Technique Guide. chronos Strip. Osteoconductive betatricalcium phosphate ( -TCP) composite.

Transcription

1 Technique Guide chronos Strip. Osteoconductive betatricalcium phosphate ( -TCP) composite.

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3 Table of Contents Introduction chronos Strip 2 Indications and Contraindications 3 Surgical Technique Preparation 4 Perfuse chronos Strip 5 Implant chronos Strip 7 Product Information Product Information 9 Also Available 10 Bibliography 12 Warning This description is not sufficient for immediate application of the product. Instruction by a surgeon experienced in handling this product is highly recommended. Synthes 1

4 chronos Strip. Osteoconductive betatricalcium phosphate ( -TCP) composite. chronos Strip is a synthetic bone void filler manufactured from chronos beta tricalcium phosphate ( -TCP) granules and a resorbable polymer [poly (lactide-co- -caprolactone)]. The result is a porous, osteoconductive, three-dimensional composite that is flexible, with excellent memory characteristics. chronos Strip conforms to the implant site, allowing site-specific placement. Each strip is sterile-packaged in a perfusion pack, allowing easy perfusion with autologous bone marrow and/or blood. Perfusion with bone marrow aspirate (BMA) provides a favorable environment for bony ingrowth. 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 -TCP ceramic scaffold with the handling advantage of a resorbable polymer Resorbed and replaced by bone usually in 6 18 months during the bone remodeling process Can be used alone or with autograft 100% synthetic, consistent quality, sufficient quantity Standardized pores are within the size range identified as ideal for bony ingrowth Perfusion pack allows thorough loading of chronos Strip with autologous bone marrow and/or blood 2 Synthes chronos Strip Technique Guide

5 Indications and Contraindications Indications* chronos Strip 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 indications only. The porous structure of chronos Strip acts as a matrix for the ingrowth of bone. chronos Strip implants must always be applied by endosteal or subperiosteal implantation, i.e. by direct contact with the vital bone. chronos Strip combined with autologous bone marrow and/or blood is intended for use in spine, trauma and CMF indications, such as: Bone voids or gaps that are not intrinsic to the stability of the bony structure Use in the treatment of bony defects created surgically or through traumatic injury Contraindications* chronos Strip 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 Cranioplasty * For complete indications, contraindications, precautions and warning notices, please refer to the instructions for use. Synthes 3

6 Preparation 1 Surgical considerations chronos Strip must always be applied by endosteal or subperiosteal implantation (i.e. in direct contact with healthy bone). chronos Strip may be used in conjunction with autograft. When combining with autograft, a 1:1 ratio should be used. It is recommended that chronos Strip be saturated with the patient s own bone marrow and/or blood prior to implantation. To facilitate the homogenous saturation of chronos Strip, it is provided in a perfusion pack with a Luer fitting to allow attachment of a syringe, such as the one found in the bone marrow aspiration system. 4 Synthes chronos Strip Technique Guide

7 Perfuse chronos Strip 2 Perfuse chronos Strip Optional system S Bone Marrow Aspiration System (Biopsy Needle: 11 ga 11.0 cm, with Side Holes), sterile S Bone Marrow Aspiration System (Biopsy Needle: 11 ga 15.0 cm, with Side Holes), sterile S Bone Marrow Aspiration System (Biopsy Needle: 11 ga 15.0 cm, with distal Hole), sterile Aspirate bone marrow using the bone marrow aspiration system or fill a syringe with the patient s blood. Note: Refer to the Synthes Technique Guide chronos Perfusion Concept. Enhancing chronos with biological factors (Art. No ) for the suggested surgical technique for aspirating bone marrow. Unscrew the protective cap on the perfusion pack port. Attach the syringe containing fluid to the Luer fitting on the chronos Strip perfusion pack. Synthes 5

8 Perfuse chronos Strip Inject the perfusion pack with fluid following the recommended volume ranges to thoroughly wet the chronos Strip. Recommended volumes for perfusion of chronos Strip Strip size Perfusion (mm) volume range (cc) (2 Implants) 5 10 Perfuse the chronos Strip by gently pumping the syringe plunger 3 to 5 times or until the implant appears loaded throughout (figure 1). Remove the syringe to relieve any pressure from the perfusion pack. Remove the implant by grasping it through the perfusion pack to secure it, while tearing at the designated notch at the top of the pack (figure 2). figure 1 Caution: Do not exceed the recommended upper volume limit as this may over-pressurize the perfusion pack. Note: 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. figure 2 6 Synthes chronos Strip Technique Guide

