Porous Tantalum Implants Research Articles

Additively manufactured porous tantalum implants

The medical device industry’s interest in open porous, metallic biomaterials has increased in response to additive manufacturing techniques enabling the production of complex shapes that cannot be produced with conventional techniques. Tantalum is an important metal for medical devices because of its good biocompatibility. In this study selective laser melting technology was used for the first time to manufacture highly porous pure tantalum implants with fully interconnected open pores. The architecture of the porous structure in combination with the material properties of tantalum result in mechanical properties close to those of human bone and allow for bone ingrowth. The bone regeneration performance of the porous tantalum was evaluated in vivo using an orthotopic load-bearing bone defect model in the rat femur. After 12weeks, substantial bone ingrowth, good quality of the regenerated bone and a strong, functional implant–bone interface connection were observed. Compared to identical porous Ti–6Al–4V structures, laser-melted tantalum shows excellent osteoconductive properties, has a higher normalized fatigue strength and allows for more plastic deformation due to its high ductility. It is therefore concluded that this is a first step towards a new generation of open porous tantalum implants manufactured using selective laser melting.

Acetabular distraction: an alternative approach to pelvic discontinuity in failed total hip replacement.

A pelvic discontinuity occurs when the superior and inferior parts of the hemi-pelvis are no longer connected, which is difficult to manage when associated with a failed total hip replacement. Chronic pelvic discontinuity is found in 0.9% to 2.1% of hip revision cases with risk factors including severe pelvic bone loss, female gender, prior pelvic radiation and rheumatoid arthritis. Common treatment options include: pelvic plating with allograft, cage reconstruction, custom triflange implants, and porous tantalum implants with modular augments. The optimal technique is dependent upon the degree of the discontinuity, the amount of available bone stock and the likelihood of achieving stable healing between the two segments. A method of treating pelvic discontinuity using porous tantalum components with a distraction technique that achieves both initial stability and subsequent long-term biological fixation is described.

The Process of Porous Tantalum Implants Osseous Integration a Review

Porous tantalum is a biomaterial that was recently introduced in orthopaedics in order to overcome problems of the past related to implant loosening. Its use has led to very good results, especially in difficult cases where severe bone defect is present, as it is found to have osteoconductive and possibly, osteoinductive properties. So, it is of great inter est to shed light to the mechanisms through which t his material leads to new bone formation after being im planted. For this reason, a review of the current literature was undertook. Porous tantalum is, biolo gically, relatively inert, meaning that its bonding capacity to the bone is restricted. In order to overcome this o bstacle, it undergoes thermal processing in alkalin e environment. This process leads to extensive hydroxyapatite form ation on its surface and thus, to better integratio n of porous tantalum implants. Apart from this, new bone tissue formation occurs inside the pores of porous tantal um after its implantation and this new bone retains the characte ristics of normal bone, i.e., bone remodeling and H aversian systems formation. This finding is enhanced by the observation that porous tantalum is an appropriate substrate for osteoblast adherence, proliferation and differe ntiation. Furthermore, the finding that osteoblasts derived from old women (>60 years old) and cultivated on porous tantalum may grow faster than osteoblasts taken fro m younger women (<45 years old) and cultivated on other substrates, can partially explain porous tantalu m good performance in cases of patients with severe bone d efects. In conclusion, porous tantalum chemical and mechanical properties are those that, probably, def ine the already noticed good performance of this ma terial. However, further research is needed to totally clar ify the mechanisms through which they contribute to that.

Porous tantalum rods for treating osteonecrosis of the femoral head.

This study evaluated the outcomes of using porous tantalum rods for the treatment of osteonecrosis of the femoral head (ONFH). We performed core decompression and inserted porous tantalum implants in 149 patients (168 consecutive hips) with ONFH. Hips had large (65), medium (64), or small (39) lesions; 63 lesions were lateral, 68 were central, and 35 were medial. Conversion to total hip arthroplasty (THA) was the end point of this survey. A total of 130 cases (138 hips) were followed. The mean follow-up time was 38.46 ± 5.76 months; 43 hips (31%) were converted to or needed THA. Of the 43 hips requiring THA, 33 had large lesions, including 1 medial, 3 central, and 29 lateral lesions; 9 had medium, lateral lesions, and 1 hip had a small, lateral lesion. Bone grafting was used in 59 hips, with 3 hips failing; 40 of 79 hips without bone grafts failed. The sum distances between the tops of the rods and the lateral lesion boundaries (SDTL, mm) were measured in anteroposterior and lateral radiographs. In the failure and spared groups, the average SDTLs were 7.65 ± 2.759 and 0.83 ± 2.286 mm, respectively. The survival of porous tantalum rods used for treating early-stage ONFH was affected by the size and location of the lesion, whether or not a bone graft was used, as well as the distance between top of the rod and the lateral boundary of the lesion.

