bone grafting

AVAILABLE IN 3 FORMS
PELLETS
Absorbable pellets for open procedure
PERCUTANEOUS DISPENSER
For minimally invasive procedure
INJECTABLE PASTE
Fully setting paste with individual pelletising kit
SYNTHETIC HIGH PURITY CaSO4
Stimulan® implant grade calcium sulphate is a synthetic biocompatible
bone graft material that completely resorbs, to be replaced by new
bone. It has a rate of resorption that corresponds with the rate of
new bone growth.
Stimulan® calcium sulphate is produced using a proprietary
synthetic process# ensuring consistent and reproducible results.
The physical and chemical properties are tightly controlled with no
traces of potentially toxic impurities, which have been associated
with naturally occurring mineral sources of calcium sulphate.
Stimulan® represents a major breakthrough in resorbable bone
graft technology. In terms of purity and consistency, it is unrivalled
by virtue of its unique and proprietary process, which has been
developed by Biocomposites’ biomaterial development team over
years of careful, in-depth research.
# International Patents Pending
BONE GRAFTING THE FUTURE
Bone grafting techniques have been widely used in orthopaedic
surgery and bone is the second most frequently transplanted
material after blood. Bone grafts are increasingly used to fill bone
cavities resulting from disease, trauma or surgery and also to fuse
joints and non-unions.
The Case for Synthetic Bone Substitutes
Autograft
Autograft availability is limited and its harvesting, usually from the iliac
crest, increases surgery time, can prolong hospital stay and very often
results in donor site morbidity.
Allograft
Galea et al stated that the source from bone banks cannot meet
the demand for the increasing incidence of revision surgery.
J Bone Joint Surgery (Br) Vol. 80-B No. 4, July 1998
Palmer et al referred to their findings of pathological lesions present
in osteoarthritic femoral heads; unknown to both the patient and
the medical staff.
J Bone Joint Surgery (Br) Vol. 81-B No. 2, March 1999
“...tissue banks vary in complexity and scope of operation and
depend on a variety of techniques in the selection of donors and
the exclusion and preparation of bone and tissue allografts...”
“...therefore it behoves orthopaedic surgeons to find out
specifically how the allografts they are about to use were excised
and prepared...”
“...irradiation clearly alters biomechanical properties of collagen,
hence bone structure, and diminishes its osteoinductive potential...”
Extracts taken from - Bone Loss in Revision Surgery: How to Manage the Femoral Side.
C.A. Engh, Sr., W.C. Head, A.G. Rosenberg, F.H. Sim
American Academy of Orthopaedic Surgeons 68th Annual Meeting, 2001.
page 2
PROFILE
TECHNICAL
Specification of Stimulan®
Characteristic
Specification
Chemical
CaSO4 2H2O
Physical
Regular pellets or injectable setting paste
Purity
100%
Comparison Table - Competitor Products
Nd
*
**
Phase analysis
Commercial
calcium sulphate
Medical/surgical
grade
Stimulan®
implant grade
CaSO4 2H2O
80-94%>
98%>
100%
CaCO3 MgCO3*
5.1%
0.5%
Nd
CaCO3
1.0%
0.3%
Nd
Aggregate**
4.5%
0.3%
Nd
Not detected
The earth mineral, dolomite
Aggregate, or “earth impurities” are present in calcium sulphate sourced from mined
gypsum rock. They are non-bioabsorbable and can include such elements as feldspar, clay and crystalline
silica (quartz)
Key advantages to the Surgeon
Controlled phase purity ensures consistent resorption
Higher chemical purity ensures total biocompatibility
The resorption rate is consistent with the formation
of new bone
Safe to use even in infected cases
Calcium sulphate
chemical form
Stimulan® product
geometry and form
Presentation to surgical site
Hemihydrate
Powder and
mixing solution
Injectable, mouldable,
setting paste
Di-hydrate
Preformed, uniform
pellets
Dispenser for percutaneous,
minimally invasive
implantation or in jars
page 3
BONE REGENERATION THE EVIDENCE
In-Vitro Studies - Stimulan®
Stimulan® Calcium Sulphate
Osteoblast
Stimulan® Calcium Sulphate
In-vitro Studies - Scanning electron micrograph showing human osteoblasts growing on
surface of Stimulan® at 21 days
In-Vivo Studies - Stimulan®
Stimulan® calcium sulphate pellets were implanted into a sheep’s
epiphyseal humerus.
