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Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_9 | Pages 18 - 18
1 Jun 2021
Cushner F Schiller P Gross J Mueller J Hunter W
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PROBLEM

Since the COVID-19 pandemic of 2020, there has been a marked rise in the use of telemedicine to evaluate patients following total knee arthroplasty (TKA). Telemedicine is helpful to maintain patient contact, but it cannot provide objective functional TKA data. External monitoring devices can be used, but in the past have had mixed results due to patient compliance and data continuity, particularly for monitoring over numerous years. This novel stem is a translational product with an embedded sensor that can remotely monitor patient activity following TKA

SOLUTION

The Canturio™ TE∗ System (Canary Medical) functions structurally as a tibial extension for the Persona® cemented tibial plate (Zimmer Biomet). The stem is instrumented with internal motion sensors (3-D accelerometer and gyroscope) and telemetry that collects and transmits kinematic data. Raw data is converted by analytics into clinically relevant gait metrics using a proprietary algorithm. The Canturio™ TE∗ will monitor the patient's gait daily for the first year and then with lower frequency thereafter to conserve battery power enabling the potential for 20 years of longitudinal data collection and analysis. A base station in the OR activates the device and links the stem and data to the patient. A base station in the patient's home collects and uploads data to the Cloud Based Canary Data Management Platform (Canary Medical). The Canary Cloud is structured as an FDA regulated and HIPPA-compliant database with cybersecurity protocols integrated into the architecture. A third base station is an accessory used in the health care professional's office to perform an on-demand gait analysis of a patient. A dashboard allows the health care professional and patient to monitor objective data of the patient's activity and progress post treatment.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_5 | Pages 2 - 2
1 Mar 2021
Higuera-Rueda C Emara A Nieves-Malloure Y Klika AK Cooper H Cross M Guild G Nam D Nett M Scuderi G Cushner F Silverman R
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Aim

This was a multicenter, randomized, clinical trial to compare the 90-day 1) incidence of surgical site complications (SSC); 2) health care utilization (the number of dressing changes, readmission, and reoperation); and 3) the patient-reported outcomes (PRO) in high-risk patients undergoing revision total knee arthroplasty (rTKA) with postoperative closed incision negative pressure wound therapy (ciNPT) versus a standard of care (SOC) silver-impregnated occlusive dressing.

Method

A total of 294 rTKA patients (15 centers) at high-risk for wound complications were prospectively randomized to receive either SOC or ciNPT (n = 147 each). The ciNPT system was adjusted at 125 mmHg of suction. Investigated outcomes were assessed weekly up to 90 days after surgery. A preset interim analysis was conducted at 50% of the intended sample size, with planned discontinuation for clear efficacy/harm if a significance of p < 0.005 was attained.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXV | Pages 33 - 33
1 Jun 2012
Cushner F
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Introduction

The purpose of this study was to determine the efficacy of a Multi-modal Blood Conservation protocol that involves pre–operative autologous blood donations (2 units) in conjunction with Erythropoietin supplementation as well as intra-operative conservation modalities.

Methods

A retrospective review of 104 patients with simultaneous bilateral total knee arthroplasty done between 2006-2009 was performed. Patients donated two units of blood, 4 weeks prior to surgery and also received Erythropoetin injections (40 k units 3weeks,2 weeks and 1 week prior to surgery). Intra- operative Blood Management included symptom-based transfusions, blood salvage devices, local epinephrine injections and fibrin spray. Pre-donation blood levels, peri-operative hemoglobin and hematocrit levels along with transfusion records were assessed.


Blood loss during the perioperative period of total joint arthroplasty has been well described in the literature. Despite numerous advances, allogeneic transfusion rates are still reported as high as 50%. Often the literature focuses on one area or mechanism of blood loss prevention but this article focuses on a multimodal approach to blood loss prevention including preoperative optimization, intraoperative technique, and postoperative management. Hemoglobin drop and transfusion rates were retrospectively reviewed for 134 control patients undergoing total knee arthroplasty (TKA) in three groups. Group 1 included low risk patients (Hb >14 g/dl), Group 2 included intermediate risk patients (Hb 13-14 g/dl) utilizing reinfusion drain and preoperative autologous blood donation, and Group 3 included high risk (Hgb <13) patients treated with preoperative erythropoietin (EPO). These controls were then compared to two groups of patients undergoing minimally invasive total knee arthroplasty (MIS TKA). Group 4 included 20 consecutive patients undergoing MIS TKA with intraoperative injection of lidocaine and epinephrine along the arthrotomy site. Group 5 included 22 consecutive patients treated with similar technique plus the additional intraoperative use of a bipolar sealer device. The combined utilization of MIS TKA, epinephrine, and bipolar sealer minimized hemoglobin drop (2.74 (Std Dev 0.77) vs 3.29 (SD 1.05) g/dl, p= 0.01) and total blood transfusions (0.05 (SD 0.21) vs 0.86 (SD 0.63) units, p< 0.01) compared with the traditional TKA approach for high risk patients using reinfusion drain and preoperative autologous donation (Group 2). This series demonstrates how a busy knee practice minimizes hemoglobin drop and transfusion requirements with preoperative optimization of high risk patients utilizing EPO, minimally invasive technique, intraoperative hemostasis obtained with epinephering injection, use of a bipolar sealer, and postoperative management with a reinfusion drain.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 436 - 436
1 Nov 2011
Cushner F
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Introduction: Wound Hemearthrosis remains a major concern following TKA. This prospective study evaluates the use of a knotless interlocking suture system and its relationship to wound appearance and OR efficiency.

Methods: Two groups of patients undergoing TKA in our institution were evaluated using two different wound closure techniques. Group I consisted of twenty five patients who underwent standard closure using interrupted vicryl for the arthrotomy, deep fascia, superficial fascia, followed by staples. Group II consisted of twenty five patients who underwent closure using three separate running barbed sutures (Quill, Angiotech Inc)– first for the arthrotomy, followed by deep fascia, subcuticular and staples. We compared closure times, drain output and postoperative day to achieve zero wound drainage on the dressings.

Results: Closure times for Group II averaged 10 minutes faster than Group I. Drain output was decreased in the barbed suture cohort. Wounds achieved zero drainage, on average, one day sooner in Group II and no patients were returned to the OR for hematoma evacuation or arthrotomy disruption.

Conclusions: Use of this new technique for closure of TKA incisions can lead to faster operative times, lower drainage outputs and less immediate postoperative wound drainage. It appears that hemostasis is obtained quicker with the use of this barbed suture system while at the same time while maximizing OR efficiency.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_II | Pages 329 - 329
1 May 2010
Turpie A Bauer K Davidson B Gent M Kwong L Lassen M Cushner F Lotke P Fisher W
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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.