Bone Cements & Accessories for Endoprosthetics

Bone Cements & Accessories for Endoprosthetics

OSARTIS GmbH offers a wide range of bone cements and accessories, primarily for application in arthroplasty, vertebroplasty and kyphoplasty.

High quality bone cements serve as filler between prosthesis components and bone to anchor the endoprosthetic parts firmly and securely to the bone. The cements contribute to the longevity and functionality of the endoprosthesis. In addition to cements, OSARTIS GmbH provides its customers with accessories such as lavage systems and cement restrictors.

For vertebroplasty and kyphoplasty, OSARTIS GmbH provides a specialized bone cement and an applicator system.

BonOs® R NF & BonOs® R NF Genta

BonOs® R NF and BonOs® R NF Genta are bone cements for use in artificial joint replacement.

BonOs® R NF and BonOs® R NF Genta are fast-setting acrylic bone cements for use in bone surgery.
BonOs® R NF Genta contains the antibiotic gentamicin sulfate that protects the implant and the surrounding tissue from colonization with pathogens that are sensitive to gentamicin.

Properties

The mechanical properties of BonOs® R NF and BonOs® R NF Genta guarantee reliable bone anchorage of the prosthesis.
The composition of BonOs® R NF and BonOs® R NF Genta is based on Charnley’s principles of using PMMA bone cements in artificial joint replacements, which was established as the gold standard 50 years ago. In accordance with Charnley’s principles, OSARTIS bone cements contain only the necessary raw materials.

BonOs® R NF and BonOs® R NF Genta rely on established procedures in the operating room and on well-known and safe processes of mixing and application.
Depending on the user’s needs, the cement can be mixed by hand or in a vacuum mixing system. Vacuum mixing can be done with pre-chilled bone cement.

Zirconium dioxide is added to BonOs® R NF and BonOs® R NF Genta to guarantee optimal X-ray visualization. The surgeon can at any time assess the distribution of the cement in the bone and around the implant on the X-ray image and thus assure an optimal outcome of the procedure.

BonOs® R NF Genta contains the established antibiotic gentamicin sulfate. The local application of gentamicin is gentle on the patient. BonOs® R NF Genta releases the established antibiotic gentamicin in a proven way, over a prolonged period and in effective, reproducible concentrations.


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EASYMIX® uno

EASYMIX® uno mixing system is a sterile disposable vacuum mixing system for the secure mixing of bone cement.

The vacuum mixing and cementing technique reduces the porosity of the cement. Reduced porosity leads to a considerable increase of strength of the cement.

Properties

EASYMIX® uno is comfortable to handle. Just a few secure steps provide excellent mixing results. The use of EASYMIX® uno in combination with PMMA bone cements relies on established procedures in the operating room and on well-known and safe processes of mixing and application.

Mixing with the EASYMIX® uno vacuum mixing system reduces the porosity of the cement. Studies indicate that reduced cement porosity lowers the risk of subsequent revisions resulting from aseptic loosening. 1) 2)

The reduced porosity of the cement leads to an increase of the fatigue and bending strength of the cement. The usage of EASYMIX® uno vacuum mixing system improves the cementing results and therefore the stability of the connection of prosthesis and host bone.2)

EASYMIX® uno is suitable for retrograde filling.

Compositions

The EASYMIX® mixing system consists of the EASYMIX® vacuum pump, the EASYMIX® cement injector and the EASYMIX® uno cartridge sets.

1) Walenkamp,G.H. and Murray,D.W. (2001) Bone Cements and Cementing Technique, Springer Verlag, Heidelberg.

2) Horas,U., Seidel,P. and Heiss,C. (2002) Vakuummischsysteme zur Knochenzementfertigstellung: ein Vergleich unterschiedlicher Systeme. Z Orthop Ihre Grenzgeb 140, 603-610.


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EASYMIX® pro

The EASYMIX® pro mixing system is based on the successful concept of EASYMIX® uno and moreover has an improved innovative closing mechanism that ensures an easier handling with less work steps.

For the EASYMIX® cement mixing systems used in the field of arthroplasty the following instruments are available:

  • EASYMIX® cement injector
  • EASYMIX® vacuum pump – different types
  • Compressed air hose – different types

Find more information on the EASYMIX® products in the respective product brochure.

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EASYMIX® bowl

EASYMIX® bowl is a mixing system for mixing PMMA bone cement powder and liquid monomer.

EASYMIX® bowl can mix up to three units (total 120 g powder) of bone cement of any viscosity under vacuum.

