Surgical Technique *smith&nephew

SchenkelhalsprotheseFracture Head and Bipolar Prosthesis

Fracture Head and Bipolar Prosthesis

Table of Contents

Introduction ........................................................................... 3Concept ................................................................................ 4Indications ............................................................................ 5Contraindications .................................................................. 5Surgical Technique ................................................................ 6Sterilization ........................................................................... 9Implants ............................................................................... 10Instrumentation .................................................................... 14

Nota BeneThe technique description herein is made available to the healthcare professional to illustrate the authors’ suggested treatment for the uncomplicated procedure. In the final analysis, the preferred treatment is that which addresses the needs of the patient.

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The purpose of any surgical procedure is to insert an implant matched to the patient’s needs using the most appropriate technique.

For the femoral neck fractures commonly suffered by elderly patients, a hemiarthroplasty represents one of the most con-servative procedures, as the prospects for rehabilitation in the elderly are greater the less stressful the operation. This applies both to intraoperative and late complications.

Fewer surgical risks are associated with a Fracture Head Prosthesis than with a total hip replacement thanks to the shorter operating time and reduced average blood loss. The Fracture Head Prosthesis supplied by Smith & Nephew Orthopaedics AG is available in CrNiMo and CoCrMo in 12 different sizes (in 2 mm increments) and two neck lengths (S and M), thus ensuring the closest possible approximation to natural conditions. The resulting improvement in load distribution helps to reduce wear in the acetabulum. The Fracture Head Prosthesis is the ideal, cost-effective solution for a femoral neck fracture.

The use of a Bipolar Prosthesis also optimally conserves the acetabulum and acetabular cartilage since the main articula-tion occurs not between the acetabulum and the prosthesis head, but between the prosthesis head and the Bipolar Prosthesis. 22 sizes in CoCrMo and CrNiMo (in 1 mm increments) allow the optimal restoration of anatomical conditions.

Introduction

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Fracture Head Prosthesis

The Fracture Head Prosthesis is available in stainless CrNiMo steel according to ISO 5832-1, or in CoCrMo according to ISO 5832-12.

Twelve sizes (38–60 mm, in 2 mm increments) and two neck lengths (S and M, difference of 5 mm) help provide effective restoration of anatomical conditions.

A highly polished metal surface minimizes friction between the implant and the acetabulum.

The standard 12/14 taper allows various options for combining with all stems supplied by Smith & Nephew Orthopaedics AG.

Bipolar Prosthesis

The Bipolar Prosthesis consists of an outer shell of stainless CrNiMo steel according to ISO 5832-1, or CoCrMo according to ISO 5832-4 and a polyethylene (UHMWPE, according to ISO 5834-2) insert and locking ring. The Bipolar Prostheses are available in 22 sizes (39–60 mm, in 1 mm increments) and can be combined with a 22 mm diameter femoral head (39–42) and with a 28 mm diameter femoral head (43–60), respectively the optimal restoration of anatomical conditions.

Up to five neck lengths (S, M, L, XL, XXL) are possible, thanks to the various combination options with femoral heads from Smith & Nephew Orthopaedics AG.

The acetabulum is conserved since the main articulation occurs between the prosthesis head and the Bipolar Prosthesis. Additionally, the highly polished metal surface minimizes friction between implant and acetabulum.

The self-centering action of the positively eccentric Bipolar Prosthesis promotes the neutral positioning of the implant.

The PE-insert is firmly anchored in the metal shell and prevents micromotion and polyethylene wear. The insert ring provides optimum protection against the risk of dislocation.

Concept

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For elderly patients whose mobility is already substantially restricted preoperatively operating time and risks can be reduced by the use of a Fracture Head or Bipolar Prosthesis.

For femoral neck fractures, moreover, a hemiarthroplasty certainly represents one of the most conservative procedures .

Contraindications

Acute or chronic infections, local or systemicSevere damage to muscles, nerves or vessels that are a risk to the affected extremityLacking bone substance or inadequate bone quality that endangers a stable seating of the prosthesis All concomitant diseases or associated disorders that may endanger or interfere with the function of the implant, such as: – Any allergies to implant materials – Renal insufficiency – Cardiac insufficiency (e.g. as a result of increased metal/ions concentration in the blood) Pregnancy

Indications

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Surgical Technique

Procedure for the Fracture Head and Bipolar Prosthesis Position the patient and expose the femoral head to produce a clear view of the fracture.

