The Comparative Analysis of Antegrade Versus Retrograde Approach for a Failed Porous Tantalum Rod Removal During Conversion to Total Hip Arthroplasty.

BACKGROUND The failure of porous tantalum rods applied to patients with osteonecrosis of the femoral head (ONFH) has been increasingly reported during the last few years. Very few studies have reported methods for implant removal. This study aimed at comparing 2 procedures used for the removal of a failed tantalum rod during conversion to total hip arthroplasty (THA). MATERIAL AND METHODS A total of 65 patients (65 hips), who underwent THA after failed implantation of a tantalum rod between June 2007 and December 2016, were retrospectively evaluated. These patients were classified into 2 groups depending on whether the antegrade approach (removal of the tantalum rod from the tip to the butt at the lateral femoral cortex, n=27) or retrograde approach (removal of the tantalum rod from the butt at the lateral femoral cortex to the proximal tip, n=38) was used for rod extraction. These 2 groups were compared for incision length, operation time, blood loss, fracture, tantalum debris, Harris hip scores, and the presence of osteolysis and/or radiolucency. RESULTS These 2 groups did not present any significant differences in terms of Harris hip score and incision length. However, the operation time (P=0.000), blood loss (P=0.000), amount of tantalum debris (P=0.000), and presence of radiolucency (P=0.046) were greater for the retrograde approach than for the antegrade approach. CONCLUSIONS The risk of conversion to THA following failed tantalum rod implantation is high. In such cases, the antegrade procedure was found to be a simple and efficient method for removing the trabecular metal rod with the use of a trephine.

Outcomes of Onyx® Embolization of Type II Endoleaks After Endovascular Repair of Abdominal Aortic Aneurysms.

BACKGROUND: Type II endoleaks (T2ELs) are common following endovascular repair of abdominal aortic aneurysms (EVAR). Embolization with ethylene vinyl alcohol copolymer (Onyx) may present an effective treatment alternative for T2ELs. Due to limited data supporting its use, we sought to analyze outcomes of Onyx embolization for T2ELs. METHODS: Retrospective review of consecutive patients treated for T2ELs utilizing Onyx embolization agent from 2009-2018. All pre- and post-Onyx intervention CT scans were analyzed for diameter and volume changes with 3D reconstruction software. The primary outcomes were change in maximum AAA diameter and volume. Secondary outcomes included additional interventions, rupture, and mortality. A subset analysis was performed with patients with isolated T2ELs (no other types of endoleaks present). RESULTS: We identified 85 patients (73 males, mean age 77.6 ± 7.6 years) who underwent 112 Onyx interventions. Average time to first Onyx intervention after index EVAR was 3.3 ± 2.6 years and average sac growth was 6.3 ± 6.7 mm. Patients underwent mean 1.3 Onyx interventions using a mean of 4.9 ± 4.7 ml for treatment. Three complications occurred (Onyx extravasation, colon ischemia, and access site hematoma). Mean follow-up was 2.5 ± 2.1 years after initial Onyx treatment. At the most recent follow-up, sac diameter stabilization was seen in 47% and reduction >5 mm was seen in 19%. Sac growth of >5 mm was seen in 34% of patients following the first Onyx intervention. In our subset of isolated T2EL, 72% had sac stabilization or reduction >5 mm. Four patients experienced a ruptured aneurysm (3 had active type 1 endoleaks). Rupture-free survival was 95% at 5 years, and overall survival was 54% at 5 years. Notably, increasing Onyx interventions were not associated with sac stabilization or reduction (OR 0.6, P = 0.1). On multivariable analysis, AAA sac diameter stabilization or reduction was independently associated with BMI >30 kg/m2 (OR 4.2, P = 0.01) and having only 1 Onyx intervention (OR 3.8, P = 0.02). CONCLUSIONS: Onyx for embolization of T2ELs resulted in AAA sac diameter stabilization or reduction in 66% of patients, and up to 72% in isolated T2ELs. Further, increasing Onyx interventions were not associated with either aneurysm sac stabilization or reduction. Given its similar outcomes to other embolization strategies in the literature, Onyx embolization for management of T2ELs needs to be judiciously considered, particularly for T2ELs persisting after an initial Onyx embolization intervention.

