Benefits and Biosafety of Use of 3D-Printing Technology for Titanium Biomedical Implants: A Pilot Study in the Rabbit Model.

BACKGROUND: Titanium has been used in osteosynthesis for decades and its compatibility and safety is unquestioned. Studies have shown that there is release and collection of titanium in the organ systems with little note of toxicity. The gold standard is considered to be titanium osteosynthesis plate produced by milling methods. The use of customized titanium plates produced with 3D printing, specifically direct metal laser sintering, have found increasing use in recent years. It is unknown how much titanium is released in these printed titanium implants, which is known to be potentially porous, depending on the heat settings of the printer. We hypothesize that the amount of titanium released in printed titanium implants may be potentially more or equal compared to the gold standard, which is the implant produced by milling. METHODS: We studied the biosafety of this technology and its products by measuring serum and organ titanium levels after implantation of 3D-printed versus traditionally fabrication titanium plates and screws in a pilot study using the rabbit model. A total of nine rabbits were used, with three each in the control, milled and printed titanium group. The animals were euthanized after six months. Serum and organs of the reticuloendothelial system were harvested, digested and assayed for titanium levels. RESULTS: Organ and serum titanium levels were significantly higher in rabbit subjects implanted with titanium implants (milled and printed) compared to the control group. However, there was no significant difference in organ and serum titanium levels of subjects implanted with milled and traditionally fabricated titanium implants. CONCLUSIONS: The biosafety of use of 3D-printed titanium implants and traditionally fabricated titanium implants are comparable. With this in mind, 3D-printed custom implants can not only replace, but will very possibly surpass traditionally fabricated titanium implants in the mode and extent of use.

Serum Metal Levels in Maxillofacial Reconstructive Surgery Patients: A Pilot Study.

PURPOSE: The aim of this pilot study was to assay metal concentrations in the serum of patients who had undergone dental implant placement, orthognathic surgery using rigid metal fixation plates and screws, and total temporomandibular joint replacement (TMJ TJR). MATERIALS AND METHODS: Thirty patients were identified and included in this pilot study. Sixteen patients (9 men and 8 women), with an average age of 44 years (range, 19 to 79 yr), provided informed consent to participate and were divided into 3 study groups with 4 patients in each (group 1, orthognathic surgery; group 2, TMJ TJR; and group 3, dental implant placement). A control group consisted of volunteers without any implanted metallic devices. Blood samples for serum metal analysis were obtained and analyzed in accordance with the standardized collection and testing protocols used at the Trace Metal Analysis Laboratory of the Department of Orthopedic Surgery at the Rush University Medical Center (Chicago, IL). RESULTS: All control participants had levels below the normal reference range for all serum markers assessed. In the orthognathic group, 1 patient had an increased serum cobalt level. In the TMJ TJR group, 1 patient had an increased serum cobalt level and another patient had an increased serum chromium level. In the dental implant group, 1 patient had an increased serum titanium level and another had increased serum levels of titanium and chromium. CONCLUSIONS: This is the first study to report on the release of metal into the bloodstream in patients with different maxillofacial implanted metallic objects. The results raise questions regarding the types and magnitude of metal released from maxillofacial reconstruction devices and their potential long-term local and systemic effects. Future large-scale prospective studies involving serial measurements in homogeneous groups of patients could further elucidate the impact of these findings.

What Are Normal Metal Ion Levels After Total Hip Arthroplasty? A Serologic Analysis of Four Bearing Surfaces.

