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
  Purpose

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.


Condition Intervention
Degenerative Lumbar Disc Disease
Spondylolisthesis
Spinal Stenosis
Procedure: Device used in surgery with or without instrumentation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Clinical Investigation of Posterolateral Lumbosacral Spinal Fusions With BMP-2 and Titanium Pedicle Screw Instrumentation Versus BMP-2 Alone.

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: November 2006
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Device
Device used in surgery with or without instrumentation
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.

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. 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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405600

Locations
Canada, Nova Scotia
Capital Health Health Authority, QEII Health Sciences Centre, Halifax Infirmary site,
Halifax, Nova Scotia, Canada, B3H-3A7
Sponsors and Collaborators
Capital District Health Authority, Canada
Investigators
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
  More Information

No publications provided

Responsible Party: David Alexander, Principal Investigator, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT00405600     History of Changes
Other Study ID Numbers: CDHA016
Study First Received: November 28, 2006
Last Updated: February 13, 2013
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by Capital District Health Authority, Canada:
Lumbar degenerative disease
spinal stenosis
spondylolisthesis
non instrumented surgery
instrumented surgery
BMP-2

Additional relevant MeSH terms:
Spinal Stenosis
Spondylolisthesis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis

ClinicalTrials.gov processed this record on October 19, 2014