Introduction

The objective of this study was to compare the performance of the Explant Acetabular Cup Removal System (Zimmer), which has been the favored system for many surgeons during hip revision surgery, and the new EZout Powered Acetabular Revision System (Stryker).

This video presentation serves to illustrate the pertinent aspects of bone preparation and implant insertion in cementless total knee arthroplasty (TKA) utilizing porous tantalum as a fixation surface integral to the success of the procedure.

The patient is typical of the surgical candidate frequently encountered for arthroplasty—a 60-year-old female with three compartment osteoarthritis of the knee, and manifesting a 10-degree varus deformity and 5-degree flexion contracture. She is a limited community ambulator without the use of support.

A standard surgical exposure is utilised and the bone preparation is identical to that used in the fixation of cemented implants—no alignment guides, cutting guides, or referencing instrumentation is used that is unique in the femoral or tibial bone preparation. The principal difference is in the patellar preparation. Instrumentation unique to the cementless porous tantalum patella is utilised in order to achieve three goals: a composite implant/residual bone thickness that replicates the thickness of the native patella, the generation of a planar patellar resection that is parallel to the anterior cut of the femur, and secure initial stability of fixation.

Keys to the initial fixation of the porous tantalum tibial and patellar components include the high surface friction of the material against bone, as well as the interference between the hexagonal pegs of each implant within the fixation holes (which are dimensionally smaller in diameter than the major and minor dimensions of the peg geometry). Care must be instituted to ensure that no bone or soft tissue debris is interposed at the mating surfaces of the implants that would compromise interface contact, and to carefully suction the peg holes to ensure that no debris impedes the complete seating of the pegs and the prosthesis. Lastly, all mating surfaces at the implant/bone interface must approach each other in a parallel fashion to optimise contact between the fixation surfaces and the bone resection surfaces.

The procedure is simply, easily performed, and is time saving. Total elapsed time for insertion of all three TKA implants in this video is 90 seconds.

Total knee arthroplasty (TKA) is a successful operation associated with a high rate of clinical success and long-term durability. Cementless technology for TKA was first explored 30 years ago with the hope of simplifying the performance of the procedure and reducing an interface for potential failure by eliminating the use of cement. Poor implant design and the use of first generation biomaterials have been implicated in many early failures of these prostheses due to aseptic loosening and reflected the failure of either the tibial or patellar component. Despite this, many excellent intermediate and long-term series have clearly demonstrated the ability of cementless TKA to perform well with good to excellent survival, comparable to that of cemented designs.

Lessons learned from the initial experiences with cementless technology in TKA have led to improvements in prosthetic design and materials development. One of the most innovative biomaterials introduced into orthopaedics for cementless fixation is porous tantalum. Compared to other commonly used materials for cementless fixation, porous tantalum has the highest surface friction against bone, optimizing initial stability at the implant-bone interface as a prerequisite for long-term stability of the reconstruction.

At the 2013 AAOS Annual Meeting, Abdel presented the 5-year Mayo Clinic experience with cementless TKA utilizing a highly porous monoblock tibial component in 117 knees and found NO difference in survivorship compared to cemented fixation with a re-operation rate of 3.5% in both groups. They had no revisions for aseptic loosening. These early to intermediate results reflect our own experience with all cementless TKA utilizing a cobalt-chromium fibermesh femoral component, as well as monoblock porous tantalum tibial and patellar components with up to 11-year follow up. In that series of 115 patients, there was a 95.7% survival of implants, with no revisions of any components for aseptic loosening.

Further advantages to using cementless fixation include the elimination of concerns with regard to monomer-induced hypotension, thermal necrosis from PMMA polymerization, and third body wear secondary to retained or fragmented cement. Savings are also realised from elimination of the costs of cement, a PMMA mixing system, cement gun, pulse lavage system, and irrigation solution. Perhaps the greatest cost savings is derived from the reduction in operating room time. At our institution–a Level 1 county trauma center with an orthopaedic residency training program–we typically spend an average of 19 minutes of operating room time for the cementing of a total knee arthroplasty. Our average time expended for insertion of all three cementless implants is 47 seconds–representing a significant savings in the hospital operating room time charge. From the standpoint of the patient, the shorter operating time reduces the time under anesthesia, the blood loss, the risk of venous thromboembolism, as well as the infection risk–optimizing the conditions for a reduction in post-operative complications, directly impacting a potential reduction in morbidity and mortality.

Overall, the performance of all cementless TKA at our facility is cost-saving, is easily performed and reproduced by orthopaedic residents, and brings potential advantages to the patient in the form of a reduction in complications and an improvement in outcomes. Cementless fixation is the wave of the future, and the future is now.