BACKGROUND: The recent experiences with adverse local tissue reactions have highlighted the need to establish what are normal serum levels of cobalt (Co), chromium (Cr), and titanium (Ti) after hip arthroplasty. METHODS: Serum Co, Cr, and Ti levels were measured in 80 nonconsecutive patients with well-functioning unilateral total hip arthroplasty and compared among 4 bearing surfaces: ceramic-on-ceramic (CoC); ceramic-on-polyethylene (CoP); metal-on-polyethylene (MoP), and dual mobility (DM). The preoperative and most recent University of California, Los Angeles (UCLA) and Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores were compared among the different bearing surfaces. RESULTS: No significant difference was found among serum Co and Cr levels between the 4 bearing surface groups (P = .0609 and P = .1577). Secondary analysis comparing metal and ceramic femoral heads demonstrated that the metal group (MoP, modular dual mobility (Stryker Orthopedics, Mahwah, NJ) [metal]) had significant higher serum Co levels compared with the ceramic group (CoC, CoP, MDM [ceramic]) (1.05 mg/L ± 1.25 vs 0.59 mg/L ± 0.24; P = .0411). Spearman coefficient identified no correlation between metal ion levels and patient-reported outcome scores. CONCLUSION: No serum metal ion level differences were found among well-functioning total hip arthroplasty with modern bearing couples. Significantly higher serum Co levels were seen when comparing metal vs ceramic femoral heads in this study and warrants further investigation. Metal ion levels did not correlate with patient-reported outcome measures.

Ten-Year Cross-Sectional Study of Mechanically Assisted Crevice Corrosion in 1352 Consecutive Patients With Metal-on-Polyethylene Total Hip Arthroplasty.

BACKGROUND: Mechanically assisted crevice corrosion (MACC) in metal-on-polyethylene total hip arthroplasty (THA) is of concern, but its prevalence, etiology, and natural history are incompletely understood. METHODS: From January 2003 to December 2012, 1352 consecutive THA surgeries using a titanium stem, cobalt-chromium alloy femoral head, and highly cross-linked polyethylene liner from a single manufacturer were performed. Patients were followed at 1-year and 5-year intervals for surveillance, but also seen earlier if they had symptoms. Any patient with osteolysis >1 cm (n = 3) or unexplained pain (n = 85) underwent examination, radiographs, complete blood count, erythrocyte sedimentation rate, and C-reactive protein, as well as tests for serum cobalt and chromium levels. RESULTS: Symptomatic MACC was present in 43 of 1352 patients (3.2%). Prevalence of MACC by year of implant ranged from 0% (0 of 61, 2003; 0 of 138, 2005) to 10.5% (17 of 162; 2009). The M/L Taper stem had a greater prevalence (4.9%) of MACC than all other Zimmer (Zimmer, Inc, Warsaw, IN) 12/14 trunnion stem types combined (1.2%; P < .001). Twenty-seven of 43 (62.8%) patients have undergone revision surgery, and 16 of 43 (37.2%) patients have opted for ongoing surveillance. Comparing symptomatic THA patients with and without MACC, no demographic, clinical, or radiographic differences were found. MACC was significantly more common in 0 length femoral heads (compared with both -3.5 mm and +3.5 mm heads). CONCLUSION: The prevalence of MACC in metal-on-polyethylene hips is higher in this cross-sectional study than previously reported. A significantly higher prevalence was found in patients with M/L Taper style stem and THA performed both in 2009 and also between 2009 and 2012 with this manufacturer.

A Comparison of Blood Metal Ions in Total Hip Arthroplasty Using Metal and Ceramic Heads.

