technique guide - atlasteb.ir head add-on system.pdf · going ablative surgery requiring the...

Condylar Head Add-on System.Adjustable system for condylar headreconstruction.

Technique Guide

Synthes 1Synthes 1

Table of Contents

Introduction

Surgical Technique

Product Information

Bibliography 24

Condylar Head Add-on System 2

AO Principles 4

Indications 5

6

Implants 15

Sets 21

WarningThis description alone does not provide sufficient background for direct use ofthe instrument set. Instruction by a surgeon experienced in handling theseinstruments is highly recommended.

Reprocessing, Care and Maintenance of Synthes InstrumentsFor general guidelines, function control and dismantling of multipart instrumentsplease refer to: www.synthes.com/reprocessing

System Overview

2 Synthes Condylar Head Add-on System Technique Guide

Condylar Head Add-on System.Adjustable system for condylar headreconstruction.

Temporary reconstruction of the mandibular condyleThe Condylar Head Add-on System is designed to providetemporary reconstruction of the mandibular condyle in patients undergoing disarticulation resection of the mandibleas part of ablative tumor surgery.

The Condylar Head Add-on is attached to a ReconstructionPlate with a fixation plate and two set screws.

Important: The Condylar Head Add-on System must only beused with the MatrixMANDIBLE Reconstruction Plates 2.5 mmor 2.8 mm thick or 2.4 UniLOCK Reconstruction Plates.

Condylar Head Add-on− Maintains temporary function of temporomandibular joint − Oval head for a large contact area− Offset in a medial direction for anatomically correct posi-

tioning of the implant − Highly polished oval head − Symmetrical design allows right or left placement

Fixation plates − Fixation plate for height-adjustment allows optimal fit of

the condylar head in the patient’s glenoid fossa− Four different positions: 0 mm to 6 mm, in 2 mm increments− Labeled to identify position height

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Used with reconstruction platesThe Condylar Head Add-on System is used with a recon-struction plate. It can be used with either of the followingsystems:– MatrixMANDIBLE – the condylar head add-on can attach

to either the 2.5 mm thick reconstruction plate or the2.8 mm thick reconstruction plate.

– 2.4 UniLOCK reconstruction plate.

Optimal fit in the patient’s glenoid fossaTo achieve optimal fit in the patient’s glenoid fossa, the system includes four fixation plates which allow height adjustment of the condylar head add-on relative to the proximal end of the reconstruction plate (from 0 mm to6 mm in 2 mm increments).

Set screws− Two screws are used to attach the condylar head add-on

and fixation plate to the reconstruction plate− The MatrixMANDIBLE screw is color-coded light blue and

has a self-holding MatrixMANDIBLE screwdriver blade recess

− The 2.4 UniLOCK screw is color-coded gray for identifica-tion and has a self-holding cruciform screwdriver blade recess


AO Principles

In 1958, the AO formulated four basic principles, which havebecome the guidelines for internal fixation.1 These principles,as applied to the Condylar Head Add-on System, are:

Anatomic reductionThe height adjustment of the condylar implant allowsrestoration of facial form and anatomic relationships, includ-ing the occlusion.

Stable fixationThe condylar implant allows stable fixation when used with aMatrixMANDIBLE Reconstruction Plates 2.5 mm or 2.8 mmthick or 2.4 UniLOCK Reconstruction Plate.

Preservation of blood supplyUse of surgical technique preserves the blood supply to softtissue and bone, minimizes disruption of soft tissue and pre-serves vascular blood flow for bone healing.

Early, active mobilizationThe Condylar Head Add-on System preserves facial form andsymmetry; permits jaw movement, chewing function andspeech; and improves quality of life.

1 Müller ME, Allgöwer M, Schneider R, and Willenegger H (1991) AO Manual ofInternal Fixation, 3rd Edition. Berlin: Springer.

Indications

The Condylar Head Add-on System is intended for temporaryreconstruction of the mandibular condyle in patients under-going ablative surgery requiring the removal of the mandibu-lar condyle.

Important: The Condylar Head Add-on System is not in-tended for use as a permanent prosthetic device,for patients with temporomandibular joint disorders (TMD),or patients with traumatic injuries to the temporomandibularjoint (TMJ).

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Surgical Technique

The following steps are additional to the technique guide forthe MatrixMANDIBLE System (Art. No. 036.000.971)and Compact 2.4 UniLOCK System (Art. No. 036.000.051).

1Determine surgical approach

If possible, place the patient in MMF to maintain the poste-rior ramus height and the occlusion.

Surgeon preference determines the surgical approach.

