chronos STRIP Bone Void Filler

Transcription

1 chronos STRIP Bone Void Filler Osteoconductive beta-tricalcium phosphate (b-tcp) composite This publication is not intended for distribution in the USA. SURGICAL TECHNIQUE

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3 TABLE OF CONTENTS INTRODUCTION chronos Strip Bone Void Filler 2 Indications and Contraindications 3 Warnings and Precautions 4 SURGICAL TECHNIQUE Preparation 5 Perfuse chronos Strip Bone Void Filler 6 Implant chronos Strip Bone Void Filler 8 PRODUCT INFORMATION Product Information 10 Also Available 11 BIBLIOGRAPHY 12 Warning This description alone does not provide sufficient background for direct use of DePuy Synthes products. Instruction by a surgeon experienced in handling these products is highly recommended. Processing, Reprocessing, Care and Maintenance For general guidelines, function control and dismantling of multi-part instruments, as well as processing guidelines for implants, please contact your local sales representative or refer to: For general information about reprocessing, care and maintenance of Synthes reusable devices, instrument trays and cases, as well as processing of Synthes non-sterile implants, please consult the Important Information leaflet (SE_023827) or refer to: chronos Strip Bone Void Filler Surgical Technique DePuy Synthes 1

4 chronos STRIP Bone Void Filler OSTEOCONDUCTIVE BETA-TRICALCIUM PHOSPHATE (b-tcp) COMPOSITE chronos Strip Bone Void Filler is a synthetic bone void filler manufactured from chronos Bone Void Filler beta tricalcium phosphate (b-tcp) granules imbedded in a matrix of poly(l-lactide-co- -caprolactone). The flexible composite provides contourability and malleability of the device to the bony implant site. chronos Strip Bone Void Filler is initially radio-opaque. chronos Strip Bone Void Filler is resorbed in vital bone and replaced by autologous bone 1,4 6. chronos Strip Bone Void Filler conforms to the implant site, allowing site-specific placement. Each strip is sterile-packaged in a perfusion pouch, allowing easy perfusion with autologous bone marrow and/or blood. Perfusion with bone marrow aspirate (BMA) provides a favorable environment for bony ingrowth 1 3. May be folded, twisted, cut, or sutured intraoperatively for optimal placement Flexible and conforms to patient anatomy Features and Benefits A composite pairing the structure of an osteoconductive b-tcp ceramic scaffold with the handling advantage of a resorbable polymer Resorbed and replaced by autologous bone in 6-18 months, depending on factors like patient age, and condition 1, % synthetic, consistent quality, sufficient quantity Majority of pores within the size range identified as ideal for bony ingrowth 7 9 Perfusion pouch allows thorough loading of chronos Strip Bone Void Filler with autologous bone marrow and/or blood 2 DePuy Synthes chronos Strip Bone Void Filler Surgical Technique

5 INDICATIONS AND CONTRAINDICATIONS chronos Strip Bone Void Filler Indications chronos Strip Bone Void Filler should be used as bone void filler or augmentation material in zones requiring cancellous rather than cortical bone. This includes the filling of bone defects after trauma, reconstruction or correction in non-load bearing spinal indications only. The porous structure of chronos Strip Bone Void Filler acts as a matrix for the ingrowth of bone 2,4. chronos Strip Bone Void Filler implants must always be applied by endosteal or subperiosteal implantation, i.e. by direct contact with the vital bone. The implant must completely fill the bone defect (pressfit). However, it is essential to avoid overfilling to ensure tension-free wound closure. chronos Strip Bone Void Filler may be combined with autogenous bone marrow and/or blood. The size of the chronos Strip Bone Void Filler implant used depends on the size of the bone defect. As a rule, chronos Strip Bone Void Filler is resorbed within 6 to 18 months depending on patient conditions and converted into autologous bone 1,4 6. Contraindications chronos Strip Bone Void Filler should not be used in the following circumstances: Acute and chronic infections in the operation area, e.g. inflammation, bacterial bone diseases (posttraumatic or chronic osteomyelitis) and soft-tissue infections Untreated malignant myeloma, Burkitt s lymphoma and other lymphomas Defects and fractures in the region of an open epiphysis Osteoporosis Areas where there is significant vascular impairment proximal to the graft site Severe instability or deformation at the extraction point (harvesting site) Cranioplasty Bone Access Needle Intended use The Bone Access Needle is a sterile-packed kit used in procedures where access to bone is required. The Bone Access Needle is inserted into the bone with the aid of imaging procedures. The Bone Access Needle can also be used for providing access for appropriate guide wires, for obtaining bone marrow by aspiration technique and for inserting therapeutic materials, including bone cements. When using the Bone Access Needle in connection with other instruments and/or therapeutic materials, the Surgical Technique and/or the Instructions for Use issued by the relevant manufacturers should be observed. Contraindications This product must not be used in patients with coagulation disorders or infections. chronos Strip Bone Void Filler is not indicated for use in load bearing and unstable indications unless used in conjunction with appropriate osteosynthesis fixation systems or if the cortical bone can bear the full load. chronos Strip Bone Void Filler Surgical Technique DePuy Synthes 3

