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Trial Shows Bioactive Glass Stops Bone Infections

Implanting bioactive glass granules

Implanting bioactive glass granules (BonAlive Biomaterials Ltd.)

8 March 2017. Grafts of glass-based substitute material were shown in a clinical trial to stop bacterial bone infections from osteomyelitis, in most cases without additional antibiotics. Results of the study were reported in January 2017 as part of the Advances in Experimental Medicine and Biology series published by Springer.

The study, led by Nina Lindfors, a professor of surgery at University of Helsinki, tested the bioactive glass product code-named BAG-S53P4 by BonAlive Biomaterials Ltd. in Turku, Finland among patients with chronic osteomyelitis. The condition often results from trauma, where infections spread from nearby tissue or through the blood stream, to longer bones in the arms or legs. Infections can also affect bones in the feet as a result of diabetic foot ulcers.

BonAlive designs BAG-S53P4 as granules for surgical implants for grafts to fill voids in infected bones. The product, says BonAlive, is made with materials found in the body including silicon, sodium, calcium, and phosphorous. When bioactive glass comes in contact with fluids in the body, sodium is released from the granules’ surfaces causing an increase in pH, which discourages bacterial growth. The release of silicon, calcium, and phosphorous ions, along with sodium, also increases osmotic pressure in the bone, further inhibiting growth of bacteria.

At the same time, says the company, bioactive glass forms a silica gel layer on the surface of granules to receive calcium phosphate precipitation, which crystallizes into bone-like material. This crystallized calcium phosphate bonds with surrounding bone in the patient to fill voids caused by the infections.

For the study, Linford and colleagues recruited 116 individuals in 6 countries in Europe and central Asia with chronic osteomyelitis, age 15 to 87 (median: 48), with infections in their tibia or femur bones in the leg, or heel bones. Many patients already received previous surgeries, in some cases for as long as a decade. Most (85%) participants received only the BAG-S53P4 granules, with the remainder first being treated with antibiotics. The results show nearly all (90%) participants reported total clearance of their infections, followed by a full recovery.

“The use of bioglass is a new approach without local antibiotics, thus the risk of creating resistant bacteria is reduced and the bone has a good template to grow,” says Arnold Suda, an orthopedic surgeon at Mannheim University Medical Center in Germany, and a co-author of the study. “With the amount of refugees with rare and very aggressive bacteria from the near east, Africa or Afghanistan, antibiotic treatment encounters its limits and bioglass seems to be an effective opportunity in these cases.”

BonAlive bioactive glass granules are used in smaller sizes for facial bone reconstruction. The product is used in neuro, trauma, orthopedic, and ear surgery for both adults and children. The company says some 10,000 surgeries used bioactive glass last year.

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