cranios reinforced bone void filler

CRANIOS REINFORCED®

BONE VOID FILLERThe tougher bone cement

TECHNICAL MONOGRAPH

* Toughness is defined as a measure of a material’s resistance to fracture when stressed. Data on file with DePuy Synthes Companies, mechanical test number FRN test 132.

CRANIOS REINFORCED® Bone Void Filler is a biocompatible, self-setting calcium phosphate cement intended to fill defects in the restoration or augmentation of the cranial skeleton.

It contains reinforcing fibers that impart an increase in toughness* to reduce crack propagation during the setting process.

CRANIOS REINFORCED Bone Void Filler also incorporates a sodium hyaluronate solution to enhance viscosity, and improve handling and injection properties.

When the cement is fully cured, the composition closely approximates the mineral phase of bone. It is gradually resorbed and replaced with bone during the healing process.

CRANIOS REINFORCED Bone Void Filler contains reinforcing fibers that impart an increase in toughness* to reduce crack propagation during the setting process.

INTRODUCTION

PP DePuy Synthes Companies Name of Product Surgical Technique

1 DePuy Synthes Companies CRANIOS REINFORCED® Pone Void Filler Technical Monograph

Burr hole

Cranial defect

Temporal bone augmentation

Orbital rimSuboccipital cranioplasty

IndicationsCRANIOS REINFORCED Fast Set Putty and CRANIOS REINFORCED Rotary Mix are indicated for repairing or filling cranial defects and craniotomy cuts with a surface area no larger than 25 cm². CRANIOS REINFORCED Fast Set Putty and CRANIOS REINFORCED Rotary Mix are also indicated for the restoration or augmentation of bony contours of the cranial skeleton (including fronto-orbital areas), such as burr hole voids and other cranial defects.

Please see Directions for Use for full prescribing indications, contraindications, precautions and warnings.

CRANIOS REINFORCED BONE VOID FILLER

Contraindications CRANIOS REINFORCED Fast Set Putty and CRANIOS REINFORCED Rotary Mix are not intended for use in the spine and should not be used in the presence of active or suspected infection. CRANIOS REINFORCED Fast Set Putty and CRANIOS REINFORCED Rotary Mix are not for use in:• patients with traumatic open injuries that are predisposed to infection • stress-bearing applications, such as the temporomandibular joint• areas where adjacent bone is avascular, or is incapable of supporting or

anchoring the implant• patients with compromised health (e.g., abnormal calcium metabolism,

metabolic bone disease, a recent local untreated infection, vascular or severe neurological disease, infection, immunologic deficiencies, or systemic disorders) that result in poor wound healing or will result in tissue deterioration over the implant site

• patients who have not reached an age at which skull/facial growth is essentially complete

• defects contiguous with any of the paranasal sinuses• defects greater than 25 cm2

• CRANIOS REINFORCED is not intended for use in the spine

CRANIOS REINFORCED® Pone Void Filler Technical Monograph DePuy Synthes Companies 2

CHEMICAL PROPERTIES

Calcium Phosphate Calcium phosphate has been widely used in clinical applications for decades. There are a number of publications and clinical cases available which demonstrate its safety and effectiveness to address bone regeneration.¹,²

Sodium Hyaluronate SolutionSodium hyaluronate solution is a pH-neutral viscous solution that provides enhanced mixing and flow properties for a smooth and easy application.

Bioresorbable FibersThe bioresorbable poly(lactide co-glycolide) polymer fibers are randomly oriented and uniformly distributed in the material to impart an increase in toughness.* This incorporation of fibers into the matrix increases the material’s resistance to cracking during the setting process.


* Toughness is defined as a measure of a material’s resistance to fracture when stressed. Mechanical test data on file with DePuy Synthes Companies, mechanical test number FRN test 132. Mechanical test results may not necessarily be indicative of clinical results.


