surgical technique shoulder resurfacing of the humeral joint · CAPICA® resurfacing shoulder system 2 ... K.Sellenschloh, Prof.Dr. habil M.Morlock Ph.D.; Institut für Biomechanik,

surgical techniqueshoulder resurfacing of the

humeral joint

The CAPICA® shoulder systemwas developed in cooperation

with Prof. Dr. med. Dr. h.c. J. Jerosch,Johanna-Etienne-Krankenhaus,

Neuss.

Table of contents

DESIGN FEATURES 2 PREOPERATIVE PLANNING 4SURGICAL TECHNIQUE 5IMPLANTS 11INSTRUMENTS 12MEDICAL INFORMATION 14

Nota Bene: The described surgical technique is the suggested treatment for the uncomplicated procedure. In the fi nal analysis the preferred treatment is that which addresses the needs of the individual patient.

Copyright Information: MUTARS®, Capica®, DiaLoc®, ACS®, AJS®, Cepthar®, GIS®, DiaLoc®, EcoFit®, WinX®, CarpoFit®,LOAD SHIFT®, implavit® and implatan® are registered trademarks of implantcast GmbH. The use and copy of the content of this

brochure are only allowed with prior permit given by the implantcast GmbH.

The Capica® design is pending for patent.

CAPICA® resurfacing shoulder system

2


2

Design features

CAPICA®

neutralCAPICA®

Indications CAPICA® neutral

When a mild omarthrosis without rotator cuff defect is observed the neutral CAPICA® im-plants are used to reconstruct the articulating surface. The biomechanical circumstancesare not modifi ed or only slightly modifi ed (fi g. A; d0: distance of Tuberculum majus and Tu-berculum supraglenoidale will remain).

All CAPICA® Implants are made of implatan® Titanium alloy and are available in diametersfrom 42mm to 54mm (2mm increments).An additional design feature of the CAPICA® prosthesis is the polished inner rim of the implant.This enables the surgeon to place sutures through the bone for the refi xation of thesubscapular muscle without the risk of tearing. The ceramic coating of the articulating withTiN improves the tribological properties. To enhance the osteointegration of the CAPICA®

caps a pure titanium plasma coating is added to the bone contact surface. The primaryfi xation of the CAPICA® implants was tested and was found higher than the primary fi xa-tion of the compared prosthetic design[1]. In addition to the CAPICA® implantswith an enhanced central thickness the system includes the neutral CAPICA® implants totreat patients without rotator cuff insuffi cencies.

fi gure A

CAPICA® neutralresurfacing

omarthosis without rotator cuff

insuffi censies


3


The CAPICA® resurfacing enables the treatment of young patients with rotator cuffinsuffi ciencies (fi g. B; d1: distance between Tuberculum majus and Tuberculum supra-glenoidale is reduced), a reverse shoulder system is implanted regularly.To activate the deltoid muscle in a better way, the CAPICA® implant with the enhancedthickness will enlarge the distance between acromion and the centre of rotation ofhumeral joint. This will show the similar effect as the implantation of a reverse shoulderimplant (fi g. B; d2 and d3a). The great advantage is that the amount of bone resectionis much smaller when compared to a reverse shoulder implant. In addition the shortersurgery time and the lower intraoperative blood loss lead to faster rehabilitation afterthe resurfacing procedure. In case of revision of a resurfacing implant there are stillseveral options for treatment (i.e. arthrodesis, use of stemmed prosthesis or use ofa reverse implant). The CAPICA® effect can be enhanced with a possible valgisationof the implant (fi g. B; d3b). The special drill guide allows the adjustment of the valgusangle between 0° and 30°.

Comparative study of the primary fi xation of two different cementless humerus resurfacing implants[1] “Vergleichende Analyse zweier zementloser Schulteroberfl ächenersatzsysteme”; Dipl.Ing.K.Sellenschloh, Prof.Dr. habil M.Morlock Ph.D.; Institut für Biomechanik, Technische Universität Ham-burg-Harburg

Indikationen CAPICA®

fi gure B

3

defect arthropathy reverse shouldersystem

CAPICA®

resurfacingCAPICA® (valgus)

resurfacing


4


4

Please perform a planning on the preop-erative x-rays while using the specialCAPICA® templates (fi g. C).Note:Please consider that the A/P dimensionsof the humeral bone are bigger than M/Ldimensions, so the planning should con-sider an inlay A/P positioning of the cap inorder to prevent an M/L overhang of theimplant.

