Spine Fusion Instrumented With BMP-2 vs Uninstrumented With Infuse BMP-2 Alone
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.
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Degenerative Lumbar Disc Disease
Intervention
Device used in surgery with or without instrumentation
Location
Capital Health Health Authority, QEII Health Sciences Centre, Halifax Infirmary site,
Halifax
Nova Scotia
Canada
B3H-3A7
Status
Completed
Source
Capital District Health Authority, Canada
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00405600
- Information obtained from ClinicalTrials.gov on March 14, 2013
Medical and Biotech [MESH] Definitions
Failed Back Surgery Syndrome
A condition of persistent pain and discomfort in the BACK and the LEG following lumbar surgery, often seen in patients enrolled in pain centers.
Surgical Procedures, Minimally Invasive
Procedures that avoid use of open invasive surgery in favor of closed or local surgery. These generally involve use of laparoscopic devices and remote-control manipulation of instruments with indirect observation of the surgical field through an endoscope or similar device. With the reduced trauma associated with minimally invasive surgery, long hospital stays may be reduced with increased rates of short stay or day surgery.
Spinal Osteophytosis
Outgrowth of immature bony processes or bone spurs (OSTEOPHYTE) from the VERTEBRAE, reflecting the presence of degenerative disease and calcification. It commonly occurs in cervical and lumbar SPONDYLOSIS.
Safety-based Medical Device Withdrawals
Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.
Spinal Puncture
Tapping of the subarachnoid space in the lumbar region, usually between the third and fourth lumbar vertebrae.
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