Vagal Nerve Palsy After Transarterial Embolization of Transverse-Sigmoid Dural Arteriovenous Fistula Using Onyx.

OBJECTIVE: We report a case of a 70-year-old man who developed a transverse-sigmoid dural arteriovenous fistula (TS-DAVF) that was successfully treated by transarterial embolization (TAE) with Onyx. CASE PRESENTATION: The patient presented with sudden and progressive disturbance of consciousness and left hemiparesis. Magnetic resonance imaging (MRI) revealed venous infarction and hemorrhagic changes with brain swelling in the right parietal lobe. Angiography revealed a right TS-DAVF and multiple occlusions with retrograde leptomeningeal venous drainage into the cortical veins. The TS-DAVF was graded as Borden type III and Cognard type IIa+b. Because of its progressive clinical nature and wide distribution of DAVF in the occluded sinus wall, he underwent emergent TAE with liquid embolic materials including n-butyl cyanoacrylate and Onyx under informed consent by his family. Complete obliteration of the TS-DAVF was achieved, leading to a marked amelioration of symptoms, and MRI after treatment confirmed a decrease in the brain swelling. However, he suffered transient dysphagia due to right vagal nerve palsy caused by occlusion of vasa nervorum of ascending pharyngeal artery. He returned home 5 months later with a modified Rankin Scale of 1. CONCLUSIONS: TAE with Onyx appears to be effective for aggressive TS-DAVF with a widely distributed shunt. However, the blood supply to the cranial nerves and potentially dangerous anastomoses between the external-internal carotid artery and vertebral artery should be taken into account to avoid serious complications.

Beam hardening artifacts of liquid embolic agents: comparison between Squid and Onyx.

BACKGROUND: Initial clinical experience with Squid shows subjectively reduced artifacts on post-embolization CT scans compared with Onyx. To further investigate these observations, we aimed to perform a comparison of artifacts between Squid and Onyx in a controlled in vitro model. MATERIALS AND METHODS: Onyx 18 and all four variants of Squid (Squid 18, Squid 18 low density (LD), Squid 12, Squid 12 LD) were each injected in dimethylsulfoxide (DMSO) compatible test tubes. The tubes containing precipitated embolic material were inserted in a CT phantom for conventional and flat panel CT acquisitions. Beam hardening artifacts were quantified using objective and subjective measurements. RESULTS: Objective evaluation of artifacts within regions of interest (ROIs) placed around the embolic material on CT and flat panel CT images demonstrated significantly lower noise and Hounsfield unit (HU) range values for all four Squid products compared with Onyx 18. On both CT and flat panel CT, LD variants of Squid 18 and Squid 12 had significantly lower noise and HU range values than their normal density counterparts on longitudinal ROIs. When using subjective measures for diagnostic value within ROIs placed around the embolic material on both CT and flat panel CT images, the number of non-diagnostic ROIs was significantly higher for Onyx 18 than for all four Squid variants. CONCLUSION: All four variants of Squid induced fewer beam hardening artifacts than Onyx 18 on CT and flat panel CT acquisitions. LD variants of Squid induced fewer artifacts than their normal density counterparts.

May the Inferior Petrosal Sinus Recanalization During Endovascular Treatment for Carotid-Cavernous Fistulas Increase the Risk of Sixth Nerve Palsy?

BACKGROUND: Sixth nerve palsy is a common complication of endovascular treatment for carotid-cavernous fistulas (CCF). Two hypotheses are evoked: the spontaneous venous congestion into the cavernous sinus and the direct compression of the nerve by the embolic agent into the cavernous sinus. Nevertheless, the evidence is still uncertain. Knowing the vicinity of the sixth nerve with the inferior petrosal sinus (IPS) in the Dorello canal, we hypothesized that the recanalization of the IPS increased the risk of nerve damage. METHODS: We analyzed a prospective database of patients treated for CCFs from March 2009 to April 2016. We excluded patients who did not need treatment, cases of high-flow CCF, and patients lost to follow-up, obtaining a homogeneous population of 82 patients with indirect CCFs. This population was divided in 2 groups: patients without new-onset/worsening of sixth nerve palsy and patients with this postprocedural complication. RESULTS: Our main endpoints were the potential differences between patients with or without recanalization of IPS and between those who underwent or not an embolization with Onyx-18. We did not find any statistically meaningful difference between the 2 groups concerning the necessity of IPS recanalization (P > 0.999, odds ratio 0.97, 95% confidence interval 0.32-2.96) or with the use of Onyx-18 as an embolic agent (P = 0.56; odds ratio 1.41, 95% confidence interval 0.41-2.45). CONCLUSIONS: The recanalization of a thrombosed IPS does not increase the risk of procedural sixth nerve damage. The initial injury seems to relate with development/worsening of a sixth nerve palsy.

