1. FIRST CLINICAL AND RADIOLOGICAL RESULTS OF A NEW CALCIUM
VIIth BIOMATERIALS Sydney, May, 2004
FIRST CLINICAL AND RADIOLOGICAL
RESULTS OF A NEW CALCIUM
PHOSPHATE INJECTABLE CEMENT
USED AS A COMPLEMENT IN BONE
REPAIR IN 25 CASES
OF COMPACTED FRACTURES
C SCHWARTZ, Colmar D MAINARD, Nancy
FRANCE.

2. I) Physical, chemical and biological characteristics
VIIth BIOMATERIALS Sydney, May, 2004
A NEW CALCIUM PHOSPHATE CEMENT
I) Physical, chemical and
biological characteristics
C SCHWARTZ, Colmar D MAINARD, Nancy.
J AMEDEE (Bordeaux)
P FRAYSSINET (Toulouse)
A LERCH (Toulouse)

3. For us PHOSPHOCALCIUM CEMENTS are:
a new form, complementary to calcium phosphate ceramics which
- must be injectable to have a
- better fill of bone cavities
- better fit with the bone tissue
- and permit mini-invasive approaches
- setting and hardening must be possible
in vivo (in a humid environment)
with a setting time of +/- 10 mn
and some mechanical stability and strength
- idealy must be absorbable

4. According to the nature of cements,
this cement is a DCPD Cement
(DiHydrated DiCalcic Phosphate)
- magnesian calcium phosphate cements
- octocalcic phosphate cements
- apatite cements

5. Ca3(PO4)2 + H3PO4 + 6 H2O  3 CaHPO4 , 2 H2O
DCPD cement
- acid-base reaction
- mixing of a liquid phase and a solid phase
solid phase :
essentially tricalcium phosphate  (> 97%)
+ sodium pyrophosphate
liquid phase :
orthophosphoric acid 4 M
+ sulphuric acid 0,1 M
react with water DCPD
Ca3(PO4)2 + H3PO4 + 6 H2O  3 CaHPO4 , 2 H2O

6. - the setting is a very fast reaction
dissolution of TCP 
and cristallisation of DCPD
- the setting is a very fast reaction
which leads to a paste (injectability)
addition of PPNa brings a better control of setting time
addition of H2SO4 improves the mechanical properties
Powder / liquid ratio = 2

7. very sensitive to temperature
IMPORTANT +++ FOR SURGEON
Maximal injectable
time curve
Minimal injectable
time curve
Setting time
curve
Hardening
time
Waiting time
Injectable
time
Time of filling
the syringe
Mixing
time
Setting speed is
very sensitive to temperature

8. The result: Micropores # 1 m Porosity : 40 % SEM - DCPD = 55 %
< 5 m platelet-shaped grains
- remaining TCP = 45 %
particles between 2 and 50 m
Micropores # 1 m
Porosity : 40 % SEM
Impurities < 1%
Traces elements Cd, Pb, As, Hg

9. Reaction temperature = 45°C
Time (min)
Température (°C)
10.2
45 °C
14.3
Reaction temperature = 45°C
not dangerous
to cells or proteins
Exothermic reaction

10. compression strength : 37 MPa
We asked for some mechanical stability and strength
The compression
pressure resistance
was tested
Cylinder 12 x10 mm
compression strength : 37 MPa
(ambient air, not in vivo)
Young’s Modulus : 900 MPa

11. It is a acid-base reaction: acidity?
It was checked by…

12. was deposited in culture medium
1) DCPD cement
was deposited in culture medium :
pH changes of DCPD deposited in culture medium
- IMDM medium
- Dilution : 1, 5, 10, 25%
t : 30 s, 1, 5, 10, 15,
20, 60 min
- pH of medium : 7.70
- t° : 18.5°C
Time
pH remains in physiological limits

