Repairing the flat on the side of the road, the new injectable hydrogel shows promise as a remedy for aging spinal discs that pump backup and relieve chronic back pain.
The gel, with the brand name Hydrafil, is injected directly into the discs using X-rays to direct the needle. As explained in the experimental study,. the gel fills the cracks and tears in the spinal disc, attaching to the center of the disc and the outer layer.
It penetrates like a hot liquid that cools and becomes a kind of solid medium. It creates a Fix-a-Flat type, fills the disk, and restores the biomechanical integrity of the disk. Twenty gel-treated patients experienced a 67% reduction in back pain during one-year follow-up.
Patients also experienced an 85% improvement in disability due to their back pain. The gel did not cause any adverse reactions in any patient.
It penetrates like a hot liquid that cools and becomes a kind of solid medium. It creates a Fix-a-Flat type, fills the disk, and restores the biomechanical integrity of the disk.
Twenty gel-treated patients experienced a 67% reduction in back pain during one-year follow-up. Patients also experienced an 85% improvement in disability due to their back pain. The gel did not cause any adverse reactions to any patient.
The degenerative disease occurs as people get older. Spinal discs tend to dry out and wear out over time. They can also be torn or damaged as a result of daily activities or games.
As many as three out of three people with back pain caused by disc degenerative disease can be considered as alternatives to this type of hydrogel therapy.
Hydrafil was selected as a successful tool in 2020 by the U.S. The researchers said that the Food and Drug Administration allows for a quick review where evidence shows that the test product can provide more effective treatment for the condition compared to current options.
Other hydrogels already are being used to treat injured or worn discs, but those products are inserted surgically as a soft solid, “which can pop out of place if you’re not highly skilled in placing it,” Beall said.
“Because this gel is injectable, it requires no incision, and it augments the whole disc, restoring its structural integrity, which nothing we have currently can do,” he said.
Dr. J. David Prologo, an interventional radiologist at Emory University School of Medicine in Atlanta, reacted to the findings.
“The impact of this study I don’t think can be overstated — degenerated disc disease is a condition that affects hundreds of millions of people worldwide, for which there is really no definitive treatment other than a big surgery, with all of the associated costs and risks,” he said.
“Dr. Beall is spearheading the ability to literally inject a liquid replacement to the disc using only a needle and image guidance, removing the needle after the injection and sending the patient home with a replaced disc and Band-Aid over the puncture site,” said Prologo, who chairs the Society for Interventional
Disc repairs conducted via injection are “almost like the holy grail of treatment for back problems,” he said.
Hilibrand noted that other research groups are trying to repair discs by injecting growth factors or biologic agents intended to promote the regrowth of healthy disc material.
These new results come from what Beall characterized as an early feasibility trial, which was conducted among 20 patients ages 22 to 69 in Colombia. All had chronic low back pain due to degenerative disc disease.
A pilot trial involving more patients is underway in Canada and based on those results a full-scale clinical trial will be conducted in the United States.
The hydrogel therapy is new, but relies on existing techniques and skills regularly used by interventional radiologists, surgeons and other specialists.
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