Inhibition of bacterial growth - Osteomyelitis · Inhibition of bacterial growth Osteostimulation* Bioactive bone bonding *non-osteoinduction Clinical Cases Orthopaedics & Trauma

Inhibition of bacterial growth

Osteostimulation*

Bioactive bone bonding

*non-osteoinduction

Clinical Cases Orthopaedics & Trauma

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BonAlive® granules is a resorbable bioactive glass based biomaterial for bone regeneration. Composition: 53% SiO2, 23% Na2O, 20% CaO, 4% P2O5

Mechanism of action (after implantation)

1 hour

1 day1 week

Si

NaCa

P

CaPCaP

CaPCaP

Surface reaction cascade1 hour

Release of ions increases pH and osmotic pressure (Na, Ca, P, Si)

Inhibits bacterial growth on granule surface1 day

Silica gel layer forms on granule surface

CaP precipitates on surface1 week

CaP crystallizes to natural HA

Bonds to bone and promotes osteointegration

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Hydroxyapatite starts to form on BonAlive® granules surface

Hydroxyapatite covers BonAlive® granules surface

BonAlive® granules bonds to bone and stimulatesnew bone formation (osteostimulation*)

Histological 20 µm-thick section from the mastoid area at 3 months after obliteration with BonAlive® granules (human biopsy). ©

Päijät-Häm

e Central H

ospital, Finland

Basis for osteostimulation*Osteostimulation* signifies that BonAlive® granules has the capacity to: 1) stimulate the recruitment and differentiation of osteoblasts 2) activate osteoblasts to produce new bone 3) activate specific osteoblast genes as a response to ion dissolution from the material

The bioactive glass surface is not only conductive but also osteoproductive in promoting migration, replication, and differentiation of osteogenic cells and their matrix production.

(Virolainen et al. 1997)

Bone formation (scanning electron microscopy images)

*non-osteoinduction

© Turku U

niversity Hospital, Finland

BonAlive® surface

Collagen fibres

1 day 1 week 6-12 weeks

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Bactericidal effects of bioactive glasses on clinically important aerobic bacteria. Munukka E. et al. J Mater Sci: Mater Med. 2008;19:27-32.Antibacterial effect of bioactive glasses on clinically important anaerobic bacteria in vitro. Leppäranta O. et al. J Mater Sci: Mater Med. 2008;19:547-551.Comparison of antibacterial effect on three bioactive glasses. Zhang D. et al. Key Engineering Materials. 2006;309-311:345-348.Interactions between bioactive glass and periodontal pathogens. Stoor P. et al. Microbial Ecology in Health and Disease,1996;9:109-114.Interactions between the frontal sinusitis-associated pathogen Heamophilus Influenzae and the bioactive glass S53P4. Stoor P. et al. Bioceramics. 1995;8:253-258.

Test with pigmented P. gingivalis

Hydroxyapatite (HA) BonAlive® granules

Stoor P. et al. 1996

Inhibition of bacterial growth

Bacteria(non-adherence)Bacteria

(adherence)

Munukka et al. 2008

Aerobic bacteria Growth inhibitionGram positiveS. epidermidis EffectiveS. aureus EffectiveS. aureus (MRSA) Effective

E. faecalis EffectiveS. pneumoniae Effective

Leppäranta et al. 2008

Anaerobic bacteria Growth inhibition

S. difficile EffectiveB. adolecentis EffectiveE. lentum Effective

P. gingivalis EffectiveP. acnes EffectiveP. anaerobius Effective

Munukka et al. 2008

Aerobic bacteria Growth inhibitionGram negativeE. coli EffectiveP. aeruginosa EffectiveK. pneumoniae Effective

H. influenzae Effective

A total of 29 aerobic and 17 anaerobic clinically important bacterial species have been tested. Growth was inhibited in all tested species.Selected species are listed below:

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© H

elsinki University C

entral Hospital, Finland

X-ray MRI CT

CaP cement 5 months post-op

BonAlive® granules 2 months post-op





Patient: A male with a comminuted calcaneus fracture.Operation: The hardware was removed at 8 weeks post-op and CaP cement was applied to a bone defect. Infection and fistula formation to the bone was observed and radical debridement was performed. The bone cavity was filled with BonAlive® granules (3 months after hardware removal). Clinical outcome: At 12 months post-op the healing was uneventful and clear osteointegration could be seen in the area of the BonAlive® granules.

