The Science of CERAMENT

Bone remodelling - Osteoconductive

Controlled bone ingrowth


  • Hydroxyapatite forms a direct bond with osteoblasts which form new bone
  • Osteoclasts absorb calcium sulphate to increase contact between
    hydroxyapatite and the osteoblasts

 Bone remodelling - Osteoconductive scaffold

Keys to Bone Remodelling

Bone remodelling - Osteoconductive scaffold

  1. Provide a Scaffold or accepted Surface:
    • A “ladder” to support new bone growth
  2. Optimum Environment:
    • CERAMENT™ = Physiologic pH
    • Blood = pH 7.4
    • Pure CaS = more acidic*
      • Can create an inflammatory response leading to reduced wound healing and risk of serous exudate
    • Pure HA = more alkaline*
    • Directly connected to the Bioactivity of the material
  3. Micropores:
    • Controlled resorption of the CaS allows the growth of new bone into the material
      • Resorption and the rate of bone ingrowth must match each other
      • Too slow = presence of material obstructs new bone growth
      • Too fast = lack of bone ingrowth to fill the void

* When compared to CERAMENT™

 

Animal evidence Rabbit model

Cancellous Bone Defect Healing with a Novel Bi-Phasic Calcium Sulphate-Hydroxyapatite
Composite Injectable Bone Substitute; Voor MJ, Burden RL, Borden J, Nilsson M.

Poster Presentation ORS (Orthopedic Research Society) 6th to 9th March 2010 New Orleans USA.

  • Hypothesis: CERAMENT™ filled defects heal more quickly than completely empty defects, producing more bone formation
    • Serum tested for iodine content
    • Calcein injection before sacrifice
    • Histologic analyses of samples
    • µCT scanning 2D and 3D

Bone remodelling - Osteoconductive scaffold

  • Conclusions:
    • Empty defect results were as expected
    • Osteoconductive scaffold within the CERAMENT™ filled defects greatly improved the ingrowth of new bone
    • After dissolution of the calcium sulphate phase the remaining osteoconductive HA becomes surrounded by infiltrating precuror cells and new bone

Reproduced by kind permission of Dr M Voor

Animal evidence Rat model

Biomechanics and bone integration on injectable calcium sulphate and hydroyxapatite in large bone defect in rat; Wang JS, Zhang M, McCarthy I, Tanner KE, Lidgren L

Poster presentation at ORS (Orthopedic Research Society) 2006, Chicago USA

  • Conclusions:
    • Calcium Sulphate with hydroxyapatite showed new bone completely
      surrounding and embedding the HA particles once the calcium sulphate
      had been absorbed
    • The new trabeculae became thicker and denser increasing the mechanical
      strength after 3 weeks
  • Therefore better quality, thicker and denser trabeculae had formed in the
    CERAMENT™ filled defects

Bone remodelling - Osteoconductive scaffold

Clinical evidence

CERAMENT™|SPINE SUPPORT in vivo bone remodelling


  • Bone ingrowth was documented in a patient study where osteotomy was performed on the distal radius
  • CERAMENT™|BONE VOID FILLER was applied in the osteotomy wedge and the defect was fixated internally with metal fixation (Trimed™)
  • At 6 months post-op new bone had integrated with CERAMENT™ and bone remodelling in the defect site was evident

Bone remodelling - Osteoconductive scaffold

  • Histology slide from a patient included in the referenced study
    • Removal of one of the pins facilitated the bone biopsy
    • This illustration is not included within the publication

Ref: Osteotomy of Distal Radius Fracture Malunion Using a Fast Remodelling Bone Substitute Consisting of Calcium Sulphate and Calcium Phosphate; Antonio Abramo, Mats Geijer, Philippe Kopylov, Magnus Tägil. J of Biomed Materials Research (B) Nov 2009 281-286