Radiographic examination 6 weeks after implantation shows no
evidence of the pellets, indicating complete resorption
Trabecular bone can be clearly seen interspersed with healthy bone
marrow (Figure 1) and osteoblast activity is much in evidence (Figure 2).
Trabecular Bone
Bone Marrow
Figure 1
Trabecular bone interspersed with healthy bone marrow - sheep study
Newly formed
trabecular bone
Single cell layer of
osteoblasts on surface
of new bone - indicating
remodelling activity
Osteoblasts
Figure 2
Osteoblasts at 6 weeks in a sheep model
* Full data available on request from Biocomposites
page 4
CLINICAL EVIDENCE
SYNTHETIC HIGH PURITY CaSO4
Pellets
Absorbable pellets for open
procedure
CASE
STUDY
MA/SK090106
53 year old male sustained comminuted distal
tibial fracture
Reduction of ankle fracture fragments was achieved using Stimulan®
to maintain space and promote ingrowth of new bone
Stimulan® placed using
posterior approach with
decortication and
reconstruction of articular
surface
8 weeks post op showing
advanced resorption
with healing and callus
formation
18 months post op
showing total resorption
and advanced healing
Normal physiologic absorption of CaSO4 occurs with the
simultaneous deposition of autogenous cancellous bone
Andries S. Coetzee, Mmed (ORL) Arch Otolaryngol-Vol.106, July 1980
Calcium Sulphate is the material of choice when infection
is present or anticipated
Leonard F. Peltier, M.D. Professor of Surgery, University of Kansas Medical Centre, Kansas City,
Kansas - The Use of Plaster of Paris to Fill Defects in Bone, Clin Orthop 21-31, 1961
Indications
Spinal Fusion
Dia
3.0mm
Trauma
Pot Size/
Dosage
Dispenser/
Cannula
Catalogue Ref
5cc
600-30-005
10cc
600-30-010
10cc
600-48-010
20cc
600-48-020
Benign Cystic Lesions
Revision Surgery
Diabetic Foot
4.8mm
page 5
SYNTHETIC HIGH PURITY CaSO4
Dispenser
CLINICAL EVIDENCE
Percutaneous dispenser (1.5cc & 5cc)
for minimally invasive procedure
CASE
STUDY
MA/SK100106
10 year old male with femoral cyst
Femoral cyst below the lesser trochanter, previous treatment of the
cyst involved cortisone injections. However, the hole left by the
needle in the cortex caused the femur to fracture.
Fracture was treated with Stimulan® pellets placed percutaneously.
The patient was reviewed at 14 weeks and the X-rays show
complete resorption and new bone formation.
Femoral cyst, 10 year old male
Previous treatment failed
Intra-operative placement of
Stimulan® using dispensers
14 week follow up showing
total resporption and new
bone formation
Calcium Sulphate is an outstanding bone substitute ensuring bone
formation and gives results comparable with autogenous bone
Andries S. Coetzee, Mmed (ORL) Arch Otolaryngol-Vol.106, July 1980
Products
Stimulan® Dispensers
Stimulan® Instrument Set
Sterilisation Tray
page 6
Dia
Pot Size/
Dosage
Dispenser/
Cannula
Catalogue Ref
3.0mm
1.5cc
600-30-s1
4.8mm
5cc
600-48-s1
3mm
650-C3
4.8mm
650-C2
650-001
Cannulas instrumentation set to aid
dispenser insertion
CLINICAL EVIDENCE
SYNTHETIC HIGH PURITY CaSO4
Kit
Fully setting injectable paste
with individual pelletising kit
CASE
STUDY
MA/SK170106
80 year old male with spinal stenosis
Fusion of Lumbar vertebral interbodies (L2-L5) was achieved using
Stimulan® in combination with autograft
Post-op
Stimulan® placed in combination with
autograft
9 months post-op
Total resorption of Stimulan®. New bone
growth and fusion of Lumbar Vertebrae.
L2-L5.
An injectable and mouldable matrix which sets at body temperature
and fully resorbs to be remodelled by new bone.