What is the rate of patients undergoing a total hip arthroplasty after core decompression and insertion of a tantalum rod in osteonecrosis of the femoral head: a systematic review.

PURPOSE: Core decompression (CD) may be effective when performed during the early stages of osteonecrosis of the femoral head (ONFH). Tantalum may be added as a rod that would allow putting some mechanical constraints on the femoral head. We aimed to estimate the rate of total hip arthroplasty after CD and insertion of a tantalum rod during early stages of OFNH. METHODS: We searched systematically Medline via PubMed and the Cochrane Library. Our primary endpoint was the rate of patients undergoing a total hip arthroplasty after CD and insertion of a tantalum rod. Secondary endpoints were the delay between the initial surgery and the arthroplasty, the functional improvement, and the rate of complications. RESULTS: We included seven  studies reporting the results of 232 patients (297 hips) that were operated on by CD and insertion of a tantalum rod. At a mean follow-up of 26.97 months, 24.63% of the included hips underwent a hip arthroplasty (6-56%, SD = 17.34%). The mean delay between the initial surgery and the arthroplasty was 14.94 months (10.20-22.90; SD = 5.25), the mean improvement of Harris Hip Score was 27.66 (20.20-36.90; SD = 6.48), and the mean rate of femoral fracture was 2.43% (0-13%, SD = 4.89%). CONCLUSION: CD and insertion of a tantalum rod may represent a solution in order to improve the mechanical support and to give a rate of conversion in arthroplasty that is acceptable.

Septal reduction therapy using nonalcohol agent in hypertrophic obstructive cardiomyopathy: Single center experience.

AIMS: Percutaneous septal reduction therapy by either alcohol or nonalcohol agents is an alternative approach to surgery in drug-refractory symptomatic patients with hypertrophic obstructive cardiomyopathy (HOCM). Nonalcohol agents have some advantages and disadvantages over alcohol during the procedure. Nowadays, a novel non-alcohol agent, named as Ethylene-vinyl alcohol (EVOH) copolymer (Onyx® and Squid® ), is used during septal ablation. Thus, in this study, we aimed to evaluate both acute and long-term efficacy and safety profile of EVOH during septal ablation in HOCM. METHODS AND RESULTS: A total of 25 patients (52% female; mean age: 55.8 ± 17.1 years) with symptomatic HOCM were enrolled in the study. All subjects underwent clinical and laboratory assessment before and after the procedure. Peak left ventricular outflow tract (LVOT) gradient was significantly reduced just after the procedure (68 vs. 20 mmHg; P < 0.001). Peak serum creatine kinase-myocardial band and troponin I levels were 112 (35-282) ng/ml and 11 (4-93) ng/ml. EVOH embolization to diagonal artery was observed in 1 patient (4%) and the complete atrioventricular block was noted in 2 (8%) patients. During the 12-month follow-up, there was no mortality. There was a significant improvement in New York Heart Association functional class of the subjects P < 0.001). Both interventricular septum thickness and LVOT gradient showed a significant reduction during follow-up (P < 0.05). However, there was no reduction in the LVOT gradient of 3 patients (12%). CONCLUSIONS: In conclusion, our small-sized preliminary study results showed that septal reduction therapy using EVOH is an effective alternative option in reducing symptoms and LVOT gradient in HOCM.

Multi-elemental nanoparticle exposure after tantalum component failure in hip arthroplasty: In-depth analysis of a single case.