When a rotator cuff insuffi ciency is found(fi g. D ) please use the special templateand consider the implantation of theCAPICA® implant in a valgus positionPlease determine the angle while usingthe template.

Preoperative planning

fi gure C

fi gure D


5


5

Open the joint in the usual way, using thedeltopektoral or the anterosuperioral ap-proach.Choose the drill guide of the preoperativedetermined size and attach the cannulatedadapter to it. Place the instrument on thearticulating surface of the humerus (fi g. 1b).Align the drill guide parallel to the Collumanatomicum. This will lead to a angle ofabout 125-135°.Optionally you may lock the drill guideto the bone using the short fi xation pins.Therefore please use the pin inserter (fi g.2a).

For implantation of the CAPICA® implantin an outstanding valgus position, pleaseunlock the adapter, adjust the angle andlock the adapter again between 0° and 30°(fi g. 2b).It is recommended to determine the suitablevalgus angle from the preoperative x-rays.Insert the 3,2mm fi xation pin through thecannulated adapter until the mark hasreached the upper end of the sleeve as youcan see on the left (fi g. 3a and 3b).Remove the drill guide, but leave the fi xa-tion pin in the bone.

Surgical technique

fi gure 1a fi gure 1b




6


6

The fi xation pin is only 120mm long, so a cannulated machine is normally not needed. When you use the ic-adapters while reaming the fi xation pin will stop the reamer order to prevent over reaming.

Mount the surface reamer of the correct size(also refer to the colour coding of the instru-ments) to the ic-adapter and start reamingcarefully.The open design of the reamers allows tocheck the surface during reaming. Make surethat the reamer already rotates before itreaches the bone surface the fi rst time (fi g. and 4b).

When sclerotic bone is presentyou should interrupt and cleanthe reamer from time to time.

Note: With increasing reamer depth theforces during reaming are also increasing.

The open design of the reamers allow thevisual control of the bone chip removal during reaming. Please ream until the reamer has reach the collum and is stopped by the fi xation pin. While using the scale on the impactor (fig. 5a) you can double check if the reaming is deep enough. Make sure that subchondralebone is reached (fi g. 5b and 5c).

Please remove the surface reamer,but leave the fi xation pin in the bone (fi g. 5c).

Please add the core reamer to the ic-adapterand ream over the fi xation pin until the reamerstops on the surface (fi g. 6a and 6b).


fi gure 5a


fi gure 5b fi gure 5c


7


7

Remove the core reamer and the fi xationpin (fi g. 7a) by the use of the pin extractor.

The bone preparation is now fi nished andthe trial cap can be impacted (fi g. 7b).

Note: If at that point a switch to a smallersize is needed it is possible insert againthe fi xation pin stabilized by the use of theguide sleeve and use the smaller surfacereamer in the usual manner.

Screw the impactor into the trial cap andimpact the trial until it is fully seated on thebone surface.

Note: The impaction of the trial cap will fi nish the bone preparation, because the ro-tational fl anges of the stem will be prepared by the use of the trial caps. The fi nal im-plant will have additional PressFit fi xation.

Impact the trial cap carefully until it restscompletely on the surface of the bone (fi g.8a and 8b).

Unlock the impactor/extractor from the trialcap (fi g. 9a and fi g. 9b).

Check the seating through the spare holesof the trial cap and perform a trial reductionof the joint.





8


8

After succesful trial reduction you canmount the extractor to the trial cap andremove the trial (fi g. 10a and 10b).

The fi nal implant can now be implanted.The cap is guided by the entry cross of thecentral hole (fi g. 11a).

Insert suture for the fi xation of the sub-scapularis tendon into the bone beforeinserting the implant. The polished innerrim will protect the suture material fromdamage.

Use the impactor to impact the fi nal cap(fi g. 11b).

