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generic background for product detail page Joint prosthetic spacer

SpaceFlex Shoulder

SpaceFlex is the joint prosthetic spacer customizable in less than 15 minutes.



Smart

The design provides unique features and excellent mechanical performance.

Modular

SpaceFlex is customizable intraoperatively, basing on first implant sizes and patient’s anatomy.

Active and User friendly

The antibiotic bone cement version enhances the in-situ treatment of the infection. The easy mold preparation which does not require the use of scalpel or other sharp tools.

About

SpaceFlex Shoulder offers innovative features for shoulder spacers, such as a metal inner core for improved resistance, and holes for potential suturing of cuff muscles.

The bone cement pressurization which develops into the mold ensures a smooth contact surface of the humeral head. The semi-transparent mold and insertion channel ensure a visual control of the bone cement injection. SpaceFlex also avoids cement leakage during the injection.


[1] Saleh KJ, El Othmani MM, Tzeng TH, Mihalko WM, Chambers MC, Grupp TM. Acrylic bone cement in total joint arthroplasty: A review. J Orthop Res. 2016 May;34(5):737-44. [2] Sodhi N, Dalton SE, Khlopas A, Sultan AA, Curtis GL, Harb MA, Naziri Q, Newman JM, Barrington JW, Mont MA. Doe s a simple syringe applicator enhance bone cement set up time in knee arthroplasty? Ann Transl Med. 2017 Dec;5(Suppl 3):S25. [3] Celik T, Mutlu I, Ozkan A, Kisioglu Y. The effect of cement on hip stem fixation: a biomechanical study. Australas Phys Eng Sci Med. 2017 Jun;40(2):349-357. [4] Becks L, Gaydos C, Stroud N, Roche CP. Optimization of cemented glenoid peg geometry. A comparison of resistance to axial distraction. Bull Hosp Jt Dis (2013). 2015 Dec;73(Suppl 1):S33-36. [5] Vaishya R, Chauhan M, Vaish A. Bone cement. J Clin Orthop Trauma. 2013 Dec;4(4):157-63. [6] Kelly MP, Illgen RL, Chen AF, Nam D. Trends in the use of high-viscosity cement in patients undergoing primary total knee arthroplasty in the United States. J Arthroplasty. 2018 Nov;33(11):3460-3464. [7] van der Voort P, Valstar ER, Kaptein BL, Fiocco M, van der Heide HJ, Nelissen RG. Comparison of femoral component migration between Refobacin bone cement R and Palacos R + G in cemented total hip arthroplasty. A randomised controlled roentgen stereophotogrammetric analysis and clinical study. Bone Joint J. 2016 Oct;98-B(10):1333–41. [8] Hinarejos P, Guirro P, Puig-Verdie L, Torres-Claramunt R, Leal-Blanquet J, Sanchez-Soler J, Monllau JC. Use of antibiotic-loaded cement in total knee arthroplasty. World J Orthop 2015 Dec 18; 6(11): 877-885. [9] Howlin RP, Winnard C, Angus EM, Frapwell CJ, Webb JS, Cooper JJ, Aiken SS, Bishop JY, Stoodley P. Prevention of Propionibacterium acnes biofilm formation in prosthetic infections in vitro. J Shoulder Elbow Surg. 2017 Apr;26(4):553-563. [10] Dati ottenuti da un test interno eseguito dal produttore. [11] Stone JJ, Rand JA, Chiu EK, Grabowski JJ, An KN. Cement viscosity affects the bone-cement interface in total hip arthroplasty. J Orthop Res. 1996 Sep;14(5):834-7. [12] Martínez-Moreno J, Merino V, Nácher A, Rodrigo JL, Climente M, Merino-Sanjuán M. Antibiotic-loaded bone cement as prophylaxis in total joint replacement. Orthop Surg. 2017 Nov;9(4):331-341. [13] Ciucio F, Viola E, Ghiara M, Benazzo F. Le infezioni nella chirurgia protesica di anca e di ginocchio. Bollettino della Società Medico Chirurgica di Pavia 126(2):421-430. [14] Iarikov D, Demian H, Rubin D, Alexander J, Nambiar S. Choice and doses of antibacterial agents for cement spacers in treatment of prosthetic joint infections: review of published studies. Clin Infect Dis. 2012 Dec;55(11):1474-80. [15] Chang Y, Tai CL, Hsieh PH, Ueng SW. Gentamicin in bone cement: A potentially more effective prophylactic measure of infection in joint arthroplasty. Bone Joint Res. 2013 Oct 15;2(10):220-6. [16] International Organization for Standardization (ISO). ISO 5833:2002. Implants for surgery - Acrylic resin cements. 2002. p22. [17] Cacciola G, De Meo F, Cavaliere P. Mechanical and elution properties of G3 Low Viscosity bone cement loaded up to three antibiotics. J Orthop. 2018 Sep 6;15(4):1004-1007.

Sizing and Options

SpaceFlex offers the widest range of shoulder spacer options currently available on the market; available in 46 different configurations. The 4 stem diameter options enable potential cementless fixation into the humeral diaphysis, with the possibility to suture the final spacer to the rotator cuff through two pre-holes present on the back of the spacer. The smooth humeral head of SpaceFlex Shoulder (2 diameter available) aims at minimizing the risk of friction and glenoid bone deterioration.

Please note that not all products are available and registered in every market. Please contact your Enovis' Sales Representative for any further information.
LPSI, SpaceFlex and SYMBOL® are distributed by Limacorporate S.p.A.

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