Porous tantalum components are widely used for complex acetabular reconstructions in revision hip arthroplasty. Multiple other metal alloys such as titanium-aluminum-vanadium or cobalt-chromium-molybdenum are principally used in artificial joint setups. We report a case of tantalum component failure being both cause and effect of a multiple metal exposure. Our aims were to assess and to characterize associated particle exposure and biological consequences. Metal level quantification revealed substantial in vivo exposure to particulate and dissociated tantalum, zirconium, chromium, cobalt, molybdenum, titanium, aluminum and vanadium in periprosthetic compartments. Aside from micron-sized particles, nanoparticles of a broad size range and elemental composition were obtained. Histological exams verified a spectrum of necrotic changes in the periprosthetic tissues. In the presented case tantalum release was accompanied by concomitance of particles originating from other utilized metals. We conclude that an overall in vivo exposure assessment is mandatory for realistic appraisal of metal toxicity and associated risks.

A Case Report of Onyx Pulmonary Arterial Embolism Contributing to Hypoxemia During Awake Craniotomy for Arteriovenous Malformation Resection.

A healthy 26-year-old man with cerebral arteriovenous malformation underwent staged endovascular embolization with Onyx followed by awake craniotomy for resection. The perioperative course was complicated by tachycardia and severe intraoperative hypoxemia requiring significant oxygen supplementation. Postoperative chest computed tomography (CT) revealed hyperattenuating Onyx embolization material within the pulmonary vasculature, and an electrocardiogram indicated possible right heart strain, supporting clinically significant embolism. With awake arteriovenous malformation resection following adjunctive Onyx embolization becoming increasingly employed for lesions involving the eloquent cortex, anesthesiologists need to be aware of pulmonary migration of Onyx material as a potential contributor to significant perioperative hypoxemia.

Early and midterm outcomes after transcatheter embolization of type I endoleaks in 25 patients.

OBJECTIVE: This study reports the technical success and follow-up results of transcatheter embolization of type I endoleak (ELI) in 25 patients after endovascular aortic repair (EVAR). METHODS: Twenty-five patients with ELI (20 men, five women; mean age 80 years; range, 64-96 years) underwent embolization of abdominal ELI (23 proximal, 2 distal endoleaks) after EVAR. All patients were unsuitable for standard endovascular methods for treatment of ELI. The average aneurysm sac size before embolization was 8.2 cm (range, 5.3-12.9 cm). The average time between EVAR and endoleak diagnosis was 685 days (range, 1-4220 days) and from endoleak diagnosis to embolization was 27 days (range, 2-94 days). Onyx (ev3 Endovascular, Inc, Plymouth, Minn) alone or with detachable coils was used for embolization. RESULTS: A total of 27 embolization procedures were performed, with two patients having undergone a repeat procedure. Onyx alone was used in 16 cases and Onyx and coils were used in 11. Immediate technical success with complete isolation of the endoleak on completion angiography was achieved in all procedures. Six procedural complications occurred: three puncture site hematomas and three cases of non-target Onyx embolization. None of the complications had long term sequelae. During the follow-up period (average, 311 days; range, 1-1357 days), seven patients (28%) developed endoleak recurrence, and two underwent a second embolization procedure. Of these, one has had no further endoleak recurrence, but the other developed a recurrent endoleak and died of sac rupture. Two of the other five cases of endoleak recurrence were successfully managed by other procedures, one had a persistent endoleak despite aortic cuff placement, and the other two were deemed unsuitable for further intervention. Three of the four patients with persistent endoleaks died of sac rupture. At the average follow-up time of 311 days, freedom from endoleak recurrence was 80%, and freedom from sac growth was 85%. CONCLUSIONS: Transcatheter embolization of ELI offers a safe, feasible, and sustainable treatment option for patients who are unsuitable for standard methods of ELI treatment. Additional coil embolization before Onyx injection may result in better outcome.

Development of syndrome of inappropriate antidiuretic hormone secretion (SIADH) after Onyx embolisation of a cavernous carotid fistula.

