Total Hip Arthroplasty Modular Neck Failure

Skendzel, Jack G.; Blaha, John; Urquhart, Andrew G.

doi:10.1016/j.arth.2010.03.011

Cited by 119 publications

(105 citation statements)

References 21 publications

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“…However, failures of these components have been reported [2,7,15,27,28,30,31]; thus long-term survivorship of and complications associated with bimodular femoral neck components must be assessed to determine if the benefits outweigh the risks of failure. In our retrospective study, we evaluated a series of bimodular femoral neck implants used for primary THA to determine survivorship, main causes of failure, and the risk factors associated with them.…”

Section: Discussionmentioning

confidence: 99%

“…Failures of bimodular necks have been reported, including bimodular neck fracture and corrosion with pseudotumor and periprosthetic loosening [2,7,15,27,28,30,31]. Mechanical analyses have suggested that corrosion-assisted fatigue is an important mechanism of failure, and design choices in metallurgy, offset, caput-column diaphysis angle, and mechanical stresses of physical activity are factors contributing to corrosion [7,11,16,33].…”

Section: Introductionmentioning

confidence: 99%

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High Risk of Failure With Bimodular Femoral Components in THA

Pour

Borden

Murayama

et al. 2016

Clinical Orthopaedics &Amp; Related Research

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Background The bimodular femoral neck implant (modularity in the neck section and prosthetic head) offers several implant advantages to the surgeon performing THAs, however, there have been reports of failure of bimodular femoral implants involving neck fractures or adverse tissue reaction to metal debris. We aimed to assess the results of the bimodular implants used in the THAs we performed. Questions/purposes We asked: (1) What is the survivorship of the PROFEMUR 1 bimodular femoral neck stems? (2) What are the modes of failure of this bimodular femoral neck implant? (3) What are the major risk factors for the major modes of failure of this device?Methods Between 2003 and 2009, we used one family of bimodular femoral neck stems for all primary THAs (PRO-FEMUR 1 Z and PROFEMUR 1 E). During this period, 277 THAs (in 242 patients) were performed with these implants. One hundred seventy were done with the bimodular PROFE-MUR 1 E (all are accounted for here), and when that implant was suspected of having a high risk of failure, the bimodular PROFEMUR 1 Z was used instead. One hundred seven THAs were performed using this implant (all are accounted for in this study). All bearing combinations, including metal-on-metal, metal-on-polyethylene, and ceramic-on-ceramic, are included here. Data for the cohort included patient demographics, BMI, implant dimensions, type of articular surface, length of followup, and C-reactive protein serum level. We assessed survivorship of the two stems using Kaplan-Meier curves and determined the frequency of the different modes of stem failure. For each of the major modes of failure, we performed binary logistic regression to identify associated risk factors. Results Survivorship of the stems, using aseptic revision as the endpoint, was 85% for the patients with the PROFE-MUR 1 E stems with a mean followup of 50 months (range, 1-125 months) and 85% for the PROFEMUR 1 Z with a mean followup of 50 months (range, 1-125 months)(95% CI, 74-87 months). The most common modes of failure were loosening (9% for the PROFEMUR 1 E), neck fracture (6% for the PROFEMUR 1 Z and 0.6% for the PROFEMUR 1 E), metallosis (1%), and periprosthetic fracture (1%). Only the bimodular PROFEMUR 1 E was associated with femoral stem loosening (odds ratio [OR] =1.1; 95% CI, 1.04-1.140; p = 0.032). Larger head (OR = 3.2; 95% CI, 0.7-14; p = 0.096), BMI (OR = 1.19; 95% CI, 1-1.4; p = 0.038) and total offset (OR = 1.83; 95% CI, 1.13-2.9; p = 0.039) were associated with neck fracture.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

High Risk of Failure With Bimodular Femoral Components in THA

Pour

Borden

Murayama

et al. 2016

Clinical Orthopaedics &Amp; Related Research

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“…Skupno smo našli 9 člankov, ki opisujejo zlom izmenljivega vratu (6,7,(11)(12)(13)(14)(15)(16)(17). Prvih osem člankov opisuje zlome pri 13 bolnikih (11 bolnikov pri modelu Profemur Z in 2 bolnika pri modelu GSP), ki jih zbirno prikazujemo v Tabeli 1.…”

Section: Rezultati Pregled Literatureunclassified

“…Poleg tega na zlom pospeše-valno vpliva tudi višji navor, zato je do večine zlomov prišlo v primerih, ko je bil uporabljen dolgi vrat. Upogibni moment na stiku dolgega vratu in proteze je za 32 % višji kot pri kratkih vratovih (14). Kombinacija 30 % višje telesne mase pri bolnici z vstavljenim dalgim izmenljivim vratom je v študiji, objavljeni leta 2016, povzročila 2,45-krat večjo obremenitev izmenljivega vratu na mestu, kjer je le--ta zagozden v deblo endoproteze, v primerjavi z bolnikom z vstavljenim kratkim izmenljivim vratom (24).…”

Section: Razpravljanjeunclassified

Inovacijska past: izmenljivi vrat totalne kolčne endoproteze

Fokter¹,

Levašič

Kovač

2017

SlovMedJour

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IzvlečekIzhodišča: Inovacije so ključnega pomena za uspešnost ortopedske kirurgije. Žal lahko včasih že majhne spremembe v sicer ustaljenih kirurških postopkih in preizkušenih oblikah vsadkov vodijo v katastrofo. Zdi se, da nas razsežnost zlomov izmenljivih vratov (24 od okoli 4.000 vgrajenih) pri popolnoma modularni artroplastiki kolka, priljubljeni v naši deželi v zadnjih 20 letih, preizkuša v takšnih nesrečnih posledicah. Namen prispevka je analizirati obseg in vzroke problema ter predlagati možne rešitve.Metode: Zaradi težav z modelom kolčne endoproteze z izmenljivim vratom Profemur Z (ali zgodnejših različic z enako izvedbo samozapornega konusa), izdelane iz titanove zlitine (Ti6Al4V), smo iskali zapise o tem v ustrezni strokovni literaturi. Za natančno ovrednotenje uspešnosti tega tipa debla endoproteze smo pregledali registre artroplastike. Pozornost smo namenili tudi proučevanju mehanizmov zlomov modularnega vratu navedenega kolčnega vsadka.Rezultati: Posamezna poročila o katastrofalnih zlomih izmenljivih vratov kolčnih endoprotez Profemur Z so bila objavljena od leta 2010 dalje. Prvi slovenski primer je bil opisan v letu 2012. Dve večji skupini bolnikov z zlomi izmenljivih vratov sta bili objavljeni v letu 2016. Pogostejšo pojavnost revizijskih operacij zaradi zlomov obravnavanega pripomočka za rekonstrukcijo kolka je leta 2013 zaznal Avstralski register artroplastike. Javna agencija za zdravila in medicinske pripomočke (JAZMP) je prvi dve poročili o zapletu z izmenljivim vratom Profemur Z iz tujine prejela v letu 2010, prvo slovensko poročilo v letu 2012, skupno pa so do decembra 2016 prejeli 7 poročil iz slovenskih bolnišnic. Odgovornost za nesprejemljivo visoko pojavnost zlomov pripomočka pripisujemo koroziji na stiku izmenljivega vratu z deblom endoproteze, ki je posledica kombinacije dveh enakih ali različnih materialov, podvrženih nenehni obrabi ob prisotnosti telesne tekočine.Zaključki: Odgovornost za izdelavo in trženje izključno varnih izdelkov je na strani proizvajalcev, zdravniki pa moramo biti posebej pozorni na morebitne neželene učinke uvedenih novosti. JAZMP je ustrezno ukrepala šele po prejetju obvestila o odpoklicu medicinskega pripomočka -izmenljivega vratu dolge izvedbe iz kobalt-kromove zlitine s strani proizvajalca v letu 2015, saj zaradi neporočanja o vigilančnih zapletih v Republiki Sloveniji ni bila v celoti seznanjena z razsežnostjo zapleta. Nacionalni register artroplastike bi ortopedsko skupnost najverjetneje lahko prej opozoril na slabe rezultate obravnavane vprašljive inovacije. Vse deležnike zato s člankom pozivamo, da čimprej omogočijo vzpostavitev takšnega registra v dobrobit naših bolnikov. AbstractBackground: Innovations play the key role in the success of orthopaedic surgery. However, even minor modifications in the established concepts and proven designs may result in disasters. The endemic of modular femoral neck fracture (24 cases of about 4000 implanted) in fully modular total hip arthroplasty, popular in our country for the last 20 years, seems to challenge us wit...

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“…There have been several case reports describing modular neck fractures with the subject stem [13][14][15][16][17][18]. In each report, the patient was a large man with a mean weight and body mass index (BMI) of 111.1 kg and 31.5 kg/m 2 , respectively.…”

Section: Modular Neck Fracturesmentioning

confidence: 99%

Long-term survivorship and complication rate comparison of a cementless modular stem and cementless fixed neck stems for primary total hip replacement

Fitch¹,

Ancarani

Bordini

2015

International Orthopaedics (SICOT)

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Purpose Modular necks used in total hip replacement (THR) have become an increasingly discussed topic with the recent recall of multiple modular systems, but it is anticipated that outcomes for these devices are highly design-specific. The objectives of this study were to determine if the survivorship and complication rates of a specific modular femoral stem (PROFEMUR® Z, MicroPort Orthopedics Inc., Arlington, TN, USA) were significantly lower than those of all cementless fixed neck stems in an arthroplasty registry. Methods The database of an arthroplasty registry was searched for all patients implanted with a specific modular stem and all those implanted with cementless fixed neck stems. Kaplan-Meier survivorship and complication rates were compared between the two groups. Results The 12-year survivorship of the modular stem (95.8 %) was not significantly less than that of all cementless fixed neck stems (96.1 %). There was also no difference in revision rates for dislocation, periprosthetic fractures, aseptic loosening or septic loosening between the two groups. Conclusions The use of the specific modular stem did not adversely affect long-term component survivorship or complication rates when compared to all cementless fixed neck THRs in an arthroplasty registry.

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Total Hip Arthroplasty Modular Neck Failure

Cited by 119 publications

References 21 publications

High Risk of Failure With Bimodular Femoral Components in THA

High Risk of Failure With Bimodular Femoral Components in THA

Inovacijska past: izmenljivi vrat totalne kolčne endoproteze

Long-term survivorship and complication rate comparison of a cementless modular stem and cementless fixed neck stems for primary total hip replacement

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