Our American Academy of Orthopaedic Surgeons (AAOS) and the American College of Chest Physicians (ACCP) have come to a consensus that the use of routine prophylaxis against venous thromboembolism (VTE) is indicated for our patients undergoing total joint arthroplasty. The new guidelines acknowledge differences in efficacy of the various agents and the variable risk of VTE among patients. Agents include warfarin, low molecular weight heparin, aspirin, oral Xa inhibitors, and direct thrombin inhibitors. The use of pneumatic compression devices have been found to be effective in decreasing risk of deep vein thrombosis (DVT) as a stand-alone strategy after total knee arthroplasty (TKA) and is given a level 1C recommendation by ACCP while the data is less strong for use following total hip arthroplasty (THA). Mechanical devices are not associated with an increased bleeding risk, and address the concerns of some surgeons with regard to post-operative bleeding. The availability of mobile compression devices has expanded the indications for use as a result of portability.

While the use of mobile pump technology in DVT prophylaxis adds to the armamentarium of tools available for use in VTE risk mitigation, it does not eliminate the need for pharmacologic prophylaxis. While all arthroplasty patients are at elevated risk of VTE, the highest risk is associated with those having a prior history of DVT or pulmonary embolism (PE), having had prior surgery within the preceding three months, or requiring prolonged immobilization post-operatively for any reason. In these patients, thromboprophylaxis with any of a number of agents will play a valuable role in VTE risk reduction. Additionally, not all patients tolerate the use of the pump device. Those individuals with chronic peripheral arterial disease or arterial ulcers in the legs are also poor candidates for mechanical compression strategies which may exacerbate existing vascular compromise and perfusion of the limb. Assessment of the medical comorbidities of the patient may also stratify them to higher risk where the demonstrated benefits of pharmacologic prophylaxis outweigh the considerations of bleeding associated with their use (such as in the morbidly obese/high BMI patients).

Mobile pump technology is a valuable adjunct to our VTE reduction strategies, but do not eliminate the need for pharmacologic agents. The judicious selection of DVT prophylaxis strategies based on the totality of the constellation of orthopaedic and medical factors unique to each patient allows us to make clinical decisions tailored to their needs, their risk of VTE, and their reliability in functioning as an active partner in their own post-operative care.

Introduction: Venous thromboembolism (VTE) after major orthopaedic surgery remains an important clinical problem. Convenient, oral antithrombotic agents that are both safe and effective could improve adherence to guidelines for VTE prevention. Recently, the focus has been on the development of oral agents that target a single step in the coagulation cascade. Factor Xa is the pivotal point in the coagulation cascade, making it a particularly attractive target for anticoagulant drugs. Rivaroxaban is an oral, direct Factor Xa inhibitor. Four international phase III trials (the RECORD programme) are being undertaken to investigate the safety and efficacy of once-daily rivaroxaban for thromboprophylaxis after major orthopaedic surgery. The results of RECORD3 showed that rivaroxaban was more effective than enoxaparin 40 mg once daily after total knee replacement (TKR), with a 48% risk reduction in VTE and all cause mortality. RECORD4 is designed to compare rivaroxaban 10mg once daily with enoxaparin 30 mg every 12 hours for thromboprophylaxis following TKR.

Methods: RECORD4 is a prospective, double-blind trial in which approximately 3000 TKR patients worldwide are being studied. Patients are randomized to receive either oral rivaroxaban 10 mg (starting 6–8 hours after surgery and continued once daily), or subcutaneous enoxaparin 30 mg (given every 12 hours and starting 12–24 hours after surgery). Study medication is given for 10–14 days, and mandatory bilateral venography is undertaken the following day. The primary efficacy outcome is a composite of deep vein thrombosis (DVT; symptomatic, or detected by mandatory venography), non-fatal pulmonary embolism (PE), and all-cause mortality. The major secondary efficacy outcome is major VTE (the composite of proximal DVT, PE and VTE-related death). The primary safety outcome is major bleeding. Other safety endpoints include all bleeding events, cardiovascular events and abnormal laboratory parameters.

Results: The final results of this trial will be presented.

Conclusions: The results of this trial will provide valuable data concerning the use of rivaroxaban for thromboprophylaxis after TKR in the North American setting.

In this report, porous tantalum was used to achieve abductor tendon reattachment to structural allograft of the proximal femur in salvage reconstruction of a failed total hip arthroplasty.

