{0>Metal Ion, Radiological and Cross-Sectional Testing Protocols<}0{>Protokoller for metalion-, radiologisk og tværsnitstestning<0}

{0>Guidance for the ASR™ XL Acetabular System/DePuy ASR™ Hip Resurfacing System Recall<}0{>Retningslinjer for tilbagekaldelse af ASR™ XL Acetabular System/DePuy ASR™ Hip Resurfacing System<0}

{0>On August 24, 2010, DePuy Orthopaedics, Inc. issued a voluntary recall of all ASR products.<}0{>Den 24. august 2010 udsendte DePuy Orthopaedics, Inc. en frivillig tilbagekaldelse af alle ASR-produkter.<0} {0>Since the recall, DePuy has received inquiries from surgeons concerning how to evaluate patients who received an ASR product.<}0{>Siden tilbagekaldelsen har DePuy modtaget forespørgsler fra kirurger mht. hvordan de skal evaluere patienter, der har fået et ASR-produkt.<0} {0>This update is designed to provide information related to frequently asked questions, and should not preclude any other routine clinical evaluation or treatment.<}0{>Denne opdatering er udformet til at give information med tilknytning til de ofte stillede spørgsmål og bør ikke udelukke anden rutinemæssig klinisk evaluering eller behandling.<0}

{0>We hope this information assists you in the evaluation and treatment of your ASR patients.<}0{>Vi håber denne information hjælper Dem med at evaluere og behandle Deres ASR-patienter.<0} {0>This information is not meant to substitute for the exercise of your own medical judgment.<}0{>Denne information er ikke tænkt som erstatning for udøvelse af Deres egen medicinske vurdering.<0}

{0>Patient Follow Up<}0{>Patientopfølgning<0}

{0>In the Field Safety Notice dated 24 August 2010, DePuy provided certain guidance for the follow-up of patients.<}0{>I feltsikkerhedsmeddelelsen dateret 24. august 2010 gav DePuy visse retningslinjer for opfølgning af patienter.<0} {0>A copy of this Field Safety Notice is attached for your convenience.<}0{>En kopi af denne feltsikkerhedsmeddelelse er vedhæftet til information.<0}

{0>The following provides additional information to assist you with the implementation of this guidance.<}0{>Det efterfølgende giver yderligere information til hjælp med implementering af disse retningslinjer.<0}

{0>Whole Blood Collection Suggestions<}0{>Råd om indsamling af fuldblod<0}

{0>At the evaluation visit, if the patient is symptomatic or if you or the patient has concerns about the hip, blood metal ion testing (cobalt and chromium in whole blood) should be considered.<}0{>Hvis patienten er symptomatisk ved evalueringsbesøget, eller hvis De eller patienten har bekymring mht. hoften, bør De overveje at foretage blodmetaliontestning (cobalt og chrom i fuldblod).<0}

{0>Patients should be advised to refrain from taking mineral supplements, vitamin B-12 or vitamin B complex at least three days prior to specimen collection.<}0{>Patienterne skal rådes til at undlade at tage mineraltilskud, B12-vitamin eller B-vitaminkompleks i mindst 3 dage før prøvetagning.<0}

{0>Results may be reported in different units.<}0{>Resultaterne kan blive rapporteret i forskellige enheder.<0} {0>Please note the following are equivalent:<}0{>Bemærk at følgende har samme værdi:<0}

{0>1 ppb = 1 µg/l = 1 ng/ml<}0{>1 ppb = 1 µg/l = 1 ng/ml<0}

{0>Radiological Protocol Suggestions<}0{>Råd om radiologisk protokol<0}

1. {0>X-rays should be obtained on an annual basis or as per standard of care<}0{>Der bør tages røntgenbilleder årlig eller iht. standard omsorg.<0}

2. {0>All efforts should be in place to have consistency of positioning in each view which could be reliably used to compare with previous radiographic exams in order to assess any radiographic changes since the original procedure.<}0{>Man skal gøre alt hvad man kan, for at positioneringen er den samme på de af perspektiverne, der pålideligt kan bruges til sammenligning med tidligere radiografiske undersøgelser med henblik på at vurdere alle radiografiske forandringer siden den oprindelige procedure. <0}