Management of Metastatic Bone Disease of the Acetabulum

Metastatic acetabular disease can be severely painful and may result in loss of mobility. Initial management may consist of diphosphonates, narcotic analgesics, radiation therapy, protected weight bearing, cementoplasty, and radiofrequency ablation. Patients with disease affecting large weight-bearing regions of the acetabulum and with impending failure of the hip joint are unlikely to gain much relief from nonsurgical treatment and interventional procedures. The profound osteopenia of the acetabulum, limited healing potential of the fracture, and projected patient life span and function necessitate surgical techniques that provide immediate stable fixation to reduce pain and restore ambulatory function. Current reconstructive procedures, including cemented total hip arthroplasty, the saddle or periacetabular endoprosthesis, and porous tantalum implants, are based on the quality of remaining acetabular bone as well as the patient's level of function and general health. Well-executed acetabular reconstructions can provide durable hip joints with good pain relief and function.

Free radicals generated by tantalum implants antagonize the cytotoxic effect of doxorubicin

Little is known about the interaction between antineoplastic drugs and implants in bone cancer patients. We investigated the interaction between commercially available porous tantalum (Ta) implants and the chemotherapeutic drug, Doxorubicin (DOX). DOX solutions were prepared in the presence of Ta implant. The changes in fluorescence intensity of the DOX chromophore were measured by spectrofluorometry and the efficacy of DOX was evaluated by viability of rabbit rectal tumor cells (VX2). After 5 min interaction of the DOX solution (5 μg/ml) with the Ta implant, the fluorescent intensity of the DOX solution was 85% degraded, and only 20% the drug efficacy to kill VX2 cells was retained. However, after adding a reducing agent, Dithiothreitol (DTT, 10 μg/ml), 80% of the original fluorescence and 50% of the drug efficacy were restored while UV irradiation enhanced drug degradation in the presence of Ta implant. The action of DTT and UV irradiation indicated that reactive oxygen species (ROS) were involved in the drug degradation mechanism. We detected that Ta implants in aqueous medium produced hydroxyl radicals. Cells showed higher intracellular ROS activity when culture medium was incubated with the Ta implant prior to cell culture. It is concluded that the porous Ta implant antagonizes the cytotoxicity of DOX via ROS generation of the porous Ta implant.

Subtrochanteric Fracture following Removal of a Porous Tantalum Implant

Osteonecrosis of the hip accounts for about 10% of all total hip arthroplasty cases and presents a significant challenge for those patients with and without femoral head collapse. Subtrochanteric femur fractures have been reported with numerous types of proximal femoral implants. Care must be taken to avoid penetrating the lateral cortex of the proximal femur inferior to the distal border of the lesser trochanter. Core decompression requires a 3 mm to 20 mm defect in the lateral femoral cortex. Subtrochanteric femur fractures are a well-known complication of core decompression as well. We present a case of a subtrochanteric fracture following the removal of a porous tantalum implant.

Osseous integration in porous tantalum implants.