Visual appearance of BonAlive® granules vs. CaP

6Treatment of a recurrent aneurysmal bone cyst with bioactive glass in a child allows for good bone remodelling and growth. Lindfors N. Bone, 2009;45(2):398-400.

Preop 1 month 12 months 24 months3 monthsPostop

Pre-op X-ray

1 month post-op X-ray

3 monthspost-op X-ray

12 monthspost-op X-ray

24 months post-op X-ray

Aneurysmal bone cyst (ABC) in the proximal phalanx in a child

Patient: A three year old child with a recurrent aneurysmal bone cyst of the proximal phalanx of the index finger.Operation: The bone tumour was removed and the defect was grafted with 2 cc/0.5-0.8 mm BonAlive® granules and two 2-3 mm pieces of autogenous bone.Clinical outcome: Follow-up was at 1, 3, 12 and 24 months post-op. At 24 months, no cavity was observed and the homogenous region resembled normal trabecular bone. The phalanx had grown in length and remodelled to almost normal shape. BonAlive® granules does not disturb the natural growth of bone in children.

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Immediate post-op X-ray 7-month post-op X-ray

© H



Large aneurysmal bone cyst (ABC) in the proximal femur in a child

Patient: 16-year old male with a large aneurysmal bone cyst in the proximal femur.Operation: In the 1st operation the cavity was filled with autograft and the 2nd time with a CaP based synthetic bone graft. In both cases the grafts had resorbed. In the 3rd opera-tion 60 cc/2.0-3.15 mm BonAlive® granules was used for the grafting.Clinical outcome: Healing could be observed due to the os-teostimulative* and slow resorbtion properties of BonAlive® granules.

*non-osteoinductive

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Patient: 15-year old girl with a large pelvic aneurysmal bone cyst.Operation: The large bone cyst was evacuated, the defect was fenolized and filled with 60 cc/2.0-3.15 mm BonAlive® granules.Clinical outcome: At 9 months post-op the patient had fully healed and was free of any symptoms and signs of recurrence of the ABC.

Pre-op X-ray

Clinical peri-operative picture illustrating an egg shell thin cortex surrounding the ABC

Immediate post-op X-ray 9-month post-op X-ray

Large pelvic aneurysmal bone cyst (ABC)

© D

epartment of Paediatric O

rthopedic Surgery, Turku University H

ospital, Finland

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Immediate post-op X-ray 12-month post-op X-ray 11-year post-op X-ray

© Turku U


BonAlive® has fully remodelled

Patient included in the following study: Bioactive glass S53P4 and autograft bone in treatment of depressed tibial plateau fractures. A prospective randomized 11-year follow-up. Pernaa K. et al. J Long-term Eff Med Impl. 2011;21(2):139-148.

11-year post-op X-ray

Depressed tibial plateau fracturePatient: 57-year old male with a depressed lateral tibial plateau fracture.Operation: 15 cc/1.0-2.0 mm of BonAlive® granules was used to fill the defect.Clinical outcome: No complications, current status is excellent. BonAlive® granules is a slowly resorbing biomaterial, but has completely remodelled to bone during the 11-year follow-up.

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Pre-op X-ray

© H



CaP 2 months post-op

BonAlive® granules7 months post-op

Patient: 45-year old male with an ulnar fracture.Bacterial species: Staphylococcus epidermis.Operation: The fracture was stabilised and CaP cement was applied to the bone defect. At 2 months post-op, fistula formation to CaP with Staphylo-coccus epidermis infection was observed. A two-stage revision was performed using antibiotic beads, radical debridement and grafting with BonAlive® granules (1.0-2.0 mm).Clinical outcome: At 7 months after revision surgery the patient had healed well and the clinical outcome was considered to be good.

