From the «BioBall Company» OsteoBridge Family OsteoBridge Knee Arthrodesis The modular system for the fusion of the knee joint
OsteoBridge Knee Arthrodesis System 01. OsteoBridge Knee Arthrodesis The OsteoBridge Knee Arthrodesis serves as an implant to fuse the knee after failed primary knee arthroplasty. The implant can also be used for bridging large bone defects and the resection of the metaphysis of femur and tibia. The System is available in three different variations: I. Standard System II. Extended System III. Extended System PLUS Page 4/5 The Standard System consists of an angled spacer for bridging the damaged joint as well as nails with a collar in different lengths and diameters to anchor the implant in the femur and tibia. The nails are trumpet-shaped to optimize their stability into the damaged bone. Page 6 The Extended System contains additional nails that do not have a collar. These nails are tapered and ribbed for a better anchorage in the bone. To bridge medium sized bone defects spacers in the length of 20 mm without a collar and 30 mm with collar can be clamped onto the nails. Page 8 The Extended System PLUS includes spacers in the lengths from 40 to 70 mm to bridge particulary large bone defects. They can be connected with a spacer connector. Page 10 Advantages of the OsteoBridge Knee Arthrodesis Modularity of the system ensures flexible supply Cementless and cemented implantation possible Immediate mobility and analgesia possible Simple handling, short time surgery Indications Failed surgery (total knee replacement) Arthrodesis or knee prostheses infections Periprothetic fractures Posttraumatic condition preventing an implantation of a knee prosthesis Tumors in the proximity of the knee Loosening or impairment of the pulley 2
Service package for the surgical assistance 02. Service Package for Surgical Assistance Preoperative Planning On the basis of the patient s x-rays the surgeon will be provided with a preoperative planning. Necessary implants will be selected and a graphical exposition of the proposed provision can be drawn. Supply For the first surgeries all necessary implants and instruments will be provided on a loan basis. In-House Training Before the Surgery our product specialist demonstrates the use of the instruments and implants and performs saw bone training for your staff. Surgical Assistance A Merete product specialist attends the surgery and assists the assembly and instrumentation of the implants. Merete Medical GmbH Alt-Lankwitz 102 12247 Berlin Germany Phone: +49 (0)30-77 99 80-0 Fax: +49 (0)30-77 99 80-177 Mail: service@merete.de www.merete.de 3
OsteoBridge Knee Arthrodesis System 03. Properties and System Structure The modularity of the system enables intraoperative adaption to the particular bone defect by using variable spacer lengths and spacer combinations. Primary stability is achieved by pressfit and a partly tapered, wedge-shaped nail design with radiating ribs Secure secondary stability due to biological integration of the prosthesis stem into the bone structure (osseointegration) stimulated by a roughened titanium surface Rotational stability by distal interlocking screws, static or dynamic All implant components are made of titanium alloy (TiAl6V4) Adjustment of the extension/flexion and valgus/varus positioning of the joint by rotation of the angled spacer Trial nails and a trial spacer for an intraoperative selection of implant components Hollow spacer shells can be used as a carrier of antibiotics as well as bone graft for an active stimulation of bone growth Cementless and cemented implantation possible I. Standard System Basic Supply Clamping Screws Nail with Collar Standard System Interlocking Screws Spacer in den Längen 20 und 30 mm Angled Spacer 4
OsteoBridge Knee Arthrodesis System II. Extended System Flexible Supply Spacer with/without Collar Nail without Collar III. Extended System PLUS Complete Supply Spacer Connector Extended System Extended System PLUS Extended spacer Merete Medical GmbH Alt-Lankwitz 102 12247 Berlin Germany Phone: +49 (0)30-77 99 80-0 Fax: +49 (0)30-77 99 80-177 Mail: service@merete.de www.merete.de 5
