Reliability, Innovation, Versatility, Safety... in the hands of the surgeon.

Transcription

1 o r t h o p a e d i c s Reliability, Innovation, Versatility, Safety... in the hands of the surgeon.

2 Reliability SPACER: a great idea from Tecres Advantages for surgeons: Saving Time: ready to use, with preformed shapes and different sizes. It makes faster both the first and the second stage. Prosthetic infection is one of the most serious complications in orthopedic surgery and is very difficult to treat. The latest data available in the literature indicate that in the first two years after implanting hip or knee prosthesis,,6% will encounter some form of infection. (-2) Safety: the devices have mechanical and pharmacological performances standardized and certified. Effectiveness: known, extended and long release of antibiotic. Less responsibility: using of an industrial device, not an hand-made one. Advantages for patients Better quality of life: spacer allows deambulation with partial weight-bearing and permits to make some basic daily activities, this allows the patient to be independent. Possibility to make physiotherapy. In recent years, bacteria have developed resistance to classic antibiotics and the problem is now even more difficult to face. Reduction of functional recovery time: faster discharge from hospital. Moreover, resistance to methicillin by Staphylococci (MRS) reaches peaks of 0% in Mediterranean Europe, UK and USA. 3- The two-stage revision process is considered the standard for the treatment of prosthetic infections. Tecres has successfully produced pre-formed spacers with antibiotic since 996.

3 Research and innovation Antibiotic release from hand-made spacers Excellent mechanical properties that allow the patient to deambulate with partial weight-bearing The devices have been tested as permanent prosthesis to support full weight-bearing for 6 months. (0-) The device must be used at partial weight-bearing. (0-) Effectiveness and extended release of antibiotics Commercial cement loaded with antibiotic is unsuitable for spacers For both the Cement A and Cement B spacers, there was hardly any additional release after the first week. () Concentration (µg/ml) At implantation The release of gentamicin presents high local concentrations (range 0-00 mg/l) in the first 2-8 hours after spacer implant. The concentrations are largely above the susceptibility of bacteria. Serum levels are low ( mg/l). (6) Concentration (mg/l) Concentration of antibiotic in drains Hip Spacer Gentamicin Increasing the dose of antibiotics in commercial cement: It only influences initial release Gentamicin release was most rapid during the first 6 h and continued at a much lower (µg/ml) Antibiotic release from hand-made spacers Days rate thereafter. () Hours Hours At spacer removal The median intra-articular gentamicin levels were 0. mg/l (0.2 to 2.36 mg/l) which would be considered therapeutic. The second stage revision occurred at a median of 99 days following spacer insertion. (2) Gentamicin levels at 2 nd stage revision It significantly reduces mechanical performances When gentamicin was added to unloaded cement (- g), there was a significant reduction in the mechanical performance of the loaded cements compared to unloaded cement. () Fatigue Performance Mechanical Performance Patients unloaded cement cement + G After use After 2-2 weeks in the hip, the removed spacers still released appreciable amounts (80-800µg) of gentamicin, representing 0.0%-0.09% of the initial total amount, and in the range.7-0.0µg/cm 2. (3) Spacer no. Mean Gentamicin release Duration of implantation (months) Residual total release µg It does not protect against bacterial adhesion The incorporation of additional gentamicin did result in an initial reduction in bacterial colonization but this beneficial effect was no longer apparent at 72 h, with the clinical strains forming biofilms on the cements despite the release of high levels of gentamicin. () Number of adherent bacteria (CFU cm 2 ) Number of adherent bacteria S. aureus Hours

4 Versatility Spacer for Hip: Spacer G The Tecres spacer resembles a femoral prosthesis. It has a load-bearing structure in stainless steel coated with gentamicin bone cement. Available in 6 sizes (3 head sizes with standard stem and 3 head sizes with XL stem). The proximal cementation of the neck with bone cement is suggested if unstable and compulsory in case of XL use. Spacer G Flat Spacer G flat stem resembles Spacer G but has a thinner, flatter stem that fits more easily in the narrow femoral cavity. The top of the stem has been designed to preserve the greater trochanter. Available in 6 sizes (3 head sizes with standard stem and 3 head sizes with long stem). The proximal cementation of the neck with bone cement is compulsory. Spacer for Knee: Spacer K - InterSpace Knee (USA) Spacer K resembles a knee prosthesis made in bone cement with gentamicin. It comprises two independent articulating elements. The tibial component has a flat base on which the femoral component articulates. Available in 3 sizes. The cementation of the components with antibiotic bone cement is compulsory. Vancogenx - Space Knee The exclusive line of spacers with gentamicin and vancomycin, for the infections caused by resistant bacteria Gram+ as S. epidermidis, MRS, CoNS o Enterococci. Available in sizes. The cementation of the components with antibiotic bone cement is compulsory, we suggest to use vancogenx bone cement. Vancogenx - Space Hip The exclusive line of spacers with gentamicin and vancomycin for the infections caused by resistant bacteria Gram+ as S. epidermidis, MRS, CoNS o Enterococci. Available in 6 sizes (3 head sizes with short stem and 3 head sizes with long stem) and 2 different stem shapes (round and flat stem). The proximal cementation of the neck with Vancogenx bone cement is suggested if unstable and compulsory in case of XL use SURGICAL TECHNIQUE Remove the prosthesis. Clean the host site by aggressive debridment, removing all residues of cement, if present. Bore the acetabulum in order to obtain an optimal shape. Select the right size with the trial device (Trial). Fit the stem into the diaphyseal canal. We suggest a proximal cementation to avoid instability, rotation or dislocation of the spacer. The latter procedure is compulsory when using Spacer Flat and XL SURGICAL TECHNIQUE Remove the prosthesis and clean the host site by aggressive debridment, removing all residues of cement, if present. Select the right size with the trial device (Trial). Apply a coat of cement to the surface of the femoral part. Fix the femoral part on the femoral condyles. Apply the cement on the tibial plate. Apply the tibial part. Reduce the joint before the polymerization of the cement in the tibial component.

