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 BMP Improves Spinal Fusion Results

Jeffrey C. Wang, MD
Chief, Orthopaedic Spine Service
UCLA Comprehensive Spine Center
Santa Monica, CA, USA
Ms. Mary Claire Walsh
SpineUniverse Staff Writer
Medical content is copyright 2000-2006 spineuniverse.com

Bone morphogenetic protein, or BMP, may be the most exciting development in spine surgery in the past decade. Finally, it seems, there may be a better way to achieve spinal fusion with more success and less complications. Sound too good to be true? Perhaps, but studies are showing BMP to be very effective and may forever change the way fusion surgery is done.

What is Fusion Surgery?
Spinal fusion surgery is a common treatment for such spinal disorders as spondylolisthesis, scoliosis, severe disc degeneration or spinal fractures. Fusion surgery is usually considered only after conservative therapies to reduce pain have failed.

Spinal fusion surgery involves the joining or fusing of one or more vertebrae to reduce pain and stabilize the spine. This surgical technique includes a grafting procedure utilizing autograft. Autograft is when bone chips from a patient’s pelvic bone are transplanted, or grafted, to the spinal vertebra to help fuse them together. (When bone is harvested from a bone bank or other source it is called allograft).

However, harvesting bone graft from a patient’s own body carries with it numerous problems. Grafting prolongs surgical time and can increase the risks of blood loss and infection. It often prolongs the length of time a patient has to stay in the hospital. Many patients also report significant and long-lasting post-operative pain at the grafting site. In addition, grafting does not always produce successful fusion, even when used in combination with instrumentation such as screws, cages or dowels or when attempted for numerous vertebrae.

And Along Came BMP
Scientists have searched for years for a better way to promote bone growth and alleviate the need for grafting. BMP was “discovered” in the 1960s when Dr. Marshall Urist, a pioneer in this field, identified a group of protein extracts that help bones grow. At that time, Dr.Urist was affiliated with the Department of Orthopaedic Surgery at UCLA in Los Angeles, California.

In the 1980s, the proteins were individually identified and reproduced. It was strongly felt that this bone-growing material could be the answer scientists were looking for. Could this genetically produced synthetic grafting material, that actually stimulates cells in the body to make more bone, eliminate the need for grafting? Scientists quickly began to study it.

After numerous animal studies using BMP, it was used for the first time in 1997 in a clinical trial of patients undergoing spinal fusion. 10 of the 11 patients enrolled in the study had successful fusions within 3 months of surgery, all without the unpleasant side effects of bone grafting.

Additional clinical trials investigating the effectiveness of BMP have been conducted and continue to show its ability to successfully stimulate bone fusion. Studies have proven that BMP not only successfully creates fusion, but it seems to do so more quickly and reliably than autograft. For example, in a recent study * conducted at The Houston Clinic in Columbus Georgia, 46 patients underwent anterior lumbar interbody fusion surgery and were followed for 2 years. The patients who received BMP bone graft (InFUSE™) showed higher rates of fusion at 6, 12 and 24 months after surgery than the patients who received autograft bone. These patients recovered faster and had less back and leg pain than patients who received autograft. Furthermore, and most importantly, these patients were able to return to normal activities faster.

Availability
BMP has not yet been approved for use in the United States. However there are indications that the Food and Drug Administration (FDA) is close to granting approval for the use of BMP in spine surgery. It is widely believed that BMP will eventually be useful in a variety of spinal surgeries, creating less invasive surgical techniques, shortening recovery time and relieving pain of millions of back pain sufferers.

SpineUniverse will continue to monitor and report the use of BMP in spinal fusion surgery. Stay tuned.

rhBMP-2 has recently received clearance from the Food and Drug Administration (FDA) for specific uses. Consult your surgeon to learn if you are a candidate.

* Burkus, KJ. Clinical and Radiographic Outcomes of Anterior Lumbar Interbody Fusion Using Recombinant Human Bone Morphogenetic Protein-2. Total Spine Pre-Course Symposium. March 2002.


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Article written 04/10/2002
Published online 04/24/2002
Last updated 06/07/2007

Recombinant Human bone morphogenetic protein-2 (rhBMP-2) is available for specific use in promoting spinal fusion. The surgical approach, reviewed by the FDA, was Anterior Lumbar Interbody Fusion (ALIF) with threaded fusion cages. For this use, the rhBMP-2 was delivered on a collagen sponge carrier, which was inserted inside two hollow threaded titanium cages in the lumbar spine. The study demonstrated that rhBMP-2 was safe and highly effective in promoting spinal fusion for ALIF. The fusion rate was higher than those achieved with patients own bone (allograft). Physicians and patients should be cautious regarding other possible applications of this new technology because there is not enough data regarding the safety or efficacy of rhBMP-2 for other techniques of spinal fusion other than ALIF. The high success rates and low complication rates that are observed with rhBMP-2 for ALIF may not be the same with other techniques of spinal fusion (such as posterior spinal fusion or fusions in the cervical or thoracic spine). Currently, other clinical studies are in progress to examine the effects of rhBMP-2 for other techniques of spinal fusion. Until the results of these studies are available, rhBMP-2 should be used in a judicious manner. It is important that application of this new technology be limited until sufficient scientific data is available that supports widespread use for different techniques of spinal fusion.

Curtis A. Dickman, MD

Studies have shown the potential benefits of BMP. The FDA has granted approval for the use of BMP in specific types of spine surgery.

Howard S. An, MD

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