BonAlive Clinical Cases

Transcription

1 BonAlive Clinical Cases Inhibition of bacterial growth Osteostimulation* Bioactive bone bonding *Non-osteoinduction

2 BonAlive mechanism of action BonAlive composition: 53% SiO 2, 23% Na 2 O, 20% CaO, 4% P 2 O 5 After implantation: 1 hour Release of ions increases ph and osmotic pressure (Na, Ca, P, Si) Inhibits bacterial growth on granule surface 1 day Silica gel layer forms on granule surface CaP precipitates to surface 1 week CaP crystallizes to natural HA Bonds to bone and promotes osteointegration 1 day 1 week 1 hour

3 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) BonAlive surface Collagen fibers Turku University Hospital 1 day 1 week Päijät-Häme Central Hospital Histological 20µm-thick section from the mastoid area at 3 months after obliteration with BonAlive granules (human biopsy).

4 A unique feature of BonAlive granules: Inhibits Bacterial Growth A 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: Test with pigmented P. Gingivalis Aerobic species Growth inhibition Gram negative E. coli Effective P. aeruginosa Effective K. pneumoniae Effective H. influenzae Effective Aerobic species Growth inhibition Gram positive S. epidermidis Effective S. aureus Effective E. faecalis Effective S. pneumoniae Effective Munukka et al Anaerobic species Growth inhibition C. difficile Effective B. adolescentis Effective E. lentum Effective P. gingivalis Effective P. acnes Effective P. anaerobius Effective Leppäranta et al Bacteria and HA Hydroxyapatite (HA) BonAlive Bacteria Munukka E. et al. Bactericidal effects of bioactive glasses on clinically important aerobic bacteria. Journal of Materials Science: Materials in Medicine, 2008;19: 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: Zhang D. et al. Comparison of antibacterial effect on three bioactive glasses. Key Engineering Materials, 2006; : Stoor et al. Interactions between bioactive glass and periodontal pathogens. Microbial Ecology in health and Disease,1996;9: Stoor P. et al. Interactions between the frontal sinusitis-associated pathogen Heamophilus Influenzae and the bioactive glass S53P4. Bioceramics, 1995;8: Stoor et al. 1996

5 Visual appearance of BonAlive vs CaP cement with X-ray, MRI and CT X-Ray MRI CT CaP cement 5 months post-op BonAlive 2 months post-op CaP cement 5 months post-op BonAlive 2 months post-op CaP cement 15 months post-op BonAlive 12 months post-op Helsinki University Central Hospital

6 Benign bone tumour in the proximal phalanx in a child 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. Post-op Pre-op 1 month 3 months 12 months 24 months 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. 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):

7 Large aneurysmatic bone tumor cavity in a child Patient: 16-year old male Defect size: 60 cc ( mm granules) Operation: January 2007, University Hospital of Helsinki Patient history: Cavity filled 1 st time with autograft and a 2 nd time with CaP based synthetic bone graft. In both cases the grafts had resorbed and 3 rd time BonAlive was used for the grafting. Current status: Patient fully healed due to bone growth promotion and slow resorbtion properties of BonAlive. Helsinki University Central Hospital Post-op Post-op 7 months

8 Depressed tibial plateau fracture Patient: Male (57 years), non smoker, no medication Operation: May 1998, 15 cc of mm BonAlive granules was used Results: No complications, current status excellent Post-op Post-op 1 year Post-op 11 years BonAlive has fully remodeled Turku University Hospital 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):

9 Chronic osteomyelitis in the distal tibia Patient: 36-year old male Defect size: cm (100 cc) BonAlive amount used: 48 cc ( 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 fusion is stabile and the patient outcome has been up-todate successful. Post-op 2.5 years Turku University Hospital, Finland

10 Chronic osteomyelitis in the spine 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 reconstruction. Abscess formation in L III (arrow) Helsinki University Hospital, Finland Pre-op MRI Pre-op CT 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:

11 Procedure: Posterolateral fusion (50/50 with autograft) and application of BonAlive around the anterior cage Outcome: The patient has fully healed at 2-years post-op Lateral view Anteroposterior (AP) view BonAlive BonAlive BonAlive Post-op 2-year post-op CT Post-op 2-year post-op CT Helsinki University Central Hospital, Finland

12 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: - SiO 2 53%, Na 2 O 23%, CaO 20%, P 2 O 5 4% (by weight) *non-osteoinduction 91316f/1