BACKGROUND: In recent time, metal ion debris and adverse local tissue reaction have reemerged as an area of clinical concern with the use of large femoral heads after total hip arthroplasty (THA). METHODS: Between June 2014 and January 2015, 60 patients with a noncemented THA using a titanium (titanium, molybdenum, zirconium, and iron alloy) femoral stem and a V40 trunnion were identified with a minimum 5-year follow-up. All THAs had a 32- or 36-mm metal (n = 30) or ceramic (n = 30) femoral head coupled with highly cross-linked polyethylene. Cobalt, chromium, and nickel ions were measured. RESULTS: Patients with metal heads had detectable cobalt and chromium levels. Cobalt levels were detectable in 17 (56.7%) patients with a mean of 2.0 µg/L (range: <1.0-10.8 µg/L). Chromium levels were detectable in 5 (16.7%) patients with a mean of 0.3 µg/L (range: <1.0-2.2 µg/L). All patients with a ceramic head had nondetectable cobalt and chromium levels. Cobalt and chromium levels were significantly higher with metal heads compared to ceramic heads (P < .01). Cobalt levels were significantly higher with 36-mm metal heads compared with 32-mm heads (P < .01). Seven patients with metal femoral heads had mild hip symptoms, 4 of whom had positive findings of early adverse local tissue reaction on magnetic resonance imaging. All ceramic THA was asymptomatic. CONCLUSION: The incidence and magnitude of cobalt and chromium levels is higher in metal heads compared to ceramic heads with this implant system (P < .01). Thirty-six millimeter metal femoral heads result in larger levels of cobalt compared with 32-mm metal heads.

Diagnosis and Management of Adverse Local Tissue Reactions Secondary to Corrosion at the Head-Neck Junction in Patients With Metal on Polyethylene Bearings.

We reviewed 27 patients who underwent revision for an adverse local tissue reaction (ALTR) secondary to corrosion at the head-neck junction with MoP bearings. Serum cobalt and chromium levels were elevated in all cases, with a mean cobalt of 11.2 ppb and chromium of 2.2 ppb. Patients underwent modular bearing exchange, including a ceramic head with a titanium sleeve in 23 of 27 cases with only one recurrence of ALTR in one of the four patients not treated with a ceramic head. The diagnosis of ALTR secondary to corrosion is associated with cobalt levels of >1 ppb with cobalt levels elevated above chromium. Retention of a well-fixed stem and modular exchange to a ceramic head leads to resolution of symptoms and decreases in metal levels.

Serum Metal Ions with a Titanium Modular Neck Total Hip Replacement System.

The goal of this study is to evaluate serum levels of chromium (Cr), cobalt (Co), and titanium (Ti) within the first two years following total hip arthroplasty using a Ti modular neck system. Twenty-five patients were randomized to a metal-on-metal (MoM) bearing with an all CoCr shell, and the remaining 25 received a metal-on-polyethylene (MoP) with a Ti shell. Serum levels demonstrated increases for Cr, Co, and Ti at 1 year (P < .001). MoM had similar Ti levels to MoP hips at 1 year (P=0.11) but lower at 2 years (P=0.03). Results suggest that the passive corrosion (i.e., chemical, pitting, and crevice corrosion) of exposed non-articular metal surfaces may be a greater source of ions than the neck-stem or head-neck interfaces.

Metal Ion Concentrations in Young, Active Patients Following Total Hip Arthroplasty with the Use of Modern Bearing Couples.

The purpose of this study was to compare whole blood metal ion levels in young, active patients undergoing primary total hip arthroplasty with the use of a cobalt-alloy (ten patients), ceramic (15 patients), or oxinium (11 patients) femoral head and highly crosslinked polyethylene acetabular liner. At 2 years postoperatively, mean cobalt concentrations were 3.0 times higher in the cobalt-alloy cohort versus the ceramic cohort, and 2.3 times higher versus the oxinium cohort (P=0.3-0.5). Titanium levels were consistently elevated at all postoperative time points versus preoperatively in all cohorts. Young, active patients following THA demonstrate elevated cobalt and titanium concentrations. Use of a ceramic or oxinium femoral head decreased the degree of cobalt elevation versus a cobalt-alloy femoral head, but did not reach statistical significance.

Porous titanium particles for acetabular reconstruction in total hip replacement show extensive bony armoring after 15 weeks. A loaded in vivo study in 10 goats.

