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MedStar Health Research Institute is among the first study sites to explore an exciting new way to fuse bones that could change the treatment of degenerative spinal disc disease.
The spine is a remarkable structure, bending and twisting its bones and rubbery discs to support large amounts of force. Yet for many people in the U.S., especially those over 40, discs can begin to break down and cause debilitating pain and other symptoms in the lower back or neck.
MedStar Health Research Institute is among the first sites in the nation to enroll patients in OASIS, a Phase I randomized clinical trial of a novel implant that could change how degenerative disc disease is treated. Our research seeks to understand the safety and effectiveness of the OsteoAdapt™ SP system designed to help the spine’s bones fuse after spinal fusion surgery to stabilize the surgically repaired spine.
About 1.5 million people in the U.S. have spinal fusion surgery each year. With traditional methods, bones fail to fuse in 5%-20% of surgeries. This condition, known as pseudarthrosis, results in continued instability and can require additional surgeries.
OsteoAdapt aims to improve fusion rates and reduce complications by enabling surgeons to use bone morphogenic proteins (BMP) more precisely than in the past. The body naturally makes BMP, one of the only clinically available solutions to induce new bone growth.
If OsteoAdapt is proven safe and effective, it could become a very powerful tool to help fuse the spine’s bones, reducing the need for revision surgery and providing many patients relief from back pain with one procedure.
OASIS: A first-in-humans trial.
Study sites across the country, including MedStar Southern Maryland Hospital Center, are enrolling a limited number of patients with degenerative disc disease in OASIS—the first time OsteoAdapt has been studied in humans.
Before patients enroll, we conduct several tests and imaging exams, including CT scans and MRI, to ensure they will be good candidates for the study. These criteria include:
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Age between 18 and 80
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At least six months of conservative treatment, such as physical therapy, lifestyle modifications, or anti-inflammatory steroid injections
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Body mass index less than 40
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Need for spinal fusion surgery
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No major health conditions
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Not a smoker
Participants are randomly assigned to one of three groups when they enroll:
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A control group that gets traditional spinal fusion surgery
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A group that receives a half-strength dose of OsteoAdapt
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A group that gets a full dose of OsteoAdapt
Detailed planning before surgery allows us to customize the procedure to each patient’s degeneration. After surgery, we’ll check in with patients every few weeks for the first three to six months. After that, visits will be less frequent over the next two years. We’ll compare their results to learn whether OsteoAdapt is safe and effective for improving spinal fusion.
Related reading: Research: Spine-inspired Exosuit Could Help Relieve Low Back Pain.
OsteoAdapt: A new way to perform spinal fusion surgery.
Created by Maryland-based biotechnology company Theradaptive, OsteoAdapt could be a significant advancement in how bones in the spinal cord are fused, allowing surgeons to have more confidence that bone will grow where it’s intended.
Several factors can cause degenerative disc disease, including genetics, wear and tear, and prior trauma. Because there is minimal blood flow to discs, they don’t regenerate when injured like other parts of the body. This can cause disc degeneration, which can:
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Lead to back pain
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Change from mild to severe and/or come and go
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Move into the arms and hands or to the buttocks and thighs
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Worse when sitting or after lifting, twisting, or bending
For patients with a compromised spinal disc, there are many treatments. One standard surgical option is spinal fusion.
In this procedure, an orthopaedic or spine surgeon connects two or more vertebra (spinal bones) with an implant. The graft material is placed between these vertebrae, and the body converts this material into bone, permanently connecting them.
Fusion can be challenging when there’s too much motion, or the bones are in the wrong place. To simulate a cast around the spine, surgeons use rods, screws, and spacers to keep the bones close together and supported. Bone graft, tiny pieces of bone or bone-like material, is packed into the area to encourage new bone to form.
About 20 years ago, BMP changed the spinal fusion process, allowing us to initiate bone growth. However, it has drawbacks. We have to use a lot of it, and it’s expensive. It causes the bone to grow anywhere it’s placed, including where bone isn’t welcome.
OsteoAdapt is designed to improve treatment with BMP. The developers made an essential change to the structure of BMP so that it no longer comes in a liquid form and functions much more efficiently. Now called AMP, the product is hoped to require a much lower dosage with less collateral impact since the medication only acts locally.
Related reading: 3 Signs It’s Time to Consider Spine Surgery for Your Back Pain.
A promising advancement for patients.
As a spine surgeon, I find the promise of OsteoAdapt inspiring. This product could significantly improve the success rate for spinal fusion, making pseudarthrosis and revision surgery less common.
We’re still very early in this research, so it’s difficult to say what we might find. Additional clinical trials will be necessary. If OsteoAdapt is proven to be as safe and effective as BMP, this innovation could change our practice and improve treatment for many patients with degenerative disc disease.
