BonAlive® Clinical Cases - CMO Ortopedia Posterolateral fusion (50/50 with autograft) and...

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

1 daySilica gel layer forms and CaP precipitates to surface CaP crystallizes into natural hydroxyapatite

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 forms 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).


Anaerobic species Growth inhibition

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

Leppäranta et al. 2007

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: Materials in Medicine, 2008 Jan: 19(1):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 2007, Jan; 19(1):27-32. Zhang D. et al. Comparison of antibacterial effect on three bioactive glasses. Key Engineering Materials, 2006, Vols 309-311: 345-348. Stoor P. et al. Interactions between the frontal sinusitis associated pathogen Heamophilus Influenzae and the bioactive glass S53P4. Bioceramics 1995, Vol. 8: 253-258.

Test with pigmented P. Gingivalis

Bacteria

Bacteria and HA

Hydroxyapatite (HA) BonAlive®

Munukka et al. 2008

BonAlive® resorbs without forming bone in soft tissues

BonAlive® stimulates bone growth only in a bony environment, hence it is not osteoinductive.When BonAlive® is accidentally misplaced in soft tissues it will gradually resorb without forming bone.

© St. Heliers Hospital, London

Postop 8 months 13 months 22 months 29 months


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 Aug;45(2):398-400.

Preop 1 month 12 months 24 months3 monthsPostop

Treatment of a 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®. Follow-up was at one, three, 12 and 24 months post-operatively.

Treatment of a large aneurysmatic bone tumor cavity in a child

Post-op Post-op 7 months

© H

elsinki University H

ospital

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

Treatment of a 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

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.

Treatment of 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

Treatment of chronic osteomyelitis in an infected 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)

Post-op 2 years post-op CT Post-op 2 years post-op CT

© Helsinki University 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®


Treatment of a comminuted calcaneus fracture with a post-op infection complication

Pre-op CT of fractured area

© Helsinki University Hospital, Finland

40-month post-op CT image of BonAlive

40-month post-op CT image of BonAlive

CaP cement 15 months post-op

BonAlive® 12 months post-op

Fixation plates removed and CaP cement applied 8 weeks post-op


Treatment of a ulnar fracture with post-op infection complication

X-ray of pre-op situation

© H

elsinki University C

entral Hospital

Fistular formation to CaP with Staph epidermidis infection resistant to almost all antibiotics

CaP 2-month post-op

BonAlive®

Procedure: Two-stage revision using antibiotic beads 4 months and 5 months after primary surgery and grafting with BonAlive®

Outcome: 7-month post-op X-ray image after revi-sion surgery and grafting with BonAlive®

• Naturally inhibits bacterial growth (UNIQUE FEATURE) • Bioactive (bonds chemically to bone)• Stimulates new bone formation (Osteostimulation*)• Accelerates 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 - CMO Ortopedia Posterolateral fusion (50/50 with autograft) and...

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