3. {0>Views for plain x-rays:<}0{>Perspektiv for almindelige røntgenbilleder:<0}

a. {0>AP-Pelvis (centered at symphysis pubis)<}0{>AP-hofteskål (centreret i symphysis pubis)<0}

b. {0>AP-Hip (at hip joint center)<}0{>AP-hofte (i hofteleddets midte)<0}

c. {0>Cross table lateral<}0{>På tværs af lejet, lateralt<0}

4. {0>If using digital radiographs, it is recommended to have the image size at 1:1 to facilitate any linear dimension analysis.<}0{>Hvis der anvendes digitale radiogrammer, anbefales det at have billedstørrelsen indstillet til 1:1 for at lette evt. lineær dimensionsanalyse.<0}

5. {0>Radiographic signs of interest:<}0{>Radiografiske tegn af interesse:<0}

{0>While we encourage you to familiarize yourself with the available medical literature on the subject, our current understanding of potential radiographic signs of interest discussed in the literature is as follows:<}0{>Mens vi opfordrer Dem til at gøre Dem bekendt med tilgængelig medicinsk litteratur om emnet, er vores nuværende opfattelse af potentielle radiografiske tegn af interesse, der omtales i litteraturen, denne:<0}

· {0>Interface implant-bone demarcations<}0{>Demarkering af grænsefladen mellem implantat og knogle<0}

· {0>Periprosthetic osteolysis lesion(s)<}0{>Periprostetisk osteolyselæsion(er)<0}

· {0>Femoral neck narrowing (resurfacing)<}0{>Femurhalsindsnævring (resurfacing)<0}

· {0>Acetabulum inclination angle subtended by a horizontal reference line delineated by interobturator line tangent to inferior aspect of both obturator foramen and a line through the open face of the acetabulum.<}0{>Acetabuluminklinationsvinkel der ligger lige over for en vandret referencelinje aftegnet af intraobturatorlinjen tangent på det inferiore aspekt af begge obturatorforamen og en linje gennem acetabulums åbne flade.<0}

· {0>Hip joint center relative to vertical line through tear-drop and a horizontal reference line, i.e. intraobturator line.<}0{>Hofteleddets midtpunkt i forhold til en lodret linje gennem teardrop og en vandret referencelinje dvs. intraobturatorlinje.<0}

· {0>Acetabulum coverage (superior-lateral and inferior-medial)<}0{>Acetabulumdækning (superior-lateral og inferior-medial)<0}

· {0>Visible changes from previous radiographs<}0{>Synlige forandringer fra tidligere radiogrammer<0}

{0>Additional Cross-sectional Imaging Suggestions<}0{>Yderligere råd om tværsnitsbilleddannelse<0}


{0>Magnetic Resonance Imaging (MRI)<}0{>Magnetisk resonans scanning (MR)<0}

{0>MRIs should be ordered as MRI with metal artifact reduction sequences (MARS) to reduce the size and intensity of magnetic field distortion created by the implant<}0{>MR-scanninger bør bestilles som MR med metalartifaktreduktionssekvenser (MARS) for at reducere størrelsen og intensiteten af magnetisk feltforvrængning skabt af implantatet.<0}

{0>Patient Position<}100{>Patientleje<0}

{0>Supine, feet first<}0{>Rygleje, fødderne først<0}

{0>Position pelvis in the centre of body matrix coil (top of prosthesis at top of coil)<}0{>Anbring hofteskålen i midten af spolen til kropsmatricen (toppen af protesen ud for toppen af spolen)<0}

{0>Landmark at centre of coil<}0{>Markering i midten af spolen <0}

{0>Machine Settings<}0{>Maskinindstillinger<0}

{0>Machine settings are specific to each MRI scanner.<}0{>Maskinindstillinger er specifikke for hver MR-scanner.<0} {0>The manufacturer of the MRI scanner should be contacted to identify the appropriate settings for the metal artifact reduction sequence (MARS).<}0{>Der bør tages kontakt til producenten af MR-scanneren for at identificere de mest hensigtsmæssige indstillinger for metalartifaktreduktionssekvensen (MARS).<0} {0>The MARS order provided by the surgeon to radiology should include “MARS fast spin echo” or “MARS turbo spin echo” to reduce artifacts.<}0{>MARS-bestillingen fra kirurgen til radiologen bør omfatte “MARS fast spinekko” eller “MARS turbo spinekko” med henblik på at reducere artefakter.<0}