Divide the femoral neck using the oscillating saw.

Remove the head and the rest of the femoral neck.

Measure the resected femoral head.

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Subsequent Procedure for the Fracture Head Prosthesis Screw the appropriate trial head onto the handle and check the head diameter.

Remove the trial head from the handle and mount on the stem, reduce the trial.

Remove the trial head. Clean and dry the prosthesis taper.

Attach the selected Fracture Head with the correct neck length and permanently fix with a blow of a plastic hammer. If a metal ham-mer is used, a plastic coupling or the head impactor must be used to protect the head from direct contact with the hammer.

ImportantPressing the prosthetic head onto the trunnion solely by hand provides inadequate fixation. Reduce the prosthesis again and close the wound.

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Subsequent Procedure for the Bipolar Prosthesis Determine the definitive femoral head diameter with a trial head of size M. If the measurement is between two sizes, select the smaller im-plant.

The Bipolar Prosthesis is supplied in preas-sembled form, and the ring has to be removed first using the special reduction forceps. If the Bipolar Prosthesis has to be separated from the prosthesis stem, the special reduc-tion forceps are also used for removing the locking ring.

For the trial reduction, place a trial head matching a size M femoral head on the stem. If the joint fit is too tight, use a size S head. If excessive play results with neck length M, switch to neck length L. In extreme cases, a metal head with neck lengths XL or XXL may be used.

Place the locking ring over the stem neck (holes for reduction forceps on the distal side).

Mount the selected femoral head with the correct neck length and permanently fix with a blow of a plastic hammer. If a metal ham-mer is used, a plastic coupling or the head impactor must be used to protect the head from direct contact with the hammer.

ImportantPressing the prosthetic head onto the trunnion solely by hand provides inadequate fixation.

Mount the Bipolar Prosthesis on the prosthe-sis head and secure with the locking ring. Ensure that the locking engages correctly.

Reduce the prosthesis again and close the wound.

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Implants

All the implants described in this Surgical Technique are sterile when they are delivered by the manufacturer. Resterilization is not allowed.

Instruments

System components and instruments are not sterile when they are delivered. Before use they must be cleaned by the usual methods in accordance with internal hospital regulations and sterilized in an autoclave in accordance with the legal regulations and guidelines applicable in the relevant country. (For detailed information please refer to leaflet Lit. No. 1363.)

The correct settings are given in the instructions for use issued by the autoclave manufacturer. Instrument manufacturers and dealers accept no responsibility for sterilization of products by the customer.

Sterilization

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Implants

Fracture Head Prosthesis

Material Stainless Steel (CrNiMo) according to ISO 5832-1Taper 12/14

SAP No. Art. No. Size75004266 16449 38 S75004270 16459 40 S75004228 16401 42 S75004229 16402 44 S75004230 16403 46 S75004231 16404 48 S75004232 16405 50 S75004233 16406 52 S75004234 16407 54 S75004235 16408 56 S75004236 16409 58 S75004239 16410 60 S 75004268 16450 38 M75004272 16460 40 M75004254 16421 42 M75004255 16422 44 M75004256 16423 46 M75004257 16424 48 M75004258 16425 50 M75004259 16426 52 M75004260 16427 54 M75004261 16428 56 M75004262 16429 58 M75004264 16430 60 M

Please be aware that- Stainless Steel Fracture Heads should be only combined

with stainless steel stems.

