Over 400,000 spinal fusion surgeries are performed annually in the United States and as the population ages, that number is expected to rise.
The goal of many spinal fusion surgeries is to reduce or eliminate pain as a result of degenerative disc disease. This is often done by removing the degenerated disc and then fusing the spine’s vertebral bones above and below the disc to form a single, solid bone. A successful fusion can help reduce pain and enable patients to return to enjoying their lives. However, spinal fusion success rates vary from 70% to 90% and fluctuate depending on the patient’s underlying condition and the surgical technique the surgeon uses.
To learn more about the challenges affecting spinal fusions and innovation in the space, Becker’s Healthcare spoke with neurosurgeon Sharad Rajpal, MD, Medical Director of the Advanced Spine Program at AdventHealth Avista in Louisville, Colorado and Valeska Schroeder, PhD, CEO of Cerapedics, a global commercial-stage orthopedics company.
Spinal fusion’s unique complexities
A spine patient’s journey can be long and difficult. Prior to considering surgery, most patients spend months, if not years, attempting to manage and alleviate their back pain before concluding that spinal fusion surgery presents the best long-term solution.
As an experienced spine surgeon, Dr. Rajpal sees multiple challenges and complexities with spinal fusion procedures, including patient factors that can negatively impact bone growth.
Every patient is different, and factors such as the patient’s age, health, spinal condition and bone quality can impact the chance of a successful fusion. For example, patients with osteoporosis can have compromised bone healing, which puts them at increased risk of a non-union. Lifestyle factors, like obesity and smoking, and comorbidities such as diabetes, malnutrition and steroid use can also negatively impact the fusion process.
As a result of these factors, spinal fusion surgery is becoming more difficult, with an increasing need for interventions to help overcome the biological challenges of bone growth for patients.
“Our spinal fusion patients are not becoming less risky; they’re becoming higher risk,” Dr. Rajpal said. “We have not achieved a 100% fusion rate for any spinal fusion procedure yet. We still have failures and non-unions, so we need to be thoughtful about our biologics choices during these surgeries, especially in our higher-risk patients.”
An overlooked challenge
Without a successful bone fusion, symptomatic motion can occur, and the longer it takes for the bones to fuse, the greater the risk of developing additional complications, like hardware failures, etc.
There are more than 300 products in the bone graft space, but almost all are used to support healing, not to actively drive it. These widely used products have helped millions of patients, yet few activate bone repair.
With increasing patient complexity, Dr. Rajpal stressed the importance of surgeons better understanding bone healing and adopting best practices, techniques and products to promote better, faster bone healing.
“When we think about bone grafting options, surgeons want to use a product that can help address the fusion challenges that we constantly encounter in the OR ,” Dr. Rajpal said. “This includes understanding the challenges that cause delayed and impaired bone fusions.”
Innovation drives better outcomes
Over the past few decades, spinal fusion surgical techniques and hardware have advanced rapidly, but innovation in bone grafts has largely remained stagnant, with none proving to be superior to the patient’s own bone or increasing fusion speed.
With a deep understanding of bone repair and extensive research on the mechanism of action of the P-15 Peptide, Cerapedics believed they could develop a product to safely accelerate controlled bone formation and achieve fusion sooner. This led their team to conduct a randomized controlled trial (RCT) of its latest P-15 Peptide drug-device in single-level transforaminal lumbar interbody fusion (TLIF) surgery and test for speed-to-fusion.
As a result of the RCT, Cerapedics secured FDA Class III drug-device approval for PearlMatrix™ P-15 Peptide Enhanced Bone Graft, and demonstrated statistically superior fusion speed at 24 monthsi with over twice as many patients fused at six months compared to the controli,ii the patient’s own bone.
“Our goal wasn’t just to create another bone graft,” Ms. Schroeder said. “It was to create a whole new category…a bone growth accelerator.”
In Dr. Rajpal’s experience, every spine surgeon is looking to improve fusion rates, reduce complications, and accelerate healing time for their patients.
Evidence-based care
PearlMatrix is a drug-device combination product with Level 1 RCT data and FDA Class III drug-device approval. As the first surgeon in the United States to use PearlMatrix following FDA approval, Dr. Rajpal shared that a key reason he trusted PearlMatrix for his patients was the rigor and evidence required by the FDA to achieve Class III drug-device approval.
In addition, over 60% of the participants in Cerapedics’ clinical trial presented with one or more risk factors such as nicotine use, BMI greater than 30 and/or type 2 diabetes. High-risk patients are often excluded from these types of studies, so the Cerapedics trial uniquely represents the patient population that surgeons perform fusions on each day.
Cerapedics is committed to advancing spine care by educating clinicians about the P-15 Peptide and continuing to build the body of evidence that demonstrates the clinical benefits of faster fusion. The company is also exploring other high-need areas where accelerated bone growth can make a difference for patients.
While hundreds of bone graft products are commercially available, only three have achieved the biologically active Class III drug-device designation, with Cerapedics responsible for developing two of the three products, PearlMatrix and i-FACTOR™.
“The data is robust and shows PearlMatrix is safe for my patients. The biologics space has hundreds of products out there, but we’re talking about a very elite group of products that have Class III approval. The scientific rigor is what distinguishes PearlMatrix from other biologic options,” Dr. Rajpal said.
The future of fusion
With so many bone graft products on the market, Dr. Rajpal believes it’s essential for surgeons to become educated about PearlMatrix to understand the robust, high-quality clinical data supporting the approval of this product, especially for higher-risk fusion patients.
He also emphasized that using PearlMatrix hasn’t resulted in any substantial change in his surgical workflow and that the product has excellent handling characteristics. The material is moldable, making it easy to use, stays where the surgeon puts it, and is efficient to use in the operating room.
As a global orthopedics company, Cerapedics is committed to addressing unmet clinical needs that matter to patients. While patients will continue to take steps to try to avoid surgery, when surgery is required, surgeons can now provide options like PearlMatrix P-15 Peptide Enhanced Bone Graft.
“We think speed to fusion is one of the most important unmet clinical needs,” Ms. Schroeder said. “There is a real need to safely accelerate fusion to improve outcomes in spinal fusion procedures, and we expect to help a lot of patients achieve that goal.”
i PearlMatrix Instructions For Use. Cerapedics.
ii Internal Data on File as of 9/9/24