BACKGROUND AND PURPOSE: The bone impaction grafting technique restores bone defects in total hip replacement. Porous titanium particles (TiPs) are deformable, like bone particles, and offer better primary stability. We addressed the following questions in this animal study: are impacted TiPs osteoconductive under loaded conditions; do released micro-particles accelerate wear; and are systemic titanium blood levels elevated after implantation of TiPs? ANIMALS AND METHODS: An AAOS type-III defect was created in the right acetabulum of 10 goats weighing 63 (SD 6) kg, and reconstructed with calcium phosphate-coated TiPs and a cemented polyethylene cup. A stem with a cobalt chrome head was cemented in the femur. The goats were killed after 15 weeks. Blood samples were taken pre- and postoperatively. RESULTS: The TiP-graft layer measured 5.6 (SD 0.8) mm with a mean bone ingrowth distance of 2.8 (SD 0.8) mm. Cement penetrated 0.9 (0.3-1.9) mm into the TiPs. 1 reconstruction showed minimal cement penetration (0.3 mm) and failed at the cement-TiP interface. There were no signs of accelerated wear, metallic particle debris, or osteolysis. Median systemic titanium concentrations increased on a log-linear scale from 0.5 (0.3-1.1) parts per billion (ppb) to 0.9 (0.5-2.8) ppb (p=0.01). INTERPRETATION: Adequate cement pressurization is advocated for impaction grafting with TiPs. After implantation, calcium phosphate-coated TiPs were osteoconductive under loaded conditions and caused an increase in systemic titanium concentrations. However, absolute levels remained low. There were no signs of accelerated wear. A clinical pilot study should be performed to prove that application in humans is safe in the long term.

The unfavorable role of titanium particles released from dental implants.

Titanium is considered to be a metal material with the best biological safety. Studies have proved that the titanium implanted in the bone continuously releases titanium particles (Ti particles), significantly increasing the total titanium content in human body. Generally, Ti particles are released slowly without causing a systemic immune response. However, the continuous increased local concentration may result in damage to the intraepithelial homeostasis, aggravation of inflammatory reaction in the surrounding tissues, bone resorption and implant detachment. They also migrate with blood flow and aggregate in the distal organ. The release of Ti particles is affected by the score of the implant surface structure, microenvironment wear and corrosion, medical operation wear, and so on, but the specific mechanism is not clear. Thus, it difficult to prevent the release completely. This paper reviews the causes of the Ti particles formation, the damage to the surrounding tissue, and its mechanism, in particular, methods for reducing the release and toxicity of the Ti particles.

Titanium levels in the organs and blood of rats with a titanium implant, in the absence of wear, as determined by double-focusing ICP-MS.

Titanium (Ti) has long been regarded as an inert and biocompatible metal, ideal for biomedical applications such as dental implants or joint replacements. However, concerns about the biocompatibility of Ti have lately arisen. Unfortunately, information on reliable Ti baseline physiological levels in blood and organ tissues is still pending and the real effects of physiological corrosion as opposed to wear processes of Ti or Ti alloys implants is controversial so far. In this work a previously developed and validated methodology, based on using double-focusing inductively coupled plasma mass spectrometry (DF-ICP-MS) has been used to establish Ti basal levels in blood and organs (heart, liver, spleen, kidneys, and lungs) of Wistar rats. These data were compared with the levels found in three Wistar rats implanted with a Ti wire embedded in their femur for 18 months, in order to assign possible Ti released purely due to non-wear physiological mechanisms. Results showed that Ti content in all the selected organ tissues and blood was higher than previously determined Ti basal levels, clearly showing both corrosion of the Ti implant and systemic Ti accumulation in target tissues. These results indicate that Ti metal corrosion occurs. This seems to be the only mechanism responsible in the long term for the observed passive dissolution of Ti of the implant in the absence of wear. A comparative study of the systemic distribution of the soluble and particulate Ti potentially released from Ti implants was also carried out by intraperitoneally injection of soluble Ti(citrate)(3) and insoluble TiO(2) particles, respectively. Different systemic Ti storage was observed. Whereas soluble Ti was rapidly transported to all distal organs under study, TiO(2) particles were only accumulated in lung tissue.