In each case, a porous tantalum segment with trapezoidal cross section was fixed to a dovetail joint of complementary geometry cut into the lateral greater trochanter. Fixation of the porous tantalum to the allograft was supplemented with polymethylmethacrylate cement. Residual abductors were mobilized from the surrounding soft tissues and secured against the porous tantalum segment with a short greater trochanteric reattachment device and cables.

Patients were followed up at 73 and 80 months. Harris Hip Scores of 74 and 80 respectively were found. Both were unlimited community ambulators without support, had negative Trendelenberg signs, and were satisfied with the clinical outcomes.

This preliminary experience suggests that porous tantalum has potential application in cases of severe proximal femoral bone loss involving abductor deficiency.

Rivaroxaban is an oral, direct Factor Xa inhibitor in clinical development for the prevention of VTE after major orthopaedic surgery. Data from three phase II trials of twice-daily (bid) rivaroxaban in patients undergoing elective, total hip or knee replacement were pooled to determine whether age, gender or weight affected the efficacy or safety of rivaroxaban, and thus whether dose adjustment would be necessary. Patients received 5–9 days of oral rivaroxaban (2.5–30 mg bid, post-operatively), or s.c. enoxaparin. A logistic regression model using total daily dose of rivaroxaban as a covariate, and adjusted for differences between dose groups with respect to study, age and gender, was used to estimate rates of the primary efficacy endpoint (DVT, PE or all-cause mortality; n=1380 intention-to-treat patients) and clinically relevant bleeding (major and non-major clinically relevant bleeding; safety population, n=1854). Rivaroxaban at total daily doses of 5–20 mg had similar efficacy and safety to enoxaparin. Overall, logistic regression showed a positive dose–response relationship with rivaroxaban for clinically relevant bleeding (p< 0.001), and a flat relationship for the primary efficacy endpoint (p=0.115). The risk of VTE increased with age – the efficacy endpoint was estimated to occur in 17.3–9.4%, 18.7–17.3% and 26.6–20.2% of patients aged < 60 yrs, 60–70 yrs and > 70 yrs receiving rivaroxaban (total daily dose 5–60 mg), respectively, in separate regression models. Age was also prognostic for clinically relevant bleeding with rates of 1.4–12.0% (< 60 yrs), 2.7–15.4% (60–70 yrs) and 5.7–15.4% (> 70 yrs). The rates are for a population distributed equally across the studies and genders. Incidences of the efficacy endpoint were higher in females (25.8–20.5%) than males (16.6–10.7%), while clinically relevant bleeding occurred more frequently in males (5.4–16.3%) than in females (1.7–11.6%), after adjustment for age. Weight was not prognostic for the efficacy endpoint or clinically relevant bleeding (p=0.87 and p=0.48, respectively, after adjustment for age, gender and study), nor did it modify the dose–response relationships with rivaroxaban. Incidences of the efficacy endpoint for a population of equal study and gender distribution and of mean patient age were 23.4–15.7% and 19.1–14.6% in patients weighing < 65 kg and ≥90 kg, respectively, with corresponding bleeding rates of 3.3–16.5% and 3.2–17.5%. This analysis indicates that age, gender or weight did not affect the dose–response relationships (or lack thereof) between rivaroxaban and the primary efficacy endpoint or clinically relevant bleeding. As expected, age was prognostic for VTE and bleeding. These findings suggest that rivaroxaban may not require dose adjustment for age, gender or weight in orthopaedic patients.

Routine prophylaxis is recommended to prevent venous thromboembolism (VTE) – manifesting as deep vein thrombosis (DVT) and/or pulmonary embolism (PE) – in patients undergoing major orthopaedic surgery. Rivaroxaban (BAY 59-7939) is a novel, oral, direct Factor Xa inhibitor in development for the prevention and treatment of VTE. The efficacy and safety of 5–9 days’ prophylaxis with rivaroxaban were investigated in three randomized, double-blind, phase IIb trials in patients undergoing elective, total hip or knee replacement (THR or TKR), relative to subcutaneous enoxaparin.

Two trials (one in patients undergoing THR, N=722; and one in patients undergoing TKR, N=621) investigated twice-daily (bid) rivaroxaban (at total daily doses of 5–60 mg); the third (in patients undergoing THR, N=873) investigated once-daily (od) rivaroxaban (at doses of 5, 10, 20, 30 or 40 mg od).

