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1 e4(1) the Orthopaeic forum Risk Stratification Algorithm for Management of Patients with Metal-on-Metal Hip Arthroplasty Consensus Statement of the American Association of Hip an Knee Surgeons, the American Acaemy of Orthopaeic Surgeons, an The Hip Society Young-Min Kwon, MD, PhD, Aolph V. Lombari, MD, FACS, Joshua J. Jacobs, MD, Thomas K. Fehring, MD, Courtlan G. Lewis, MD, an Miguel E. Cabanela, MD Peer Review: This article was reviewe by the Eitor-in-Chief an one Deputy Eitor, an it unerwent bline review by two or more outsie experts. The Deputy Eitor reviewe each revision of the article, an it unerwent a final review by the Eitor-in-Chief prior to publication. Final corrections an clarifications occurre uring one or more exchanges between the author(s) an copyeitors. Metal-on-metal (MoM) bearings were reintrouce over the last two ecaes because of their lower volumetric wear rates in comparison to conventional metal-on-polyethylene bearings 1. This has the potential to substantially reuce wear-inuce osteolysis as the major cause of failure. Other propose avantages of MoM hip arthroplasty inclue greater implant stability ue to use of large-iameter femoral components, an bone conservation (for hip resurfacings). It has been estimate that since 1996 more than 1,000,000 MoM articular couples have been implante worlwie 2.However,withincreasingclinicalexperience, the national joint registries have recently reporte the failure rate of total hip arthroplasty (THA) with MoM bearings to be two to threefol higher than contemporary THA with nonmetal-on-metal bearings 3,4. Moreover, averse periprosthetic tissue reactions involving the hip joint have emerge as an importantreasonforfailureinmompatients. The information provie in this consensus paper is intene as an ai to the orthopaeic surgeon in the assessment an management of patients with MoM bearings. It is recognize that each patient may have specific circumstances or features that may require iniviualize approaches, an this ocument is not intene to be proscriptive in any fashion. In aition, it is recognize that there is insufficient high-quality evience in this area to evelop a formal guieline for optimal management of patients with MoM THA base on a systematic review of the literature. Thus, a ocument base on a consensus of experience practitioners is in orer given the state of the publishe literature. Averse Local Tissue Reaction Risk Stratification Algorithm for Evaluating Patients with Metal-on-Metal Hip Arthroplasty A painful MoM hip arthroplasty has various intrinsic an extrinsic causes (Table I). As with all painful THAs 5, a thorough clinical history, a etaile physical examination, as well as raiographic an laboratory tests are essential to elineate potential Disclosure: None of the authors receive payments or services, either irectly or inirectly (i.e., via his or her institution), from a thir party in support of any aspect of this work. One or more of the authors, or his or her institution, has ha a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomeical arena that coul be perceive to influence or have the potential to influence what is written in this work. No author has ha any other relationships, or has engage in any other activities, that coul be perceive to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitte by authors are always provie with the online version of the article. This article is a moifie version of Information Statement 1035 Current Concerns with Metal-on-Metal Hip Arthroplasty, publishe in December 2012 an available at Publishe with permission from the American Acaemy of Orthopaeic Surgeons. J Bone Joint Surg Am. 2014;96:e4(1-6)

2 e4(2) TABLE I Differential Diagnosis for the Painful MoM Hip Arthroplasty Extrinsic to the hip Spine isease: stenosis; isc herniation; sponylolysis or sponylolisthesis Peripheral vascular isease Hernia (femoral, inguinal) Peripheral nerve injury (e.g., sciatic, femoral, meralgia paresthetica) Malignancy or metastases Metabolic bone isease (e.g., Paget s isease, osteomalacia) Complex regional pain synrome Psychological isorer Intrinsic to the hip Intracapsular/implant-relate: Infection Loosening Instability/subluxation Periprosthetic fracture Averse soft-tissue reaction Extracapsular: Trochanteric bursitis Iliopsoas tenonitis Rectus femoris tenonitis cause(s) of pain in patients with MoM hip arthroplasty 6.A systematic risk stratification recommenation for multiple moes of failure, incluing averse local tissue reactions, base on the currently available evience, is presente here to optimize management (Tables II, III, an IV). The algorithm presente in this review will continue to evelop as further evience becomes available. For patients who have a stemme total hip or surface replacement evice that has been recalle by the manufacturer, this risk stratification scheme still applies. In aition, the surgeon shoul inform patients about the recall, an irect them to information from the manufacturer (on their website) regaring the recall an suggeste follow-up. Clinical Evaluation A complete history is essential to evaluate patients with MoM hip arthroplasty. The temporal onset, uration, severity, location, an character of the pain help narrow the ifferential iagnosis. A history of elaye woun healing an pain after ental or gastrointestinal proceures all hint of possible periprosthetic joint infection. Other symptoms such as a feeling of swelling or fullness about the hip, an mechanical symptoms of crepitus, clicking, clunking, or squeaking shoul be elicite. A clinical history of metal allergy manifeste as a ermal reaction to metal jewelry may also be helpful in assessing potential hypersensitivity reactions as positive lymphocyte transformation tests to nickel have been reporte in MoM hip arthroplasty patients with a clinical history of metal allergy 7. Furthermore, a thorough review of systems shoul be note for any potential systemic symptoms as case reports of neurological an cariac ysfunction have been reporte in the literature 8. Comprehensive neurovascular examination is necessary to rule out neurogenic an vascular causes of pain. Inspection of the skin shoul note previous scars an signs of infection. Careful palpation shoul be performe aroun the hip to etect any soft-tissue masses. Range of motion shoul be examine to etermine the positions that may elicit the patient s pain, clunking, or catching as reprouction of pain on active hip flexion an passive hip extension may suggest iliopsoas teninitis. Abuction strength must be assesse as loss of strength may suggest averse muscle involvement. TABLE II MoM Low Risk Group Low Risk Group Stratification Patient factors Symptoms Clinical examination Implant type Raiographs (2 views ± serial for comparison when available) Infection work-up (ESR, CRP, ± hip aspiration) Metal ion level test (if available) Cross-sectional imaging (if available): these stuies inclue MARS MRI; ultrasoun or CT when MRI contrainicate or MARS protocol not available Treatment recommenation Patient with low activity level Asymptomatic (incluing no systemic or mechanical symptoms) No change in gait (i.e., no limp, no abuctor weakness) No swelling Small-iameter femoral hea (<36 mm) moular MoM THA; hip resurfacing in males <50 with osteoarthritis Optimal acetabular cup orientation (40 ± 10 inclination for hip resurfacing) No implant osteolysis/loosening Low (<3 ppb) Annual follow-up

3 e4(3) TABLE III MoM Moerate Risk Group Moerate Risk Group Stratification Patient factors Symptoms Clinical examination Implant type Raiographs (2 views ± serial for comparison when available) Infection work-up (ESR, CRP, ± hip aspiration) Metal ion level test Cross-sectional imaging (MARS MRI; ultrasoun or CT when MRI contrainicate or MARS protocol not available) Treatment recommenation Revision surgery Male or female Dysplasia (for hip resurfacing) Patient with moerate activity level Symptomatic Mil local hip symptoms (e.g., pain, mechanical symptoms) No systemic symptoms Change in gait (i.e., limp) No abuctor weakness No swelling Large-iameter femoral hea ( 36 mm) moular or nonmoular MoM THA Recalle MoM implant Hip resurfacing with risk factors (female with ysplasia) Moular neck evice Optimal acetabular cup orientation No implant osteolysis/loosening Moerately elevate (3-10 ppb) Presence of abnormal tissue reactions without involvement of surrouning muscles an/or bone Simple cystic lesions or small cystic lesions without thickene wall Follow-up in 6 months Consier revision surgery if symptoms progress, imaging abnormality progresses, an/or there are rising metal ion levels over 6 months Raiographic Evaluation After a complete history an physical examination, evaluation of an MoM hip arthroplasty shoul follow with a critical review of serial plain raiographs, focusing on signs of implant-relate complications such as loosening or osteolysis, particularly in retro-acetabular, ischial, an pubic regions. For hip resurfacing implants, the presence of a raiographic sign of impingement (an inentation typically locate in the lateral or anterolateral aspects of the femoral neck) shoul be note. As the acetabular components with high inclination angle have been shown to emonstrate elevate serum 9 an joint flui levels of metal ions an increase wear seconary to ege loaing 10, it is important to measure the acetabular component orientation in both planes, incluing abuction angle relative to the pelvic horizontal on anteroposterior view. A shoot-through lateral is also helpful in assessing acetabular component anteversion. ESR/CRP an Hip Aspiration In contrast to metal-on-polyethylene (MoPE) THA, where elevation of both erythrocyte seimentation rate (ESR) an C-reactive protein (CRP) have specificity for infection as high as , interpretation of elevate ESR an CRP shoul be one with caution in MoM hip arthroplasty patients as elevate ESR/CRP have been reporte in non-infecte cases of averse soft-tissue reactions 12. Synovial flui white cell count greater than 3000 WBC/mL combine with preominant polymorphonuclear cells (>80%) has been reporte to have the highest accuracy an sensitivity for infection in MoPE THA 13.However, these parameters may not be applicable in MoM hip arthroplasty as averse soft-tissue reactions (proven to be culture negative) often have white cell counts greater than 3000 WBC/mL combine with >95% polymorphonuclear cells. Although manual cell count (instea of automate cell count) shoul be obtaine as tissue ebris in suspension may lea to falsely elevate automate cell counts, no absolute quantity of cells can be suggeste at this time. However, the higher the number of cells an the preominance of monocytes woul warrant further investigation. Sensitivity an Specificity of Metal Ion Levels in Preicting MoM Failure Metal ions are release from the bearing surfaces an from moular connections by virtue of mechanically assiste crevice corrosion (MACC) 14. Metal ion levels are influence by factors such as the implant type, implant materials an esign, iameter of the bearings, an positioning of the implant. In 2010, the British Meicines an Healthcare proucts Regulatory Agency issue a safety alert pertaining to all types of MoM hip implants an recommene cross-sectional imaging stuies in patients with either cobalt or chromium ion levels above 7

4 e4(4) TABLE IV MoM High Risk Group High Risk Group Stratification Patient factors Symptoms Clinical examination Implant type Raiographs (2 views ± serial for comparison when available) Infection work-up (ESR, CRP, ± hip aspiration) Metal ion level test Cross-sectional imaging (MARS MRI; ultrasoun or CT when MRI contrainicate or MARS protocol not available) Treatment recommenation Female with ysplasia (for hip resurfacing) Patient with high activity level Symptomatic Severe local hip an/or mechanical symptoms Systemic symptoms Change in gait (i.e., limp) Abuctor weakness Swelling Large-iameter femoral hea ( 36 mm) moular or nonmoular MoM THA Recalle MoM implant Suboptimal acetabular cup orientation Implant osteolysis/loosening High (>10 ppb) Presence of abnormal tissue reactions with involvement of surrouning muscles an/or bone Soli lesions Cystic lesions with thickene wall Mixe soli an cystic lesions Consier revision surgery parts per billion (ppb or mg/l) ( groups/tsbs/ocuments/meicalevicealert/con pf). More recently, the sensitivity an specificity of the 7 ppb cut-off level have been reporte to be 52% an 89%, respectively 15, inicating that the 7 ppb has relative poor ability to ientify MoM failures. The lowering of the cut-off level to 5 ppb increases the sensitivity to 63% an lowers specificity to 86%. In measuring trace metals cobalt an chromium with concentrations in the parts-per-billion range, the risk of contamination is a major technical challenge. Aherence to stringent protocols is require from specimen collection using trace-element verifie equipment to sample introuction to the analysis at a specialize laboratory 16. While metal ion levels are a useful iagnostic test for assessing MoM hip arthroplasty, its role is limite to being an important ajunct to systemic clinical assessment an other investigative tools. Therefore, metal ion levels alone shoul not be relie on as the sole parameter to etermine clinical recommenation for revision surgery. Furthermore, the correlation between cobalt or chromium serum, bloo, or synovial flui levels an averse local tissue reactions observe at the time of revision surgery is incompletely unerstoo 17,withmetal ion levels reporte to be unreliable preictors of periarticular soft-tissue amage at the time of revision surgery 18. In aition, the interpretation of metal ion levels is confoune in patients who have other Co- an Cr-containing metallic implants, particularly bilateral MoM total hip or surface replacements. In light of the current limitations of the metal ion levels in guiing surgical intervention, research efforts are currently unerway to ientify iagnostic tests, such as biomarkers in synovial flui that woul be helpful in etecting periprosthetic necrosis prior to the occurrence of significant averse local tissue reactions. Ultrasoun an Magnetic Resonance Imaging As ultrasoun is not affecte by metal artifacts 19, ultrasoun is a useful tool to etect the presence of a soft-tissue mass ajacent to an MoM implant 20. It can ifferentiate soli lesions from cystic lesions, an can also be use