13. 2) Kinetic study : 10% DCPD cement and
50% of medium renewed at each 5 minutes and pH measurement
(to simulate buffer-effect, as we find in the human body)
pH changes kinetics of DCPD (10%) mixed with culture medium
IMDM medium
- pH of medium: 7,70
- dilution : 10 %
t : 5, 10, 15, 20,
30 and 60 mn
- t° : 18,5°C
15 mn
pH return in physiological limits in

14. After 4 to 6 days the proliferation curve resumes with the same speed.
3) Study of cytocompatibility:
cells growth on DCPD cement
MG63 bone cells
IMDM + SVF medium
- t : 1, 3, 6, 9 days at 37°C
- MTT test
After 4 to 6 days the proliferation curve resumes with the same speed.
MG63 cells proliferation on the cement
plastic
wet
DCPD
dry
Time in days

15. 9 NZ rabbits (6-7 months, 3,7-5, 1 kg)
IN VIVO STUDY
Short-term implantation effects
of a DCPD-based calcium phosphate cement
Frayssinet P and All, Biomaterials, 1998
9 NZ rabbits (6-7 months, 3,7-5, 1 kg)
DCPD : 95% -TCP : 4%
density 1,43 ; porosity 45% ; pores diameter 7m
Model: lesions 4x5 mm on femoral lateral condyle R = injected
L = control
sacrificed at 2, 6 and 18 weeks

16. At 2 weeks was noticed : coming from the adjacent bone
formation of thin bone trabeculae
coming from the adjacent bone
This bone was apposed
at the cement and
coated with osteoid
tissue lined with
osteoblasts
300
100

17. At 6 weeks were noticed : and surrounded by immature bone
The cement was fragmented,
and surrounded by
immature bone
- a gradual dissolution
of the cement
- Grains loosened from the
cement are phagocytosed  by
macrophages and giant cells
As in a foreign body reaction
250

18. Cement breakdown and bone growth
are different / phosphocalcic ceramics
- no creeping substitution
- no osteoblasts directly on cement surface
- trabeculae are formed from adjacent bone
- quick dissolution of DCPD
- bone incorporation and cell degradation
of remaining -TCP particles

19. A NEW CALCIUM PHOSPHATE CEMENT
VIIth BIOMATERIALS Sydney, May, 2004
A NEW CALCIUM PHOSPHATE CEMENT
II) Clinical aspects
C Schwartz, Colmar. D Mainard, Nancy.
C Cuny , Metz. P Laffargue, Lille.
L Obert, Besançon. P Simon,Strasbourg

20. « Instructions for use » What MUST be done!
Compacted bone
1) Reduce the fracture
BONE LOSS

22. Pour all the liquid in the bowl
EUROBONE® Kasios, FH Orthopedics
23° C
Pour all the liquid in the bowl
T = 0
Add all the powder
T = s
Mix with stirrer
Fill in the syringe
T = 1mn
Allow to stand
Inject the cement
T = 4mn - 5mn
Final setting
T = 10 mn

23. 4) Cement injection
Inject under visual control
… to prevent leaks

24. Indications Post- or non post-traumatic cancellous bone defects
As a supplement
to a conventional osteosynthesis

25. FRACTURE of the distal RADIUS
Mrs PER. 43 year-old PO
C Schwartz, Colmar

26. Mid-term result…

27. absorption seen to be species dependant
1 year follow-up
C Schwartz, Colmar
absorption seen to be species dependant
perhaps even individual dependant?

28. Tibial Plateau fracture
JUL.F. pre-operative
P Laffargue, Lille

29. post-operative

30. after 4 months
P Laffargue, Lille

31. Calcaneum fracture
Mr BEGA, 23 year-old PO
C Schwartz, Colmar

32. 6 M
After 6 M

33. Fractures of the proximal humerus
C Cuny, Metz

34. BENIGN TUMORS
Mini-invasive
P Simon, Strasbourg

35. CONCLUSION: What’s about absorption? No adverse effect in this series
+ Mechanical benefit
+ Less invasive approach
What’s about absorption?

36. Thank you for your attention