{0>MRI Findings<}0{>MR-resultater<0}

{0>MRI findings should be correlated with clinical examination.<}0{>MR-resultaterne bør sammenholdes med en klinisk undersøgelse.<0} {0>MRI may demonstrate changes that appear to correspond to macroscopic surgical findings (soft-tissue necrosis, abnormal masses, sterile fluid collections and bone necrosis).<}0{>MR kan påvise forandringer der synes at svare til makroskopiske kirurgiske resultater (bløddelsnekrose, abnorme masser, sterilvæskeansamlinger og knoglenekrose).<0}

{0>MRI Signs of Interest<}0{>MR-tegn af interesse<0}

{0>While we encourage you to familiarize yourself with the available medical literature on the subject, our current understanding of potential MRI signs of interest discussed in the literature is as follows:<}97{>Mens vi opfordrer Dem til at gøre Dem bekendt med tilgængelig medicinsk litteratur om emnet, er vores nuværende opfattelse af potentielle MR-tegn af interesse, der omtales i litteraturen, denne:<0}

· {0>Periprosthetic soft tissue mass with no hyperintense T2W fluid signal or fluid-filled peri-prosthetic cavity<}0{>Periprostetisk bløddelsmasse uden hyperintens T2W-væskesignal eller væskefyldt periprostetisk kavitet<0}

· {0>Peri-prosthetic soft tissue mass/fluid-filled cavity or lesions with either of following:<}0{>Periprostetisk bløddelsmasse/væskefyldt kavitet eller læsioner med en af følgende:<0}

o {0>Muscle atrophy (fatty infiltration) or edema in any muscle other than short external rotators or<}0{>Muskelatrofi (fedtinfiltration) eller ødem i andre muskler end korte eksterne rotatorer eller<0}

o {0>Bone marrow edema:<}0{>Knoglemarvsødem:<0} {0>hyperintense on short inversion recovery sequence (STIR)<}0{>hyperintens på STIR (fedt undertrykkes)<0}

o {0>Fluid-filled cavity extending through deep fascia<}0{>Væskefyldt kavitet der rækker gennem dyb fascia<0}

· {0>Tendon defect and/or avulsion, intermediate T1W soft tissue cortical or marrow signal<}0{>Senedefekt og/eller avulsion, mellemliggende T1W-bløddels kortikalt eller marvsignal<0}

{0>Fluid collections are usually well circumscribed and best seen on T2-weighted sequences.<}0{>Væskeansamlinger er som regel godt defineret og kan bedst ses på T2-vægtede sekvenser.<0} {0>Cores have signal intensities similar to that of bladder fluid, while the pseudocapsules appear hypointense to skeletal muscle and often feature areas of no signal.<}0{>Kerner har signalintensiteter der svarer til blærevæskers, samtidig med at pseudoposerne syner hypointense for skeletmuskler og ofte har områder uden signal.<0}

{0>Soft-tissue masses are more solid and best seen on a T2-weighted sequence.<}0{>Bløddelsmasser er fastere og ses bedst på en T2-vægtet sekvens.<0} {0>They may appear less circumscribed than the fluid collections and may have no obvious capsule and can characterize loss of muscle definition and tissue planes.<}0{>De syner mindre defineret end væskeansamlinger og kan mangle en klar pose samt karakterisere tab af muskeldefinering og vævsplaner.<0}

{0>Ultrasound<}0{>Ultralyd<0}

{0>Ultrasound can be used when a MARS MRI is not available.<}0{>Ultralydsscanning kan bruges når der ikke er en tilgængelig MARS MR-scanning.<0} {0>Ultrasound should be performed by staff experienced in conducting musculoskeletal ultrasound scans.<}0{>Ultralydsscanninger bør foretages af personale med erfaring i gennemførelse af muskelskeletale ultralydsscanninger.<0} {0>Ultrasound findings should be correlated with clinical examination; these may demonstrate changes that appear to correspond to macroscopic surgical findings (soft-tissue swelling, abnormal masses, fluid collections, muscle or tendon abnormalities and bone necrosis).<}0{>Ultralydresultaterne bør sammenholdes med en klinisk undersøgelse. Disse kan påvise forandringer der synes at svare til makroskopiske kirurgiske resultater (bløddelshævelse, abnorme masser, sterilvæskeansamlinger, muskel- eller seneabnormiteter og knoglenekrose)<0}