Porous tantalum is a biomaterial that was recently introduced in orthopedics in order to overcome problems related to implant loosening. It is found to have osteoconductive, and possibly, osteoinductive properties hence useful in difficult cases with severe bone defects. So, it is of great interest to shed light on the mechanisms through which this material leads to new bone formation, after being implanted. Porous tantalum is biologically relatively inert, with restricted bonding capacity to the bone is restricted. In order to overcome this obstacle, it undergoes thermal processing in an alkaline environment. This process leads to extensive hydroxyapatite formation on its surface, and thus, to better integration of porous tantalum implants. Apart from this, new bone tissue formation occurs inside the pores of the porous tantalum after its implantation and this new bone retains the characteristics of the normal bone, that is, bone remodeling and Haversian systems formation. This finding is enhanced by the observation that porous tantalum is an appropriate substrate for osteoblast adherence, proliferation, and differentiation. Furthermore, the finding that osteoblasts derived from old women (> 60 years old) and cultivated on porous tantalum may grow faster than osteoblasts taken from younger women (< 45 years old) and cultivated on other substrates, can partially explain porous tantalum's good performance in cases of patients with severe bone defects. In conclusion, porous tantalum's chemical and mechanical properties are those that probably define the already noticed good performance of this material. However, further research is needed to totally clarify the mechanisms.

Host Bone Response to Polyetheretherketone Versus Porous Tantalum Implants for Cervical Spinal Fusion in a Goat Model

In vivo assessment of polyetheretherketone (PEEK) and porous tantalum (TM) cervical interbody fusion devices in a goat model. Directly compare host bone response to PEEK and TM devices used for cervical interbody fusion. PEEK devices are widely used for anterior cervical discectomy and fusion but are nonporous and have limited surface area for bone attachment. Twenty-five goats underwent single-level anterior cervical discectomy and fusion and were alternately implanted with TM (n = 13) or PEEK devices (n = 12) for 6, 12, and 26 weeks. Both devices contained a center graft hole (GH), filled with autograft bone from the animal's own iliac crest. The percentage of bone tissue around the implant, percentage of the implant surface in direct apposition with the host bone, and evidence of bone bridging through the implant GH were assessed by using backscattered electron imaging. Bone matrix mineral apposition rate was determined through fluorochrome double labeling, and sections were stained for histological analysis. The TM-implanted animals had significantly greater volumes of bone tissue at the implant interface than the PEEK animals at all-time points. The TM animals also had a significantly greater average mineral apposition rate in the GH region at 6 and 12 weeks than the PEEK animals. No difference was observed at 26 weeks. A greater number of TM-implanted animals demonstrated connection between the autograft bone and both vertebrae compared with the PEEK implants. Histological staining also showed that the TM devices elicited improved host bone attachment over the PEEK implants. The TM implants supported bone growth into and around the implant margins better than the PEEK devices. TM's open cell porous structure facilitated host bone ingrowth and bone bridging through the device, which could be beneficial for long-term mechanical attachment and support in clinical applications.

Electrostatic self-assembly of multilayer copolymeric membranes on the surface of porous tantalum implants for sustained release of doxorubicin

Many studies in recent years have focused on surface engineering of implant materials in order to improve their biocompatibility and other performance. Porous tantalum implants have increasingly been used in implant surgeries, due to their biocompatibility, physical stability, and good mechanical strength. In this study we functionalized the porous tantalum implant for sustained drug delivery capability via electrostatic self-assembly of polyelectrolytes of hyaluronic acid, methylated collagen, and terpolymer on the surface of a porous tantalum implant. The anticancer drug doxorubicin was encapsulated into the multilayer copolymer membranes on the porous tantalum implants. Results showed the sustained released of doxorubicin from the functionalized porous tantalum implants for up to 1 month. The drug release solutions in 1 month all had inhibitory effects on the proliferation of chondrosarcoma cell line SW1353. These results suggest that this functionalized implant could be used in reconstructive surgery for the treatment of bone tumor as a local, sustained drug delivery system.

Porous tantalum stimulates the proliferation and osteogenesis of osteoblasts from elderly female patients

Porous tantalum (Ta) implants have been successful in various orthopedic procedures for patients with compromised bone-forming abilities. Previous studies demonstrated that human osteoblast (HOB) cultures from older female patients produced less bone on implant materials in vitro compared to HOBs from age-matched male and younger female patients. In this study, the responses of HOBs from younger (< 45) and older (> 60 years old) female patients were compared on Ta, titanium fiber mesh (TFM) and tissue culture plastic. Adhesion, proliferation, and mineralization were greater in cells from younger patients than from older patients. Cell adhesion was slightly higher on Ta than TFM or plastic. However, Ta highly stimulated cell proliferation with a 4- and 6-fold increase compared to TFM for cells from younger and older patients, respectively, and 12- and 16-fold increase in proliferation compared to cells on plastic (p ≤ 0.001). At 3 weeks, mineralization was significantly higher on Ta compared to TFM for HOBs from older patients (p ≤ 0.05). Expression levels of bone matrix markers demonstrated differences dependent on age and substrate. Scanning electron micrographs revealed HOBs covering the surfaces and entering the pores of both Ta and TFM. In conclusion, tantalum greatly stimulates cell proliferation, and improves the ability of HOBs from older patients to form bone.