Note: Most disarticulation resections and condylar head/re-construction plate placements will occur with transcutaneousaccess.

2Measure ramus height

Prior to the resection, measure the patient’s ramus heightfrom the tip of the condyle to the bottom of the ramus (angle).

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3Select and cut and/or contour reconstruction plate

Select the appropriate reconstruction plate to match theplanned resection and measured ramus height.

Cut and/or contour the plate to match the patient’s anatomy.

Refer to the MatrixMANDIBLE Technique Guide or Compact2.4 UniLOCK Technique Guide for plate contouring andmandible resection.

The Condylar Head Add-on System will add between 11 mmto 17 mm of height to the vertical (ramus) end of the plate.


Surgical Technique

Technique tip: Use bending screws to prevent plate hole de-formation while contouring the plate.

Warning: After resection, the ramus height and the antero-posterior (AP) length must be maintained.

Note: It is recommended that the plate’s ramus section is cutone hole longer than anticipated to ensure proper fit.

Warning: To ensure proper fit of the Condylar Head Add-onon the reconstruction plate, the last three holes in the regionof the mandibular ramus should not be bent or restricted.

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4Position reconstruction plate

From an anterior approach, clamp the plate to the mandibleusing two plate holding forceps.

Caution: It is essential to hold and stabilize the plate usingthe plate holding forceps, as its weight can disrupt verticalposition, potentially causing an “open bite” deformity.

5Position condylar head add-on

Instruments for MatrixMANDIBLE Reconstruction Plates

03.503.070 Screwdriver Shaft MatrixMANDIBLE, short,self-holding, for Hexagonal Coupling

or 03.503.071 Screwdriver Shaft MatrixMANDIBLE,

medium, self-holding, for HexagonalCoupling

or03.503.072 Screwdriver Shaft MatrixMANDIBLE, long,

self-holding, for Hexagonal Coupling

Instrument for 2.4 UniLOCK Reconstruction Plate

314.447 Screwdriver Shaft 2.4, cruciform,self-holding, for Quick Coupling

Before securing the plate, place the patient in temporaryMMF to maintain posterior ramus height.

Place the neutral fixation plate (position 0 mm) onto the con-dylar head, and fasten to the lateral aspect of the recon-struction plate using the screwdriver blade and two setscrews.

Position the assembled condylar head add-on in the fossaensuring that there is enough room for the natural articulardisc or a soft tissue graft.


Surgical Technique

0 mm position

2 mm position

4 mm position

6 mm position

If additional ramus height is required to properly seat thecondylar head into the fossa, up to 6 mm of height can beadded by using different fixation plates (2 mm, 4 mm or6 mm).

If the ramus height is excessive, one or more holes can becut from the ramus section of the reconstruction plateand the fixation plates can be used to adjust the height ofthe condylar head.

For example, cutting one hole section (8 mm long) from thereconstruction plate, then using the 6 mm fixation plate withthe condylar head will yield a net reduction of 2 mm in ramus height.

Warning: The device should be used with a soft tissue inter-face, either the natural articular disc or a soft tissue flap, between the condylar head and the bone.

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6Secure Reconstruction Plate to distal fragment

Instruments for MatrixMANDIBLE Reconstruction Plates

03.503.044 Drill Sleeve 1.8, short, with thread, for MatrixMANDIBLE

03.503.046 Drill Sleeve 2.4, short, with thread, for MatrixMANDIBLE

03.503.070 Screwdriver Shaft MatrixMANDIBLE, short, self-holding, for Hexagonal Coupling

or 03.503.071 Screwdriver Shaft MatrixMANDIBLE,

medium, self-holding, for Hexagonal Coupling

or03.503.072 Screwdriver Shaft MatrixMANDIBLE, long,

self-holding, for Hexagonal Coupling

03.503.461 Drill Bit � 1.8 mm, length 90 mm, for J-Latch Coupling*, for 03.503.044

03.503.471 Drill Bit � 2.4 mm, length 90 mm, for J-Latch Coupling*, for 03.503.046

Instruments for 2.4 UniLOCK Reconstruction Plate

310.520 Drill Bit � 1.8 mm, length 125 mm, 2-flute, for Quick Coupling

310.540 Drill Bit � 2.4 mm, length 125 mm, 2-flute, for Quick Coupling

314.447 Screwdriver Shaft 2.4, cruciform, self-holding, for Quick Coupling

397.441 Drill Sleeve 1.8, with thread, for UniLOCK Reconstruction Plates

397.442 Drill Sleeve 2.4, with thread, for UniLOCK Reconstruction Plates


Surgical Technique

*Drill bits with mini quick coupling also available.