2008 John Charnley award: metal ion levels after metal-on-metal total hip arthroplasty: a randomized trial.

UNLABELLED: Metal-on-metal bearing total hip arthroplasty is performed more commonly than in the past. There may be manufacturing differences such as clearance, roughness, metallurgy, and head size that affect performance. In a prospective, randomized trial, we compared 2-year postoperative ion levels for a 28-mm metal-on-polyethylene bearing with 28-mm and 36-mm metal-on-metal bearings. We measured serum, erythrocyte, and urine ion levels. We observed no difference in the ion levels for the 28-mm and 36-mm metal-on-metal bearings. The ion levels in these patients were lower than reported for most other metal-on-metal bearings. Although both erythrocyte and serum cobalt increased, erythrocyte chromium and erythrocyte titanium did not increase despite a four- to sixfold serum chromium and a three- to fourfold serum titanium increase. This may represent a threshold level for serum chromium and serum titanium below which erythrocytes are not affected. LEVEL OF EVIDENCE: Level I, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.

Metal release and corrosion effects of modular neck total hip arthroplasty.

Modular neck implants are an attractive treatment tool in total hip replacement. Concerns remain about the mechanical stability and metal ion release caused by the modular connection. Five different implant designs were investigated in an experimental set-up. In vivo conditions were simulated and the long-term titanium release was measured. Finally, the modular connections were inspected for corrosion processes and signs of fretting. No mechanical failure or excessive corrosion could be identified for the implants tested. The titanium releases measured were extremely low compared to in vivo and in vitro studies and were not in a critical range.

Clinical and biological assessment of cemented titanium femoral stems: an 11-year experience.

This study prospectively assessed the outcome of 134 cemented titanium stems and serum ion levels. The stems were polished (0.1 microm Ra) with circular cross section. At the end point, only one stem revision was performed for aseptic loosening, and two were planned due to subsidence greater than 5 mm. Non-progressive radiolucencies in zones 1 and 7 were observed in 16 hips at the cement-bone interface without osteolysis. Median serum titanium concentrations were below the detection limit (30 nmol/l) except in patients with failed stems. The overall stem survival rate was 97.7% at nine years, which is comparable to other series of cemented stems. The protective layer of titanium oxide coating the stem and a thick cement mantle may help resist aseptic loosening. In addition, satisfactory monitoring of the stem was reached using titanium serum level determination.

Outcome and serum ion determination up to 11 years after implantation of a cemented metal-on-metal hip prosthesis.

BACKGROUND AND PURPOSE: Little is known about the long-term outcome of cemented metal-on-metal hip arthroplasties. We evaluated a consecutive series of metal-on-metal polyethylene-backed cemented hip arthroplasties implanted in patients under 60 years of age. METHODS: 109 patients (134 joint replacements) were followed prospectively for mean 9 (7-11) years. The evaluation included clinical score, radiographic assessment, and blood sampling for ion level determination. RESULTS: At the final review, 12 hips had been revised, mainly because of aseptic loosening of the socket. Using revision for aseptic loosening as the endpoint, the survival rate at 9 years was 91% for the cup and 99% for the stem. In addition, 35 hips showed radiolucent lines at the bone-cement interface of the acetabulum and some were associated with osteolysis. The median serum cobalt and chromium levels were relatively constant over time, and were much higher than the detection level throughout the study period. The cobalt level was 1.5 microg/L 1 year after implantation, and 1.44 microg/L 9 years after implantation. INTERPRETATION: Revisions for aseptic loosening and radiographic findings in the sockets led us to halt metal-on-metal-backed polyethylene cemented hip arthroplasty procedures. If the rigidity of the cemented socket is a reason for loosening, excessive release of metal ions and particles may be involved. Further investigations are required to confirm this hypothesis and to determine whether subluxation, microseparation, and hypersensitivity also play a role.