to guie biopsy an aspirations. Ultrasoun has been use to screen a large number of asymptomatic MoM patients in orer to establish prevalence of asymptomatic pseuotumors 21. However, this imaging technique remains operator epenent an its utility may be limite in evaluating the eep structures. Metal artifact reuction sequence magnetic resonance imaging (MARS MRI) has the capacity to prouce high-resolution images of the periprosthetic tissues in patients with MoM hip arthroplasty. Image istortion ue to susceptibility artifact generate by the ferromagnetic property of the cobalt-chromium implantisreucewithvariousmoificationsofpulsesequence 19. Moifie MRI has been emonstrate to be the most accurate test to etect the wear-inuce synovial response preating the presence of osteolysis on raiographs or stanar MRI 22. MARS MRI is an important cross-sectional imaging moality in etection of averse local soft-tissue reactions. MRI can elineate anatomical extension bounaries of periprosthetic flui collections an soli masses, as well as etection of

5 e4(5) any compression of juxtapose neurovascular structures, which is of particular importance in preoperative planning. It also allows evaluation of the surrouning soft-tissue envelope such as the integrity of hip abuctor an gluteal musculature 23. Therefore, early application of MRI may be an important tool that allows early etection of averse soft-tissue reactions. As wearinuce synovitis has been observe in both symptomatic an asymptomatic MoM patients, a prospective stuy is currently unerway to monitor these patients longituinally. Metal artifact reuction technique continues to be refine with the evelopment of new imaging optimization protocols. Therefore, the utility of MARS MRI in evaluating patients with MoM hip arthroplasty is likely to have an increasing role in the clinical ecision-making process. Frequency of Follow-up The frequency of follow-up examinations nees to be tailore to the iniviual patient base on the risk stratification category an intervening clinical course. Annual follow-up is recommene for patients with an MoM total hip or surface replacement arthroplasty. Patients in the moerate risk category an patients electing to forego surgery in the high-risk category shoul be followe at four to six month intervals. Follow-up evaluation shoul inclue a careful history an physical an plain raiography. In aition, the orthopaeic surgeon shoul consier repeat MARS MRI testing an metal ion analysis, epening on the iniviual patient s signs, symptoms, raiographs, an clinical course. Implant Retrieval Analysis For those patients who unergo revision surgery of their MoM bearing, it is recommene that the implant be evaluate at a center experience in implant retrieval analysis of such evices. The mechanism of failure of the hip reconstruction can be ascertaine by a gross an microscopic evaluation of the implant in concert with clinical, raiographic, an histopathologic finings. Delineating the mechanism(s) of failure will provie valuable information to surgeons, manufacturers, an implant esigners. Summary There shoul be a low threshol to perform a systematic evaluation of patients with MoM hip arthroplasty as early recognition an iagnosis will facilitate the initiation of appropriate treatment prior to significant averse biological reactions. A painful MoM hip arthroplasty has various intrinsic an extrinsic causes, an a systematic treatment approach base on the currently available ata is presente to optimize management of MoM patients. The risk stratification algorithm presente will continue to evelop as further evience becomes available proviing aitional insights. While specialize tests such as metal ion analysis are useful moalities for assessing MoM hip arthroplasty, over-reliance on any single investigative tool in the clinical ecision-making process shoul be avoie. Future research focusing on valiation of the current iagnostic tools for etecting averse local tissue reactions as well as optimization of MoM bearings an moular connections to further iminish wear an corrosion is warrante. Source of Funing There was no external funing source use for this consensus statement. n Young-Min Kwon, MD, PhD Department of Orthopaeic Surgery, Massachusetts General Hospital, Harvar Meical School, 55 Fruit Street, Boston, MA Aolph V. Lombari, MD, FACS Joint Implant Surgeons, Inc., The Ohio State University, 7277 Smith s Mill Roa, Suite 200, New Albany, OH Joshua J. Jacobs, MD Department of Orthopaeic Surgery, Rush University Meical Center, 1653 West Congress Parkway, Chicago, IL Thomas K. Fehring, MD Ortho Carolina Hip an Knee Center, 2001 Vail Avenue, #200a, Charlotte, NC Courtlan G. Lewis, MD Orthopeic Associates of Hartfor, 85 Seymour Street, Hartfor, CT Miguel E. 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