Effect of a porous tantalum rod on early and intermediate stages of necrosis of the femoral head

The aim of this study was to evaluate the effect of a porous tantalum rod implant for the treatment of early femoral head necrosis. From April 2007 to June 2009, a total of 35 femoral head necrosis patients (with 49 hips) were treated with core decompression in combination with the insertion of a porous tantalum rod. The mean age was 38.2 years (22–50 years) and the mean follow-up period was 15.2 months (12–36 months). The surgical time and blood loss were recorded. The Harris hip scores and radiological results were adopted for evaluation. The mean surgical time was 35 min, and the mean blood loss was 50 ml. The mean Harris score improved from 48.3 ± 3.2 preoperative to 83.7 ± 4.1 at the last follow-up (p < 0.05). Eight affected hips exhibited progressive pain including three hips that progressed to femoral collapse, and one revision followed by total hip arthroplasty (THA). For the patient who underwent revision and THA, the articular cartilage surface was seen to be damaged and fragmented. High-density metal particle residuals were observed on radiograph in the bone channel and femoral marrow cavity. We conclude that the selection criteria for porous tantalum implants should be early and intermediate stages of femoral head necrosis. Further study is warranted to reveal whether the metal particles released play a role in the progression of pain and failure.

Trabecular Metal Endoprosthetic Limb Salvage Reconstruction of the Lower Limb

Currently, porous tantalum (trabecular metal) implants are widely accepted and frequently used for primary and revision hip and knee replacement surgery. This study examines the results of porous tantalum endoprostheses used to reconstruct large skeletal defects following resection of bone tumors. Seven custom tantalum implants were used to reconstruct 7 patients following resection for skeletal sarcomas in the femur and proximal tibia. Patient ages ranged from 13 to 71, with a mean of 34 years. Minimum patient follow-up was 6 years. The average Musculoskeletal Tumor Society functional evaluation score was 95 % of normal. There were no infections, hardware failures, or adverse events. One implant was revised 98 months post insertion because of fibrosis, loss of motion and loosening. In this small clinical series, the use of porous tantalum for limb salvage reconstruction is shown to be safe, to successfully provide osteointegration and soft tissue ingrowth, and to facilitate return of limb girdle muscle function.

Histopathologic Retrieval Analysis of Clinically Failed Porous Tantalum Osteonecrosis Implants

An Osteonecrosis Intervention Implant made of porous tantalum was recently developed to provide structural support and a compatible surface for tissue ingrowth in osteonecrotic femoral heads. From an investigational device exemption study that comprised 113 implants, we carried out a retrieval analysis of clinically failed implants. Seventeen porous tantalum implants that had been used for the treatment of Steinberg stage-II osteonecrosis of the hip were retrieved at the time of conversion to a total hip arthroplasty. Fifteen implants that had been transected near the base of the femoral neck with the proximal portion left in situ within the femoral head underwent histopathologic analysis at an average of 13.4 months (range, three to thirty-six months) after implantation. Residual osteonecrosis was present in fourteen of the fifteen specimens. Fracture of the subchondral bone of the femoral head was present in all instances, and collapse of the femoral head was present in nine instances (60%). Backscattered scanning electron microscopy confirmed the presence of bone ingrowth in thirteen (87%) of the fifteen specimens. The mean extent of bone ingrowth was 1.9% (range, 0% to 4.4%). The retrieved implants were associated with little bone ingrowth and insufficient mechanical support of subchondral bone. The implant design, the surgical technique, its application, and the clinical characteristics of candidates for this procedure should continue to be monitored closely.

