Spine Fusion Instrumented With BMP-2 vs Uninstrumented With Infuse BMP-2 Alone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Alexander, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT00405600
First received: November 28, 2006
Last updated: February 13, 2013
Last verified: February 2013

November 28, 2006
February 13, 2013
November 2006
December 2010   (final data collection date for primary outcome measure)
  • To evaluate bone fusion; [ Time Frame: 3mon., 6mon., 12mon., 24mon ] [ Designated as safety issue: Yes ]
  • Radiology tests; CT spine 24mon. [ Time Frame: 3mon., 6mon., 12mon., 24mon ] [ Designated as safety issue: Yes ]
  • Clinical neurological evaluations; patient questionnaires [ Time Frame: 3mon., 6mon., 12mon., 24mon ] [ Designated as safety issue: Yes ]
  • To evaluate bone fusion;
  • Radiology tests; 3mon., 6mon., 12mon., 24mon., CT spine 24mon.
  • Clinical neurological evaluations; patient questionnaires; 3mon., 6mon., 12mon., 24mon.
Complete list of historical versions of study NCT00405600 on ClinicalTrials.gov Archive Site
  • Hospital and surgical data [ Time Frame: hospitalization; ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: hospitalization, clinic visits, unscheduled visits ] [ Designated as safety issue: Yes ]
  • Hospital and surgical data; hospitalization;
  • Adverse events
Not Provided
Not Provided
 
Spine Fusion Instrumented With BMP-2 vs Uninstrumented With Infuse BMP-2 Alone
A Prospective Randomized Clinical Investigation of Posterolateral Lumbosacral Spinal Fusions With BMP-2 and Titanium Pedicle Screw Instrumentation Versus BMP-2 Alone.

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 facilitate bone growth and a fusion thus preventing movement of the bones of the spine.

In this research study, bone graft substitute material called Bone Morphogenetic Protein-2 known as BMP-2 Infuse will be used. No hip bone will be used. The surgical procedure will consist of BMP-2 Infuse with or without the use of rods and screws.

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. It has demonstrated equivalence to the iliac crest bone graft with regard to both fusion rate and clinical outcome.

Currently, the acceptable standard of care for spinal fusion surgery requires instrumented or non-instrumented procedure with the use of bone graft materials, to facilitate bone growth, and a fusion, thus eliminating movement between the inciting vertebrae.

In this study, the surgical procedure will be BMP-2 Infuse with instrumentation or BMP-2 Infuse alone.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Degenerative Lumbar Disc Disease
  • Spondylolisthesis
  • Spinal Stenosis
Procedure: Device used in surgery with or without instrumentation
Infuse Bone Graft BMP-2, Large Kit will be used in all surgeries. Spine surgeries will be either instrumented or uninstrumented.
Active Comparator: Device
Device used in surgery with or without instrumentation
Intervention: Procedure: Device used in surgery with or without instrumentation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2010
December 2010   (final data collection date for primary outcome measure)

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)
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00405600
CDHA016
No
David Alexander, Capital District Health Authority, Canada
Capital District Health Authority, Canada
Not Provided
Principal Investigator: Dr. David Alexander, M.D. Capital Health District Authority, Centre for Clinical Research, Queen Elizabeth II, Health Sciences Centre, 1278 Tower Rd.,Halifax, Nova Scotia, B3H-9Z9, Canada
Capital District Health Authority, Canada
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP