SMARTSET Bone Cements. Product Information

Transcription

1 SMARTSET Bone Cements Product Information

2 INTRODUCTION Our experience in PMMA bone cements is extensive. The long clinical heritage of our DePuy CMW bone cement product range has allowed us to evaluate and refine the product range over time. SMARTSET Bone Cements are the latest cements in the DePuy Synthes portfolio. Available in medium and high viscosity formulations, with and without Gentamicin, SMARTSET Bone Cements were developed to meet the needs of today s orthopaedic surgeons. SMARTSET MV ENDURANCE is a medium viscosity bone cement which was first launched in 1995 as ENDURANCE Bone Cement. It was developed to give surgeons a medium viscosity (less doughy) cement. SMARTSET HV Bone Cement was first launched in 2003 together with a variant of the cement containing the active substance Gentamicin. SMARTSET HV is a high viscosity bone cement with handling characteristics tailored to the needs of the surgeon by way of a slightly longer setting time compared to DePuy CMW 1 Bone Cement. 2 DePuy Synthes SMARTSET Bone Cements Product Information

3 WORKING TIMES High Viscosity Cement SMARTSET HV Bone Cement offers a faster pick-up time compared to medium viscosity bone cement and the working time is targeted at cementing procedures which require a longer working time such as a fully cemented total knee replacement. SMARTSET HV Bone Cement offers an overall setting time of approximately 13 ½ minutes at 19 C (66 F). 1 The handling times displayed are with digital (manual) mixing. Please note that mixing under vacuum will accelerate these times. Medium Viscosity Cement SMARTSET MV ENDURANCE Bone Cement combines the benefits of a medium viscosity cement with extended working time compared to DePuy CMW 3. SMARTSET MV ENDURANCE Bone Cement sets in approximately 16 ½ minutes at 19 C (66 F). 1 The handling times displayed are with digital (manual) mixing. Please note that mixing under vacuum will accelerate these times. SMARTSET Bone Cements Product Information DePuy Synthes 3

4 CLINICAL EVIDENCE Clinical Results SMARTSET HV/SMARTSET GHV GENTAMICIN Bone Cement SMARTSET HV has been studied clinically: in a 2-year and 5-year radiostereometric analysis (RSA) study. 2,3 The randomised controlled study lead by Prof. Otto Husby (St Olaf University Hospital, Trondheim, Norway) used a cemented Charnley Hip, comparing SMARTSET HV to the outcome of PALACOS R. The studies concluded that: there were no statistically significant differences in Migration 3 and Fixation 2 between the SMARTSET HV group and the PALACOS R group. The graph below contains data relating to the five year study that shows translation along the y-axis comparing SMARTSET HV with PALACOS R. The data represents the mean and 95% confidence interval (CI) for the pooled data. 3 5 Year Comparison of SMARTSET HV and Palacos R 3 POOLED PALACOS R SMARTSET HV Translation along the y-axis. The graph represents the mean and 95% confidence interval (CI) for the pooled data. 3 4 DePuy Synthes SMARTSET Bone Cements Product Information

5 ANTIBIOTIC Gentamicin Antibiotic-Loaded Cements It has been demonstrated in the Norwegian Arthroplasty Registry that patients receiving antibiotic-loaded bone cement and systemic antibiotics show lower revision rates than no antibiotic prophylaxis or antibiotic cement on its own. 4 Furthermore, antibiotic loaded bone cement is proven to reduce infection risk as demonstrated in the Parvizi et al study on primary hip replacement which showed that antibiotic in the cement provides effective prophylaxis against infection leading to an incidence of deep infection of only 1.2% compared to 2.3% when no antibiotic was used in the bone cement. 5 Bone cement with admixed Gentamicin leads to much higher levels of Gentamicin in the joint than systemic antibiotic can achieve. 6 Therefore, our bone cements are also available with the addition of Gentamicin. SMARTSET GHV Gentamicin Bone Cement and SMARTSET GMV ENDURANCE Gentamicin Bone Cement are antibiotic-loaded with 1g active Gentamicin in a standard 40g pack. Gentamicin is effective in reducing the risks presented by gram-positive and a few gram-negative bacteria. 7 The graph displays the most relevant micro-organisms associated with infected hip replacement. In vitro testing of SMARTSET GHV Gentamicin has shown a fast initial elution of Gentamicin, typical of bone cements containing antibiotic, with the highest cumulative release of Gentamicin occurring over the first 24 hours. 8 Staphylococcus Aureus Anaerobics Pseudomonas 3p Staphylococcus Coag. Negative Streptococcus Species Others Enterobacteriaceae This fast initial elution was also demonstrated in vivo, where SMARTSET GHV Gentamicin was tested with regard to Gentamicin release in total hip and total knee replacement. 9 As shown in the table, peak concentrations of Gentamicin in serum and wound drainage fluid were observed in the first few hours. Serum Levels Urine Wound Drainage Hip Replacement Max 0.16 μg/ml at 1 hour Max 6.99 μg/ml at 6 hours Max μg/ml was reached at 1 hour Knee Replacement Max 0.17 μg/ml at 3-6 hours Max μg/ml at 12 hours Max μg/ml at 3 hours All levels mentioned above declined over time following the observed maximum concentration. SMARTSET Bone Cements Product Information DePuy Synthes 5

6 MECHANICAL PROPERTIES Strong Bone Cements with Good Mechanical Properties Even the most advanced cemented knee or hip prosthesis will not produce the intended outcome without strong fixation. The mechanical properties of SMARTSET GHV Gentamicin Bone Cement have been studied. A study lead by G Lewis of the University of Memphis compared the fatigue performance of six commercially available antibiotic loaded PMMA Bone Cements. 10 In this fatigue study, SMARTSET GHV Gentamicin Bone Cement at 15MPa demonstrated relatively high resistance to failure, as shown in graph 1 below. SMARTSET GMV ENDURANCE Gentamicin Bone Cement was similarly tested for fatigue properties as part of this study, the results of which are shown in graph 2 below. Graph 1: High Viscosity Cements PALACOS R-G SMARTSET GHV GENTAMICIN COBALT G-HV REFOBACIN BONE CEMENT R40 Please note that the graph has been altered from that contained in the referenced study to remove and segregate data that is not relevant to high viscosity cement products.10 Note: 10 specimens were tested for each cement type. The run-out limit of the test was pre-set at million cycles. The test was continued until specimen fracture, or the run-out was reached without fracture. Where none of the specimens fractured before the run out limit (as for SMARTSET GHV) a conservative estimate of cycles to failure was made. Graph 2: Medium Viscosity Cements SMARTSET GMV ENDURANCE GENTAMICIN SIMPLEX P with Tobramycin Please note that the graph has been altered from that contained in the referenced study to remove and segregate data that is not relevant to medium viscosity products DePuy Synthes SMARTSET Bone Cements Product Information

7 ORDERING INFORMATION The DePuy Synthes Portfolio Our broad portfolio of different bone cements with different viscosities, working properties and the possibility of an antibiotic version allow flexibility according to surgeon preference. Cat. No. Description SMARTSET GHV GENTAMICIN Bone Cement, 20g SMARTSET GHV GENTAMICIN Bone Cement, 40g Cat. No. Description SMARTSET GMV Endurance GENTAMICIN Bone Cement, 40g Cat. No. Description SMARTSET HV Bone Cement, 20g SMARTSET HV Bone Cement, 40g Cat. No. Description SMARTSET MV ENDURANCE Bone Cement, 20g SMARTSET MV ENDURANCE Bone Cement, 40g SMARTSET Bone Cements Product Information DePuy Synthes 7

8 References 1. Instruction for Use (March 2007) 2. Husby OT, Haugan K, Benum P, Foss OA. A prospective randomised radiostereometric analysis trial of SMARTSET HV and Palacos R bone cements in primary total hip arthroplasty. J Orthopaed Traumatol, 2010, Vol. 11: Haugan K, Husby OS, Klaksvik J, Fos OA. The migration pattern of the Charnley femoral stem: a five-year follow-up RSA study in a well-functioning patient group. J Orthopaed Traumatol, 2012, Vol. 13: Espehaug B, Engesaeter LB, Vollset SE, Havelin LI, Langeland N. Antibiotic prophylaxis in total hip arthroplasty. The Journal of Bone and Joint Surgery, 1997, Vol. 79B. 5. Parvizi J, Saleh KJ, Ragland PS, Pour AE, Mont MA. Efficacy of antibiotic-impregnated cement in total hip replacement. Acta Orthopaedica, 2008; 79 (3): Srivastav AM, Nadkarni B, Srivastav S, Mittal V, Agarwal S. Prophylactic use of antibiotic-loaded bone cement in primary total knee arthroplasty: Justified or not. Indian J Orthop 2009; 43(3): Förster G. et al.: Die infizierte Hüftendoprothese Spätinfektion nach der 6. postoperativen Woche, In: Kühn, KD (2000). Bone cements. Springer Verlag. Page DePuy CMW Internal Test Report: R244; Research independently supervised by Dr. L. Frommelt, Hamburg, DePuy CMW Internal Study (interim report): CMW ; A study to evaluate the safety, performance and Gentamicin elution profile of a new bone cement SMARTSET GHV Gentamicin in comparison to an existing bone cement CMW 1 Gentamicin when used in primary hip and knee arthroplasty. 10. Lewis G. Comparative Fatigue Performance of Commercially-Available Antibiotic-Loaded PMMA Bone Cements. Poster No. 43, UK Society for Biomaterials 11th annual conference, 27th & 28th of June The third-party trademarks used herein are trademarks of their respective owners. Johnson & Johnson Medical Limited PO BOX 1988, Simpson Parkway, Livingston, West Lothian, EH54 0AB, United Kingdom. Incorporated and registered in Scotland under company number SC Manufactured by: DePuy International Ltd Trading as DePuy CMW Cornford Road Blackpool Lancashire, FY4 4QQ United Kingdom Tel: +44 (0) depuysynthes.com Johnson & Johnson Medical Limited All rights reserved. CA#DSEM/BIO/0516/0056 Issued: 11/16