Before securing the plate, ensure that the patient is in tem-porary MMF.

Once the plate and the Condylar Head Add-on implant arepositioned properly, use at least four screws to secure theplate to the mandible.

For 2.4 mm screws, use the 1.8 mm drill bit and 1.8 mmthreaded drill guide. For 2.9 mm screws (or 3.0 mmwhen using 2.4 UniLOCK plates), use the 2.4 mm drill bitand 2.4 mm threaded drill guide.

Refer to the Technique Guide of MatrixMANDIBLE(Art. No. 036.000.971) / Compact 2.4 UniLOCK(Art. No. 036.000.051) for detailed plate application.

Note: In osteoporotic bone, MatrixMANDIBLE 2.9 mm LOCKscrews / UniLOCK 3.0 mm locking screws are recommended.

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Surgical Technique

7Check the fit of the condylar head in the glenoid fossa

Remove the patient from MMF and check to ensure that thecondylar head articulates properly in the fossa.

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Implants

04.449.000 Condylar Head Add-on

04.449.010 Fixation Plate for Condylar Head Add-on,Position 0 mm




04.497.000 Set Screw for Condylar Head Add-on(for use with 2.4 UniLOCK plates)

04.497.001 MatrixMANDIBLE Set Screw for CondylarHead Add-on (for use withMatrixMANDIBLE Reconstruction Plates)


Implants

The following plates can be used with the CondylarHead Add-on System

MatrixMANDIBLE Reconstruction Plates

04.503.739 MatrixMANDIBLE Reconstruction Plate,angled, left, 7+23 holes, thickness 2.5 mm, Pure Titanium

04.503.740 MatrixMANDIBLE Reconstruction Plate,angled, right, 7+23 holes, thickness 2.5 mm, Pure Titanium

04.503.741S MatrixMANDIBLE Reconstruction Plate,double-angled, small, thickness 2.5 mm,Pure Titanium, sterile

04.503.742S MatrixMANDIBLE Reconstruction Plate,double-angled, medium, thickness 2.5 mm, Pure Titanium, sterile

04.503.743S MatrixMANDIBLE Reconstruction Plate,double-angled, large, thickness 2.5 mm,Pure Titanium, sterile

04.503.772 MatrixMANDIBLE Reconstruction Plate, angled, left, 7+23 holes, thickness 2.8 mm, Pure Titanium

04.503.773 MatrixMANDIBLE Reconstruction Plate,angled, right, 7+23 holes, thickness 2.8 mm, Pure Titanium

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Implants

2.4 mm cortex, 2.4 mm and/or 2.9 mmMatrixMANDIBLE LOCK screws used to secure theMatrixMANDIBLE Reconstruction Plates to themandible

04.503.435.01C– MatrixMANDIBLE Screws � 2.4 mm,04.503.448.01C self-tapping, Titanium Alloy (TAN),04.503.435.04C– length 5 to 18 mm04.503.448.04C

04.503.638.01C– MatrixMANDIBLE LOCK Screws 04.503.648.01C � 2.4 mm, self-tapping, 04.503.638.04C– Titanium Alloy (TAN), length 8 to 18 mm04.503.648.04C

04.503.465.01C– MatrixMANDIBLE Emergency Screws 04.503.478.01C � 2.7 mm, self-tapping,

Titanium Alloy (TAN), length 5 to18 mm

04.503.668.01C– MatrixMANDIBLE LOCK Screws 04.503.678.01C � 2.9 mm, self-tapping, 04.503.668.04C– Titanium Alloy (TAN), length 8 to 18 mm04.503.678.04C

449.628 UniLOCK Reconstruction Plate 2.4, angled,right, 13+5 holes, length 110/40 mm,Pure Titanium

449.629 UniLOCK Reconstruction Plate 2.4, angled,left, 13+5 holes, length 110/40 mm,Pure Titanium

449.636 UniLOCK Reconstruction Plate 2.4,double-angled, 4+20+4 holes,length 33/162/33 mm, Pure Titanium



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2.4 UniLOCK Reconstruction Plates

449.626 UniLOCK Reconstruction Plate 2.4, angled,left, 21+6 holes, length 170/50 mm,Pure Titanium

449.627 UniLOCK Reconstruction Plate 2.4, angled,right, 21+6 holes, length 170/50 mm,Pure Titanium


2.4 mm cortex, 2.4 mm and/or 3.0 mm UniLOCK screwsused to secure the 2.4 UniLOCK Reconstruction Platesto the mandible

401.506– MF Cortex Screws � 2.4 mm, self-tapping, 401.540 Pure Titanium, gold, length 6 to 40 mm