6 WARNINGS AND PRECAUTIONS chronos Strip Bone Void Filler Warnings Do not use chronos Strip Bone Void Filler as a standalone product unless the cortical bone can bear the full load. Maximum mechanical stability in filling the defect with chronos Strip Bone Void Filler is a prerequisite for a good bony incorporation. If there is instability, use appropriate internal fixation to assure rigid stabilization in all planes. chronos Strip Bone Void Filler is radio-opaque until replaced with new bone. Radio-opacity may mask underlying pathological conditions. Radio-opacity may also make it difficult to radiographically assess the ingrowth of new bone. The Perfusion Pouch is intended for the impregnation of chronos Strip Bone Void Filler with bone marrow or blood. Examine the package for damages before using the sterile bone substitute, as they might impair sterility. This applies to the aluminium peel-off package. In removing the implant from its package, strictly observe the instructions concerning aseptic procedures. Do not attempt to re-sterilize the unused contents of an opened package, but dispose it. Re-sterilization of chronos Strip Bone Void Filler can result in product not being sterile, and/or not meeting performance specifications and/or alters material properties. Do not use chronos Strip Bone Void Filler after the expiry date printed on the packaging. Do not use chronos Strip Bone Void Filler instead of ODL Spacers with the Arch Laminoplasty System Do not fill into artificial compartments (e.g. filling of interbody fusion devices). Precautions The use of chronos Strip Bone Void Filler has a more restricted indication in: Severe, endocrine-induced bone diseases (e.g. hyperparathyroidism) Current therapy with steroids and with drugs, which intervene in calcium metabolism (e.g. calcitonin) Severe, poorly controlled diabetes (diabetes mellitus) with bad wound healing tendencies Immunosuppressive therapy Poor bone quality The use of chronos Strip Bone Void Filler is not known in: Cardiovascular diseases Pregnancy and lactation period Filling of bone defects in congenital deformations Immunosuppressive or radiation therapy Compromised immune system, compromised wound healing When using osteosynthesis fixation systems, the use of Synthes implants is recommended. The effect of mixing chronos Strip Bone Void Filler with medicinal products or other synthetic bone void fillers is not known. Bone Access Needle Notes, cautions and restrictions The bone access needle can be inserted into the bone with gentle taps of the hammer. Strong hammer blows should be avoided, even if sclerotic or thicker cortical bone is involved. Under certain circumstances, there might be a risk of splitting the bone. The safe use of the bone access needle cannot be guaranteed if used in conjunction with MRI, which is associated with certain risks, including: Heating or migration of the product and Artifacts on the MRI image. 4 DePuy Synthes chronos Strip Bone Void Filler Surgical Technique

7 PREPARATION 1 Surgical considerations chronos Strip Bone Void Filler must always be applied by endosteal or subperiosteal implantation (i.e. in direct contact with vital bone). It is recommended that chronos Strip Bone Void Filler be saturated with the patient s own bone marrow and/ or blood prior to implantation. To facilitate the homogenous saturation of chronos Strip Bone Void Filler, it is provided in a perfusion pouch with a Luer fitting to allow attachment of a syringe. Two Bone Access Needles (page 10) can be used as access instruments for the aspiration of autologous bone marrow. The syringe needed for the aspiration and the perfusion in the perfusion pouch (not included) should have a volume of at least 20 ml, feature a standard Luer fitting and be approved for the aspiration of blood/ autologous bone marrow. chronos Strip Bone Void Filler Surgical Technique DePuy Synthes 5

8 PERFUSE chronos STRIP Bone Void Filler 2 Perfuse chronos Strip Bone Void Filler Optional system S S Bone Access Needle, diamond tip, 11G front-opening cannula, 100 mm, violet, pack of 1 unit, sterile Bone Access Needle, diamond tip, 11G front-opening cannula, 150 mm, violet, pack of 1 unit, sterile Aspirate bone marrow using a Bone Access Needle or fill a syringe with the patient s blood. The syringe used (not included) should have a volume of at least 20 ml, feature a standard Luer fitting and be approved for the aspiration of blood / autologous bone marrow. Unscrew the protective cap on the perfusion pouch port. Attach the syringe containing autologous bone marrow or blood to the chronos Strip Bone Void Filler perfusion pouch using the port with the luer fitting. 6 DePuy Synthes chronos Strip Bone Void Filler Surgical Technique

