surgical technique guide
Transcription
surgical technique guide
TeCorp TM TE LE S C O P I C C O R P ECTO MY SYSTE M SURGICAL TECHNIQUE GUIDE FEATURES & BENEFITS The simplified Vertebral Body Replacement Features of Thoraco-Lumbar TeCorp Modular endplates 3 colour coded endplates permit 9 possible angular combinations Safe support and anchorage in the vertebral endplates respect the adjacent vertebrae Large graft areas improve fusion rate 2 In situ distraction Secure locking mechanism allows precise adjustement of the implant height maintains the distracted implant height (1mm increment) Please refer to the Instructions For Use document enclosed within product packaging prior to use. The titanium TeCorp VBR system implanted via the anterior or anterolateral approach is designed to replace the vertebral body at the cervical, thoracic or lumbar level. This VBR system allows the restoration of the intervertebral height as well as lordosis (at the cervical and lumbar level) and kyphosis (at the thoracic level). Indications include pathologies which require vertebral reconstruction such as: • vertebral tumors • anterior column fractures Features of Cervical TeCorp In-built variable cervical endplate Posterior wall allows lordosis angulation from 0° to 7° avoids graft migration and prevents damage to the canal and surrounding tissues Only two steps for in situ distraction and locking system Please refer to the Instructions For Use document enclosed within product packaging prior to use. 3 Surgical protocol for the cervical spine 1 Patient positioning/Anterior approach The procedure is performed under general anesthesia. The patient is placed in dorsal decubitus, the approach is left or right pre-sterno-cleido-mastoid according to the surgeon’s preference. 2 Discectomy and corpectomy First, a discectomy above and below the affected area is performed, followed by a corpectomy using the usual instruments. According to the pathology, the posterior longitudinal ligament (PLL) may also be resected as well as posterior vertebral osteophytes adjacent to the corpectomy performed. 3 Determining the intervertebral distance Once the decompression is finished, the measurement of the intervertebral distance is estimated using the measuring device. This will enable implant height to be chosen. 4 Implant choice Cervical TeCorp device diameter is 16 mm, different heights are available: • 20 mm to 25 mm • 26 mm to 37 mm • 38 mm to 61 mm Intervertebral measuring device 20PAC01 4 Please refer to the Instructions For Use document enclosed within product packaging prior to use. 5 Positioning the implant Before positioning the implant on the parallel distractor it is important to lock the implant. This secures the implant on the parallel distractor prior to insertion. The choosen implant is placed into the space created by the corpectomy and correctly positioned. This is important in order to achieve optimal reduction and stabilization. The implant is then unlocked with the screwdriver and distracted in situ. Distraction is maintained while turning the locking screw. For precise positioning and reduction of the cervical spine, the angulation of the upper integrated endplate can be adjusted in situ. 6 Associated osteosynthesis It is recommended to add an osteosynthesis plate with the cervical TeCorp device such as the low profile cervical Stella plate. 7 Closing the approach Closure is as usual with suction drainage. Parallel distractor for cervical corpectomy implant 20DST01 / 21EDC01 Graft compactor 22COM05 Please refer to the Instructions For Use document enclosed within product packaging prior to use. Screwdriver for corpectomy implants 22TRV10 5 Surgical protocol for the thoracic spine To simplify the surgical technique, we have deliberately chosen a right thoracotomy. The lumbar vertebral reconstruction is technically similar except for the approach which consists in a median or lateral retroperitoneal postero-lumbar incision. 1 Patient positioning The procedure is performed under general anaesthesia, the patient is ventilated with a doublelumen tube. The patient is placed in left lateral decubitus position, thus thoracotomy is performed to access the thoracic spine. 2 Discectomy and corpectomy Lesion level is located, corpectomy is performed using the usual instrumentation, assuring proper decompression of the vertebral canal. 6 Please refer to the Instructions For Use document enclosed within product packaging prior to use. IMPLANTS & INSTRUMENTS 3 Implant choice and modular endplates Implant choice is determined by the extent and level of the corpectomy. A range of implant sizes is available: Thoracic TeCorp, diameter 21 mm • 21 mm to 27 mm • 27 mm to 39 mm • 39 mm to 63 mm Lumbar TeCorp, diameter 27 mm • 28 mm to 40 mm • 40 mm to 64 mm Customization of the implant to suit the individual patient can be achived by the addition of the modular endplates which can be used in combinations that can create angles from 0° to 14°. 4 Endplates orientation According to approach choice, endplates may be oriented by successive 18º rotations to restore spinal curvature. 