BonAlive® Clinical Cases - Medeco-ch. coli Effective P. aeruginosa ... Large aneurysmatic bone...

BonAlive Biomaterials LtdBiolinja 12, FI-20750 Turku, Finlandt. +358 (0)401 77 4400, f. +358 (0)421 9177 4400www.bonalive.com

BonAlive® Clinical Cases

Inhibition of bacterial growth

Osteostimulation*

Bioactive bone bonding

*Non-osteoinduction


1 hour

1 day 1 week

After implantation:

1 hourRelease of ions increases pH and osmotic pressure (Na, Ca, P, Si) Inhibits bacterial growth on granule surface

1 daySilica gel layer forms on granule surface CaP precipitates to surface

BonAlive® mechanism of action

BonAlive® composition: 53% SiO2, 23% Na2O, 20% CaO, 4% P2O5

1 weekCaP crystallizes to natural HA Bonds to bone and promotes osteointegration

Bone formation cascade with BonAlive® (Scanning electron microscopy pictures)

Hydroxyapatite starts to form on surface

Hydroxyapatite covers BonAlive® surface

BonAlive® bonds to bone and stimulates new bone formation (6-12 weeks)

1 day 1 week

© Turku U

niversity Hospital

Collagen fibers

BonAlive® surface

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

© Päijät-H

äme C

entral Hospital


Anaerobic species Growth inhibition

C. difficile EffectiveB. adolescentis EffectiveE. lentum EffectiveP. gingivalis EffectiveP. acnes EffectiveP. anaerobius Effective

Leppäranta et al. 2008

Aerobic species Growthinhibition

Gram positiveS. epidermidis EffectiveS. aureus EffectiveE. faecalis EffectiveS. pneumoniae Effective

Aerobic species Growthinhibition

Gram negativeE. coli EffectiveP. aeruginosa EffectiveK. pneumoniae EffectiveH. influenzae Effective

A unique feature of BonAlive® granules: Inhibits Bacterial GrowthA total number of 29 aerobic and 17 anaerobic clinically important bacterial species tested. Results show clear inhibition towards all species.

Selected species are listed below:

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

Test with pigmented P. Gingivalis

Bacteria

Bacteria and HA

Hydroxyapatite (HA) BonAlive®

Munukka et al. 2008

Stoor et al. 1996

Visual appearance of BonAlive® vs CaP cement with X-ray, MRI and CT

© Helsinki University Central Hospital

X-Ray MRI CT

CaP cement 5 months post-op

BonAlive® 2 months post-op






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

Preop 1 month 12 months 24 months3 monthsPostop

Benign bone tumour in the proximal phalanx in a child

RESULTS

• At two years, no cavity was observed and the homogenous region resembled normal trabecular bone.

• The phalanx had grown in length and remodeled to almost normal shape.

• BonAlive does not disturb the growth of bone in children.

Pre-op 1 month 3 months 12 months 24 months

Post-op

CASE

Patient was a three year old child with a recurrent aneurysmal bone cyst of the proximal phalanx of the index finger. The bone tumour was removed and the defect was grafted with BonAlive® and two 2-3 mm pieces of autogenous bone. Follow-up was at one, three, 12 and 24 months post-operatively.

Large aneurysmatic bone tumor cavity in a child

Post-op Post-op 7 months

© H

elsinki University C

entral Hospital

Patient: 16-year old male

Defect size: 60 cc (2.0-3.15 mm granules)

Operation: January 2007, University Hospital of Helsinki

Patient history: Cavity filled 1st time with autograft and a 2nd

time with CaP based synthetic bone graft. In both cases the grafts had resorbed and 3rd time BonAlive® was used for the grafting.

Current status: Patient fully healed due to bone growth pro-motion and slow resorbtion properties of BonAlive®.


Post-op Post-op 1 year Post-op 11 years

Depressed tibial plateau fracture

Patient: Male (57 years), non smoker, no medicationOperation: May 1998, 15 cc of 1.0-2.0 mm BonAlive® granules was usedResults: No complications, current status excellent

© Turku U

niversity Hospital

BonAlive® has fully remodeled

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, Koski I, Mattila K, Gullichsen E, Heikkilä J, Aho AJ, Lindfors N. J Long-term Eff Med Impl. 2011;21(2):139-148.

Chronic osteomyelitis in the distal tibia

Patient: 36-year old male Defect size: 10-12 cm (100 cc)

BonAlive® amount used: 48 cc (2.0-3.15 mm) Operation: March 2008, Turku University Hospital Patient history: Car crash, pilon fracture, fixation with anterior plate. Patient was diagnosed with severe chronic osteomyelitis with extensive pus formation in the distal tibia. Anterior fixation plate removed. Large part of the anterior cortex removed through radical debridement. The defect was filled with BonAlive and autologous bone (50/50).

Patient clinical outcome: The soft tissue healed well. Although a significant part of the cortex was removed new cortical bone was formed within 2.5 years. The fu-sion is stabile and the patient outcome has been up-to-date successful.

© Turku University Hospital, Finland

Post-op 2.5 years


Patient: 75-year old female, abscess formation due to Mycobacterium tuberculosis

Operation: April 2009, Helsinki University Hospital.

Clinical situation: Posterior decompression LII/III-LIII/IV, spondylodesis LII-V, lumbotomy, canalisation of paravertebral abscess, resection of LIII, IV, anterior decompression and recon-struction. ©

Helsinki U

niversity Hospital, Finland

Chronic osteomyelitis in the spine

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.

Abscess formation in L III (arrow)

Pre-op MRI Pre-op CT

Post-op 2-year post-op CT Post-op 2-year post-op CT

© Helsinki University Central Hospital, Finland

BonAlive®

Procedure: Posterolateral fusion (50/50 with autograft) and application of BonAlive® around the anterior cageOutcome: The patient has fully healed at 2-years post-op

BonAlive®BonAlive®

Lateral view Anteroposterior (AP) view

• Naturally inhibits bacterial growth (UNIQUE FEATURE) • Bioactive (bonds chemically to bone)• Stimulates new bone formation (Osteostimulation*)• Increases bone remodelling • Biocompatible (Safe) • Over 15 years of proven clinical performance and safety• 100% synthetic and resorbable: - SiO2 53%, Na2O 23%, CaO 20%, P2O5 4% (by weight)

*non-osteoinduction


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BonAlive® Clinical Cases - Medeco-ch. coli Effective P. aeruginosa ... Large aneurysmatic bone...

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