9 Inject the perfusion pouch with fluid following the recommended volume ranges to thoroughly wet the chronos Strip Bone Void Filler. Recommended volumes for perfusion of chronos Strip Bone Void Filler Strip size (mm) (2 Implants) 5 10 Perfusion volume range (ml) Do not exceed the recommended upper volume limit as this may over-pressurize the perfusion pouch. Perfuse the chronos Strip Bone Void Filler by gently pumping the syringe plunger 3 to 5 times or until the implant appears loaded throughout (Figure 1). Figure 1 Do not pull the syringe plunger back to its maximum stroke as this may cause the plunger to disengage from the syringe barrel, resulting in the loss of the syringe contents. Remove the syringe to relieve any pressure from the perfusion pouch. Remove the implant by grasping it through the perfusion pouch to secure it, while tearing at the designated notch at the top of the pouch (Figure 2). Implant chronos Strip Bone Void Filler immediately or place in a sterile bowl for later use during the same surgical procedure. Figure 2 chronos Strip Bone Void Filler Surgical Technique DePuy Synthes 7

10 IMPLANT chronos STRIP Bone Void Filler 3 Implant chronos Strip Bone Void Filler as an example in posterolateral fusion Mechanical stability is a prerequisite for good bony incor poration when using chronos Strip Bone Void Filler, as exemplified by the posterior stabilization system in the picture to the right. If there is instability, stabilize the operative area using appropriate osteosynthesis procedures and hardware fixation. Once the defect is stabilized, chronos Strip Bone Void Filler may be contoured, molded, cut, twisted, or otherwise manipulated by the surgeon intraoperatively to fit the defect as dictated by surgical preference. 8 DePuy Synthes chronos Strip Bone Void Filler Surgical Technique

11 For chronos Strip Bone Void Filler precast Prepare chronos Strip Bone Void Filler precast by tearing or cutting the notched tabs from each of the perfused strips. Place the strips bilaterally along the posterolateral gutters, making sure the perforations fit closely underneath the rod and between the pedicle screws. Mix with the previously removed tabs where desired. Implant chronos Strip Bone Void Filler precast in direct contact with bone, without any intermediate connective tissue layer. chronos Strip Bone Void Filler Surgical Technique DePuy Synthes 9

12 PRODUCT INFORMATION chronos Strip Bone Void Filler, sterile S 50 mm 25 mm 3 mm Recommended volume of bone marrow or blood: 4 10 ml length thickness S 100 mm 25 mm 3 mm Recommended volume of bone marrow or blood: 7 20 ml length thickness S 50 mm 25 mm 6 mm Recommended volume of bone marrow or blood: 7 10 ml length thickness S 100 mm 25 mm 6 mm Recommended volume of bone marrow or blood: ml length thickness chronos Strip Bone Void Filler, precast, sterile S 47 mm 18 mm 3 mm pack of 2 implants Recommended volume of bone marrow or blood: 5 10 ml length thickness length thickness 11 DePuy Synthes chronos Strip Bone Void Filler Surgical Technique

13 ALSO AVAILABLE Bone Access Needle S Diamond tip, 11G front-opening cannula, 100 mm, violet, pack of 1 unit, sterile S Diamond tip, 11G front-opening cannula, 150 mm, violet, pack of 1 unit, sterile 10 Bone Access Needle CE0482, manufactured by: Möller Medical GmbH, Wasserkuppenstrasse 29-31, Fulda, Germany Distributed by: Synthes GmbH, Eimattstrasse 3, 4436 Oberdorf, Switzerland chronos Strip Bone Void Filler Surgical Technique DePuy Synthes 11

14 BIBLIOGRAPHY 1. T. Stoll et al. New Aspects in Osteoinduction. Mat.-wiss. u. Werkstofftech. 2004;35(4): S. Becker et al. Osteopromotion by a b-tricalcium Phosphate/Bone Marrow Hybrid Implant for Use in Spine Surgery. Spine 2006;31(1): J. F. Connolly. Injectable Bone Marrow Preparations to Stimulate Osteogenic Repair. Clin Orthop. 1995;313: D. L. Wheeler et al. Grafting of Massive Tibial Subchondral Bone Defects in a Caprine Model Using b-tricalcium Phosphate versus Autograft. J Orthop Trauma 2005;19(2): M. Muschik et al. b-tricalcium phosphate as a bone substitute for dorsal spinal fusion in adolescent idiopathic scoliosis: preliminary results of a prospective clinical study. Eur Spine J. 2001;10: S. Becker et al. Osteopromotion by a b-tricalcium Phosphate/Bone Marrow Hybrid Implant for Use in Spine Surgery. Spine 2006;31(1):11 17 J. X. Lu et al. Role of interconnections in porous bioceramics on bone recolonization in vitro and in vivo. J Mater Sci Mater Med. 1999; 10(2): Y. Hiu-Yan et al. Novel Approach for Quantification of Porosity for Biomaterial Implants using Microcomputed Tomography (mct). J Biomed Mater Res. 2005;75B: T. J. Blokhuis et al. Properties of Calcium Phosphate Ceramics in Relation to Their In Vivo Behavior. J Trauma. 2000; 48(1): DePuy Synthes chronos Strip Bone Void Filler Surgical Technique

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18 Synthes GmbH Eimattstrasse Oberdorf Switzerland Tel: Fax: This publication is not intended for distribution in the USA. All surgical techniques are available as PDF files at DePuy Synthes Biomaterials, a division of Synthes GmbH All rights reserved DSEM/BIO/0314/ /