18° 36° 54° 0° 5° 7° Endplate holder for thoracic and lumbar corpectomy implants 22PRE13 Please refer to the Instructions For Use document enclosed within product packaging prior to use. Endplates 12PICxx-x 7 5 Positioning the implant The thoracic TeCorp device is firstly locked before being placed on the parallel distractor. This secures the implant on the instrument. + Note: In case of a left thoracotomy, the implant must be placed upside down in order to respect the appropriate position of the posterior wall protecting the surrounding tissus. After introduction into the corpectomy space the implant is unlocked and distracted until correct placement has been achieved and kyphosis normalised. Correction may be controlled by direct visualisation or fluoroscopically. Distraction is maintained while turning the locking screw with the screwdriver. 6 Associated osteosynthesis It is recommended that thoracic and lumbar TeCorp devices are stabilized with an osteosynthesis system such as the antero-lateral stabilization Lyra plate. 7 Closing the approach Closure is as usual with suction drainage. Parallel distractor for thoracic and lumbar corpectomy implants 8 20DST01/22EDT01/22EDL01 Graft compactor 22COM05 Please refer to the Instructions For Use document enclosed within product packaging prior to use. Screwdriver for corpectomy implants 22TRV10 SCIENT’X please read carefully INSTRUCTION FOR USE Tecorp corporectomy implant � AIM: The Tecorp corporectomy implant is an implant designed to replace the vertebral body. The different sizes of the Tecorp corporectomy implant allow replacement of the vertebral body in the cervical, thoracic and lumbar region. � GENERAL DESCRIPTION: The Tecorp corporectomy implant allows replacement of the vertebral body of the segment involved. The device, which is expandable in situ, permits peroperative distraction of the vertebral segment involved. Distraction of the implant is performed using a specific ancillary device that serves both as a prehensor and a distractor. For thoracic and lumbar implantation, contact with the overlying and underlying vertebrae is made via plates, the angulation of which conforms to the angulation to be restored. The plates are assembled on the implant peroperatively and several angulations are available. The upper and lower plates have a notched surface to promote anchoring with the vertebrae involved. Tecorp cervical corporectomy implants are equipped with a fixed upper plate; this plate makes it possible to restore an angulation peroperatively via a mechanism internal to the implant. Several sizes are offered to suit the different morphologies. The Tecorp corporectomy implant is manufactured from implantable titanium alloy according to ISO 5832-3 or ASTM-F 136 standards. The Tecorp corporectomy implant must not be used with components derived from other manufacturers. � INDICATIONS: The corporectomy implant is a surgical implant that allows reconstruction of the intervertebral space via the anterior approach. The indications include: Vertebral body tumours, Fracture of the anterior spine, Vertebral reconstruction following monosegmental or multisegmental corporectomy. � CONTRAINDICATIONS: The contraindications of the Tecorp corporectomy implant include: - local infection or inflammation, - vertebral osteoporosis, - allergy to or intolerance of titanium or its alloys, - incompatible age and physical condition of the patient, - any case not included in the indications. The Tecorp corporectomy implant is not designed, intended or sold for any uses other than those indicated. � POSSIBLE ADVERSE EVENTS: - infection, - secondary collapse, - loss of correction, - intolerance of the material. Note: an additional surgical operation may be necessary in order to correct an adverse event. Warnings: an entirely satisfactory result is not always systematically obtained with each surgical operation. This applies particularly to spinal surgery in which many external elements may compromise the results. � S URGICAL PRECAUTIONS: The surgeon must be perfectly acquainted with the Tecorp corporectomy device, the application method, instruments and surgical technique. The size of the Tecorp corporectomy implant must be chosen according to the clinical case and the desired correction. The angulation of the plates must be selected according to the segmental angulation that one is endeavouring to restore. Before implantation of the Tecorp corporectomy implant, the end plates must be carefully curetted and refreshed without being weakened in order to avoid risks of collapse of the implant. The Tecorp corporectomy implant must be filled with autologous, allogenic bone, cement or a bone substitute in order to achieve bone fusion. It is imperative to combine the Tecorp corporectomy implant with an anterior or anterolateral and/or posterior fixation system. A control X-ray allows confirmation of correct positioning of the implant in relation to the vertebrae. DOREG103 en 1/1 Before implantation, the batch number and reference of the Tecorp corporectomy implant inserted must be systematically recorded in the patient’s surgical file. . This product is a single use device. Under no circumstances