2-month post-op X-ray 7-month post-op X-ray

Ulnar fracture with post-op chronic infection

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© Turku U


Immediate post-op X-ray 2.5-year post-op X-ray

Patient: 36-year old male with a chronic osteomyelitis in the distal tibia. After surgical debridement the defect size was 100 cc.Operation: The patient received a pilon frac-ture in a car crash and the fracture was stabi-lised with an anterior plate in the distal tibia. The patient was diagnosed with severe chronic osteomyelitis with extensive pus formation in the distal tibia. The anterior fixation plate wasremoved and the area was surgically cleaned through radical debridement. The defect was filled with BonAlive® granules 48 cc/2.0-3.15 mm mixed with an equal amount of auto-logous bone.Clinical outcome: The soft tissue healed well. Although a significant part of the anterior cortex of the distal tibia was removed, new cortical bone was formed. At 2.5 years post-op the fusion was stabile and the patient outcome continued to be successful.

Chronic osteomyelitis in the distal tibia

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Pre-op Pre-op X-ray

Patient: 32-year old female, type A host, was in a car crash and received an exposed pilon fracture that was stabilized with an external fixator.Bacterial species: Staphylococcus aureus.Surgeon: Prof. Carlo Romanó, Istituto Ortopedico Galeazzi, Milan, Italy.Operation: The patient was diagnosed with septic non-union 9 months after trauma. The patient refused new external fixation. The external fixator was re-moved and, after 15 days, an osteotomy of the fibula, debridement of the non-union septic focus, local application of BonAlive® granules (20 cc/1.0-2.0 mm granules) and intramedullary nailing were performed.

© Istituto O

rtopedico Galeazzi, Italy

Chronically infected non-union of the distal tibia

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© Istituto O

rtopedico Galeazzi, Italy

Immediate post-op X-ray 14-month post-op X-ray 24-month post-op X-ray

Clinical outcome: Bone healing was achieved in 6 months from implantation. The soft tissue healed well, with no clini-cal or laboratory signs of infection recurrence. Dynamisation of the nail was performed 14 months post-op and the nail was removed 24 months post-op.

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© H



Bioactive glass S53P4 as bone graft substitute in treatment of osteomyelitis. Lindfors NC, J. Bone. 2010;47:212-218.

Abscess formation in L III

Pre-op MRI Pre-op CT

Patient: 75-year old female, abscess formation in the spine. Bacterial species: Mycobacterium tuberculosis.Operation: Posterior decompression L2-L3 and L3-L4, spondylodesis L2-L5, lumbotomy, canalisation of paravertebral abscess, resection of L3-L4, anterior decompression and reconstruction. Posterolateral fusion and application of BonAlive® granules and autograft bone (50/50) around the anterior cage.

Chronic osteomyelitis in the spine

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Clinical outcome: Complete fusion at 2 years post-op. The patient was fully healed.

© H



Immediate post-op X-ray 2-year post-op CT Post-op X-ray 2-year post-op CT

BonAlive®

BonAlive® granules

BonAlive® granules

Lateral view Anteroposterior view

New bone formationNew bone formation

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Mechanism of action (osteostimulation*)Osteoblast response to continuous phase macroporous scaffolds under static and dynamic culture conditions.Meretoja VV, Malin M, Seppälä JV, Närhi TO. J Biomed Mater Res. 2008;89A(2):317-325.

Molecular basis for action of bioactive glasses as bone graft substitute.Välimäki VV, Aro HT. Scandinavian Journal of Surgery. 2006;95(2):95-102.

Intact surface of bioactive glass S53P4 is resistant to osteoclastic activity.Wilson T, Parikka V, Holmbom J, Ylänen H, Penttinen R. J Biomed Mater Res. 2005;77A(1):67-74.

Granule size and composition of bioactive glasses affect osteoconduction in rabbit.Lindfors NC, Aho AJ. J Mater Sci: Mater Med. 2003;14(4):265-372.

Osteoblast differentiation of bone marrow stromal cells cultured on silica gel and sol-gel-derived titania.Dieudonné SC, van den Dolder J, de Ruijter JE, Paldan H, Peltola T, van ‘t Hof MA, Hap-ponen RP, Jansen JA. Biomaterials. 2002;23(14):3041-3051.

