A New Alternative for Spinal Fusion
Degenerative disc disease (DDD) and treatment options
Degenerative disc disease (DDD) occurs when your discs degenerate (break down) and cause pain. As you age, the discs can lose flexibility, elasticity, and shock absorbing characteristics. When all that happens, the discs change from a supple state that allows fluid movement to a stiff and rigid state that restricts your movement and may cause pain1. In order to treat the pain associated with DDD, physicians typically start to treat with exercise, physical therapy, pain medications and more. If those treatments do not provide relief, you may be referred to a surgical procedure, such as a fusion, to relieve the pain.
During a fusion, the surgeon will fuse (connect) the bones surrounding your damaged disc. The gold standard is to fuse the bone surrounding the damaged disc using your own bone (autograft bone). This bone is taken from your own body and is the most popular type of bone graft because it has no risk of disease transmission, and your body accepts the transplant well. Because your body is already familiar with the bone, it creates the optimal environment for a healthy bone fusion2. When there isn’t enough of your own bone, other materials can be used to help fuse the bones. One of these can include donor bone (allograft). In recent years, other bone graft substitutes have been invented to help fuse the bones including P-15L, a new product being tested in the ASPIRE trial.
What is P-15L?
P-15L Bone Graft is a bone graft substitute that contains calcium phosphate particles and P-15 in a carrier. Calcium phosphate is a mineral found in your own bones. P-15 peptide is a synthetic (man-made) segment of collagen (main component of the tissues in your body) that is responsible for natural cellular attachment and activation. The carrier is a collagen putty made from bovine (cow) tissue that holds these components together. The P-15L Bone Graft triggers your body’s natural cellular bone healing response and then it will resorb after healing has occurred. P-15L is the only biologic bone graft made of a synthetic small peptide (P-15) that is attached to an anorganic bone mineral (ABM). This unique combination creates a surface-bound “Attract, Attach, Activate” mechanism of action that enhances the body’s natural bone healing process.
What is the ASPIRE trial?
The ASPIRE trial is a new clinical study being conducted at 30 locations throughout the United States. This research study has been designed to determine if the use of P-15L Bone Graft is as good at fusing bones surrounding your damaged disc as using your own bone and possibly donor bone following a spinal fusion surgery. It is believed that fusing the bones will help in relieving your pain and loss of function. Currently, P-15L Bone Graft is only available for use in this trial.
Has P-15 been studied before?
P-15 has been studied in the cervical spine (neck) and was approved by the FDA in 2016. In that study, 319 people were studied and P-15 was found to be superior to autograft (the patient’s own bone) at 1 year for the composite endpoint of overall success3. To have this product approved for lumbar fusion, Cerapedics (the company Sponsoring the trial) must conduct the study and provide the data for FDA to review and determine if it can be approved.
Who are good candidates for the ASPIRE trial?
There are many factors that will affect whether a person can participate in this study. Some of the criteria to participate include:
- Between 22 and 75 years old at the time of starting the study;
- Have disc pain between L2 and S1 at a single level;
- Had the pain for at least 6 months without relief from non-operative treatment;
- Experiencing leg pain;
- Not pregnant or planning to become pregnant;
- Planned lumbar fusion at one level
There are more study criteria that can be determined by your study doctor.
What if I’m interested in participating in this study?
If you are interested in being considered for the trial or have questions, contact: The Scientific Education and Research Foundation at 303-287-2800 ext. 323 or email @ firstname.lastname@example.org
1Accessed on January 24, 2019: https://www.spineuniverse.com/conditions/degenerative-disc-disease
2Accessed on January 24, 2019: https://www.spineuniverse.com/treatments/surgery/bone-graft-types-spinal-fusion-surgery
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