Properties

  • Easy to use and almost no installation required.
  • Rotating axis creates a far more uniform mix with least unmixed powder compared to hand mixing system.
  • Reduced porosity of cement mix due to vacuum mixing, creates optimal fatigue strength.
  • Closed mixing system minimizes exposure to monomer fumes.
  • Ergonomically designed curette and spatula that perfectly fit contour of bowl; for easy removal and handling of cement dough.
  • Sterile product

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PulsaClean® & PulsaClean® AC

PulsaClean® is an effective and easy-to-use disposable Pulse Lavage System used for intense wound debridement of bone and tissue defects.

The system features two nozzles and can be used for knee and hip arthroplasties.

Properties

Due to its rinsing and sucking mechanism, PulsaClean® allows optimal treatment flexibility for the user without any additional logistic effort. The PulsaClean® Disposable Lavage System includes a short and long nozzle, and an optional femoral canal brush is available. The short and strong bristles allow an intense cleaning deep into the marrow canal while also providing a rinsing and sucking function.

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C~plug®

C~plug® is a resorbable distal cement restrictor that seals the intramedullary cavity and improves cement grouting to the implant surface for better implant fixation.

A distal plug inhibits the cement penetration into cancellous bone and improves the cement’s molding into the implant surface.

Properties

The C~plug® resorbs within approximately four weeks and does not need to be removed in potential future revisions. Furthermore the C~plug® is distinguished by its increased contact surface, accurate positioning and reduced distal pressure.

Modern cementing techniques allow the creation of an optimal cement mantle within the femoral canal. Using the C~plug® reduces the risk of a revision.

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TPA-18 / TPA-24 / POLYPLUG

These cement restrictors are made of Ultra-High-Molecular-Weight Polyethylene (UHMWPE) and available in two different sizes:

  • TPA-18 / POLYPLUG-18 (12-18 mm)
  • TPA-24 / POLYPLUG-24 (18-24 mm)

Therefore, they are suitable to accommodate various patient anatomies and to help restrict cement flow into the distal femoral shaft.

Properties
With these cement restrictors the medullary space is occluded distal to the subsequent location of the prosthesis tip, to seal the femoral canal.
This sealing is achieved by pressing the cement restrictor inside the femur.

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Bone Cements & Accessories for Spinal Surgery

Bone Cements & Accessories for Spinal Surgery

OSARTIS GmbH offers a wide range of bone cements and accessories, primarily for application in arthroplasty, vertebroplasty and kyphoplasty.

High quality bone cements serve as filler between prosthesis components and bone to anchor the endoprosthetic parts firmly and securely to the bone. The cements contribute to the longevity and functionality of the endoprosthesis. In addition to cements, OSARTIS GmbH provides its customers with accessories such as lavage systems and cement restrictors.

For vertebroplasty and kyphoplasty, OSARTIS GmbH provides a specialized bone cement and an applicator system.

BonOs® Inject

BonOs® Inject is a PMMA bone cement that is specifically adapted for spine surgery.

The cement is suitable for the fixation and filling of symptomatic vertebral compression fractures, vertebral tumors and vertebral hemangioma as well as for the augmentation of pedicle screws* where bone quality is poor, e.g. in patients with osteoporosis or degenerative or neoplastic changes.

Properties

BonOs® Inject is a radiopaque, injectable bone cement, characterized by its optimal combination of a short mixing period, a long working time and excellent mechanical properties.

During the mixing phase, the powder and liquid components of BonOs® Inject quickly mix together into a homogenous, ductile paste. After a short waiting period, the cement reaches an ideal viscosity for application. During the application phase BonOs® Inject is injected with a suitable viscosity which reduces the risk of cement leakage.

The unique cement formulation guarantees an optimized long application time, minimizing time pressure during application.

The viscosity of BonOs® Inject allows it to be used in combination with standard mixing and application systems for use of PMMA bone cements for spinal applications.

BonOs® Inject contains the radiopacifier zirconium dioxide (ZrO2), which allows a safe application and a good visibility of the bone cement under x-ray.

*not for the USA


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ManuMix®

ManuMix® is the mixing system for manual mixing of bone cement of low to medium viscosity and subsequent transfer in syringes for clinical application.

The unique patented design allows a homogeneous mixing of the powder and the monomer components as well as closed and clean transfer of the bone cement into syringes.

Properties

  • Easy handling
  • Safe and clean transfer process of the bone cement
  • Reduced air entrapment in syringes by use of tight Luer connection in combination with the transfer device
  • Optimal removal technique with low cement residues
  • ManuMix® is a sterile product delivered in a soft blister

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Vertebroplasty Accessories

For the application of the PMMA bone cement into the vertebral body during a vertebroplasty procedure several accessories are used e.g. injection systems/syringes. After mixing of the PMMA bone cement components the PMMA bone cement is transferred out of the mixing system into injection systems or syringes. After filling of the injection systems/syringes the PMMA bone cement is injected over cannulas into the vertebral body to be treated. The PMMA bone cement will be hard in just minutes – see handling chart of the PMMA bone cement.