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.

The main components (Ti, V, Cr, Co, Ni, and Mo) of metallic alloys currently used in hip and knee articular prostheses have been simultaneously determined in human whole blood and urine of implanted people by a (HR)-ICP-MS method previously developed in our laboratory. The determination of those elements has been carried out in patients with knee and hip prosthesis and in a group of pre-operation patients without any metallic device in their bodies, used as controls, demonstrating the usefulness of this technique to perform multielement analysis at ppt levels in complex matrices. The concentrations of V, Cr, Co, Ni, and Mo in urine and blood of implanted people turned out to be very similar to those obtained in control patients. However, raised Ti levels could be found both in urine and blood of patients with articular prostheses made or coated with a titanium alloy (Ti(6)Al(4)V).

Evaluation of Blood Titanium Levels and Total Bone Contact Area of Dental Implants.

The purpose of this study was to evaluate the effect of total implant-bone surface contact area of dental implants applied on partial or total edentulous patients on the increase in the level of blood titanium level. Changes of the blood titanium levels were evaluated after placement of the dental implants in 30 patients including 15 females and 15 males. Patients were divided into 3 groups as dental implants were applied on only maxilla, only mandible, or both of them. Taking into the consideration anatomic formation and prosthetic indication, dental implant-bone total contact area was calculated and saved for each patient after dental implants placement. Blood samples of the patients taken preoperatively and postoperatively at 12 weeks were analyzed by ICP-MS device. Blood titanium levels of preoperative and postoperative blood samples were analyzed for each patient and results were evaluated statistically. In the evaluation after analyzing blood titanium level changes, while a statistically significant decrease was observed in Group 1 patients, a statistically significant increase was observed in Group 2 and Group 3 patients to blood titanium level. A statistically significant difference was observed between Group 1 and Group 2 and between Group 1 and Group 3 patients of blood titanium levels. The change of the blood titanium level was not related to total implant-bone surface area, number of the implants, and gender. In our study, no correlation was found between change of blood titanium level and total contact area with bone of dental implants. We believe that more accurate results can be obtained with biopsy of tissues and organs on animal studies.

Surface integrity of polyethylene liners following trunnionosis of a dual modular neck total hip implant.

BACKGROUND: There has been a trend in the evolution of total hip arthroplasty towards increased modularity; with this increase in modularity come some potentially harmful consequences. Modularity at the neck shaft junction has been linked to corrosion, adverse reaction to metal debris and pseudotumour formation. AIM: The aim of this retrieval study is to assess whether the surface integrity of the polyethylene (PE) liner is affected by metal wear debris in a single implant design series of THA revised for trunnionosis. METHODS: A retrieval analysis of thirty dual-taper modular neck hip prostheses was performed; the mean time from implantation to revision was 2.7 years (1.02-6.2). PE liners were analysed using a scanning electron microscope with an energy dispersive spectrometer to assess for metal particles embedded on the liner surface. Serum metal ion levels and inflammatory markers were also analysed. RESULTS: There were small numbers of metal particles present on the PE liners. The mean number of metal particles per liner was four and the particles varied in size from 0.5 µm to 122 µm mean 16 µm. All patients had elevated metal ion levels: cobalt 6.02 µg/l, chromium 1.22 µg/l, titanium 3.11 µg/l. The cobalt:chromium ratio was 7.55:1. Inflammatory markers were also marginally raised (ESR 17; CRP 10). CONCLUSION: These results suggest that retention of PE liners may be reasonable when performing isolated revision of the femoral component in cases of failure at the modular neck stem junction, especially when the inner diameter of the liner is already optimised for head size and stability.

Local and Systemic Changes Associated with Long-term, Percutaneous, Static Implantation of Titanium Alloys in Rhesus Macaques (Macaca mulatta).