{0>Patient Position<}100{>Patientleje<0}

{0>Supine and lateral decubitus<}0{>Rygleje og sideleje<0}

{0>Probe Placement<}0{>Anbringelse af sonde<0}

{0>To obtain sagittal oblique images place probe parallel to long axis of femoral neck.<}0{>Sonden placeres parallel med femurhalsens lange akse for at tage saggitaloblikke billeder.<0}

{0>To obtain additional images, place probe anteriorly, posteriorly and directly laterally to femoral neck.<}0{>Tag yderligere billeder ved at anbringe sonden anteriort, posteriort og direkte lateralt på femurhalsen.<0}

{0>Ultrasound Findings<}0{>Ultralydresultater<0}

{0>Any abnormality needs to be examined in multiple planes.<}0{>Alle abnormiteter skal undersøges i flere planer.<0} {0>Examination includes inspection of the psoas muscle.<}0{>Undersøgelsen omfatter inspektion af psoasmuklen.<0} {0>Use probes of varying frequency depending on the size of the patient.<}0{>Brug sonder af forskellig frekvens afhængig af patientens størrelse.<0}

{0>Ultrasound Signs of Interest<}75{>Ultralydtegn af interesse<0}

{0>While we encourage you to familiarize yourself with the available medical literature on the subject, our current understanding of potential ultrasound signs of interest discussed in the literature is as follows:<}97{>Mens vi opfordrer Dem til at gøre Dem bekendt med tilgængelig medicinsk litteratur om emnet, er vores nuværende opfattelse af potentielle ultralydtegn af interesse, der omtales i litteraturen, denne:<0}

· {0>Extra-articular fluid collection<}0{>Ekstraartikulær væskeansamling<0}

· {0>Fluid collections (identified as hypoechoic areas in soft tissues)<}0{>Væskeansamling (identificeret som hypoekoiske områder i bløddele)<0}

· {0>Solid or cystic masses<}0{>Faste eller cystiske masser<0}

{0>These suggestions are based on the attached published literature references.<}0{>Disse råd er baseret på de vedhæftede, publicerede litteraturhenvisninger.<0} {0>These articles provide more information related to the MARS MRI and ultrasound techniques and the findings related to soft tissue reactions around hip replacements.<}0{>Disse artikler giver yderligere information med tilknytning til MARS MR- og ultralydmetoder samt resultater mht. bløddelsreaktioner omkring hoftealloplastikker.<0} {0>Medical practice is constantly evolving, so there may be new suggestions regarding imaging techniques in the future.<}0{>Medicinsk praksis er i konstant udvikling så der vil evt. komme nye råd mht. billeddannelsesmetoder i fremtiden.<0} {0>Any updated suggestions or guidances will be found on the DePuy website, www.DePuy.com.<}0{>Alle opdaterede råd eller retningslinjer kan findes på DePuy webstedet: www.DePuy.com.<0}

{0>If you have additional questions, please contact:<}0{>Hvis De har andre spørgsmål, bedes De kontakte:<0}

{0>Jens Krugmann, Director, Product Safety and Risk Management, +353 87 6123 872<}100{>Jens Krugmann, Director, Product Safety and Risk Management, +353 87 6123 872<0}

{0>Dirk Parwis Ghadamgahi, Manager, Customer Education, +49172 446 6209.<}0{>Dirk Parwis Ghadamgahi, Manager, Customer Education, +49172 446 6209.<0}

{0>References<}100{>Litteraturhenvisninger<0}

{0>CT and MRI of hip arthroplasty. J.G. Cahira, A.P. Toms, T.J. Marshall, J. Wimhurst, J. Nolan; Clinical Radiology, 2007; 62:1163-1171.<}0{>CT and MRI of hip arthroplasty. J.G. Cahira, A.P. Toms, T.J. Marshall, J. Wimhurst, J. Nolan; Clinical Radiology, 2007; 62:1163-1171.<0}

{0>Optimization of metal artifact reduction (MAR) sequences for MRI of total hip prostheses. A.P. Toms, C. Smith-Bateman, P.N. Malcolm, J. Cahir, M. Graves; Clinical Radiology.<}0{>Optimization of metal artifact reduction (MAR) sequences for MRI of total hip prostheses. A.P. Toms, C. Smith-Bateman, P.N. Malcolm, J. Cahir, M. Graves; Clinical Radiology.<0} 2010; 65:447–452.

