HandlingTechnique

Norian® SRS®. Tibia plateau fractures.

The answer tobone voids

1Synthes Norian SRS – Tibia plateau fractures Handling Technique

Introduction 2

System overview 3

Schedule 4

Surgical technique 6

Additional surgical procedures 9

Bibliography 10

Ordering information 12

Table of contents

Image intensifier control

WarningThis description is not sufficient for immediate application of thedevice. Instruction by a surgeon experienced in handling thisdevice is highly recommended.

2 Synthes Norian SRS – Tibia plateau fractures Handling Technique

Introduction

Description

Norian SRS (Skeletal Repair System) is an injectable, moldableand biocompatible calcium phosphate that sets at bodytemperature into carbonated apatite. It has a compressivestrength of approximately 50 MPa, which is 4–10 times greaterthan the average 5–15 MPa of cancellous bone. Norian SRSclosely resembles the mineral phase of bone and graduallyremodels to bone via osteoclastic resorption and osteoblasticnew bone formation.

Clinical applications

Norian SRS should be used in bony voids, which have beenstabilized using standard AO ASIF orthopedic techniques andimplants, i.e. external fixation, K-wires, plates and screws.These bony voids may be created surgically or result from trau-matic injury.

Clinical applications include:– Fractures of distal radius– Fractures of proximal and distal tibia– Fractures of calcaneus– Fractures of proximal and distal femur– Fractures of proximal humerus– Fractures of acetabulum– Filling of cystic lesions– Augmentation of screws

Features and benefits

AO ASIF Principle Norian SRS Design Feature Clinical Importance

Anatomic reduction Flows into bone void Fills cancellous bone between fragments of a reduced fracture

Preservation of blood supply Injectable paste, cures physiologically, Can be injected percutaneously, gradually resorbs and is replaced no harm to surrounding tissuewith bone

Stable fixation Completely hardens in the defect within 24 hours

Early mobilization Given stable fixation, the patient cando early, passive motion exercises

Forms dense crystalline structure with compressive strength 4–10times greater than cancellous bone

3

System overview

Norian SRS reactants packs for Norian Rotary Mixer

Two components are needed for mixing Norian SRS:– Calcium phosphate powder in cement packages– Sodium phosphate solution, contained in the solution syringe.

The solution is injected into the reactants pack.

Norian SRS reactants packs for Norian Rotary Mixer are availablein 3 cc, 5 cc and 10 cc sizes, with a delivery syringe integratedin the pack.

Norian Rotary Mixer

The Norian Rotary Mixer is electrically powered and is usedoutside the sterile field. Prior to starting the mixing cycle,sodium phosphate solution is manually injected into the powdercompartment of the reactants pack. When the mixing cycle be-gins, the mixer’s roller carriage operates to mix the powder andsolution to form a paste. At the end of mixing, the cementpackage is manually guided through the rollers, and the paste isinjected into the application syringe (see “Norian Rotary Mixer,Handling guide for Norian SRS” (036.000.600), p. 8).

Delivery syringe

– Integrated in the reactants pack– Provides immediate tactile feedback while injecting– Compatible with a selection of Norian needles

available in various sizes (not included)– Single use only

4 Synthes Norian SRS – Tibia plateau fractures Handling Technique

Schedule

Time and temperature properties

The handling of the Norian SRS is strongly affected by the tem-perature of the material while mixing and injecting. The follow-ing timing sequence references the specific time and tempera-ture relationships that must be followed for the material toobtain full strength. All steps have to be followed consecutively.

Note: During a long, open operation with the blood supply ar-rested for more than one hour, the extremities can easily coolbelow body temperature (37°C). This can lengthen the settingtime.

5

Mixing 70 revolutions

Mix the reactants pack using the Norian Rotary Mixer (70 revolutions).

Preparation, 3 minutes

The preparation time is 3 minutes maximum at room temperature (18–23°C).

Transfer the mixed Norian SRS paste into the delivery syringeand transfer the delivery syringe into the sterile field. Attach a Norian needle. Insert the needle into the operative site andbegin delivering the Norian SRS paste.

Implantation, 2 minutes

The implantation time is 2 minutes maximum at 37 °C.Inject the Norian SRS paste into the prepared bone void andmanipulate as necessary.

Setting, 10 minutes

The setting time at body temperature (37 °C) is 10 minutes.Restore blood flow and lightly irrigate the exposed Norian SRSwith warm saline solution, or cover the application site withwarm gauze pads.

Curing

The curing time is 24 hours at body temperature, 37 °C. Hard-ened Norian SRS reaches full compressive strength (50 MPa)within 24 hours.

Note: Do not disturb the material during the setting or curingperiod. Manipulation of the fracture or removal of K-wires em-bedded in Norian SRS must not be be done during the initial 24hours.

5 min

0 min

6 Synthes Norian SRS – Tibia plateau fractures Handling Technique

Surgical technique

The following surgical technique is shown using the exampleof a tibial plateau fracture. For other indications followthe same procedure adapting it to the individual anatomicalrequirements.

1Reduce and stabilize the fracture

The fracture should be fully reduced and stabilized and anyfixation devices put in place before injecting Norian SRS. If necessary, counteract any tensile, rotational or shear forceswhich may act on the fracture construct.

Note: In cases where the bone quality is poor, screwfixation can be improved by augmentation with Norian SRS.Please refer to page 8.

2Prepare fracture void

For the optimum filling with cement, remove blood clots and or-ganized tissue as well as loose bone fragments by rinsing andaspirating from the fracture defect.