Patients with cavernous carotid fistulas (CCFs) can present with pituitary hypoperfusion and hypopituitarism; however, there are no previous reports of pituitary or hormonal abnormalities developing after CCF embolisation in an asymptomatic patient. We describe a patient with no hormonal abnormalities who developed syndrome of inappropriate antidiuretic hormone (SIADH) secretion after CCF embolisation. The patient had bilateral indirect CCFs, which were completely embolised via a transvenous approach, and was neurologically stable postoperatively and discharged. In the subsequent 2 weeks the patient was readmitted twice for acute hyponatraemia and a tonic-clonic seizure. Laboratory studies revealed severe SIADH. Clinical status and sodium levels improved after treatment. One year later the patient was weaned off all medications and remained neurologically stable. SIADH may be a delayed phenomenon after CCF embolisation. Given the proximity of embolised vessels to the pituitary's vascular supply, CCF treatment may result in flow disturbance, ischaemia and hormonal abnormalities.

Long-term results of intra-arterial onyx injection for type II endoleaks following endovascular aneurysm repair.

Purpose The aim of this paper is to report our experience of type II endoleak treatment after endovascular aneurysm repair with intra-arterial injection of the embolizing liquid material, Onyx liquid embolic system. Methods From 2005 to 2012, we performed a retrospective review of 600 patients, who underwent endovascular repair of an abdominal aortic aneurysm. During this period, 18 patients were treated with Onyx for type II endoleaks. Principal findings The source of the endoleak was the internal iliac artery in seven cases, inferior mesenteric artery in seven cases and lumbar arteries in four cases. Immediate technical success was achieved in all patients and no endoleak from the treated vessel recurred. During a mean follow-up of 19 months, no major morbidity or mortality occurred, and one-year survival was 100%. Conclusions Treatment of type II endoleaks with Onyx is safe and effective over a significant time period.

Total hip arthroplasty following failure of core decompression and tantalum rod implantation.

AIMS: One method of femoral head preservation following avascular necrosis (AVN) is core decompression and insertion of a tantalum rod. However, there may be a high failure rate associated with this procedure. The purpose of this study was to document the clinical and radiological outcomes following total hip arthroplasty (THA) subsequent to failed tantalum rod insertion. PATIENTS AND METHODS: A total of 37 failed tantalum rods requiring total hip arthroplasty were identified from a prospective database. There were 21 hips in 21 patients (12 men and nine women, mean age 37 years, 18 to 53) meeting minimum two year clinical and radiographic follow-up whose THAs were carried out between November 2002 and April 2013 (mean time between tantalum rod implantation and conversion to a THA was 26 months, 6 to 72). These were matched by age and gender to individuals (12 men, nine women, mean age 40 years, 18 to 58) receiving THA for AVN without prior tantalum rod insertion. RESULTS: There were no functional outcome differences between the two groups. Tantalum residue was identified on all post-operative radiographs in the tantalum group. Linear wear rates were comparable between groups with no evidence of catastrophic wear in either group. CONCLUSION: In the short term, tantalum rod implantation does not demonstrate an adverse effect on subsequent total joint replacement surgery. There is however, a high rate of retained tantalum debris on post-operative radiographs and thus there is an unknown risk of accelerated articular wear necessitating longer term study. Cite this article: Bone Joint J 2016;98-B:1175-9.

In Vitro Biocompatibility of Si Alloyed Multi-Principal Element Carbide Coatings.

In the current study, we have examined the possibility to improve the biocompatibility of the (TiZrNbTaHf)C through replacement of either Ti or Ta by Si. The coatings were deposited on Si and 316L stainless steel substrates by magnetron sputtering in an Ar+CH4 mixed atmosphere and were examined for elemental composition, chemical bonds, surface topography, surface electrical charge and biocompatible characteristics. The net surface charge was evaluated at nano and macroscopic scale by measuring the electrical potential and work function, respectively. The biocompatible tests comprised determination of cell viability and cell attachment to the coated surface. The deposited coatings had C/(metal+Si) ratios close to unity, while a mixture of metallic carbide, free-carbon and oxidized species formed on the film surface. The coatings' surfaces were smooth and no influence of surface roughness on electrical charge or biocompatibility was found. The biocompatible characteristics correlated well with the electrical potential/work function, suggesting a significant role of surface charge in improving biocompatibility, particularly cell attachment to coating's surface. Replacement of either Ti or Ta by Si in the (TiZrNbTaHf)C coating led to an enhanced surface electrical charge, as well as to superior biocompatible properties, with best results for the (TiZrNbSiHf)C coating.