Histomorphometric and molecular biologic comparison of bioactive glass granules and autogenous bone grafts in augmentation of bone defect healing.Virolainen P, Heikkilä J, Yli-Urpo A, Vuorio E, Aro HT. J Biomed Mater Res. 1997;35(1):9-17.

*non-osteoinduction

Inhibition of bacterial growthAntibacterial effects and dissolution behavior of six bioactive glasses.Zhang D, Leppäranta O, Munukka E, Ylänen H, Viljanen MK, Eerola E, Hupa M, Hupa L. J Biomed Mater Res. 2010;93A(2):475-483.

Bactericidal effects of bioactive glasses on clinically important aerobic bacteria.Munukka E, Leppäranta O, Korkeamäki M, Vaahtio M, Peltola T, Zhang D, Hupa L, Ylänen H, Salonen JI, Viljanen MK, Eerola E. J Mater Sci: Mater Med. 2008;19(1):27-32.

Antibacterial effect of bioactive glasses on clinically important anaerobic bacteria in vitro.Leppäranta O, Vaahtio M, Peltola T, Zhang D, Hupa L, Ylänen H, Salonen JI, Viljanen MK, Eerola E. J Mater Sci: Mater Med. 2008;19(2):547-551.

In situ pH within particle beds of bioactive glasses.Zhang D, Hupa M, Hupa L. Acta Biomaterialia. 2008;4(5):1498-1505.

Factors controlling antibacterial properties of bioactive glasses.Zhang D, Munukka E, Hupa L, Ylänen H, Viljanen MK, Hupa M. Key Engineering Materi-als. 2007;330-332:173-176.

Comparison of antibacterial effect on three bioactive glasses.Zhang D, Munukka E, Leppäranta O, Hupa L, Ylänen H, Salonen J, Eerola E, Viljanen MK, Hupa M. Key Engineering Materials. 2006;309-311:345-348.

Interactions between the bioactive glass S53P4 and the atrophic rhinitis-associated microorganism Klebsiella ozaenae.Stoor P, Söderling E, Grenman R. J Biomed Mater Res. 1999;48(6):869-874.

Antibacterial effects of a bioactive glass paste on oral micro-organisms.Stoor P, Söderling E, Salonen JI. Acta Odontol Scand. 1998;56(3):161-165.

Interactions between the frontal sinusitis-associated pathogen Heamophilus Influenzae and the bioactive glass S53P4.Stoor P, Söderling E, Andersson OH, Yli-Urpo A. Bioceramics. 1995;8:253-258.

References

The reputation of BonAlive® is built on solid clinical evidence• Over 20 peer-reviewed published clinical articles• More than a decade of human prospective randomized clinical data

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Chronic osteomyelitisThrough the looking glass; bioactive glass S53P4 (BonAlive®) in the treatment of chronic osteomyelitis.McAndrew J, Efrimescu C, Sheehan E, Niall D. Ir J Med Sci. 2013;182(3):509-511.

Clinical Experience on Bioactive Glass S53P4 in Reconstructive Surgery in the Upper Extremity Showing Bone Remodelling, Vascularization, Cartilage Repair and Antibacte-rial Properties of S53P4. Lindfors NC. J Biotechnol Biomaterial. 2011;1(5). (An open access journal.)

Bioactive glass S53P4 as bone graft substitute in treatment of osteomyelitis. Lindfors NC, Hyvönen P, Nyyssönen M, Kirjavainen M, Kankare J, Gullichsen E, Salo J. Bone. 2010;47:212-218.

Preclinical publicationsBioactive glass as bone-graft substitute for posterior spinal fusion in rabbit.Lindfors NC, Tallroth K, Aho AJ. J Biomed Mater Res. 2002;63B(2):237-244.

Tissue response to bioactive glass and autogenous bone in the rabbit spine.Lindfors NC, Aho AJ. Eur Spine J. 2000;9:30-35.

Bioactive glass and calcium carbonate granules as filler material around titanium and bioactive glass implants in the medullar space of the rabbit tibia.Turunen T, Peltola J, Helenius H, Yli-Urpo A, Happonen, R. Clin Oral Impl Res. 1997;8:96-102.

