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chronOS Strip. Osteoconductive beta- tricalcium phosphate (-TCP) composite. Technique Guide
chronOS Strip. Osteoconductive beta-tricalcium phosphate (�-TCP) composite.
Technique Guide
Synthes 1
Introduction
Surgical Technique
Product Information
Bibliography 12
chronOS Strip 2
Indications and Contraindications 3
Preparation 4
Perfuse chronOS Strip 5
Implant chronOS Strip 7
Product Information 9
Also Available 10
WarningThis description is not sufficient for immediate application ofthe product. Instruction by a surgeon experienced in hand-ling this product is highly recommended.
Table of Contents
2 Synthes chronOS Strip Technique Guide
Features and Benefits– A composite pairing the structure of an osteoconductive
�-TCP ceramic scaffold with the handling advantage of aresorbable polymer
– Resorbed and replaced by bone usually in 6 –18 monthsduring 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
chronOS Strip is a synthetic bone void filler manufacturedfrom chronOS beta tricalcium phosphate (�-TCP) granulesand a resorbable polymer [poly (lactide-co-�-caprolactone)].The result is a porous, osteoconductive, three-dimensionalcomposite that is flexible, with excellent memory characteris-tics. chronOS Strip conforms to the implant site, allowingsite-specific placement.
Each strip is sterile-packaged in a perfusion pack, allowingeasy perfusion with autologous bone marrow and/or blood.Perfusion with bone marrow aspirate (BMA) provides a favor-able environment for bony ingrowth.
chronOS Strip. Osteoconductive beta-tricalcium phosphate (�-TCP) composite.
May be folded, twisted, cut, or sutured intraoperatively for optimal placement
Flexible and conforms to patient anatomy
Perfusion pack allows thorough loading of chronOS Strip with autologous bonemarrow and/or blood
Synthes 3
* For complete indications, contraindications, precautions and warning notices,please refer to the instructions for use.
Indications*chronOS Strip should be used as bone void filler or augmen-tation material in zones requiring cancellous rather than cor-tical bone. This includes the filling of bone defects aftertrauma, reconstruction or correction in non-load bearing in-dications only.The porous structure of chronOS Strip acts as a matrix for theingrowth of bone. chronOS Strip implants must always beapplied by endosteal or subperiosteal implantation, i.e. by di-rect contact with the vital bone.chronOS Strip combined with autologous bone marrowand/or blood is intended for use in spine, trauma and CMFindications, 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 circum-stances:– Acute and chronic infections in the operation area, e.g.
inflammation, bacterial bone diseases (posttraumatic orchronic osteomyelitis) and soft-tissue infections
– Untreated malignant myeloma, Burkitt’s lymphoma andother lymphomas
– Defects and fractures in the region of an open epiphysis– Osteoporosis– Cranioplasty
Indications and Contraindications
Preparation
1Surgical considerationschronOS Strip must always be applied by endosteal or subpe-riosteal implantation (i.e. in direct contact with healthybone). chronOS Strip may be used in conjunction with auto-graft. When combining with autograft, a 1:1 ratio should beused.
It is recommended that chronOS Strip be saturated with thepatient’s own bone marrow and/or blood prior to implanta-tion. To facilitate the homogenous saturation of chronOSStrip, it is provided in a perfusion pack with a Luer fitting toallow attachment of a syringe, such as the one found in thebone marrow aspiration system.
4 Synthes chronOS Strip Technique Guide
Synthes 5
2Perfuse chronOS Strip
Optional system
710.111S Bone Marrow Aspiration System (Biopsy Needle: 11 ga �11.0 cm, with Side Holes), sterile
710.151S Bone Marrow Aspiration System (Biopsy Needle: 11 ga �15.0 cm, with Side Holes), sterile
710.150S 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 Perfu-sion Concept. Enhancing chronOS with biological factors”(Art. No. 036.000.745) for the suggested surgical techniquefor aspirating bone marrow.
Unscrew the protective cap on the perfusion pack port.
Attach the syringe containing fluid to the Luer fitting on thechronOS Strip perfusion pack.
Perfuse chronOS Strip
6 Synthes chronOS Strip Technique Guide
Inject the perfusion pack with fluid following the recom-mended volume ranges to thoroughly wet the chronOS Strip.
Recommended volumes for perfusion of chronOS Strip
Strip size Perfusion(mm) volume range (cc)
50�25�3 4–10
100�25�3 7–20
50�25�6 7–10
100�25�6 15–20
47�18�3 (2 Implants) 5–10
Perfuse the chronOS Strip by gently pumping the syringeplunger 3 to 5 times or until the implant appears loadedthroughout (figure 1).
Remove the syringe to relieve any pressure from the perfu-sion pack.
Remove the implant by grasping it through the perfusionpack to secure it, while tearing at the designated notch atthe top of the pack (figure 2).
Caution: Do not exceed the recommended upper volumelimit as this may over-pressurize the perfusion pack.
