As the science of the 3rd generation biomaterials is further unfolding, a clear shift from traditional bone replacement technologies (osteoconduction*) to bone regeneration technologies (osteostimulation*) can be seen.
*Non-osteoinductive. Osteo-stimulation is the phenomenon in which the genes responsible for bone formation in the osteogenic cells.
BonAlive® granules are osteostimulative* and come with a range of benefits matched by no other bone graft substitute. In addition, BonAlive® granules has the unique feature of inhibiting bacterial growth making it an effective tool for bone cavity filling in the treatment of chronic osteomyelitis. During the 20 years of experience gathered BonAlive® granules have proven to be safe, reliable and effective in bone regeneration applications.
The composition of BonAlive® bioactive glass S53P4 by weight is:
53% Silicon (SiO2), 23% Sodium (Na2O), 20% Calcium (CaO), 4% Phosphorus (P2O5)
As the science of biomaterials 3rd generation develops, there is a clear shift from traditional bone replacement technology (osteoconduction) to the bone regeneration technologies (osteostimulation). BonAlive® granules and BonAlive® putty are osteostimulating and come with a wide range of benefits that no other substitute has.
Chronic osteomyelitis, or chronic bone infection, is defined and characterized by progressive infection of the bone marrow and cortex, resulting in destruction of bone, bone necrosis. It may occur at any age and can involve any bone. Often, a multidisciplinary approach is required, involving expertise in orthopedic surgery, infectious diseases and plastic surgery.
BonAlive® granules is a unique bone graft substitute that inhibits bacterial growth in a vast number of bacterial species that are related to orthopedic complications, including e.g. MRSA and MRSE.
Several long-term studies have shown that mastoid cavities with continuous infections and cleaning problems can be obliterated with BonAlive® granules. The BonAlive® granules have been used for more than 15 years with success for mastoid obliteration. The unique bacterial growth inhibiting feature and slow resorption profile of BonAlive® granules give distinct advantages when used to obliterate discharging and chronically infected mastoid cavities. In addition, the osteostimulative* property of BonAlive® granules supports new tissue formation in the cavities.
* No osteostimulative
The clinical use of BonAlive® granules in orthopedic and trauma surgery is supported by a program of long-term randomized prospective clinical trials with follow-up extending to 11 years in patients with tibial plateau fractures and 14 years in patients with benign bone tumors. The results from these studies show that the long-term performance of BonAlive® granules in bone cavity filling applications is comparable to autograft.
The solid nature of BonAlive® granules provides specific benefits, such as allowing the granules to be impacted into the bone defect. The granules maintain their volume effectively, hence they do not shrink or expand. BonAlive® granules produces a high and balanced local bone regeneration by stimulating new bone formation through osteostimulation*..
Pediatric orthopedic surgery is a special focus area for the BonAlive® products. The long-term use of BonAlive® granules for treating bone defects created by benign bone tumors, e.g. enchondromas, simple cysts and aneurysmal bone cysts, has showed that BonAlive® granules resorbs slowly and the grafted area remodels to bone over time without disturbing the normal growth of bone in children.
BonAlive® granules induces a high but balanced local bone turnover by stimulating new bone formation through osteostimulation*. The proven performance of BonAlive® granules shows that it is a well-tolerated and safe bone graft substitute for filling benign bone tumor cavities in pediatric patients.
Several long-term studies, extending over 10 years of patient follow-up, have shown that BonAlive® granules generate outstanding clinical results in bone cavity filling applications in the cranio-maxillofacial area. Th e main applications of BonAlive® granules are filling of benign bone tumor cavities, filling of the osteotomy site in bilateral sagittal split osteotomies and front orbital trauma. The solid nature of BonAlive® granules provides specific benefits, such as allowing the granules to be impacted into the bone defect. Th e granules maintain their volume effectively, hence they do not shrink or expand. BonAlive® granules produces a high and balanced local bone regeneration by stimulating new bone formation through osteostimulation*.
Most conditions of the frontal sinus requiring surgery can be treated successfully by endonasal or nasofrontal duct reconstruction procedures. However, in certain difficult cases, optimal exposure of the entire frontal sinus area is essential. Frontal sinus obliteration can be a treatment alternative for such frontal sinuses.
The unique bacterial growth inhibiting feature of BonAlive® granules gives distinct advantages in areas that are postoperatively prone to infection.
BonAlive® granules (bioactive glass S53P4) is a CE-marked class III medical device that is used in surgical procedures to regenerate bone. BonAlive® granules is osteostimulative* which means that it activates genes responsible for bone formation in osteogenic cells. It also has the special property of effectively inhibiting bacterial growth, which makes it a very unique material for regenerating bone.
In contact with body fluids bioactive glass works by leaching out ions leading to an alkaline environment (high pH) and increased osmotic pressure. This mechanism has been shown to effectively inhibit bacterial growth.
The surface reactions develop a silica gel layer on the bioactive glass, which attracts the Ca and P that has been released from from the granules.
The precipitated CaP crystallizes to natural hydroxyapatite, which is similar to the mineral component of bone. The newly formed natural surface will promote bone bonding and osteointegration.
BonAlive® granules composition:
One of the most striking features of BonAlive® granules is its ability to inhibit bacterial growth. This phenomenon has been evidenced with more than 50 clinically relevant aerobic and anaerobic bacterial species through in vitro studies, and indirectly by empirical observation of patient data over the past 15 years.
Chronic bone infections play a large role in surgery as the infection can be difficult to eradicate and might require several operations. Antibiotic resistance has become an increasing threat and new tools that are not based on antibiotics can bring significant benefits in fighting chronic bone infections. The efficacy of BonAlive® granules towards methicillin-resistant (MR) Pseudomonas aeruginosa, Staphylococcus aureus (MRSA), Staphylococcus epidermidis (MRSE) has been tested and proven effective.
The bacterial growth inhibiting effect of BonAlive® granules is based on two simultaneous processes that occur when the bioactive glass reacts with body fluids.
These two mechanisms will together effectively inhibit the adhesion and colonization of bacteria on the granule surface.
An osteoconductive material functions as a scaffold that allows bone growth on its surface or into its three-dimensional structure. BonAlive® granules is osteoconductive in nature, providing a supportive material for the osteoblast cells during bone formation. As a result of the osteoconductive process, bone grows onto and between the bioactive glass granules. Furthermore, the bioactive glass granules have been proven to activate a biological process that stimulates bone regeneration in a fashion far superior to mere osteoconductive materials. This is defined as osteostimulation*.
BonAlive® granules is a fully resorbable biomaterial that remodels completely into bone over a period of several years to allow sufficient time for bone regeneration.
These results have been presented in randomized prospective clinical trials, which show that BonAlive® granules is a safe and effective biomaterial for bone cavity filling applications.
Furthermore, BonAlive® granules has been proven to induce a high but local turnover through the simultaneous stimulation of osteoblast and osteoclast activity that promotes bone remodeling.
Single bone regenerator with broad spectrum bacterial growth inhibition capability in more than 50 bacterial species, including those resistant to Methicillin *.
* It is not antibiotic
It is a bioactive glass S53P4 (BonAlive Granules) and a synthetic polyethylene binder (PEG and Glycerol) that acts as a temporary binding agent for bioactive glass. After implantation, the binder is absorbed leaving behind only the bioactive glass, which allows the infiltration of tissue between the granules, facilitating the regeneration of the bone.
* It has not been verified if BonAlive Putty inhibits bacterial growth
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