Approximation to BoneOnce CRANIOS REINFORCED Bone Void Filler is fully cured, the resulting biomaterial formed is carbonated apatite, which has a crystallographic characteristic and chemical composition similar to bone.

The carbonate content of carbonated apatite distinguishes CRANIOS REINFORCED Bone Void Filler from hydroxyapatite. Hydroxyapatite does not contain any carbonate; however the carbonate content of CRANIOS REINFORCED Bone Void Filler is 4.0–5.0%, which more closely resembles the composition of bone (Figure 1).


A COMPOSITION SIMILAR TO BONE

CRANIOS REINFORCED Bone Void Filler

CN

TS/S

EC

Bone

2 THETA

CN

TS/S

EC

2 THETA

Figure 1


CRANIOS REINFORCED Bone Void Filler

CRANIOS REINFORCED Bone Void Filler The tougher bone cement

60

50

40

30

20

10

0Norian CRSRotary Mix

MPa

CRANIOS REINFORCED Fast Set Putty

CRANIOS REINFORCED Rotary Mix

Norian® CRS®

Fast Set Putty

HydroSetTM

(Stryker®)

Compression Load Test

Performance in a Physiological EnvironmentIn order to set properly, CRANIOS REINFORCED Bone Void Filler requires a warm, wet environment which reduces the need to limit moisture at the operative site. The setting reaction of CRANIOS REINFORCED Bone Void Filler is isothermic, which does not cause thermal damage to the surrounding tissue.

Compressive StrengthAs the carbonated apatite forms, the compressive strength of the material increases. In approximately 24 hours, CRANIOS REINFORCED Bone Void Filler has achieved its full compressive strength (Figure 2).

MECHANICAL PROPERTIES

CRANIOS REINFORCED CRANIOS REINFORCED Bone3 Rotary Mix Fast Set Putty

Compressive Strength ~35MPa ~25MPa Cancellous Bone 5–7 MPa

Figure 2


9

8

7

6

5

4

3

2

1

00 0.5 1.0 1.5 2.0 2.5

Strain (mm)

Stre

ss (M

Pa)

CRANIOS REINFORCED Bone Void FillerNorian CRS Bone Void FillerHydroSet (Stryker)

Toughness* Three-point bend testing confirms CRANIOS REINFORCED Bone Void Filler to be the tougher* bone cement with an increased ability to resist cracking.

Ceramic materials are brittle in flexural loading; however, the incorporation of bioresorbable fibers into CRANIOS REINFORCED Bone Void Filler increases the material’s resistance to fracture during flexural loading when compared to calcium phosphate cements without reinforcing fibers (Figure 3).

Comparison of Material Toughness*

Figure 3 – CRANIOS REINFORCED Bone Void Filler flexes but does not fail.

FIBERS INCREASE THE MATERIAL’S RESISTANCE TO CRACKING


CRANIOS REINFORCED Bone Void Filler also displayed a high Work of Fracture, which is directly related to the toughness* of the material (Figure 4).

700

600

500

400

300

200

100

0CRANIOS REINFORCED Fast Set Putty

CRANIOS REINFORCED Rotary Mix

Norian CRSFast Set Putty

Norian CRSRotary Mix

HydroSet(Stryker)

Wo

rk o

f Fr

actu

re (

J /m

2 )

Figure 4

Work of Fracture

CRANIOS REINFORCED CRANIOS REINFORCED Bone3 Rotary Mix Fast Set Putty

Compressive Strength ~35MPa ~25MPa Cancellous Bone 5–7 MPa

* Toughness is defined as a measure of a material’s resistance to fracture when stressed. Mechanical test data on file with DePuy Synthes Companies, mechanical test number FRN test 132. Mechanical test results may not necessarily be indicative of clinical results.



Duration of Increased Toughness*

400

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100

50

00 2 4 6 8 10 12 14

Time (months)

Wor

k of

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ctur

e (J

/m )

Norian CRS Fast Set Putty


2

Figure 5

CRANIOS REINFORCED Bone Void Filler has an increased toughness* imparted by the reinforcing fibers that is sustained over a period of several months (Figure 5). When the fibers degrade, the material is equivalent in strength to the previous, Norian CRS Bone Void Filler product.