References


  1. Biodegradation and biocompatibility of a calcium sulphate-hydroxyapatite bone substitute; Nilsson M, Wang J-S, Wielanek L, Tanner KE and Lidgren L. J Bone Joint Surg [Br] 2004; 86-B:120-125 http://web.jbjs.org.uk/cgi/reprint/86-B/1/120.pdf
  2. Biomechanics and bone integration on injectable calcium sulphate and hydroxyapatite in large bone defect in rat; Wang J-S, Zhang M, McCarthy I, Tanner KE and Lidgren L. Poster presentation at ORS, Chicago 2006.
  3. Resorption and bone ingrowth of injectable bone substitute: a comparative study in rabbit; Wang J-S, Nilsson M, McCarthy I, Tanner KE and Lidgren L. Oral presentation at EORS, Helsinki 2003
  4. Biodegradation and biocompatibility of a calcium sulphate with hydroxyapatite bone substitute; Wang J-S, Nilsson M, Wielanek L, Tanner KE and Lidgren L. Poster presentation at ORS, Tampa 2002
  5. Cancellous Bone Defect Healing with a novel Bi-Phasic Calcium Sulphate-Hydroxyapatite Composite Injectable Bone Substitute; Voor MJ, Burden RL, Borden J, Nilsson M. Poster presentation ORS New Orleans 2009
  6. Osteotomy Of Distal Radius Fracture Malunion Using a Fast Remodelling Bone Substitute Consisting of Calcium Sulphate and Calcium Phosphate; Abramo A, Geijer M, Kopylov P, Tägil M. J of Biomed Materials Research (B) Nov 2009 281-286 http://onlinelibrary.wiley.com/doi/10.1002/jbm.b.31524/abstract
  7. Animal data on file at BoneSupport
  8. Bone Healing in Vertebroplasty, H Paul Hatten. PDF poster Poster presentation Society of Interventional Radiology (SIR) 2010, Tampa USA
  9. Bioceramic vertebral augmentation with a calcium sulphate/hydroxyapatite composite (CERAMENT™|SPINES SUPPORT) in vertebral compression fractures due to osteoporosis. M Rauschmann, T Vogl, A Verheyden, R Flugmacher, T Werba, S Schmidt, J Hierholzer. Eur Spine J published online Feb 2010 http://www.springerlink.com/content/n7x28826418r1524/
  10. Metatarsal Delayed Union Management in a Diabetic Patient with CERAMENT™|BONE VOID FILLER. J C Karr. J of Diabetic Foot Complications 2010.Vol. 2 Issue 3, 65-68 http://jdfc.org/wp-content/uploads/2010/11/v2-i4-a1_Metatarsal_Delayed_Union.pdf
  11. Osteoporotic vertebral compression fractures augmentation by injectable partly resorbable ceramic bone substitute (CERAMENT™|SPINE SUPPORT): a prospective nonrandomized study. Salvatore Masala & Giovanni Nano & Stefano Marcia & Mario Muto & Francesco Paolo Maria Fucci & Giovanni Simonetti. Neuroradiology. DOI 10.1007/s00234-011-0940-5 http://www.springerlink.com/content/mw636u20r8128l6j/

Material Strength

MPa = Megapascal (1 MPa = 1 million Pascals)
GPa = Gigapascal (1 GPa = 1 billion Pascals)

Pascal = measure of force per unit area, defined as one newton per square metre

 

 Implication for patientCancellous BoneCERAMENT™
Compressive strength (MPa) Stabilisation of the fracture – pain relief 1-7* Designed to match Cancellous Bone
Stiffness (GPa) Stress shielding with risk of adjacent level fracture 0.01-0.18*

* Lumbar spine, Black J, Hastings G (eds). Handbook of Biomaterial Properties, 1998. ISBN 0412603306.

Forces acting on vertebral body

PositionPressure (MPa) 
Lying prone 0.10  
Lying laterally 0.12  
Relaxed standing 0.50  
Standing flexed forward 1.10  
Sitting unsupported 0.46  
Sitting with maximum flexion 0.83  
Nonchalant sitting 0.30  
Lifting a 20kg weight with round flexed back 2.30  
Lifting a 20kg weight with flexed knees 1.70  
Holding a 20kg weight close to the body 1.10  

Wilke et al. New in vivo measurements of pressures in the intervertebral disc in daily life, Spine 24(8): 755-762, 1999.