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

Not Applicable

Completed

• Conditions: Degenerative Lumbar Disc Disease; Spondylolisthesis; Spinal Stenosis

• Registration Number: NCT00405600
• Lead Sponsor: Nova Scotia Health Authority

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 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.

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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-28
• Study First Submitted QC: 2006-11-28
• Study First Posted: 2006-11-30
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-13
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate bone fusion;	3mon., 6mon., 12mon., 24mon
Radiology tests; CT spine 24mon.	3mon., 6mon., 12mon., 24mon
Clinical neurological evaluations; patient questionnaires	3mon., 6mon., 12mon., 24mon

Secondary Outcome Measures

Name	Time	Method
Hospital and surgical data	hospitalization;
Adverse events	hospitalization, clinic visits, unscheduled visits

Trial Locations

Locations (1)

Capital Health Health Authority, QEII Health Sciences Centre, Halifax Infirmary site,; 🇨🇦 Halifax, Nova Scotia, Canada