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Fracture Head Prosthesis

Material Cobalt Chrome (CoCrMo) according to ISO 5832-12Taper 12/14

SAP No. Art. No. Size75004273 16469 38 S75004274 16470 40 S75004275 16471 42 S75004276 16472 44 S75004277 16473 46 S75004278 16474 48 S75004279 16475 50 S75004280 16476 52 S75004281 16477 54 S75004282 16478 56 S75004283 16479 58 S75004286 16480 60 S 75004287 16489 38 M75004288 16490 40 M75004289 16491 42 M75004290 16492 44 M75004291 16493 46 M75004292 16494 48 M75004293 16495 50 M75004294 16496 52 M75004295 16497 54 M75004296 16498 56 M75004297 16499 58 M75004300 16500 60 M

Please be aware that- CoCrMo Fracture Heads must not be combined with stainless

steel stems

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Bipolar Prosthesis

Material Stainless Steel (CrNiMo) according to ISO 5832-1/ UHMWPE according to ISO 5834-2

SAP No. Art. No. Size Ø75100912 75100912 39 22 mm 75100913 75100913 40 22 mm 75100914 75100914 41 22 mm 75100915 75100915 42 22 mm

75004360 16782 43 28 mm75004363 16783 44 28 mm75004364 16784 45 28 mm75004365 16785 46 28 mm75004366 16786 47 28 mm75004367 16787 48 28 mm75004368 16788 49 28 mm75004369 16789 50 28 mm75004370 16790 51 28 mm75004371 16791 52 28 mm75004375 16792 53 28 mm75004376 16793 54 28 mm75004377 16794 55 28 mm75004378 16795 56 28 mm75004379 16796 57 28 mm75004380 16797 58 28 mm75004381 16798 59 28 mm75004382 16799 60 28 mm

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Material Cobalt Chrome (CoCrMo) according to ISO 5832-4/ UHMWPE according to ISO 5834-2

SAP No. Art. No. Size Ø75004332 16721 39 22 mm75004333 16722 40 22 mm75004334 16723 41 22 mm75004335 16724 42 22 mm

75004339 16761 43 28 mm75004340 16762 44 28 mm75004341 16763 45 28 mm75004342 16764 46 28 mm75004343 16765 47 28 mm75004344 16766 48 28 mm75004345 16767 49 28 mm75004346 16768 50 28 mm75004347 16769 51 28 mm75004348 16770 52 28 mm75004349 16771 53 28 mm75004350 16772 54 28 mm75004351 16773 55 28 mm75004352 16774 56 28 mm75004353 16775 57 28 mm75004354 16776 58 28 mm75004355 16777 59 28 mm75004356 16778 60 28 mm

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Instruments for Fracture Head Set. Art./SAP No. and Bipolar Prosthesis 0942300/75200190

SAP No. Art. No. Size Description 75004108 160417 Trial head 38 S 75004109 160418 Trial head 40 S 75004098 160401 Trial head 42 S 75004099 160402 Trial head 44 S 75004100 160403 Trial head 46 S 75004101 160404 Trial head 48 S 75004102 160405 Trial head 50 S 75004103 160406 Trial head 52 S 75004104 160407 Trial head 54 S 75004105 160408 Trial head 56 S 75004106 160409 Trial head 58 S 75004107 160410 Trial head 60 S 75004120 160437 Trial head 38 M 75004121 160438 Trial head 40 M 75004110 160421 Trial head 42 M 75004111 160422 Trial head 44 M 75004112 160423 Trial head 46 M 75004113 160424 Trial head 48 M 75004114 160425 Trial head 50 M 75004115 160426 Trial head 52 M 75004116 160427 Trial head 54 M 75004117 160428 Trial head 56 M 75004118 160429 Trial head 58 M 75004119 160430 Trial head 60 M

75004158 160901 Handle for trial heads

Instrumentation

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Head impactor

Additional Instruments for Bipolar Prosthesis

SAP No. Art. No. Size Description 75004122 160441 Trial head 39 M 75004123 160442 Trial head 41 M 75004124 160443 Trial head 43 M 75004125 160444 Trial head 45 M 75004126 160445 Trial head 47 M 75004127 160446 Trial head 49 M 75004128 160447 Trial head 51 M 75004129 160448 Trial head 53 M 75004130 160449 Trial head 55 M 75004131 160450 Trial head 57 M 75004132 160451 Trial head 59 M 75004159 160902 Reduction forceps

Trial head Handle for trial heads Reduction forceps

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Notes

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0 1 2 3™ Trademark of Smith & Nephew Lit. No. 1166-en Ed. 11/12

Manufacturer Contact

Smith & Nephew Orthopaedics AG

Oberneuhofstrasse 10d

6340 Baar

Switzerland