Bone fusion usually requires the use of bone graft material along with screws to hold the bone in place until healing occurs. There are many problems with bone from a bone bank called an allograft. Bone donated by the patient for his or her own use called autograft isn’t always possible.
In this study Dr. Nancy Epstein from The Albert Einstein College of Medicine in New York studied the use of a new artificial bone substitute. The product is called Vitoss/Beta Tricalcium Phosphate (B-TCP).
B-TCP was mixed 50-50 with bone removed from the patient’s spine as part of the procedure. All patients had a spinal fusion with the B-TCP and screws. Some had one lumbar level fused. Others had two levels fused.
The results were measured by X-rays, CT scans, and two patient surveys of general health. Two neuroradiologists reviewed the images taken at three, six, and 12 months. They did not see the patients or compare the results with each other. This is called a blinded study.
Two different scales were used to assess pain, general health, and function. The two scales commonly used were the SF-36 and the Odom Criteria. The SF-36 showed a decline in health and function in the first months after surgery.
Improvement was seen in some areas between three and six months post-op. Scores were better in all areas by the end of 12 months. The Odom Criteria showed everyone had good to excellent results by the end of the first year. The author suggested that the Odom scale may overestimate the quality of results in this patient group.
Results show that B-TCP is a good bone substitute to use in posterolateral lumbar spinal fusions. The 50-50 mix of B-TCP with patient autograft worked just as well as using an autograft without mixing it. Only one patient needed a second fusion because of nonunion in this study.