A Proposed Computed Tomography Contrast Agent Using Carboxybetaine Zwitterionic Tantalum Oxide Nanoparticles: Imaging, Biological, and Physicochemical Performance.

OBJECTIVES: The aim of this study was to produce and evaluate a proposed computed tomography (CT) contrast agent based on carboxybetaine zwitterionic (CZ)-coated soluble tantalum oxide (TaO) nanoparticles (NPs). We chose tantalum to provide superior imaging performance compared with current iodine-based clinical CT contrast agents. We developed the CZ coating to provide biological and physical performance similar to that of current iodinated contrast agents. In addition, the aim of this study was to evaluate the imaging, biological, and physicochemical performance of this proposed contrast agent compared with clinically used iodinated agents. MATERIALS AND METHODS: We evaluated CT imaging performance of our CZ-TaO NPs compared with that of an iodinated agent in live rats, imaged centrally located within a tissue-equivalent plastic phantom that simulated a large patient. To evaluate vascular contrast enhancement, we scanned the rats' great vessels at high temporal resolution during and after contrast agent injection. We performed several in vivo CZ-TaO NP studies in healthy rats to evaluate tolerability. These studies included injecting the agent at the anticipated clinical dose (ACD) and at 3 times and 6 times the ACD, followed by longitudinal hematology to assess impact to blood cells and organ function (from 4 hours to 1 week). Kidney histological analysis was performed 48 hours after injection at 3 times the ACD. We measured the elimination half-life of CZ-TaO NPs from blood, and we monitored acute kidney injury biomarkers with a kidney injury assay using urine collected from 4 hours to 1 week. We measured tantalum retention in individual organs and in the whole carcass 48 hours after injection at ACD. Carboxybetaine zwitterionic TaO NPs were synthesized and analyzed in detail. We used multidimensional nuclear magnetic resonance to determine surface functionality of the NPs. We measured NP size and solution properties (osmolality and viscosity) of the agent over a range of tantalum concentrations, including the high concentrations required for standard clinical CT imaging. RESULTS: Computed tomography imaging studies demonstrated image contrast improvement of approximately 40% to 50% using CZ-TaO NPs compared with an iodinated agent injected at the same mass concentration. Blood and organ analyses showed no adverse effects after injection in healthy naive rats at 3 times the ACD. Retention of tantalum at 48 hours after injection was less than 2% of the injected dose in the whole carcass, which very closely matched the reported retention of existing commercial iodine-based contrast agents. Urine analysis of sensitive markers for acute kidney injury showed no responses at 1 week after injection at 3 times the ACD; however, a moderate response in the neutrophil gelatinase-associated lipocalin biomarker was measured at 24 and 48 hours. Compared with other TaO NPs reported in the literature, CZ-TaO NPs had relatively low osmolality and viscosity at concentrations greater than 200 mg Ta/mL and were similar in these physical properties to dimeric iodine-based contrast agents. CONCLUSIONS: We found that a CZ-TaO NP-based contrast agent is potentially viable for general-purpose clinical CT imaging. Our results suggest that such an agent can be formulated with clinically viable physicochemical properties, can be biologically safe and cleared rapidly in urine, and can provide substantially improved image contrast at CT compared with current iodinated agents.

Development of syndrome of inappropriate antidiuretic hormone secretion (SIADH) after Onyx embolisation of a cavernous carotid fistula.

Patients with cavernous carotid fistulas (CCFs) can present with pituitary hypoperfusion and hypopituitarism; however, there are no previous reports of pituitary or hormonal abnormalities developing after CCF embolisation in an asymptomatic patient. We describe a patient with no hormonal abnormalities who developed syndrome of inappropriate antidiuretic hormone (SIADH) secretion after CCF embolisation. The patient had bilateral indirect CCFs, which were completely embolised via a transvenous approach, and was neurologically stable postoperatively and discharged. In the subsequent 2 weeks the patient was readmitted twice for acute hyponatraemia and a tonic-clonic seizure. Laboratory studies revealed severe SIADH. Clinical status and sodium levels improved after treatment. One year later the patient was weaned off all medications and remained neurologically stable. SIADH may be a delayed phenomenon after CCF embolisation. Given the proximity of embolised vessels to the pituitary's vascular supply, CCF treatment may result in flow disturbance, ischaemia and hormonal abnormalities.