401.558– Emergency Screws � 2.7 mm, self-tapping,401.568 Pure Titanium, blue, length 8 to 18 mm

497.668– UniLOCK Screws � 2.4 mm, self-tapping,497.682 Pure Titanium, violet, length 8 to 22 mm

497.690– UniLOCK Screws � 3.0 mm, self-tapping, 497.697 Pure Titanium, turquoise, length 8 to 22 mm

Implants

Sets

Insert for Implants for Condylar Head Add-on System,for use with MatrixMANDIBLE Reconstruction Platesand 2.4 UniLOCK Plates (61.449.000.01)

Fits in the auxiliary bin of the MatrixMANDIBLE Compact Recon (Art. No. 61.503.840) and Compact 2.4 UniLOCK(Art. No. 61.504.034).

Required sets

For 2.5 mm thick (blue) or 2.8 mm thick (gold) MatrixMANDIBLE Reconstruction Plates

01.503.831 Instrument Set for MatrixMANDIBLE Recon

01.503.834 MatrixMANDIBLE Recon Plates

01.503.836 MatrixMANDIBLE Recon Screwsor 01.503.831 Instrument Set for MatrixMANDIBLE Recon

01.503.840 MatrixMANDIBLE Compact Recon

For 2.4 UniLOCK Reconstruction Plates

01.504.034 Compact 2.4 UniLOCK

01.502.093 Standard Instruments Compact 2.4 Mandible

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Sets

Set for use with 2.4 UniLOCK Reconstruction Plates(01.449.000)

61.449.000 Module for Condylar Head Add-on System

Implants Quantity

04.449.000 Condylar head Add-on 4

04.449.010 Fixation Plate for Condylar 3Head Add-on, Position 0 mm




04.497.000 Set Screw for Condylar Head 10Add-on

449.626 UniLOCK Reconstruction 1Plate 2.4, angled, left, 21+6 holes, length 170/50 mm,Pure Titanium

449.627 UniLOCK Reconstruction 1Plate 2.4, angled, right, 21+6 holes, length 170/50 mm, Pure Titanium

Instruments Quantity

310.520 Drill Bit � 1.8 mm, 1length 125 mm, 2-flute,for Quick Coupling

310.540 Drill Bit � 2.4 mm, 1length 125 mm, 2-flute,for Quick Coupling

311.230 Tap for Cortex Screws 1� 2.4 mm,length 100/45 mm

314. 447 Screwdriver Shaft 2.4, 2cruciform, self-holding,for Quick Coupling

397.441 Drill Sleeve 1.8, with thread, 1for UniLOCK Reconstruction Plates

329.409 Bending Template, angled, 121+6 holes, for UniLOCKReconstruction Plate 2.4

497.689 Bending Screw for UniLOCK 8Reconstruction Plates, Pure Titanium

Additionally available

311.243 Tap for UniLOCK Screws 3.0 mm, length 100/45 mm

397.442 Drill Sleeve 2.4, with thread,for UniLOCK Reconstruction Plates

Additional instruments Additionally needed instruments for plate cutting and bend-ing are included in the Standard Instruments Compact 2.4Mandible set (Art. No. 01.502.093).

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Bibliography

AO/ASIF Video: Bridging of a Defect of the Mandible:UniLOCK Plate 2.4. Art. No. 21040

Carlson, E. R. (2002) Disarticulation Resections of theMandible: A Prospective Review of 16 Cases. J. Oral Maxillo-fac Surg 60:176-181

Driemel O., Buch R. S. R., Dammer R., Reicheneder C., Reichert T. E., Pistner H. (2005) Metallische Halbendoprothe-sen zum Ersatz des Kiefergelenkkopfes. Mund-, Kiefer- undGesichtschirurgie. 9 (2):71

Driemel O., Carlson, E. R., Müller-Richter U., Moralis A., Lien-hard S., Wagener S., Reichert T. E. (2007) Neu entwickeltesKiefergelenkkopfimplantat zur temporären Kondylus-Rekon-struktion in der ablativen Tumorchirurgie. J. Oral MaxillofacSurg 11 (4):193-199

Prein J., ed. (1998) Manual of Internal Fixation in the Cranio-Facial Skeleton. Berlin: Springer

Rutherford A. S., Ellis E. III (1998) Use of a Locking Recon-struction Bone Plate/Screw System for Mandibular Surgery. J.Oral Maxillofac Surg 56:1261-1265

Schmocker R. (1996) Universelle Rekonstruktionsplatte URP2.4, Swiss Dent 17, Nr. 4

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