Enhanced Gap Filling and Osteoconduction Associated with Alendronate-Calcium Phosphate-Coated Porous Tantalum

Porous tantalum has been shown to be effective in achieving bone ingrowth. However, in some circumstances, bone quality or quantity may be insufficient to allow adequate bone ingrowth. We hypothesized that local delivery of alendronate from porous tantalum would enhance the ability of the tantalum to achieve bone ingrowth when there is a gap between the implant and bone. We evaluated the effect of alendronate-coated porous tantalum on new bone formation in an animal model incorporating a gap between the implant and bone. A cylindrical porous tantalum implant was implanted in the distal part of each femur in eighteen rabbits (a total of thirty-six implants) and left in situ for four weeks. Three types of porous tantalum implants were inserted: those with no coating (the control group), those with microporous calcium phosphate coating, and those coated with microporous calcium phosphate and alendronate. Subcutaneous fluorescent labeling was used to track new bone formation. Bone formation was analyzed with backscattered electron microscopy and fluorescent microscopy of undecalcified samples. The relative increases in the mean volume of gap filling, bone ingrowth, and total bone formation in the group treated with the porous tantalum implants coated with calcium phosphate and alendronate were 143% (p < 0.001), 259% (p < 0.001), and 193% (p < 0.001), respectively, compared with the values in the control group treated with the uncoated porous tantalum implants. The percentage of the length of the implant that was in contact with new bone in the group treated with the calcium phosphate and alendronate coating was increased by an average of 804% compared with the percentage in the group treated with the uncoated implants. The study demonstrated significantly enhanced filling of the bone-implant gap and bone ingrowth in association with the porous tantalum implants coated with calcium phosphate and alendronate.

Options for Acetabular Fixation Surfaces

Aseptic loosening is the most common cause for revision total hip arthroplasty (THA). Due to poor long-term results with cemented acetabular components, cementless implants that rely on biologic fixation became popular in the United States for both primary and revision procedures in the early 1980s. Cementless acetabular components used in THA have been reported to have superior radiographic performance compared with cemented fixation, although the optimal method of acetabular fixation remains controversial. Cementless acetabular components require initial implant stability to allow for bone ingrowth and remodeling into the acetabular shell, providing long-term durability of the prosthesis. Many improved implant materials are available to facilitate bone growth and remodeling, including the 3 most common surface treatments; fibermesh, sintered beads, and plasma spray coatings. Recently added to these are porous metal surfaces, which have increased porosity and optimal pore sizes when compared with titanium fibermesh. The most studied of these materials is the titanium fibermesh fixation surface, which has demonstrated a mechanical failure rate of 1% at 10 to 15 years. This technology utilizes the diffusion bonding process to attach fiber metal pads to a titanium substrate using heat and pressure. The sintered bead fixation surface offers a porous coating of various sizes of spherical beads, achieved by the sintering process, and has been shown to provide long-term fixation. While there are less long-term published data regarding the titanium plasma spray surface, its early results have provided evidence of its durability, even in the face of significant osteolysis. The most recently added alternative fixation surface is porous tantalum metal, which offers potentially greater bone ingrowth and bone graft incorporation due to its high porosity (80%) and low modulus of elasticity (3 MPa). Porous tantalum implants have shown early favorable clinical results and have been reported to have excellent bone graft incorporation of the acetabular component based on serial radiograph data at a minimum 1-year follow-up. Tritanium is a porous metal, which has emerged as a promising new surface technology for acetabular shells. While no clinical data are yet available, basic science research has demonstrated enhanced bone ingrowth and mechanical strength.

Porous Tantalum Implant in Early Osteonecrosis of the Hip: Preliminary Report on Operative, Survival, and Outcomes Results

Porous tantalum implants are used in early osteonecrosis of the hip. Device evaluation included surgical time, blood loss, hospitalization, patient-controlled analgesia use, transfusions, implant survival, and outcomes. Mean blood loss was 70 mL. Mean operative time was 36 minutes. Average hospitalization was less than 1 day. No patient required patient-controlled analgesia use or transfusions. Results were compared to a historical vascularized fibular graft population. All parameters were less than the fibular graft groups ( P < .00001). All surviving implants (86%) resulted in good to excellent outcomes. Kaplan-Meier analysis at 39 months was 86% and 67% for the implant and fibular graft, respectively ( P = .21). Early outcomes demonstrate that porous tantalum implants are a safe option for femoral head salvage. Continued follow-up is necessary to determine the long-term success.

