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BETH ISRAEL'S SPINE INSTITUTE PARTICIPATES
IN MULTI-CENTERED STUDY TO DETERMINE
THE EFFECTIVENESS OF NEW SPINAL FUSION TECHNIQUE
FOR THE TREATMENT OF CHRONIC LOW BACK PAIN
New Technique Allows Surgeons to Perform
Spinal Fusions Without Harvesting Bone
From the Patient's Hip
Chronic low back pain affects an estimated 65 million Americans. Treatment
options include pain medications, physical therapy and spine surgery.
Spinal fusions, the most common type of spine surgery, essentially "welds"
two or more vertebrae together to eliminate the pain caused by movement
of problematic vertebrae. A traditional lumbar spinal fusion surgery is
divided in two parts -first, small pieces of bone are harvested from the
patient's hip (autograft). The second part of the surgery involves implanting
these grafts to the spine. However, numerous studies have shown that patients
experience considerably more pain from the harvesting than they do from
the fusion procedure itself, and the hip pain associated with graft can
last for years after surgery.
At Beth Israel's Spine Institute, a new Phase III multi-centered, randomized
controlled study is underway where individuals with single level L1-S1
degenerative disc disease (low back pain) may be eligible to participate.
In the study, patients will be randomized into two groups - the investigational
group and the control group. The investigational group will receive a
spinal fusion surgery under a new technique that eliminates the bone graft
portion of a traditional spinal fusion. This group will receive spinal
fusions with the use of a powdery substance called rhBMP-2 (a recombinant
molecule protein that has been shown to cause bone formation in animal
studies). The rhBMP-2 will be placed on a compression resistant matrix
(an absorbent collagen sponge), which will then be situated between the
vertebrae after an anchoring system -- CD Horizonâ System -- has
been put in place. The implanted "sponge" acts like a bone and
grows accordingly. The control group will receive spinal fusion surgery
via the traditional way of receiving a two-part surgery, involving the
harvest of small pieces taken from the patient's hip bone and then implantation
into the spine after the CD Horizonâ Spinal System has been put
into place. Medtronic Sofamor Danek is the sponsor for the study.
Michael Neuwirth, M.D., leading investigator of this trial and Director
of the Spine Institute at Beth Israel, says, "This new technique
allows for a much faster fusion rate and eliminates the need of taking
bone from the patient's hip - this will reduce the time, bloodloss, and
possibility of having persistent pain related to the graft. Moreover,
we hope to achieve equal, if not better, results compared to the current
standard procedure for spinal fusions. This is a tremendous milestone
in spinal fusion surgery." Doctors expect that the new technique
will equal the results of traditional bone graft technique, however, some
early animal and human studies suggest the new technique may produce even
better results.
The trial will be conducted in individuals with degenerative disc disease.
Participants must be at least 18 years of age, requiring fusion of a single
level disc space from L1 to S1. Only participants who have not responded
to non-operative treatment (bed rest, physical therapy, medications, spinal
injections) will be eligible to enroll.
The Spine Institute is located at 10 Union Square East at 14th Street.
For more information about spinal fusion surgery, please call 212/844-8692.
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