OsteoBridge Knee Arthrodesis Standard System I. Standard System Basic Supply The implant is used for the fusion of the knee joint. Due to the implant design of the OsteoBridge Knee Arthrodesis Standard System small and medium bone defects can be treated. The system consists of an angled spacer for bridging the damaged joint as well as a set of nails with collar in different lengths and diameters to anchor the implant in femur and tibia. Due to previous TKRs the bone ends have become trumpet shaped openings. The nails with collar adapt to this anatomy very well. The angled spacer enables a flexion of 10. By rotating the spacer the valgus-varus position of the joint can be adjusted. x-ray templates are available for the preoperative planning. Intraoperatively the surgeon can select the appropriate implant sizes with the aid of trial components. Interlocking screws with a diameter of 5 mm (lengths: 20 mm to 56 mm) are provided in this package. They ensure a secure fixation of the nails into the bone. The intruments are provided in two trays. Nail with Collar Interlocking Screws Standard System Nails with Collar, sterile Angled Spacer Spacer, sterile Diameter (mm) Ø =10 Ø =12 Ø =14 Ø =16 Diameter 40 mm, Angle 10 Length* (mm) L = 110 GA11011 GA11211 GA11411 GA11611 L = 130 GA11013 GA11213 GA11413 GA11613 L = 150* GA11015 GA11215 GA11415 GA11615 Ref. Length 50 mm GA04041 *Special lengths on request. Interlocking screws Diameter 5 mm Ref. Length Ref. Length GB35030 30 mm GB35044 44 mm Ref. Length GB35032 32 mm GB35046 46 mm GB35020 20 mm GB35034 34 mm GB35048 48 mm GB35022 22 mm GB35036 36 mm GB35050 50 mm GB35024 24 mm GB35038 38 mm GB35052 52 mm GB35026 26 mm GB35040 40 mm GB35054 54 mm GB35028 28 mm GB35042 42 mm GB35056 56 mm 6
OsteoBridge Knee Arthrodesis Standard System Case Study Standard System Condition after failed TKR with infection Temporary interim prosthesis Treatment with OsteoBridge Standard System preoperative postoperative Merete Medical GmbH likes to thank Prof. Dr. med. L. Rabenseifner, Stadtklinik Baden-Baden, Germany for the kind supply of the x-ray images. Standard System Trial Implant Tray with 2 Trial Nails per Size Ref. GA91003 Merete Medical GmbH Alt-Lankwitz 102 12247 Berlin Germany Phone: +49 (0)30-77 99 80-0 Fax: +49 (0)30-77 99 80-177 Mail: service@merete.de www.merete.de 7
OsteoBridge Knee Arthrodesis Extended System II. Extended System Flexible Supply The Extended System provides a second set of nails without a collar. The taper shaped nails fit perfectly into the intramedullary canal. Ribs provide firm anchorage in the bone. Spacers in the length 20 mm without collar and 30 mm with collar can optionally be clamped onto these nails. A treatment of defects up to 70 mm can be achieved. Spacer with Collar Nail without Collar Extended System Ribs Example of use: Application of a nail without collar and without additional spacer Spacer without Collar Nails without Collar, sterile Spacer without/with Collar, sterile Diameter (mm) Ø =14 Ø =16 Ø =18 Diameter 40 mm, Angle 0 Length* (mm) L = 130 GA21413 GA21613 GA21813 L = 150 GA21415 GA21615 GA21815 L = 200 GA21420 GA21620 GA21820 Ref. GA04020 Length 20 mm Ref. GA04030 Length 30 mm *Special lengths on request. 8
OsteoBridge Knee Arthrodesis Extended System Case Study Extended System Condition after failed TKR with infection Temporary treatment with bone cement spacer Treatment with OsteoBridge Extended System preoperative postoperative Merete Medical GmbH likes to thank Dr. med. A. H. Tiemann, Berufsgenossenschaftliche Kliniken Bergmannstrost, Halle, Germany for the kind supply of the x-ray images. Extended System Trial Implant Tray with 2 Trial Nails per size Ref. GA91004 Merete Medical GmbH Alt-Lankwitz 102 12247 Berlin Germany Phone: +49 (0)30-77 99 80-0 Fax: +49 (0)30-77 99 80-177 Mail: service@merete.de www.merete.de 9