Vertebroplasty is little stressful and elderly patients can be treated outpatient with local anesthesia. The treatment of several vertebral bodies is possible with one surgical procedure.

OSARTIS offers the following articles for use in vertebroplasty:

  • VerteStable® injector with 10 ml syringe
  • VerteStable® syringe with Luer-lock connection 2.5 ml
  • VerteStable® cannulas with metal handle
  • VerteStable® cannulas with plastic handle
  • VERTEBROSTEEL® cannulas with steel handle
  • VERTEBROPLASTIC® cannulas with plastic handle
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EASYMIX® shaker

EASYMIX® shaker is a closed and sterile mixing system for mixing of acrylic resin components (powder and liquid) and transfer into syringes.

Properties

  • Easy handling
  • Safe and clean transfer process of the bone cement into syringes
  • Optimal removal technique with low cement residues
  • Sterile product

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Bone Substitutes

Bone Substitutes

PerOssal®

PerOssal® is a synthetic, biodegradable and osteoconductive bone substitute material for restoration and filling of bone defects.

The unique microporous structure ensures uniform uptake of liquid substances (such as antibiotics) and their controlled sustained release [1].

The complete resorbability and simultaneous formation of new bone makes explantation of the material unnecessary [2, 3].

Nanocrystalline / porous

  • Promotes natural bone growth.
  • Suitable for increasing volume with autologous cancellous bone transplantation [4].
  • Suitable as carrier material for aqueous solutions (e.g. antibiotics [1, 5]).*

Custom loadable

  • Targeted highly effective antibiotic protection of the bone substitute material and the surrounding tissue according to the individual antibiogram with minimum systemic side effects.*

Protracted

  • Controlled long-term protection (10 days) from colonization of the bone replacement material with sensitive bacterial pathogens [6].*

*The use of the bone substitute PerOssal® as carrier for pharmaceuticals falls within the responsibility of the treating physician. The contraindications of the applied antibiotic have to be considered.


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PerOssal® Publications

A. Berner, H. J. Linde, T. Schubert, M. Nerlich, C. Englert, Osteitisbehandlung an Unterschenkeln mit Knochenersatzmaterial als lokalem Antibiotikumträger, Z Orthop Unfall 146 (2008) 371–374.
DOI: 10.1055/s-2008-1038331

Djordjevic (2015), Antibiotic-loaded hydroxyapatite and calcium sulphate composite is a potent biomaterial for one stage treatment of the extensive infected bone defect. the Third International Conference on Radiation and Applications in Various Fields of Research on 08.-12.06.2015 in Budva, Montenegro. pp. 483-486
https://www.rad2015.rad-conference.org/pdf/Book%20Abctracts%20RAD%202015.pdf

Drakou et al. (2011), Combination of calcium hydroxyapatite antibiotic carrier with spacers in periprosthetic knee infections. Orthopaedic Proceedings. 93-B(SUPP_III):326-326, 2011
https://online.boneandjoint.org.uk/doi/abs/10.1302/0301-620X.93BSUPP_III.0930326c

Erkebulanovich et al. (2017), USING BIODEGRADABLE NANOMATERIALS AS ANTIBIOTIC TRANSPORT DELIVERY IN THE TREATMENT OF CHRONIC OSTEOMYELITIS. Orthopaedic Proceedings. 99:2, 2017
https://online.boneandjoint.org.uk/doi/abs/10.1302/1358-992X.99BSUPP_2.EORS2016-097

J. Frese, A.P. Schulz, B. Kowald, U.-J. Gerlach, K.-H. Frosch, R. Schoop, Treatment outcome of the Masquelet technique in 195 infected bone defects – A single-center, retrospective case series, Injury 54 (2023) 110923
DOI: 10.1016/j.injury.2023.110923

Fleege et al. (2020), Development and current use of local antibiotic carriers in spondylodiscitis: Pilot study on reduction of duration of systemic treatment. Orthopade. 49(8):714-723, 2020
DOI: 10.1007/s00132-020-03942-4

C. Fleege, M. Rauschmann, A. Wichelhaus, Antibiotikatherapie der pyogenen Spondylodiszitis bei Erwachsenen. Die Wirbelsäule 01 (2017) 284-293.
DOI: 10.1055/s-0043-117265

C. Fleege, T.A. Wichelhaus, M. Rauschmann, Systemische und lokale Antibiotikatherapie bei konservativ und operativ behandelten Spondylodiszitiden, Orthopäde 41 (2012) 727–735.
DOI: 10.1007/s00132-012-1920-0