5 Safety & Effectiveness Spacer for Shoulder: Spacer S - InterSpace Shoulder (USA) Spacer S resembles a shoulder prosthesis, it has a load-bearing structure in stainless steel coated with gentamicin bone cement. Available in 2 sizes. The proximal cementation of the neck with antibiotic bone cement is suggested if unstable. More than 9% of Two-Stage Exchange made with Tecres Spacer were free from infection at the latest follow-up CLINICAL RESULTS Journal st Author Type N.pts Cleared at FU (reimplanted) FU mean (min-max) Center CORR (20) Corona P Hip, Knee 33/38 3 (2-6) Barcelona-3 (SPA) Int Orthop (20) Castelli CC Knee 0 /0 8 (2-6) Bergamo (ITA) J Arthroplasty (202) Garcia-Oltra E Hip 3 3/32 8 ( -8) Barcelona-2 (SPA) 2 3 SURGICAL TECHNIQUE Remove the prosthesis and clean the host site by aggressive debridement, removing all residues of cement, if present. Select the right size with the trial device (Trial). Apply antibiotic loaded bone cement to underside of spacer head (optional). Insert the shoulder spacer into the humeral canal while approximating anatomical version Remove all extruding bone cement with a curette and reduce the shoulder (optional). 2 trial SPACER CORR (202) Degen RM Hip / 30 3 (2-70) London, ON (CAN) J Arthroplasty (202) Wan Z Knee /3 (2-62) Houston, TX (USA) Hip Int (202) Romanò CL Hip 83 73/83 (2-32) Milan (ITA)-,2 J Arthroplasty (202) Neumann DR Hip 2 / 2 67 (36-20) Salzburg (AUT) BMC Infect Dis (20) Romanò CL Hip* 20 9 / 20 7 (2-0) Milan (ITA)-,2 Musculoskelet Surg (20) D Angelo F Hip / 27 3 (8-06) Varese (ITA) Int Orthop (20) Pattyn C Hip 6 9 / 6 36 (9-8) Ghent (BEL) Hip Int (200) Gil Gonzalez S Hip 3 30 / 3 32 (6-6) Barcelona- (SPA) J Shoulder Elbow Surg (200) Coffey MJ Shoulder 6 2 / 2 8 (0-2) Dayton, OH (USA) Int Orthop (200) Pitto RP Knee 2 9/9 2 (2-3) Auckland (NZ) Bergamo (ITA) 3 Acta Orthop Scand (200) Magnan B Hip 0 8/8 3 (2-8) Verona (ITA) TOTAL 8 9,80%, M Centers * septic arthritis