Metal alloys are frequently used as implant materials in veterinary medicine. Recent studies suggest that many alloys induce both local and systemic inflammatory responses. In this study, 37 rhesus macaques with long-term skull-anchored percutaneous titanium alloy implants (duration, 0 to 14 y) were evaluated for changes in their hematology, coagulation, and serum chemistry profiles. Negative controls (n = 28) did not have implants. Macaques with implants had higher plasma D-dimer and lower antithrombin III concentrations than nonimplanted animals. In addition, animals with implants had higher globulin and lower albumin and calcium concentrations compared with nonimplanted macaques. Many of these changes were positively correlated with duration of implantation and the number of implants. Chronic bacterial infection of the skin was present around many of the implant sites and within deeper tissues. Representative histopathology around the implant site of 2 macaques revealed chronic suppurative to pyogranulomatous inflammation extending from the skin to the dura mater. X-ray fluorescence microscopy of tissue biopsies from the implant site of the same 2 animals revealed significantly higher levels of free metal ions in the tissue, including titanium and iron. The higher levels of free metal ions persisted in the tissues for as long as 6 mo after explantation. These results suggest that long-term skull-anchored percutaneous titanium alloy implants can be associated with localized inflammation, chronic infection, and leaching of metal ions into local tissues.

Metal concentrations in the blood and tissues after implantation of titanium growth guidance sliding instrumentation.

BACKGROUND: Growth guidance sliding treatment devices, such as Shilla (Medtronic, Minneapolis, MN USA) or LSZ-4D (CONMET, Moscow, Russia), used for the treatment of scoliosis in children who have high growth potential have unlocked fixtures that allow rods to slide during growth of the spine, which avoids periodical extensions. However, the probability of clinical complications associated with metallosis after implantation of such devices is poorly understood. The content of metal ions in the blood and tissues of pediatric patients treated for scoliosis using fusionless growth guidance sliding instrumentation has not yet been investigated. PURPOSE: The aim of the present study was to measure the content of metal ions in the blood and tissues surrounding the implanted growth guidance sliding LSZ-4D devices made of titanium alloy (Ti6Al4V), and to identify the incidence of metallosis-associated clinical complications in some patients with these devices. STUDY DESIGN: This is a one-center, case-control retrospective study. PATIENTS SAMPLE: The study group included 25 patients with high growth potential (22 females, 3 males; average age at primary surgery for scoliosis treatment is 11.4±1.2 years old) who had sliding growth guidance instrumentation LSZ-4D (CONMET) implanted on 13 (range: 10-16) spine levels for 6±2 years. The LSZ-4D device was made from titanium alloy Ti6Al4V and consisted of two rectangular section rods and fixture elements. Locked fixtures were used on one spinal level, whereas the others were unlocked (sliding). The control group consisted of 13 patients (12 females and 1 male; 11±1.2 years old) without any implanted devices. OUTCOME MEASURES: The content of Ti, Al, and V metal ions in the whole blood and tissues around the implanted device was measured. The incidences of metallosis-associated complications in the study group were recorded. METHODS: Metal ion content was measured by the inductively coupled mass spectrometry method on quadrupolar NexION 300D (PerkinElmer Inc, Shelton, CT, USA). RESULTS: Five of 25 patients in the study group developed metallosis-associated complications (two sinuses and three seroma in the lumbar part of the spine). Revisions were carried out in two of these patients. Ninety percent of the patients in the study group had increased content of Ti and V ions in the blood (2.8 and 4 times, respectively). Median content of Ti ions in soft tissues adjacentto implanted sliding device was more than 1,500-fold higher than that of the control group. These levels are much higher than previously reported for spinal instrumentation. CONCLUSIONS: Increased content of Ti and V ions in the blood and especially in tissues around the titanium growth guidance sliding device LSZ-4D accompanied by clinical manifestations (seroma and sinuses) indicates the importance of improving wear resistance of such instrumentation with the coatings and the necessity to exchange sliding instrumentation once the child is fully grown.