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

Spinal Stenosis Clinical Trial

Official title:

A Prospective Randomized Clinical Investigation of Posterolateral Lumbosacral Spinal Fusions With BMP-2 and Titanium Pedicle Screw Instrumentation Versus BMP-2 Alone.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405600
• Other study ID #: CDHA016
• Status: Completed
• Phase: N/A
• First received: November 28, 2006
• Last updated: February 13, 2013
• Start date: November 2006
• Est. completion date: December 2010

Study information

• Verified date: February 2013
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health ResearchCanada: Ethics Review CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Degenerative Lumbar Disc Disease
• Spinal Stenosis
• Spondylolisthesis

Intervention

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.

Locations

Country	Name	City	State
Canada	Capital Health Health Authority, QEII Health Sciences Centre, Halifax Infirmary site,	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate bone fusion;		3mon., 6mon., 12mon., 24mon	Yes
Primary	Radiology tests; CT spine 24mon.		3mon., 6mon., 12mon., 24mon	Yes
Primary	Clinical neurological evaluations; patient questionnaires		3mon., 6mon., 12mon., 24mon	Yes
Secondary	Hospital and surgical data		hospitalization;	Yes
Secondary	Adverse events		hospitalization, clinic visits, unscheduled visits	Yes