-2 Infuse instead of the iliac crest bone graft for the spinal fusion. The BMP-2 Infuse has been researched in the only completed clinical trial for spinal fusions. I...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patient not currently participating in a drug or medical clinical trial.
- Patient signed informed consent.
- Patient is willing to be available for each examination scheduled over the study duration.
- Patient has clinical and radiologic history of degenerative disc disease or spondylolisthesis (no greater than grade 1 utilizing Meyerding's classification (Meyerding HW, 1932)); spinal stenosis for which conservative treatment has failed and lumbar spinal fusion is indicated.
- Eligible for non-instrumented or instrumented surgical procedure
- Has one or two levels (contiguous) involvement from L1-S1 requiring fusion
- Has preoperative Oswestry score greater than 30
- Has not responded to non-operative treatment for a period of 6 months (bed rest, physical therapy, medication, manipulations, spinal injections, other).
- Is at least 20 years of age inclusive at the day of surgery
- If female of childbearing potential, patient is non-pregnant, non-nursing, and agrees to use adequate contraception for one year following surgery.
- Exclusion Criteria:
- Patient has a systemic infection.
- Patient has had more than one previous non-fusion spinal surgery at the involved level.
- Patient requires fusion at more than 2 levels.
- Patient has pseudoarthroses from a previous fusion attempt.
- Patient has highly communicable diseases, inflammatory or autoimmune disease (e.g.osteomyelitis, crohn's, rheumatoid arthritis, systemic lupus, gout, HIV/AIDS, active tuberculosis, venereal disease, active hepatitis). A note to file written by the investigator will permit a patient into the study who experiences a mild case which will not affect the outcome of the study.
- Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
- Patient has a significant medical history that, in the Investigator's opinion would not make them a good study candidate.
- Patient requires interbody cage fusion or non-pedicle screw instrumentation.
- Pregnancy.
- Has presence of active malignancy (except basal cell carcinoma of the skin)
- Has a history of severe allergy (anaphylaxis)
- Is grossly obese, i.e. weight over 40% over ideal for their height and age.
- Has a fever (temperature over 101 F oral)
- Has an allergy to the BMP-2
- Has allergy to bovine products
- Has an allergy to collagen implants
- Is mentally incompetent(if questionable, obtain psychiatric consult)
- Is a prisoner, a transient or have been treated in an inpatient substance abuse program for alcohol and/or drug abuse within six months prior to proposed study enrollment.
- Has received drugs which may interfere with bone metabolism within two weeks prior to the planned surgery
- Has a diagnosis, which requires postoperative medication that interferes with fusion, such as steroids.
- Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, Ehlers-Danios syndrome or osteogenesis imperfecta)
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00405600
Start Date
November 1 2006
End Date
December 1 2010
Last Update
February 15 2013
Active Locations (1)
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1
Capital Health Health Authority, QEII Health Sciences Centre, Halifax Infirmary site,
Halifax, Nova Scotia, Canada, B3H-3A7