OsteoBridge Knee Arthrodesis Extended System PLUS III. Extended System PLUS Complete Supply Spacer 70mm Spacer Connector 60 mm Large bone defects can be treated with the Extended System PLUS. Spacers in the lengths of 40 to 70 mm are provided. These Spacers can be connected with a spacer connector. 50 mm 40 mm Extended EXTENSION System PLUS Spacer Connector, sterile Ref. GA40040 Spacer 70/60/50/40 mm, sterile Diameter 40 mm, Angle 0 Ref. Length GA04070 Spacer 70 mm GA04060 Spacer 60 mm GA04050 Spacer 50 mm GA04040 Spacer 40 mm Case Study Extension PLUS Condition after failed TKR with infection Temporary interim prosthesis Treatment with OsteoBridge Extended System PLUS preoperative postoperative Merete Medical GmbH likes to thank Prof. Dr. med. L. Rabenseifner Stadtklinik Baden-Baden, Germany for the kind supply of the x-ray images. 10
OsteoBridge Knee Arthrodesis Instruments Instruments Instrument Tray 1 Ref. GA91001 2 1 13 4 10 5 3 12 11 14 9 6 8 Item Ref. Item Ref. 1 2 3 4 5 Arthrodesis Nail Guiding/ Impacting Instrument Protection Sleeve 4x Guiding Pins Drill Sleeve Ø 4.5 mm Trocar GA90100 GB90101 GA90003 GB90145 GB90102 8 9 10 11 12 Depth Gauge Bradawl 6/10 Reamer 2x Cover Sleeve (cement protection for nail) 2x Cover Sleeve (cement protection for nail to use with Nail Guiding/Impacting Instrument ) AI00200 GA90020 GA90021 GA90002 GA90025 6 Extractor GB90203 13 2x Distance Holder GA90007 7 Ruler 300 mm AI90300 14 Drill Bit Ø 4.5 mm GB90245 Instrument Tray 2 Ref. GA91002 24 15 20 21 25 23 18 19 16 22 17 Item Ref. Item Ref. 15 Slotted Hammer AI00048 20 Torque Limiter with ¼ -connector GA90026 16 Screwdriver, hex. 5 (for clamping screws) GA90009 21 Impactor GA90008 17 18 Screwdriver, hex. 3.5 (for interlocking screws) Screwdriver, hex. 3.5 with AO-connector (for interlocking screws) AI00135 GA90023 22 23 24 Spacer Measuring Gauge Trial Spacer Connector Trial Spacer GA90022 GA50040 GA54041 19 Screwdriver, hex. 5.0 with ¼ -connector (for clamping screws) GA90024 25 4 Interlocking Screws apiece Ø 5 mm Länge 20-56 mm GB35020- GB35056 Merete Medical GmbH Alt-Lankwitz 102 12247 Berlin Germany Phone: +49 (0)30-77 99 80-0 Fax: +49 (0)30-77 99 80-177 Mail: service@merete.de www.merete.de 11
OsteoBridge Knee Arthrodesis surgical technique 04. OsteoBridge Knee Arthrodesis Surgical Technique Preparation of the Intramedullary Canal and Implant Selection 1 Prepare the intramedullary canal by opening it with the bradawl or by drilling with an intramedullary drill to the desired diameter. The diameter varies depending on nail form and the principle of anchoring. Cemented Cementless Nail with Collar 2 to 4 mm larger than nominal diameter nominal diameter Nail without Collar 2 mm larger than nominal diameter 2 mm smaller than nominal diameter 2 Use the reamer and shape the bone in the proximal area to implant a nail with collar. 3 Use the trial nails to check the adequate length and diameter. Different nails can be used for tibia and femur. For checking the total length the trial spacer has to be assembled. The upper spacer half-shell is guided by two pins and fastened by two screws. Remove the trial components when the leg length is accurate. 12
OsteoBridge Knee Arthrodesis surgical technique 4 Check the position of the nails inside the spacer. The nails have to be flush with the window in the upper half-shell. 5 If the angled spacer ist not long enough to bridge the defect, the length of an additional spacer can be determined with the Spacer Measuring Gauge. 6 To remove the trial nails use the extractor and slotted hammer. Insert the extractor into the proximal thread of the nail. 7 For a better allocation of trial components and implants the trial nails are labeled with pictograms of a dice indicating the diameter of the nail. The pictogram with the corresponding number of the dice can also be found on the product label. Ø 10 mm Ø 12 mm Ø 14 mm Ø 16 mm Ø 18 mm Merete Medical GmbH Alt-Lankwitz 102 12247 Berlin Germany Phone: +49 (0)30-77 99 80-0 Fax: +49 (0)30-77 99 80-177 Mail: service@merete.de www.merete.de 13