Stimulan® Preparation Protocol for Syringe Injection
Step 1
Step 2
Step 3
Step 4 (i)
Step 4 (ii)
Step 1 Empty powder into a sterile mixing bowl.
Step 2 Slowly add mixing solution from both bulbs.
(If application to pellet mould with spatula is preferred, use contents of large bulb only)
Step 3 Mix thoroughly until a smooth paste is formed (approximately 30 seconds).
Step 4 (i) Backfill the syringe with the paste. Attach the extender tube if required.
(ii) The paste can then be injected into the surgical site.
Please note the kit starts to set hard 3 minutes after mixing and will become
difficult to draw through the syringe after this time.
Step 5 Allow digitally packed or injected paste to cure undisturbed for 15 minutes
after mixing prior to closure.
Pack Contents Disposable
•
•
CaSO4 • Pre-measured mixing solution bulbs • Syringe
8cm Extension Tube • Pellet Mould • Spatula
Product
Stimulan®
Kit
Dia
Pot Size/
Dosage
5cc
10cc
Dispenser/
Cannula
Catalogue Ref
600-005
600-010
page 7
BIBLIOGRAPHY
M R Urist:
Bone Transplants and Implants, In: Fundamental and Clinical Bone Physiology
(Urist M R Editor) pp 331-368, 1980
L F Peltier, D P Speer:
Calcium Sulphate. In: Bone Grafts and Bone Substitutes
(M B Habal and A H Reddi, eds) pp. 243-251, 1993
A S Coetzee:
Regeneration of Bone in the Presence of Calcium Sulphate. Arch. Otolaryngol.
106: 405-409, 1980
D Robinson, D Alk, J Sandbank, R Farber, N Halperin:
Dept. of Orthopaedics, Assaf Harofe Medical Centre, Zefferin, Israel.
Ann Transplant 1999; (3-4):91-7
L F Peltier:
The Use of Plaster of Paris to Fill Large Defects in Bone.
Am. J. Surg 97(3): 311-315,1959
I S DeWet, C Jansen:
The Use of Plaster of Paris to Fill Large Defects in Bone.
South African J. Surg. 11: 1-8, 1973
W R Walsh PhD, P Morberg MD PhD, Y Yu PhD, J L Yang PhD,
W Haggard PhD, P C Sheath MBBS, M Svehla PhD, W J M Bruce MBBS:
Response of a Calcium Sulfate Bone Graft Substitute in a Confined Cancellous
Defect. Clinical Orthopaedics and related research, 406: pp. 228-236, 2003
R Mirzayan MD, V Panossian MD, R Avedian BS, D M Forrester
MD, L R Menedez MD:
The Use of Calcium Sulfate in the Treatment of Benign Bone Lesions –
a Preliminary Report JBJS vol. 83-A No. 3 March 2001
D G Armstrong et al:
The Use of Absorbable Antibiotic-impregnated Calcium Sulphate Pellets in the
Management of Diabetic Foot Infections. Diabetics UK, Diabetics Medicine vol.
18 pp 937-943, 2001
R Strocchi et al:
Bone Regeneration with Calcium Sulphate: Evidence for Increased Angiogenesis
in Rabbits. Journal of Oral Implantology vol. 28 no. 6 pp 273-278, 2002
A G Hadjipavlou MD, J W Simmons MD, J Yang MD, C L Nicodemus PhD,
O Esch MD, D J Simmons PhD:
Plaster of Paris as an Osteoconductive Material for Interbody Vertebral Fusion in
Mature Sheep. Spine vol. 25 no. 1 pp 10-16, 2000
T A Wichelhaus et al:
Elution Charateristics of Vancomycin, Teicoplanin, Gentamycin and Clindamycin
from Calcium Sulphate Beads. Journal of Antimicrobial Chemotherapy, 2001
B Meng-Hai et al:
An Implant of a composite of Bovine Bone Morphogenetic Protein and Plaster
of Paris for Treatment of Femoral Shaft Nonunions. Int Surg,
81:pp 390-392, 1996
page 8
INTERNATIONAL
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England. ST5 5NL
Telephone: +44 (0)1782 338580
Facsimile: +44 (0)1782 338599
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Telephone: +01 910 350 8015
Facsimile: +01 910 350 8072
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