should it be reused. While the device may appear to be undamaged, it may have small defects or internal stress patterns, as a result of the prior implantation or removal that could lead to fatigue failure. Additionally, please note that the removed implant has not been designed or validated so as to allow for decontamination of microorganisms. Reuse of this product could lead to cross-infection and/or material degradation as a result of the decontamination process. The company accepts no responsibility for products which have been reused. • Attention: no silicone, formaldehyde or latex based products should be implanted with a SCIENT’X implant � PACKAGING: The Tecorp corporectomy implants and their accompanying ancillary instruments are supplied in a single container, a “kit”, except for kit restocking at the warehouse. The kit must be closed and sealed; its packaging must be intact on receipt. If the warehouse kit system is used, the complete composition of the kit must be carefully checked. The storage conditions must make it possible to maintain intactness of the implants, the associated ancillary devices and their respective packaging. Good condition of all the implants and instruments must be controlled before any use. Damaged products must not be used and must be returned to SCIENT’X. ■ DECONTAMINATION, CLEANING AND STERILIZATION: Products delivered in sachets are not sterile. For implants delivered sterile: the implants are sterilized by Gamma radiation at doses of 25 to 40 kGy. The expiry date is 5 years. The expiry date of sterile parts is indicated on the packaging. Resterilization of implants delivered sterile is prohibited. For implants and instruments not sterile on delivery: all implants and instruments delivered non-sterile must be decontaminated, cleaned and sterilized before and after use. Implants and instruments in sachets must be removed from the original packaging for the following operations: Recommended method: - Decontamination: Plunge the implants and instruments into a bactericidal and fungicidal solution of the didecyldimethylammonium chloride type diluted to 0.5 % (5mL to 1 litre water). Length of soaking: 20 min. Rinse with demineralized water. - Cleaning: Wash the implants and instruments in a LANCER type machine with suitable cleaning products, rinse and dry. Any product that might damage the equipment is forbidden (such as bleach, formol, etc.). Sterilization: It is essential to sterilise the kit by steam using the following conditions: Ø pre-heating for 25’ at 110° (1 bar) Ø vacuum 5' (0.8 bar under atmospheric pressure) Ø heating 5' at 120° (1 bar) Ø vacuum 5' (0.8 bar) Ø sterilization 18' at 134° (2 bars) Ø drying 20' return to room temperature ■COMPLAINTS: Any complaints, together with the reference and lot number of the incriminated product, should be sent to Scient’x. � ADDITIONAL INFORMATION: For any additional information, please contact: SCIENT’X 22, rue Jean Bart 78960 Voisins le Bretonneux - FRANCE tel.: 33 (0)1 39 30 69 30 fax: 33 (0)1 30 43 82 77 e-mail: qualite@scientx.com 0459 2002 Last revision: 06/2010 Do not useuse if if Do not package is is package damaged damaged Non Nonsterile sterile Manufacturer Manufactu rer Do Donot re-use not reuse Sterile Steril e ReadIFU IFU Read Date Date of of Manufacture manufa cture Useonly Use only Date d'application : 21/02/2011 Revision :1.0 DMQ#11-106 Implants Corpectomy implants Color code Cervical implant Ø 16 mm gold Thoracic implant Ø 21 mm green Lumbar implant Ø 27 mm blue Height (mm) Ref. from 20 to 25 from 26 to 37 from 38 to 64 from 21 to 27 from 27 to 39 from 39 to 63 from 28 to 40 from 40 to 64 11ICC16-20 11ICC16-26 11ICC16-38 12ICT21-24 12ICT21-30 12ICT21-42 12ICT27-31 12ICT27-43 Endplates For thoracic implant For lumbar implant Color code Angle Maximum height (mm) Ref. purple gold silver purple gold silver 7° 5° 0° 7° 5° 0° 3.6 2.8 1 4.3 3.4 1 12PIC21-7 12PIC21-5 12PIC21-0 12PIC27-7 12PIC27-5 12PIC27-0 Instruments Ref. Parallel distractor for corpectomy implants Cervical tips for parallel distractor Thoracic tips for parallel distractor Lumbar tips for parallel distractor Endplate holder for thoracic and lumbar corpectomy implants Graft compactor Intervertebral measuring device Screwdriver for corpectomy implants Screwdriver for cervical corpectomy implants 20DST01 21EDC01 22EDT01 22EDL01 22PRE13 22COM05 20PAC01 22TRV10 21TRV08* * On request. Delivery time to be confirmed with order. 11 Corporate Headquarter: ALPHATEC SPINE, INC. 5818 El Camino Real Carlsbad, CA 92008 - U.S.A. TL +1 460 431 9286 www.alphatecspine.com International Headquarter: SCIENT’X-ALPHATEC SPINE 22, avenue Jean Bart 78960 Voisins-le-Bretonneux - FRANCE TL +33 (0)1 39 30 69 30 - FX +33 (0)1 30 43 82 77 www.scientx.com This product is not available for sale in the United States of America. Non contractual pictures. Please read carefully the instructions for use bulletin. Devices may be subject to modification. Patented. TeCorp & Scient’x-Alphatec Spine logo are trademarks of Alphatec Spine, Inc. (C) 2011 Alphatec Spine, Inc. All rights reserved. DOMKT507 en Rev1.0 - DMQ#11-315 - Approval date: August 2011