Jiménez-Martín, A., Romeo Candau, F., Pérez Hidalgo, S., Najarro Cid, F., and Gómez De Los Infantes Troncoso, J. G. 2009. '[Use of calcium sulfate and hydroxyapatite with antibiotics in osteomyelitis of the hand: Two clinical cases Utilidad del sulfato cálcico e hidroxiapatita con antibióticos en las osteomielitis de la mano, a propósito de 2 casos clínicos]', Trauma Fund MAPFRE, 20: 45-48.
https://documentacion.fundacionmapfre.org/documentacion/publico/es/media/group/1112019.do

Kamal and Ramang (2021), A simple management of massive bone defect after en-bloc resection of osteofibrous dysplasia of tibial shaft: A case report. Int J Surg Case Rep. 85:106213, 2021
DOI: 10.1016/j.ijscr.2021.106213

M. Rauschmann, A. Wichelhaus, V. Stirnal, E. Dingeldein, L. Zichner, R. Schnettler, V. Alt, Nanocrystalline hydroxyapatite and calcium sulphate as biodegradable composite carrier material for local delivery of antibiotics in bone infections, Biomaterials 26 (2005) 2677–2684.
DOI: 10.1016/j.biomaterials.2004.06.045

Rupp et al. (2022), [Fracture-related infections after intramedullary nailing : Diagnostics and treatment]. Unfallchirurg. 125(1):50-58, 2022
DOI: 10.1007/s00113-021-01117-0

Sambri, A.; Luca Cevolani; Valentina Passarino; Marta Bortoli; Stefania Claudia Parisi; Michele Fiore; Laura Campanacci; Eric Staals; Davide Maria Donati and Massimiliano De Paolis Mid-Term Results of Single-Stage Surgery for Patients with
Chronic Osteomyelitis Using Antibiotic-Loaded Resorbable PerOssal® Beads. Microorganisms 2023, 11, 1623.
DOI: 10.3390/microorganisms11071623

Sambri, A.; Pignatti, M.; Tedeschi, S.; Lozano Miralles, M.E.; Giannini, C.; Fiore, M.; Filippini, M.; Cipriani, R.; Viale, P.; De Paolis, M. Combined Orthoplastic Approach in Fracture-Related Infections of the Distal Tibia. Microorganisms 2022, 10, 1640.
DOI: 10.3390/microorganisms10081640

Sananta, P., Suryanto Dradjat, R., Pradana Putra, D., and Sugiarto, M.A. 2022. 'The effect of bone graft substitute in healing fractures with bone defects through examination of alkaline phosphatase and radiology in the murine model (Rattus norvegicus) Wistar strain', F1000Research, 11.
DOI: 10.12688/f1000research.109780.1

Scharf et al. (2023), Treatment of Fracture-Related Infections with Bone Abscess Formation after K-Wire Fixation of Pediatric Distal Radius Fractures in Adolescents—A Report of Two Clinical Cases. Children (Basel). 10(3):581, 2023.
DOI: 10.3390/children10030581

Steadman et al. (2023), Local Antibiotic Delivery Options in Prosthetic Joint Infection, Antibiotics (Basel). 12(4), 2023.
DOI: 10.3390/antibiotics12040752

Tuleubaev et al. (2017), Efficient of antibiotic loaded PerOssal pellet in the treatment of Staphylococcus aureus induced chronic osteomyelitis: in vitro and prospective clinical study (PO-058). Abstract at the 25th Annual and Anniversary Meeting of the European Orthopaedic Research Society (EORS) on Sep. 13-15, 2017 in Munich, Germany. OP-058: pp. 1-1
https://online.boneandjoint.org.uk/doi/abs/10.1302/1358-992X.2018.3.061

G. Visani, E.L. Staals, D. Donati, Treatment of chronic osteomyelitis with antibiotic-loaded bone void filler systems: an experience with hydroxyapatites calcium-sulfate biomaterials. Acta Orthop Belg. 84 (2018) 25-29.
http://www.actaorthopaedica.be/assets/2703/4-Visani-fiat.pdf

D. von Stechow M.A. Rauschmann, Effectiveness of Combination Use of Antibiotic-Loaded PerOssal® with Spinal Surgery in Patients with Spondylodiscitis, Eur Surg Res 43 (2009) 298–305.
DOI: 10.1159/000233525

Wang, G., Alagboso, F. I., Walter, N., Baertl, S., Brochhausen, C., Docheva, D., Rupp, M., and Alt, V. 2022. 'Bone regeneration after marginal bone resection in two-stage treatment of chronic long bone infection – a combined histopathological and clinical pilot study', Injury.
DOI: 10.1016/j.injury.2022.07.008

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