Tantalum coating of porous carbon scaffold supplemented with autologous bone marrow stromal stem cells for bone regeneration in vitro and in vivo.

Porous tantalum metal with low elastic modulus is similar to cancellous bone. Reticulated vitreous carbon (RVC) can provide three-dimensional pore structure and serves as the ideal scaffold of tantalum coating. In this study, the biocompatibility of domestic porous tantalum was first successfully tested with bone marrow stromal stem cells (BMSCs) in vitro and for bone tissue repair in vivo. We evaluated cytotoxicity of RVC scaffold and tantalum coating using BMSCs. The morphology, adhesion, and proliferation of BMSCs were observed via laser scanning confocal microscope and scanning electron microscopy. In addition, porous tantalum rods with or without autologous BMSCs were implanted on hind legs in dogs, respectively. The osteogenic potential was observed by hard tissue slice examination. At three weeks and six weeks following implantation, new osteoblasts and new bone were observed at the tantalum-host bone interface and pores. At 12 weeks postporous tantalum with autologous BMSCs implantation, regenerated trabecular equivalent to mature bone was found in the pore of tantalum rods. Our results suggested that domestic porous tantalum had excellent biocompatibility and could promote new bone formation in vivo. Meanwhile, the osteogenesis of porous tantalum associated with autologous BMSCs was more excellent than only tantalum implantation. Future clinical studies are warranted to verify the clinical efficacy of combined implantation of this domestic porous tantalum associated with autologous BMSCs implantation and compare their efficacy with conventional autologous bone grafting carrying blood vessel in patients needing bone repairing.

Tantalum rod implantation for femoral head osteonecrosis: survivorship analysis and determination of prognostic factors for total hip arthroplasty.

PURPOSE: The purpose of this study was to evaluate the moderate survival data of porous tantalum rod implants for the treatment of osteonecrosis of the femoral head (ONFH). Additionally, some independent prognostic factors for conversion to total hip arthroplasty (THA) were identified. METHODS: The porous tantalum rod population was obtained from a prospective, consecutive group of patients treated for Steinberg stage I and II osteonecrosis from April 2009 through July 2011. The historical core decompression and impaction of bone filling particle subjects underwent surgery from April 2007 through March 2009. Surgical data including time of surgery, blood loss, and cell transfusions were recorded. Post-operative values were measured for hospitalization length as well as days requiring a patient-controlled analgesia (PCA) pump. Primary outcomes were Harris hip score and survivorship analysis. Demographics and baseline characteristics included age, sex, etiology, bilateral disease, associated chronic systemic disease, Steinberg stage, Harris hip score, accompanied with bone marrow edema of femoral head, and osteonecrotic lesion size. RESULTS: Demographic/baseline characteristics were similar between two groups. At the post-operative follow-up of 62 months, Harris hip scores were significantly increased (P < 0.0001) when compared to that before surgery in both groups. The magnitude of increase in the tantalum rod implant group was significantly greater than that in the control group (P = 0.0426). With an average follow-up of 48 months (range, 38-62 months), the tantalum rod group had an 84.6 % survival rate. With an average follow-up of 72 months (range, 67-85 months), the control group had a 63.3 % survival rate. A comparison of Kaplan-Meier curves showed significantly higher cumulative survival rates (P = 0.048) for hips with implantation of the porous tantalum rod (74.1 % at 62 months) than for those with impaction composite bone material (49.9 % at 62 months). The Cox proportional-hazard model revealed that implantation of tantalum rod (P = 0.012), bone marrow edema (P = 0.003), corticosteroids intake (P = 0.007), and age less than 50 years (P = 0.014) were the independent prognostic factors related to conversion into THA. CONCLUSIONS: Compared with the traditional impaction composite bone material technique, implantation of tantalum rod in the treatment of Steinberg stages I and II ONFH can obtain better clinical results and higher cumulative survival rates. For patients without the use of corticosteroids, and especially for hips without bone marrow oedema, the clinical results from our study show highly encouraging survival rates and a delay in or prevention of conversion into THA.