{0>The imaging spectrum of peri-articular inflammatory masses following metal-on-metal hip resurfacing. Christopher. S. J. Fang, Paul Harvie, Christopher L. M. H. Gibbons, Duncan Whitwell, Nicholas A. Athanasou, Simon Ostlere; Skeletal Radiol.<}0{>The imaging spectrum of peri-articular inflammatory masses following metal-on-metal hip resurfacing. Christopher. S. J. Fang, Paul Harvie, Christopher L. M. H. Gibbons, Duncan Whitwell, Nicholas A. Athanasou, Simon Ostlere; Skeletal Radiol.<0} 2008; 37:715–722.

{0>The painful metal-on-metal hip resurfacing; A. J. Hart, S. Sabah, J. Henckel, A. Lewis, J. Cobb, B. Sampson, A. Mitchell, J. A. Skinner J Bone Joint Surg [Br] 2009;91-B:738-44.<}0{>The painful metal-on-metal hip resurfacing; A. J. Hart, S. Sabah, J. Henckel, A. Lewis, J. Cobb, B. Sampson, A. Mitchell, J. A. Skinner J Bone Joint Surg [Br] 2009;91-B:738-44.<0}

{0>“Asymptomatic” Pseudotumors After Metal-on-Metal Hip Resurfacing Arthroplasty Prevalence and Metal Ion Study; Young-Min Kwon, Simon J. Ostlere, Peter McLardy-Smith, Nicholas A. Athanasou, Harinderjit S. Gill, and David W. Murray, MD; The Journal of Arthroplasty, 2010.<}0{>“Asymptomatic” Pseudotumors After Metal-on-Metal Hip Resurfacing Arthroplasty Prevalence and Metal Ion Study; Young-Min Kwon, Simon J. Ostlere, Peter McLardy-Smith, Nicholas A. Athanasou, Harinderjit S. Gill, and David W. Murray, MD; The Journal of Arthroplasty, 2010.<0}

{0>Metal-on-metal hip resurfacings—a radiological perspective; Zhongbo Chen, Hemant Pandit, Adrian Taylor, Harinderjit Gill, David Murray, Simon Ostlere; European Society of Radiology, 2010.<}0{>Metal-on-metal hip resurfacings—a radiological perspective; Zhongbo Chen, Hemant Pandit, Adrian Taylor, Harinderjit Gill, David Murray, Simon Ostlere; European Society of Radiology, 2010.<0}

{0>Grading the severity of soft tissue changes associated with metal-on-metal hip replacements:<}0{>Grading the severity of soft tissue changes associated with metal-on-metal hip replacements:<0} {0>reliability of an MR grading system.<}0{>reliability of an MR grading system.<0} {0>Helen Anderson, Andoni Paul Toms, John G. Cahir, Richard W. Goodwin, James Wimhurst, John F. Nolan; Skeletal Radiol Published online July 2010.<}0{>Helen Anderson, Andoni Paul Toms, John G. Cahir, Richard W. Goodwin, James Wimhurst, John F. Nolan; Skeletal Radiol Published online July 2010.<0}

{0>Magnetic Resonance Imaging Findings in Painful Metal-On-Metal Hips:<}0{>Magnetic Resonance Imaging Findings in Painful Metal-On-Metal Hips:<0} {0>A Prospective Study.<}0{>A Prospective Study.<0} {0>Shiraz A. Sabah, Adam W.M. Mitchell, Johann Henckel, Ann Sandison, John A. Skinner, and Alister J. Hart, The Journal of Arthroplasty, 2010 [epub ahead of print].<}0{>Shiraz A. Sabah, Adam W.M. Mitchell, Johann Henckel, Ann Sandison, John A. Skinner, and Alister J. Hart, The Journal of Arthroplasty, 2010 [epub ahead of print].<0}

{0>Metal Artifact Reduction Sequence:<}0{>Metal Artifact Reduction Sequence:<0} {0>Early Clinical Applications.<}0{>Early Clinical Applications.<0} {0>Randall V. Olsen, Peter L. Munk, Mark J. Lee, DennisL.<}0{>Randall V. Olsen, Peter L. Munk, Mark J. Lee, DennisL.<0} {0>Janzen, Alex L. MacKay, Qing-San Xiang, Bassam Masri; RadioGraphics 2000; 20:699–712<}0{>Janzen, Alex L. MacKay, Qing-San Xiang, Bassam Masri; RadioGraphics 2000; 20:699–712<0}