Note: Do not pull the syringe plunger back to its maximumstroke as this may cause the plunger to disengage from thesyringe barrel, resulting in the loss of the syringe contents.
Perfuse chronOS Strip
figure 1
figure 2
Synthes 7
3Implant 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 chronOSStrip intraoperatively to fill the defect according to surgeonpreference.
Implant chronOS Strip
8 Synthes chronOS Strip Technique Guide
For chronOS Strip precastPrepare chronOS Strip precast by tearing or cutting thenotched corners from each of the perfused strips.
Place the strips bilaterally along the posterolateral gutters,making sure the perforations fit closely underneath the rodand between the pedicle screws.Mix with autograft and the previously removed cornerswhere desired.
Implant chronOS Strip precast in direct contact with bone,without any intermediate connective tissue layer.
Implant chronOS Strip
Synthes 9
Diagrams show actual dimensions of strips.
chronOS Strip, sterile
Product Information
07.801.100S 50 mm�25 mm�3 mm
Volume of bone marrow or blood: 4–10 cc
chronOS Strip, precast, sterile
07.801.200.02S 47 mm�18 mm�3 mmpack of 2 implants
Volume of bone marrow or blood: 5–10 cc
07.801.101S 100 mm�25 mm�3 mm
Volume of bone marrow or blood: 7–20 cc
07.801.110S 50 mm�25 mm�6 mm
Volume of bone marrow or blood: 7–10 cc
07.801.111S 100 mm�25 mm�6 mm
Volume of bone marrow or blood: 15–20 cc
length thickness
length length thicknessthickness
length thickness
length thickness
length thickness
Also Available
Bone Marrow Aspiration System (BMAS)
Art. No. Diameter Length Side holes Syringe
710.111S 11 ga 11 cm yes 20 ml
710.151S 11 ga 15 cm yes 20 ml
710.150S 11 ga 15 cm no 20 ml
10 Synthes chronOS Strip Technique Guide
12 Synthes chronOS Strip Technique Guide
Bibliography
chronOS: optimized scaffold induces remodelingprocessWheeler D. (2005) Grafting of Massive Tibial SubchondralBone Defects in a Caprine Model Using �-Tricalcium Phos-phate Versus Autograft. J Orthop Trauma, 19 (2), 85–91.
Lu J, Flautre B et al. (1999) Role of interconnections inporous bioceramics on bone recolonization in vitro and vivo.J Mater Sci Mater Med, 10 (2), 111–120.
chronOS: clinical studiesArlet V et al. (2006) Harvesting local cylinder autograft fromadjacent vertebral body for anterior lumbar interbody fusion:surgical technique, operative feasibility and preliminary clini-cal results. Eur Spine J 15: 1352-1359.
Knop C et al. (2006) Successful posterior interlaminar fusionat the thoracic spine by sole use of �-tricalcium phosphate.Arch Orthop Trauma Surg 126: 204-210.
Pavlov PW and Schupbach P. (2005) �-Tricalcium phosphatein anterior cervical interbody fusion – CT-study and retrivalanalysis. Poster at the CSRS Annual meeting European Sec-tion.
Pavlov PW. (2003) Anterior decompression for cervicalspondylotic myelopathy. Eur Spine J 12 (Suppl 2):188–194.
Muschik M et al. (2001) Beta-tricalcium phosphate as a bonesubstitute for dorsal spinal fusion in adolescent idiopathicscoliosis: Preliminary results of a prospective clinical study. Eur Spine J 10:178–184.
Bone marrow harvesting technique: reduced morbidityBertram H, Mayer H, Schliephake H. (2005) Effect of donorcharacteristics, technique of harvesting and in vitro process-ing on culturing of human marrow stroma cells for tissue engineered growth of bone. Clin Oral Implants Res, 16(5),524–31.
Kitchel S, Wang M, Lauryssen C. (2005) Techniques for Aspi-rating Bone Marrow for Use in Spinal Surgery. Neurosurgery,57(4), 286–289.
Bone marrow: osteogenic potentialConnolly J. (1995) Injectable bone marrow preparations tostimulate osteogenic repair. Clin Orth Rel Res, 313, 8–18.
Tiedeman J et al. (1991) Healing of a large nonossifying fibroma after grafting with bone matrix and marrow, Clin.Orth. Rel. Res., 265, 302–305.
Connolly J et al. (1989) Autologous marrow injection for delayed unions of the tibia: a preliminary report. J OrthopTrauma, 3 (4), 276–282.
Vacuum perfusion: efficient impregnation of chronOSwith bone marrowBecker S et al. (2006) Osteopromotion by a �-TCP/Bone Marrow Hybrid Implant for Use in Spine Surgery. Spine, Volume 31(1), 11–17.
Stoll T et al. (2004) New Aspects in Osteoinduction. Mat.-wiss. u. Werkstofftech, 35 (4), 198–202.
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