Researchers Investigate Novel Bone-Fusing Procedure That Could Revolutionize Spine Surgery.

MedStar Health Research Institute is concluding an early feasibility study of a new way to fuse bones that could change how degenerative spinal disc disease is treated.

The spine is a remarkable structure, bending and twisting its bones and rubbery discs to withstand large forces. Yet for many people in the U.S., especially those over 40, discs can begin to break down and cause debilitating pain in the lower back or neck.

MedStar Health Research Institute was among the first sites in the nation to enroll patients in OASIS, a 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 vertebrae connect after spinal fusion surgery and make the spine more stable.

About 1.5 million people in the U.S. have spinal fusion surgery each year. With traditional methods, bone fusion fails 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 morphogenetic proteins (BMPs) more precisely than before. 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 powerful tool to support spinal fusion recovery, reducing the need for revision surgery and providing many patients with relief from back pain with a single procedure.

OASIS: From feasibility to the future.

Our research team has completed enrollment in the Phase I/II early feasibility study of OASIS, enrolling the second highest number of patients at any U.S. trial site. The initial goal was to test safety and dosing, and this early phase has provided essential insights into the procedure itself. 

Through these early cases, we have refined the device’s implementation, learning the nuances of packing graft material and optimizing dosing for human anatomy. These are essential to understand as we prepare for the next sep, a pivotal trial that will expand internationally.

During the early feasibility study, enrolled participants were randomly assigned to one of three groups:

• Control group that gets traditional spinal fusion surgery

• Group that gets a half-strength dose of OsteoAdapt

• Group that receives a full dose of OsteoAdapt

Detailed presurgical planning allows us to tailor the procedure to each patient’s degenerative condition. After surgery, we check in with patients every few weeks for the first three to six months. Then visits become less frequent over the next two years. We’ll compare their results to determine whether OsteoAdapt is a safe and effective option for spinal fusion. 

While we don’t yet have formal results to announce from this early trial, we’ve already begun the process of bringing this breakthrough technology from the laboratory to our patients.

Related: Read “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 spinal bones are fused, allowing surgeons to have greater confidence that bone will grow where it’s intended. It has received “FDA Breakthrough Device Exemption” status because of its tremendous potential. 

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:

• Lead to back pain

• Cause of weakness in the leg muscles

• Change from mild to severe and/or come and go

• Move into the arms and hands or to the buttocks and thighs

• 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 surgeon or a spine surgeon connects two or more vertebra (spinal bones) with an implant. Graft material is placed between these vertebrae, and the body converts it into bone, permanently connecting them.

Fusion can be challenging when there’s too much motion or the bones are in the wrong spot. 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 bone to grow anywhere it’s placed, including where bone isn’t welcome. 

OsteoAdapt is designed to improve BMP treatment. The developers made an essential change to the BMP structure so that it no longer comes in a liquid BMP form, which tends to leak into areas it is not intended. This new formulation allows for a focused, reliable, and reproducible position for new bone growth. 

Now called AMP, the product may require a much lower dosage with less collateral impact since the medication only acts locally. Because of this, researchers are now exploring its use in other complex areas, such as dental reconstruction and trauma repair, further validating the device’s science. 

Related reading: 3 Signs It’s Time to Consider Spine Surgery for Your Back Pain.

Beyond the Lab: Why early feasibility studies matter.

Participating in an early feasibility study allows MHRI researchers to bridge the gap between scientific theory and patient care. In the lab, we can test whether bone grows. But we don’t get patient-reported outcomes. 

By moving into early in-human trials, we can get vital insights into recovery, such as whether it can:

• Reduce post-operative pain

• Improve mobility faster than other methods

• Integrate with human anatomy as expected

Conducting early-stage trials requires a medical center with rigorous safety infrastructure. Phase I studies are complex, and most need high-level patient monitoring. 

Health companies and government organizations partner with MHRI because these safety protocols and research pathways are already a part of our system. Our patients have access to breakthrough technologies before they become standard of care, while maintaining the highest standards of safety and research integrity.

I find the promise of OsteoAdapt inspiring. This product could significantly improve the success rate of spinal fusion, reducing the incidence of pseudarthrosis and revision surgery. While we await final data, the qualitative feedback and successful Phase III expansion suggest this is an up-and-coming innovation. If OsteoAdapt continues to prove safe and effective, it could change our practice and improve treatment for many patients with degenerative disc disease.