Make sure that the implant is seated fullyon the bone surface. The gap betweenbone preparation and rim of the cap shouldbe as narrow as possible (fi g. 12a and12b).

fi gure 10b

fi gure 11a

fi gure12a fi gure 12b

fi gure 11b

fi gure 10a


9


9

Postoperative Behandlung

Postoperative treatment

wound closure

Close the subscapularis muscle with absorb-able sutures.

Make sure that the rotator cuff is closed com-pletely.

The deltoid muscle should be fi xed to theacromion by the use of absorbable sutures.

postoperative treatment

Passiv mobilisation can be started 48 hourspostoperative and should be considered un-til the fi fth postoperative day.

Active mobilisation in consideration of thepain level should start from the fi fth day until 3 weeks postoperative.

The treatment of the physiotherapist shouldbe performed according to the commonregime of all prosthetic shoulder replace-ments.

1010


11


11

CAPICA® shoulder capMaterial: implatan®, TiAl6V4-forged alloy acc. to DIN ISO 5832/3 with TiN- and cpTi-coating

3900-0042 42 mm3900-0044 44 mm3900-0046 46 mm3900-0048 48 mm3900-0050 50 mm3900-0052 52 mm3900-0054 54 mm

CAPICA® shoulder cap neutralMaterial: implatan®, TiAl6V4-forged alloyacc. to DIN ISO 5832/3 with TiN- and cpTi-coating

3900-0142 42 mm3900-0144 44 mm3900-0146 46 mm3900-0148 48 mm3900-0150 50 mm3900-0152 52 mm3900-0154 54 mm

Implants


12


12

CAPICA® Instrument tray top tray7999-3900

CAPICA® Instrument tray lower tray7999-3900

CAPICA® trial cap3911-0242 42 mm3911-0244 44 mm3911-0246 46 mm3911-0248 48 mm3911-0250 50 mm3911-0252 52 mm3911-0254 54 mm

CAPICA® trial cap neutral3911-0342 42 mm3911-0344 44 mm3911-0346 46 mm3911-0348 48 mm3911-0350 50 mm3911-0352 52 mm3911-0354 54 mm

CAPICA® resurfacing reamer3911-0042 42mm3911-0044 44mm3911-0046 46mm3911-0048 48mm3911-0050 50mm3911-0052 52mm3911-0054 54mm

Instruments


13


13

CAPICA® drill guide 3911-0142 42mm3911-0144 44mm3911-0146 46mm3911-0148 48mm3911-0150 50mm3911-0152 52mm3911-0154 54mm

CAPICA® adapter for drill guide3911-0101 (2x)

ic-adapter4223-0022

ic-T-handle4223-0023

pin extractor4223-0007

pin inserter4223-0006

fi xation pins short4223-0029 (4x)

impactor/extractor for trial cap3911-0004

head impactor7512-4444

CAPICA® guide wire 3,2 x 120 mm3911-0000 (2x)

core reamer with stop3911-0001

guide sleeve for resurfacing reamer3911-0002

Instruments

14

1. MaterialsThis information concerns:CAPICA® components are made of implatan® TiAl6V4-forged alloy acc. to DIN ISO 5832/3. The gold coloured caps are coated with TiN and cpTi pure titanium coating.Product name, size, article number and LOT numberare indicated on the product label and the enclosed interior labels.We recommend to stick the interior labels onto thepatient fi le or the surgical report.

2. Introductory remarksThis prosthesis must only be implanted by personswhose skills can – due to their training, know-how and practicalexperience – guarantee for a proper use of the system.This user information can only provide some of thebasic information necessary for the use of the product. Furtherinformation is available from the manufacturer.Prior to surgery the surgeon must work out a surgicalplan comprising the dimensions of the prosthesis and the posi-tioning of the implant components in the patient’s bone. It must beassured that:• all necessary implant components are present• the corresponding instrument set is completeAn implant must never be re-used. Even if appearingundamaged, former stress could have lead to conditions whichmight cause a mechanical defect. The use of a new prosthesis ofthe respectively latest type is recommended.