Rivaroxaban – at all doses tested – had similar efficacy to enoxaparin in the bid trials. This promising finding was strengthened by the od trial, in which the observed incidences of the primary efficacy endpoint (DVT, non-fatal PE or all-cause mortality) were lower in patients receiving rivaroxaban 5, 10, 20, 30 and 40 mg od (14.9%, 10.6%, 8.5%, 13.5% and 6.4%, respectively) than enoxaparin (25.2%). Although there was no significant dose–response relationship between rivaroxaban and the primary efficacy endpoint in these trials, there was with major VTE (proximal DVT, PE or VTE-related death; p=0.0072) in the od trial (incidences were 8.5%, 2.7%, 0.9%, 1.9% and 1.1% with rivaroxaban 5, 10, 20, 30 and 40 mg od, respectively, vs 2.8% with enoxaparin).

Significant dose–response relationships between rivaroxaban and major bleeding were observed in all three trials. In the bid trials, major bleeding rates with rivaroxaban were similar to those with enoxaparin at total daily doses of 5–20 mg. In the od trial, major bleeding occurred in 2.3%, 0.7%, 4.3%, 4.9% and 5.1% of patients receiving rivaroxaban 5, 10, 20, 30 and 40 mg od, respectively, and in 1.9% of those receiving enoxaparin.

Rivaroxaban was generally well tolerated in the bid and od trials, and the incidence of nausea and vomiting with early post-operative oral rivaroxaban administration was low for all doses tested.

The bid trials suggest that oral rivaroxaban at total daily doses of 5–20 mg may be a safe and effective alternative to enoxaparin for the prevention of VTE after major orthopaedic surgery. The od trial suggests that the more-convenient od regimen is feasible and that 10 mg od, a dose within the range identified by the bid trials, should be investigated further. As a result, oral rivaroxaban 10 mg od is currently being investigated in four phase III trials for the prevention of VTE after major orthopaedic surgery (the RECORD trials).

Introduction and Aims: Currently, multiple femoral component types and sizes exist for primary total hip arthroplasty. However, component sizes for small femoral geometry are generally not available. The purpose of this study is to present the short-term use of a femoral component with sizes that extend into small femoral morphometry applications.

Method: Between November 2001 and December 2003, 20 primary THA cases and three revision THA cases were performed utilising a non-cemented, dual threaded, cone shaped (DTCS) modular femoral component manufactured in off-the-shelf sizes, which include those sizes for small femora. The components are made of CoCr and include a size ‘Z’ (19mm proximal, 9mm distal) and a size ‘Y’ (17mm proximal, 8mm distal). Both components have hydroxyapatite coating for stimulating increased bone on-growth and a modular neck allowing intra-operative adjustments of leg length, version, offset and neck length.

Results: The average patient follow-up was 10 months (range 64 days to 27 months). There were 19 (83%) hips in which the ‘Z’ component was used, and four (17%) hips with the ‘Y’ component. Radiographic evaluation revealed well-fixed and positioned components with evidence of bone densing in areas in intimate contact with the DTCS component. Radiographic evidence of minor stress shielding was observed in the greater trochanter (Gruen Zone 1) and the proximal calcar/neck cut region (Gruen Zone 7). Two revision cases (8%) required the additional use of a 6cm modular extension component (MEC) to bridge a proximal femoral deficiency. Two cases (8%) required adjunctive strut allografting at the time of surgery to protect a thin or deficient femoral cortex. There were no reported postoperative complications related to the femoral component. There was no disassociation of the modular neck from the femoral stem and there was no incidence of femoral component fracture.

Conclusion: While expanding component profile offerings into larger sizes is common, developing similar component designs for abnormally small femora is uncommon, beyond the scope of the materials used and only done as a ‘custom’ order. The DTCS modular femoral component used affords a versatile option when presented with cases involving small femoral morphometry. We conclude that the DTCS component in smaller sizes is promising and warranted for continued use.

The radiographic and histological features of radiolucent areas at the cement-bone interface were correlated in 15 specimens retrieved at post-mortem from patients who had undergone cemented total hip arthroplasty, two weeks to 15 years prior to death. All but one of the components were securely fixed, as demonstrated by direct measurements of micromotion. Extensive radiolucencies were present in all but one case. In 11 of the 14 specimens with radiolucencies, histological examination showed that the radiolucent areas represented regions of osteoporosis and bone remodelling. The remodelling changes were characterised by osteoporosis, cancellisation and thinning of the endosteal cortex, and osteopenia of the trabecular bone. In two specimens the appearance of radiolucency was found to be due to fibrous tissue at the cement-bone interface and in one specimen there was a mixed picture of osteolysis and fibrosis. The study demonstrates that radiolucent lines can occur with well-fixed components and that they may commonly represent osteoporosis rather than the presence of a fibrous membrane at the cement-bone interface.