Chromium and Nickel Concentrations in Subjects with a Stainless Steel Metal-on-Metal Cervical Disc Arthroplasty: Results from a Prospective Longitudinal Study with 7 Years Follow-Up

ABSTRACT Background: Cervical disc arthroplasty (CDA) has emerged as an alternative to anterior cervical discectomy and fusion for degenerative cervical disc disease. The artificial discs provide intervertebral motion using multicomponent articulation and thus tend to generate particulate debris and soluble metal ions. Limited information is available on the long-term metal concentrations and associated systemic adverse events observed in metal-on-metal CDA. Serum chromium (Cr) and nickel (Ni) concentrations were assessed in patients implanted with ball-in-trough stainless steel–based cervical disc through 7 years. Methods: A prospective, nonrandomized longitudinal study was conducted that included 25 patients following rigorous exclusion criteria that included no previous permanent metal implants and no professional exposure to metal particles. Blood serum Cr and Ni concentrations were assayed preoperatively and at 3, 6, 12, 24, 36, 60, and 84 months postoperatively using high-resolution inductively coupled plasma–mass spectrometry. Longitudinal statistical comparisons were made using the Friedman test with statistical significance at P < .05. Results: Median serum concentrations determined preoperatively and at 3, 6, 12, 24, 36, 60, and 84 months postoperatively were 0.074, 0.106, 0.132, 0.170, 0.172, 0.274, 0.192, and 0.203 ng/mL for Cr and 0.085, 0.178, 0.222, 0.175, 0.205, 0.284, 0.181, and 0.194 ng/mL for Ni. The serum Cr concentrations were statistically higher for all postoperative time periods compared to preoperative concentration (Friedman P <.01), whereas serum Ni concentration was statistically higher at the 84-month postoperative time period than the preoperative concentration (Friedman P <.01) and then the concentration at 3, 12, 24, and 60 months postoperatively (Friedman P < .03). Conclusions: The Cr concentrations detected at all postoperative times were statistically higher than preoperative concentrations, whereas Ni concentration was statistically higher than the preoperative concentration only at 84 months.

[1]  P. Li,et al.  Cervical disc arthroplasty (CDA) versus anterior cervical discectomy and fusion (ACDF) in symptomatic cervical degenerative disc diseases (CDDDs): an updated meta-analysis of prospective randomized controlled trials (RCTs) , 2016, SpringerPlus.

[2]  M. Pesu,et al.  The Inflammatory Phenotype in Failed Metal-On-Metal Hip Arthroplasty Correlates with Blood Metal Concentrations , 2016, PloS one.

[3]  R. Marx,et al.  Cost-Effectiveness of Bariatric Surgery Prior to Total Knee Arthroplasty in the Morbidly Obese: A Computer Model-Based Evaluation. , 2016, The Journal of bone and joint surgery. American volume.

[4]  C. Overgaard,et al.  Systemic cobalt toxicity from total hip arthroplasties: review of a rare condition Part 1 - history, mechanism, measurements, and pathophysiology. , 2016, The bone & joint journal.

[5]  C. Overgaard,et al.  Systemic cobalt toxicity from total hip arthroplasties: review of a rare condition Part 2. measurement, risk factors, and step-wise approach to treatment. , 2016, The bone & joint journal.

[6]  S. Jerabek,et al.  Adverse local tissue reaction (ALTR) associated with corrosion products in metal‐on‐metal and dual modular neck total hip replacements is associated with upregulation of interferon gamma‐mediated chemokine signaling , 2015, Journal of orthopaedic research : official publication of the Orthopaedic Research Society.

[7]  N. Baldini,et al.  Long-term Systemic Metal Distribution in Patients With Stainless Steel Spinal Instrumentation: A Case-Control Study , 2015, Journal of spinal disorders & techniques.

[8]  C. Liang,et al.  Cervical Total Disc Replacement is Superior to Anterior Cervical Decompression and Fusion: A Meta-Analysis of Prospective Randomized Controlled Trials , 2015, PloS one.

[9]  S. Giannini,et al.  How Do Metal Ion Levels Change over Time in Hip Resurfacing Patients? A Cohort Study , 2014, TheScientificWorldJournal.

[10]  P. Campbell,et al.  Metal ion levels in maternal and placental blood after metal-on-metal total hip arthroplasty. , 2014, American journal of orthopedics.

[11]  Regis W Haid,et al.  Clinical and radiographic analysis of an artificial cervical disc: 7-year follow-up from the Prestige prospective randomized controlled clinical trial: Clinical article. , 2014, Journal of neurosurgery. Spine.

[12]  R. Ferner,et al.  Systemic toxicity related to metal hip prostheses , 2014, Clinical toxicology.

[13]  Joshua R. Smith,et al.  Does bearing size influence metal ion levels in large-head metal-on-metal total hip arthroplasty? A comparison of three total hip systems , 2014, Journal of Orthopaedic Surgery and Research.