3. Packaging and sterilityAll implant components are packaged separately insealed triple-peel pouches or double blister packaging. Metal components have been sterilized by gamma radiation (min. 25 kGy). All polyethylene components have been sterilized by EtO-Gas or by gamma radiation (min. 25 kGy). The individual sterliza-tion method is indicated on the product labelling. (green point for EtO). The red point on the second protective cover indicatesthe performed radiation sterilization. The outer cover is for protec-tion only.Please always take note of the expiry date, indicatedbehind the symbol . After expiry of this date the product must notbe implanted any more.

4. ResterilizationThe manufacturer only guarantees for implants whichhave been implanted directly after removal of the original packag-ing.We do not accept any reliabilities for resterilized products.The following recommendations are only provided foryour information:Implants must not be resterilized• if they are coated, partly or entirely,• if they have any kind of defect, no matter of what kindor size,• if they have been implanted before.Resterilization is to be performed by autoclave. Sterilizationquality must be secured by appropriate test procedures.immediately or after a certain period of time. Any manipulationof the implant affects its performance and must therefore beavoided.

Before implantation the implant must be checked visuallyfor possible defects. Damaged implants must not be used.The use of bone cement is subject to the operationalinstructions of the respective manufacturer.Bone cement must not get in touch with or remain onthe sensitive articular surface, neither intraoperatively nor postop-eratively.All extruded cement must be carefully removed to makesure no remains can migrate to the articular surface. This couldlead to increased wear or to severe damage and failure of singleimplant components.

4. ResterilizationThe manufacturer only guarantees for implants whichhave been implanted directly after removal of the original packag-ing.We do not accept any reliabilities for resterilized products.The following recommendations are only provided foryour information:Implants must not be resterilized• if they consist of Polyethylene or DLPLA, partly orentirely,• if they are coated, partly or entirely,• if they have any kind of defect, no matter of what kindor size,• if they have been implanted before.Resterilization is to be performed by autoclave. Sterilizationquality must be secured by appropriate test procedures.

5. Operation and storageThe implant should always be kept in its original packaging,in an adequate storing room for sterile products.Before use of the implant the packaging must bechecked for damages. The product remains sterile as long as thepackaging has not been opened or damaged and before passingthe expiry date.When removing the implant from the packaging pleasemake sure that the actual implant corresponds to the informationgiven on the label on the cover (concerning LOT no. and size).Please follow the appropriate aseptic instructions whenremoving the packaging from the implant.The implant surface is extremely sensitive. The implantsmust not get in touch with objects which may damage theirsurface.Manipulation or bending of an implant can not onlyshorten its lifetime, under stress it can also cause an implantfailure, immediately or after a certain period of time. Any manipu-lation of the implant affects its performance and must therefore beavoided.Before implantation the implant must be checked visuallyfor possible defects. Damaged implants must not be used.The use of bone cement is subject to the operationalinstructions of the respective manufacturer.Bone cement must not get in touch with or remain onthe sensitive articular surface, neither intraoperatively nor postop-eratively.All extruded cement must be carefully removed to makesure no remains can migrate to the articular surface. This couldlead to increased wear or to severe damage and failure of singleimplant components.For cementless insertion a solid fi xation during thesurgical procedure is of major importance. The optimal fi xation of the components within the prepared bone is mandatory. The porous coated implants must be implanted with press fi t in the prepared bone. This requires a precise handling and the use of special instruments.

6. CompatibilityAll components of the ACS® knee system are designedas a system and do not allow the substitution and/or combinationwith components of different systems and manufacturers.Tibial inserts (PE bearings) and tibial components canbe combined freely with each other regardless which size theyare. Patella implants without metal backing can be combined withevery femoral component.

It is only allowed to combine the femoral componentsand tibial inserts (PE bearings) of the corresponding size. This isalso mandatory when metal backed patella implants are com-bined with femoral components.

medical information

14

0123

15

7. IndicationsPrior to the decision to implant an arthroplasty theresults of all examinations must be considered thoroughly. Anarthroplasty is only indicated if the prospective success of allother conservative and surgical therapeutical alternatives is con-siderably lower than that of an arthroplasty. Careful preoperativeplanning and a precise surgical technique are necessary to obtainoptimal results.In order to minimize the danger of postoperative complicationsdifferent factors must be considered, i.e. the anatomicalstress situation, the soft tissue basis and bone quality.On the basis of the a.m. principles indications for anarthroplasty are:• severe articular destruction with considerably restrictedmobility, if other therapeutical steps are not promising.• a prospective long-life result of the planned implantationalso with respect to the patient’s weight, age and physical activity.• severe arthropathy due to degenerative and rheumatoidarthritis, articular fractures or osteonecrosis.• postoperative conditions requiring revision surgery afteroperations with or without implantation of an arthroplasty.