6 Short Long Ordering information Spacer for HIP Spacer G - Gentamicin Loaded Head Size (mm) Trial Set (3-size set) Short Round Long Round Short Flat Long Flat SPG03 SPG03XL SPC90Z0 SPC9Z0 Spacer S - Gentamicin Loaded Head Size (mm) Code SPS0020 SPS/G Flat SPC/G SPC0720 Round SPC/G SPC/G SPC/GXL SPC/GXL SPC/GXL SPC0620 SPC0820 SPC0920 SPC020 SPC20 Vancogenx Space Hip - Genta + Vanco Loaded Short Long Head Size (mm) Flat SPC030 SPC0730 Round SPC0030 SPC0230 SPC0330 SPC030 SPC030 SPC0630 SPC0830 SPC0930 SPC030 SPC30 Spacer for KNEE Spacer K - Gentamicin Loaded Tibial Dimension (mm) - small 70 - medium 80 - large Trial Set Trial Set (small-medium large) Trial extralarge Spacer for SHOULDER Two-size Trial Code SPK/G SPK706/G SPK807/G Vancogenx Space K - Genta + Vanco Loaded Tibial Dimension (mm) - small 70 - medium 80 - large Code SPK0030 SPK030 SPK extralarge SPK0330 SPS90Z0 SPK03 SPK03Z0 Bibliography. Ong KL, Kurtz SM, Lau E, Bozic KJ, Berry DJ, Parvizi J. Prosthetic joint infection risk after total hip arthroplasty in the Medicare population. J Arthroplasty Sep;2(6 Suppl):0-9. Epub 2009 Jun Kurtz SM, Ong KL, Lau E, Bozic KJ, Berry D, Parvizi J. Prosthetic joint infection risk after TKA in the Medicare population. Clin Orthop Relat Res. 200 Jan;8():2-6. Epub 2009 Aug EARSS Annual Report - Antimicrobial resistance surveillance in Europe Annual report of the European Antimicrobial Resistance Surveillance Network (EARS-Net) Evans R et al. Orthopaedic infection: community-associated and healthcare-associated methicillin-resistant Staphylococcus aureus (MRSA) AAOS Magnan B et al. Preformed acrylic bone cement spacer loaded with antibiotics: use of two-stage procedure in 0 patients because of infected hips after total replacement. Acta Orthop Scand. 200 Dec;72(6):9-6. Bertazzoni Minelli E et al. PMMA as Drug delivery system and in vivo. Release from Spacers. In Infection and local treatment in orthopedic surgery Meani E, Romanò C, Crosby L, Hofmann G Eds. Springer Verlag Romanò CL et al. Long-stem versus short-stem preformed antibiotic-loaded cement spacers for two-stage revision of infected total hip arthroplasty. Hip Int. 200 Jan-Mar;20(): Pitto RP et al. Pre-formed articulating knee spacer in two-stage revision for the infected TKA. Int Orthop. 200 Oct;29(): Pattyn C et al. Preformed gentamicin spacers in two-stage revision hip arthroplasty: functional results and complications. Int Orthop. 200 Nov 30. [Epub ahead of print] 0. Baleani M et al. The mechanical behaviour of a pre-formed hip. Hip International / Vol. 3 no. 3, 2003 / pp Villa T et al. Experimental evaluation of the biomechanical performances of a PMMA-based knee spacer. Knee Mar;(2):-3. Epub 2007 Jan. 2. Mutimer J et al. Measurements of in vivo intra-articular gentamicin levels from antibiotic loaded articulating spacers in revision total knee replacement. Knee Jan;6():39-. Epub 2008 Sep 0 3. Bertazzoni Minelli E et al. Release of gentamicin and vancomycin from temporary human hip spacers in two-stage revision of infected arthroplasty. J Antimicrob Chemother. 200 Feb;3(2): Moojen DJ et al. In vitro release of antibiotics from commercial PMMA beads and articulating hip spacers. J Arthroplasty Dec;23(8):2-6. Dunne N et al. In vitro study of the efficacy of acrylic bone cement loaded with supplementary amounts of gentamicin. Acta Orthopaedica 2007; 78 (6): 77 3f78 6. Degen RM et al. Does a prefabricated gentamicin-impregnated, load-bearing spacer control periprosthetic hip infection? Clin Orthop Relat Res. 202 Apr 2. [Epub ahead of print] 7. Wan Z et al. Preformed articulating knee spacers in 2-stage total knee revision arthroplasty. Minimum 2-year follow-up. J Arthroplasty. 202 Mar. [Epub ahead of print] 8. Neumann DR et al. Two-stage cementless revision of late total hip arthroplasty infection using a premanufactured spacer. J Arthroplasty. 20 Dec. [Epub ahead of print] 9. Romanò CL et al. Two-stage revision surgery with preformed spacers and cementless implants for septic hip arthritis: a prospective, non-randomized cohort study. BMC Infect Dis. 20 May 6;():29. [Epub ahead of print] 20. D Angelo F et al. The use of a preformed spacer in two-stage revision of infected hip arthroplasties. Musculoskelet Surg. 20 Apr 9. [Epub ahead of print] 2. Gil Gonzalez S et al. Two-stage revision of hip prosthesis infection using a hip spacer with stabilising proximal cementation. Hip Int. 200 May 27;20 (Suppl 7) (S7):28-3. [Epub ahead of print] 22. Coffey MJ, Ely EE, Crosby LA. Treatment of glenohumeral sepsis with a commercially produced antibioticimpregnated cement spacer. J Shoulder Elbow Surg. 200 Sep; 9 (6): Epub 200 Apr. 23. García-Oltra E, Bori G, Tomas X, Gallart X, Garcia S, Soriano A Radiological evaluation of acetabular erosion after antibiotic-impregnated polymethylmethacrylate spacer (Spacer-G). J Arthroplasty. 203 Jun;28(6): Castelli CC, Gotti V, Ferrari R. Two-stage treatment of infected total knee arthroplasty: two to thirteen year experience using an articulating preformed spacer. Int Orthop. 20 Feb;38(2):0-2. Epub 20 Jan Corona PS, Barro V, Mendez M, Cáceres E, Flores X. Industrially prefabricated cement spacers: do vancomycin- and gentamicin-impregnated spacers offer any advantage? Clin Orthop Relat Res. 20 Mar;72(3): Epub 203 Oct Magnan B, Regis D, Biscaglia R, Bartolozzi P. Preformed acrylic bone cement spacer loaded with antibiotics: use of two-stage procedure in 0 patients because of infected hips after total replacement. Acta Orthop Scand. 200 Dec;72(6):9-.

7 BC07 rev 08/6 distributed by TECRES S. p. A. Via A. Doria, 6 - Sommacampagna - Verona (Italy) tel fax info@tecres.it