[14]  S. Nie,et al.  Cervical disc arthroplasty versus anterior cervical discectomy and fusion for treatment of symptomatic cervical disc disease: a meta-analysis of randomized controlled trials , 2014, Archives of Orthopaedic and Trauma Surgery.

[15]  J. Jacobs,et al.  Effect of a second joint arthroplasty on metal ion levels after primary total hip arthroplasty. , 2013, American journal of orthopedics.

[16]  H. Amstutz,et al.  Do ion concentrations after metal-on-metal hip resurfacing increase over time? A prospective study. , 2013, The Journal of arthroplasty.

[17]  G. Omlor,et al.  In vivo serum titanium ion levels following modular neck total hip arthroplasty--10 year results in 67 patients. , 2013, Acta biomaterialia.

[18]  J. Galante,et al.  Ten-year outcome of serum metal ion levels after primary total hip arthroplasty: a concise follow-up of a previous report*. , 2013, The Journal of bone and joint surgery. American volume.

[19]  Ming Liu,et al.  A meta-analysis comparing the results of cervical disc arthroplasty with anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic cervical disc disease. , 2013, The Journal of bone and joint surgery. American volume.

[20]  Valerio Sansone,et al.  The effects on bone cells of metal ions released from orthopaedic implants. A review. , 2013, Clinical cases in mineral and bone metabolism : the official journal of the Italian Society of Osteoporosis, Mineral Metabolism, and Skeletal Diseases.

[21]  F. Chan,et al.  Comparison of in vivo and simulator-retrieved metal-on-metal cervical disc replacements , 2012, International Journal of Spine Surgery.

[22]  S. R. Golish,et al.  Bearing surfaces for total disc arthroplasty: metal-on-metal versus metal-on-polyethylene and other biomaterials. , 2012, The spine journal : official journal of the North American Spine Society.

[23]  K. Weber,et al.  Modern metal-on-metal hip implants. , 2012, The Journal of the American Academy of Orthopaedic Surgeons.

[24]  V. Traynelis,et al.  Motion preservation in cervical spine: review. , 2012, Journal of neurosurgical sciences.

[25]  A. Woolf,et al.  Wide Variation in Reference Values for Aluminum Levels in Children , 2012, Pediatrics.

[26]  W. Bernardo,et al.  A systematic review of randomized trials on the effect of cervical disc arthroplasty on reducing adjacent-level degeneration. , 2010, Neurosurgical focus.

[27]  T. Cundy,et al.  Predictors of Serum Chromium Levels After Stainless Steel Posterior Spinal Instrumentation for Adolescent Idiopathic Scoliosis , 2010, Spine.

[28]  T. Cundy,et al.  Chromium Ion Release From Stainless Steel Pediatric Scoliosis Instrumentation , 2010, Spine.

[29]  T J Joyce,et al.  Early failure of metal-on-metal bearings in hip resurfacing and large-diameter total hip replacement: A consequence of excess wear. , 2010, The Journal of bone and joint surgery. British volume.

[30]  Andrew Dooris,et al.  The fundamentals of biotribology and its application to spine arthroplasty , 2009, SAS Journal.

[31]  A. Sanz-Medel,et al.  High-resolution ICP–MS determination of Ti, V, Cr, Co, Ni, and Mo in human blood and urine of patients implanted with a hip or knee prosthesis , 2008, Analytical and bioanalytical chemistry.

[32]  C. Swanson,et al.  Metal Ion Levels in Patients With Stainless Steel Spinal Instrumentation , 2007, Spine.

[33]  C. Case,et al.  Orthopaedic metals and their potential toxicity in the arthroplasty patient: A review of current knowledge and future strategies. , 2007, The Journal of bone and joint surgery. British volume.

[34]  J. Beguiristáin,et al.  Metal levels in corrosion of spinal implants , 2007, European Spine Journal.

[35]  P. Cripton,et al.  Wear and Corrosion in Retrieved Thoracolumbar Posterior Internal Fixation , 2006, Spine.

[36]  K. Bozic,et al.  Wear and Osteolysis in Total Hip Arthroplasty , 2005 .

[37]  D. Zurakowski,et al.  Serum Levels of Nickel and Chromium After Instrumented Posterior Spinal Arthrodesis , 2005, Spine.

[38]  S. MacDonald,et al.  A consensus paper on metal ions in metal-on-metal hip arthroplasties. , 2004, The Journal of arthroplasty.

[39]  R. Newson,et al.  Changes in metal levels and chromosome aberrations in the peripheral blood of patients after metal-on-metal hip arthroplasty. , 2004, The Journal of arthroplasty.

[40]  P. McAfee The indications for lumbar and cervical disc replacement. , 2004, The spine journal : official journal of the North American Spine Society.

[41]  P. Campbell,et al.  Serum and urine metal levels in patients with metal-on-metal surface arthroplasty , 2002, Journal of materials science. Materials in medicine.

[42]  J. Galante,et al.  Release and excretion of metal in patients who have a total hip-replacement component made of titanium-base alloy. , 1991, The Journal of bone and joint surgery. American volume.