9 Implant chronos Strip 3 Implant chronos Strip Mechanical stability is a prerequisite for good bony incor poration when using chronos Strip. If there is instability, stabilize the operative area using appropriate osteosynthesis procedures and hardware fixation. Once the defect is stabilized, manipulate or secure chronos Strip intraoperatively to fill the defect according to surgeon preference. Synthes 7

10 Implant chronos Strip For chronos Strip precast Prepare chronos Strip precast by tearing or cutting the notched corners 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 autograft and the previously removed corners where desired. Implant chronos Strip precast in direct contact with bone, without any intermediate connective tissue layer. 8 Synthes chronos Strip Technique Guide

11 Product Information chronos Strip, sterile S 50 mm 25 mm 3 mm Volume of bone marrow or blood: 4 10 cc length thickness S 100 mm 25 mm 3 mm Volume of bone marrow or blood: 7 20 cc length thickness S 50 mm 25 mm 6 mm Volume of bone marrow or blood: 7 10 cc length thickness S 100 mm 25 mm 6 mm Volume of bone marrow or blood: cc length thickness chronos Strip, precast, sterile S 47 mm 18 mm 3 mm pack of 2 implants Volume of bone marrow or blood: 5 10 cc length thickness length thickness Diagrams show actual dimensions of strips. Synthes 9

12 Also Available Bone Marrow Aspiration System (BMAS) Art. No. Diameter Length Side holes Syringe S 11 ga 11 cm yes 20 ml S 11 ga 15 cm yes 20 ml S 11 ga 15 cm no 20 ml 10 Synthes chronos Strip Technique Guide

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14 Bibliography chronos: optimized scaffold induces remodeling process Wheeler D. (2005) Grafting of Massive Tibial Subchondral Bone Defects in a Caprine Model Using -Tricalcium Phosphate Versus Autograft. J Orthop Trauma, 19 (2), Lu J, Flautre B et al. (1999) Role of interconnections in porous bioceramics on bone recolonization in vitro and vivo. J Mater Sci Mater Med, 10 (2), chronos: clinical studies Arlet V et al. (2006) Harvesting local cylinder autograft from adjacent vertebral body for anterior lumbar interbody fusion: surgical technique, operative feasibility and preliminary clinical results. Eur Spine J 15: Knop C et al. (2006) Successful posterior interlaminar fusion at the thoracic spine by sole use of -tricalcium phosphate. Arch Orthop Trauma Surg 126: Pavlov PW and Schupbach P. (2005) -Tricalcium phosphate in anterior cervical interbody fusion CT-study and retrival analysis. Poster at the CSRS Annual meeting European Section. Bone marrow: osteogenic potential Connolly J. (1995) Injectable bone marrow preparations to stimulate osteogenic repair. Clin Orth Rel Res, 313, Tiedeman J et al. (1991) Healing of a large nonossifying fibroma after grafting with bone matrix and marrow, Clin. Orth. Rel. Res., 265, Connolly J et al. (1989) Autologous marrow injection for delayed unions of the tibia: a preliminary report. J Orthop Trauma, 3 (4), Vacuum perfusion: efficient impregnation of chronos with bone marrow Becker S et al. (2006) Osteopromotion by a -TCP/Bone Marrow Hybrid Implant for Use in Spine Surgery. Spine, Volume 31(1), Stoll T et al. (2004) New Aspects in Osteoinduction. Mat.- wiss. u. Werkstofftech, 35 (4), Pavlov PW. (2003) Anterior decompression for cervical spondylotic myelopathy. Eur Spine J 12 (Suppl 2): Muschik M et al. (2001) Beta-tricalcium phosphate as a bone substitute for dorsal spinal fusion in adolescent idiopathic scoliosis: Preliminary results of a prospective clinical study. Eur Spine J 10: Bone marrow harvesting technique: reduced morbidity Bertram H, Mayer H, Schliephake H. (2005) Effect of donor characteristics, technique of harvesting and in vitro processing on culturing of human marrow stroma cells for tissue engineered growth of bone. Clin Oral Implants Res, 16(5), Kitchel S, Wang M, Lauryssen C. (2005) Techniques for Aspirating Bone Marrow for Use in Spinal Surgery. Neurosurgery, 57(4), Synthes chronos Strip Technique Guide

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