Compact the cancellous bone around the void margins with anelevator or a similar instrument to achieve a solid foundationfor the cement.

Note: Thorough preparation of the void is essential to achieve acomplete fill as Norian SRS will not displace blood clots or bonedebris when injected.

A dry bone bed is not essential as Norian SRS will set normally inthe presence of blood.

7

4Mix Norian SRS

After the operative site has been fully prepared for injection,start mixing Norian SRS as described in the handling techniquefor Norian Rotary Mixer (art. no. 036.000.600), page 8.

5Inject Norian SRS

Slowly inject Norian SRS in a retrograde fashion and control it intwo planes under image intensifier. During injection the needletip should be just next to Norian SRS. Over-advancing the needlecan cause occlusion of the needle by bone fragments and stopthe material flow (see 036.000.600, p. 16).

Observe the 2-minute application time at body temperature. Thecement must be applied and can be manipulated within this pe-riod (see page 5).

Option: Additional application

If there is not enough material to fill the defect, anotherNorian SRS packgage can be applied after a 10-minute harden-ing phase.

3Estimating cement volume*

Preoperative planning will have approximately determinedthe size of the void. Visualize the defect and explore its marginswith a K-wire or appropriate instrument to get a 3-dimensional impression of the defect and its depth.

Tibial plateau fracture 5 to 15 ccCalcaneus fracture 8 to 12 ccRadial fracture 2 to 5 cc

*volumes are approximate

8 Synthes Norian SRS – Tibia plateau fractures Handling Technique

6Setting period

Once injection has been completed and the 2-minute implan-tation time has elapsed, the Norian SRS must remain untouchedfor 10 minutes. Any disturbances of the Norian SRS during itsinitial setting period such as manipulation of the fracture,removal of K-wires, or drilling may fracture the material. K-wiresembedded in Norian SRS should not be removed until 24 hoursafter surgery.

During this 10-minute setting period it is recommended to keepNorian SRS moist either by covering it with the patient’s softtissue or by placing a moist gauze over the implant. If a tourni-quet has been applied, it may be released at the discretion ofthe surgeon. Extravasated Norian SRS can be removed and thewound site may be closed.

9

Screw augmentation

In cases where screw augmentation is required, the screw holesmust be injected first by filling the screw hole in retrogradefashion. Insert the screws. Augment the drill holes and fill thefracture defect with a cement package during the 2-minute im-plantation period.

Treatment of intra-articular fractures

To inhibit extravasation of Norian SRS into the joint space, thegaps in the fracture construct can be sealed off by the place-ment of a small bolus of Norian SRS directly below the fractureline before filling the main void in a retrograde fashion.

Additional surgical procedures

10 Synthes Norian SRS – Tibia plateau fractures Handling Technique

Horstmann WG, Verheyen CC, Leemans R (2003) An injectablecalcium phosphate cement as a bone-graft substitute in thetreatment of displaced lateral tibial plateau fractures. Injury 3Feb; 34(2):141–4

Engel T, Lill H, Korner J, Verheyden P, Josten C (2003), Aug-mentation of tibial plateau fractures. Unfallchirurg Feb; 106(2):97–101

Keating JF, Hajducka CL, Harper J (2003) Minimal internal fixa-tion and calcium-phosphate cement in the treatment of frac-tures of the tibial plateau. A pilot study. J Bone Joint Surg Br.2003 Jan; 85(1): 68–73

Lobenhoffer P, Gerich T, Witte F, Tscherne H (2002) Use of aninjectable calcium phosphate bone cement in the treatment oftibial plateau fractures: a prospective study of twenty-six caseswith twenty-month mean follow-up. J Orthop Trauma. Mar;16(3): 143–9

Betti E, Accorsini M, Calderazzi F and Aliani M (2001) Use of amineral bone substitute in tibial plateau fractures. Key Engi-neering Materials, vol. 192–195: 1043–1048

Bibliography

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12 Synthes Norian SRS – Tibia plateau fractures Handling Technique

Delivery NeedlesSingle Pack Five Pack SRS® Delivery Needles, sterile

DLS-7083 8 gauge�10 cmDLS-7103-01 DLS-7103 10 gauge�10 cm

DLS-7121 12 gauge� 5 cmDLS-7122-01 DLS-7122 12 gauge� 7.5 cmDLS-7123-01 DLS-7123 12 gauge�10 cmDLS-7124-01 DLS-7124 12 gauge�12.5 cmDLS-7126-01 DLS-7126 12 gauge�10 cm, curved

DLS-7141 14 gauge� 5 cm

MixerMXR-US-2000 Norian® Rotary Mixer

Reactants Packs for Rotary MixerSRS-0300-RMS Norian® SRS® Reactants Pack for Norian® Rotary Mixer, 3 ccSRS-0500-RMS Norian® SRS® Reactants Pack for Norian® Rotary Mixer, 5 ccSRS-1000-RMS Norian® SRS® Reactants Pack for Norian® Rotary Mixer, 10 cc

Ordering information

036.

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612

SM_7

0746

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B71

0600

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2006

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0086Presented by:

© 2004 Norian, SRS, and Skeletal Repair System are registered trademarks of Norian Corporation.

Manufactured by: EU authorized representative:Norian Corporation Synthes GmbH1230 Wilson Drive Eimattstrasse 3West Chester, PA 19380 CH-4436 OberdorfU.S.A. Switzerland