Bone Nanostructure near Titanium and porous Tantalum implants studied by Scanning small angle x-ray scattering

Bone sections including either titanium or porous tantalum implant devices used for interbody spinal fusion were investigated with position-resolved small angle X-ray scattering (sSAXS). The samples were obtained from six-month-old pigs that had undergone surgery three months prior to sacrifice. The aim of the study was to explore the possibility of using sSAXS to obtain information about thickness, orientation and shape/arrangement of the mineral crystals in bone near the implant surfaces. Detailed sSAXS scans were carried out in two different regions of bone adjacent to the implant in each of the implant samples. In the implant vicinity the mineral crystals tended to be aligned with the surface of the implants. The mean crystal thickness was between 2.1 and 3.0 nm. The mineral crystal thickness increased linearly with distance from the implant in both regions of the porous tantalum implant and in one of the regions in the titanium sample. In the second region of the titanium sample the thickest mineral crystals were found close to the implant surface. The observed differences in mineral thickness with distance from the implant surfaces might be explained by differences in mechanical load induced by the implant material and the geometrical design of the implant. The study shows that sSAXS is a powerful tool to characterize the nanostructure of bone near implant surfaces.

Evaluation of machining methods for trabecular metal implants in a rabbit intramedullary osseointegration model

Implant success is dependent in part on the interaction of the implant with the surrounding tissues. Porous tantalum implants (Trabecular Metal, TM) have been shown to have excellent osseointegration. Machining this material to complex shapes with close tolerances is difficult because of its open structure and the ductile nature of metallic tantalum. Conventional machining results in occlusion of most of the surface porosity by the smearing of soft metal. This study compared TM samples finished by three processing techniques: conventional machining, electrical discharge machining, and nonmachined, "as-prepared." The TM samples were studied in a rabbit distal femoral intramedullary osseointegration model and in cell culture. We assessed the effects of these machining methods at 4, 8, and 12 weeks after implant placement. The finishing technique had a profound effect on the physical presentation of the implant interface: conventional machining reduced surface porosity to 30% compared to bulk porosities in the 70% range. Bone ongrowth was similar in all groups, while bone ingrowth was significantly greater in the nonmachined samples. The resulting mechanical properties of the bone implant-interface were similar in all three groups, with only interface stiffness and interface shear modulus being significantly higher in the machined samples.

Biomechanical and Clinical Evaluations of a Porous Tantalum Implant for the Treatment of Early-Stage Osteonecrosis

O steonecrosis of the femoral head is a debilitating disease, caused by disruption of the blood supply to the femoral head, that typically affects the younger population1,2. Etiologies include alcoholism, use of steroidal drugs, trauma, blood disorders, radiation therapy, and dysbaria1-3. In the United States, it is estimated that 10,000 to 30,000 cases occur annually and that 5% to 12% of total hip arthroplasties are performed to treat the disease2. Surgical intervention is likely to be more effective when performed in the early stages of osteonecrosis, prior to collapse of the femoral head and subchondral plate. In these early stages, the pathological process is usually confined to a wedge-shaped area of necrosis in the superior weight-bearing portion of the femoral head. As the disease progresses, this area is subject to collapse and the occurrence of a fracture at the junction of living and dead bone. The treatment of osteonecrosis depends on the stage of the disease and the preference of the surgeon. Treatment options include restricted weight-bearing, core decompression, osteotomy, bone-grafting, vascularized bone-grafting, electrical stimulation, surface replacement, and total hip arthroplasty1. The two most common interventions are core decompression, as originally pioneered by Arlet and Ficat, and one of several bone-grafting techniques. The disadvantage of core decompression alone is the lack of structural support to the subchondral plate, whereas the disadvantages of vascularized fibular grafting include the morbidity associated with graft harvest, the substantial time needed for surgery, blood loss, and complications encountered during rehabilitation4,5. The purpose of the present study was to evaluate the biomechanical characteristics, clinical results, and survival rates associated with a porous tantalum implant used for the treatment of early-stage osteonecrosis of the femoral head. The implant is made wholly …