Long term behaviour of bioactive glass cone and granules in rabbit bone.Heikkilä JT, Salonen H, Yli-Urpo A, Aho AJ. Bioceramics. 1996;9:123-126.

Protein adsorption properties of bioactive glasses compared to their behaviour in rabbit tibia.Brink M, Söderling E, Turunen T, Karlsson KH. Bioceramics. 1995;8:471-476.

Bone formation in rabbit cancellous bone defects filled with bioactive glass granules.Heikkilä JT, Aho HJ, Yli-Urpo A, Happonen R, Aho AJ. Acta Orthopaedica. 1995;66(5):463-467.

Orthopaedics & traumaTrauma

Bioactive glass S53P4 and autograft bone in treatment of depressed tibial plateau frac-tures. A prospective randomized 11-year follow-up. Pernaa K, Koski I, Mattila K, Gullichsen E, Heikkilä J, Aho AJ, Lindfors N. J Long-term Eff Med Impl. 2011;21(2):139-148.

Bioactive glass granules: a suitable bone substitute material in the operative treatment of depressed lateral tibial plateau fractures: a prospective, randomized 1 year follow-up study.Heikkilä JT, Kukkonen J, Aho AJ, Moisander S, Kyyrönen T, Mattila K. J Mater Sci: Mater Med. 2011;22(4):1073-1080.

Instrumented spondylodesis in degenerative spondylolisthesis with bioactive glass and autologous bone. A prospective 11-year follow-up.Frantzén J, Rantakokko J, Aro H, Heinänen J, Kajander S, Koski I, Gullichsen E, Kotilainen E, Lindfors N. J Spinal Disorder Tech. 2011;24(7):455-461.

Posterolateral spondylodesis using bioactive glass S53P4 and autogenous bone in instru-mented unstable lumbar spine burst fractures - A prospective 10-year follow-up study.Rantakokko J, Frantzén J, Heinänen J, Kajander S, Kotilainen E, Gullichsen E, Lindfors N. Scan J Surg. 2012;101(1):66–71.

Benign bone tumourA prospective randomized 14-year follow-up study of bioactive glass and autogenous bone as bone graft substitutes in benign bone tumors.Lindfors NC, Koski I, Heikkilä JT, Mattila K, Aho AJ. J Biomed Mater Res. 2010;94B(1):157-164.

Treatment of a recurrent aneurysmal bone cyst with bioactive glass in a child allows for good bone remodelling and growth.Lindfors NC. Bone. 2009;45:398-400.

Bioactive glass and autogenous bone as bone graft substitutes in benign bone tumors.Lindfors NC, Heikkilä J, Koski I, Mattila K, Aho AJ. J Biomed Mater Res. 2009;90B(1):131-136.

mikä ref pitää poistaa?

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Ref. no Granule size Unit size13110 0.5-0.8 mm (small) 1 cc13120 0.5-0.8 mm (small) 2.5 cc

BonAlive® granules in small applicator

Ref. no Granule size Unit size13130 0.5-0.8 mm (small) 5 cc13140 0.5-0.8 mm (small) 10 cc13330 1.0-2.0 mm (medium) 5 cc13340 1.0-2.0 mm (medium) 10 cc

13430 2.0-3.15 mm (large) 5 cc13440 2.0-3.15 mm (large) 10 cc

BonAlive® granules in large applicator

1 cc 2.5 cc 5 cc 10 cc

Products

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Figure 1Peel open the pouch and aseptically remove the sterile tray.

Figure 2Moisten the granules by injecting sterile physiological saline slowly through the cap membrane.

Figure 3Screw tightly the shovel onto the applicator body, turn the applicator to a horizontal position, and push the plunger rod to slide the moistened granules onto the shovel.Move the applicator to the defect site and implant the moistened granules from the shovel into the defect with the aid of a sterile instrument.

Instructions for use

For complete instructions for use, see package insert.

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Documents

Inhibition of bacterial growth - Osteomyelitis · Inhibition of bacterial growth Osteostimulation* Bioactive bone bonding *non-osteoinduction Clinical Cases Orthopaedics & Trauma