ADDITIONAL TOUGHNESS*FOR SEVERAL MONTHS

* Toughness is defined as a measure of a material’s resistance to fracture when stressed. Mechanical test data on file with DePuy Synthes Biomaterials, mechanical test number FRN test 132. Mechanical test results may not necessarily be indicative of clinical results.


Figure 6

FIBERS ARE SIGNIFICANTLY RESORBED IN 12 MONTHS

Fiber Degradation

Fiber ResorptionOver time, the reinforcing fibers begin to degrade through hydrolysis (Figure 6). The relationship between Work of Fracture and the fiber molecular weight test was determined to be directly proportional.

90,000

80,000

70,000

60,000

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00 2 4 6 8 10 12 14

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r M

olec

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ght

CRANIOS REINFORCED ROTARY Mix


EASIER TO INJECT


Injection Test–Peak Load

Figure 7

35

30

25

15

10

5

0CRANIOS REINFORCED Rotary Mix

Norian CRSRotary Mix

HydroSet(Stryker)

Peak

Loa

d (lb

f)

InjectionFor ergonomic reasons, the amount of load required to inject the material out of a syringe should be minimized. An elevated injection force may make it difficult to successfully implant the biomaterial. Each material was injected through a 12 gauge, 10 cm delivery needle (available through DePuy Synthes Companies) during the material’s working time. The results of the injection test showed the amount of force required to inject both CRANIOS REINFORCED Rotary Mix and Norian CRS Rotary Mix to be comparable. While, in contrast, HydroSet (Stryker) required more than twice the injection force to inject (Figure 7).


CRANIOS REINFORCED Fast Set Putty, sterile

615.03.01S 3 cc

615.05.01S 5 cc

615.10.01S 10 cc

CRANIOS REINFORCED Rotary Mix, sterile

616.03.01S 3 cc

616.05.01S 5 cc

616.10.01S 10 cc

Delivery Needles, sterile

612.40.01S 8 gauge x 10 cm, 1/pkg.

612.41.01S 10 gauge x 10 cm, 1/pkg.

612.41.05S 10 gauge x 10 cm, 5/pkg.

612.42.01S 12 gauge x 10 cm, 1/pkg.

PRODUCT INFORMATION

MXR-US-2000 Rotary Mixer


1. Cassidy C, Jupiter JB, Cohen M, Delli-Santi M, Fennell C, Leinberry C, et al. Norian SRS cement compared with conventional fixation in distal radial fractures. A randomized study. J Bone Joint Surg Am. 2003 Nov;85-A:2127–2137.

2. Chang BS, Lee CK, Hong KS, Youn HJ, Ryu HS, Chung SS, et al. Osteoconduction at porous hydroxyapatite with various pore configurations. Biomaterials. 2000;21:1291–1298.

3. Cowin, SC, ed. Bone Mechanics Handbook, 2nd ed. New York, NY: RC Press, 2001.

REFERENCES


© DePuy Synthes 2015. All rights reserved.Norian and SRS are trademarks of DSM Biomedical or its affiliates. Stryker Orthopaedics and HydroSet are trademarks of Stryker Corp. or its affiliates. DSUS/MOC/1214/0186 12/15 DV

Limited Warranty and Disclaimer: DePuy Synthes Biomaterials products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed.

WARNING: In the USA, this product has labeling limitations. See package insert for complete information.

CAUTION: USA Law restricts these devices to sale by or on the order of a physician.

Not all products are currently available in all markets.

Manufactured by (United States):

Synthes USA Products, LLC1302 Wrights Lane EastWest Chester, PA 19380 Telephone: (610) 719-5000 To order: (800) 523-0322Fax: (610) 251-9056

www.depuysynthes.com

cranios reinforced bone void filler

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