8. ContraindicationsThe lifetime of an endoprosthesis can be limitedbecause of biological, material-specifi c and biomechanical fac-tors.Therefore the indication of an arthroplasty must be carefullyconsidered for obese patients, in cases of extraordinary stress onthe articulation due to excessive physical activity and for anypatient below 60 years of age.Moreover, special attention must be directed to patientswith allergies to one or several component materials and to pa-tients suffering from mental illness or neurosis, which may affecttheir ability to follow the restrictions in activity.Further, the success of the operation can be affected by• acute or chronical infections• extensive bone defects or inadequate bone quality,making the implantation or a solid primary fi xation of the implantimpossible• neurogenous arthropathy• severe myopathy, neuropathy or angiopathy of therespective extremity• prospective overload or excessive forces on the implant• excessive physical activity or strain• accidental falling or other joint resultant forces• severe osteoporosis• bone tumours in the implant fi xation area• severe malformity or defective axial position• metabolic disorders/allergies• drug addiction and abuse (alcohol!)

The patient must be informed about the implant’s stresslimitations and the possible consequences resulting from the a.m.conditions with regard to the surgical success. Stress bearing ofan implant can never be the same as for a healthy physiologicalbone structure. The patient must be warned of theconsequences of excessive stress on the implant especiallybefore the end of the postoperative healing process.All information given to the patient should be documentedin writing by the surgeon.

9. ComplicationsThe complications and negative consequences listedbelow are some of the most typical and most common adverseeffects of knee surgeries:• device component loosening, distortion or fracture.These effects rarely occur and are normally caused by one or several of the mentioned loosening factors, listed above or below,• under contraindications and warnings,• acute postoperative wound infection and delayed infection,possibly leading to sepsis,• migration or subluxation of the implant resulting in reducedmobility,• increased or decreased leg length or bone wear,• bone fractures due to unilateral stress bearing,• cardiovascular disorders, e.g. thrombosis and embolism,• wound haematoma and delayed healing process,• temporary or persistent neurological disorders,• tissue reaction due to allergies or foreign body-reactionscaused by frictional particles,• myositis ossifi cans.

Please give us notice in the case of any complicationsrelated to the use of our implants and instruments.Manufacturer and distributor of the system cannot acceptany reliability for any complications or negative effects arisingfrom mistakes in indication, from improper surgical techniques,inadequate material selection or handling or from asepsis. All these effects are subject to the surgeons’s responsibility.For further information please refer to:implantcast GmbHLüneburger Schanze 26D-21614 Buxtehude, Germanyphone : +49 4161 744 0fax : +49 4161 744 200e-mail: [email protected] :www.implantcast.de

Technical modifi cations are subject to change without notice.All implants have been developed, manufactured and tested according to latest technical standards. No part of this document may be duplicated without prior consent of implantcast GmbH.

implantcast GmbHLüneburger Schanze 26D-21614 Buxtehude, GermanyTel.: +49 4161 744 0Fax +49 4161 744 200e-mail: [email protected] : www.implantcast.de

medical information

15

0123 0123

implantcast GmbHLüneburger Schanze 26

D-21614 Buxtehude Germany

phone: +49 4161 744-0 fax: +49 4161 744-200

e-mail: [email protected]: www.implantcast.de

Your local distributor is:

CA

PIC

OP

E-0

5030

9

*+E1

ICCA

PICO

PE++

**+

$$E1

IC05

0309

++*

Documents

surgical technique shoulder resurfacing of the humeral joint · CAPICA® resurfacing shoulder system 2 ... K.Sellenschloh, Prof.Dr. habil M.Morlock Ph.D.; Institut für Biomechanik,