OsteoBridge Knee Arthrodesis surgical technique Insertion of the Nails 1 Attention: Clamping length of 20 mm minimum 20 mm If no interlocking screws are used the nails can be inserted into the bone with the impactor. At least 20 mm clamping range has to remain outside the bone. 2 When using interlocking screws the drill holes in the nail have to be positioned in the frontal plane, for medial insertion of the screws. To insert the nail correctly into the bone the nail guiding/impacting instrument has to be plugged into the slot and the locking screw screwed down until the nail is tightened to the nail guiding/impacting instrument. 3 Interlocking the nails: The length of the nails whose drill holes align is indicated on the nail guiding/ impacting instrument. The protection sleeve must be inserted into the corresponding hole of the guiding/impacting instrument, indicating the same length as the nail,. The trocar peak center-punches the drill hole. The trocar is removed and the drill sleeve inserted. 14
OsteoBridge Knee Arthrodesis surgical technique 4 Use the drill bit Ø 4.5 mm to drill the interlocking hole. Afterwards remove the drill sleeve. The depth gauge must be positioned onto the bone through the protection sleeve. Push the small measuring pole through the bone and hook to the opposite cortical bone. Now the required length of the interlocking screw can be read out at the end of the measure. 5 Static interlocking Insert the interlocking screw of the correct length into the protection sleeve and tighten with the enclosed screwdriver. All nails are provided with two drill holes for double interlocking. Remove the static interlocking screw to achieve a dynamisation of the nail via the long hole. After insertion of the screws remove the nail guiding/impacting instrument. Do not start locking the second nail before the locking of the first nail has been completed. Dynamic interlocking 6 Locking Non-locking In case of a cemented insertion the cover sleeves have to be placed onto the nails before starting to insert the nail. The sleeves are removed once the insertion of the nails has been completed. The diameter of the intramedullary canal should be 2 to 4 mm larger than for cementless insertion (Refering to the table on page 12, picture 1). If the nail guiding/impacting instrument is not used the covers GA90002 must be used when cementing the nails. Merete Medical GmbH Alt-Lankwitz 102 12247 Berlin Germany Phone: +49 (0)30-77 99 80-0 Fax: +49 (0)30-77 99 80-177 Mail: service@merete.de www.merete.de 15
OsteoBridge Knee Arthrodesis surgical technique Inserting and Screwing the Spacer 1 Position the lower half-shell carefully underneath the nails. Always respect the minimal clamping length of 20 mm! The colored area must be entirely positioned inside the spacer. Thereafter 4 guiding pins must be inserted into the four outside holes. Guided by the pins the upper half-shell can correctly be adjusted onto the lower half-shell. 20 mm 2 20 mm When using the Extended System PLUS, on one side of the spacer a spacer connector must be used instead of a nail. The spacer connector has to be pushed up against the side of the spacer. 3 Dot Between the spacer and each collared nail a distance holder is inserted. The distance holder defines the minimal distance needed for secure implantation. The dot on the distance holder must face the end of the nail, away from the spacer. Clamping screws must be screwed into the four vacant threaded holes, but not entirely tightened. The half-shells must always have the same distance to each other on both sides. 16
OsteoBridge Knee Arthrodesis surgical technique 4 Replace the guiding pins by four more clamping screws which are tightened down slightly. Thereafter tighten the screws firmly with the torque limiting screwdriver. The torque limiting screwdriver consists of two pieces that must be assembled before use. 5 Inside First the 4 inner clamping screws must be tightened in the defined order. ATTENTION! 1. 4. IMPORTANT! Follow the steps to tighten exactly! (see figure 5) Follow the instructions for the connection of the spacer with 8 clamping screws carefully. The exact execution of these steps is required to achieve a sufficient clamping and the necessary rotational stability.! All screws have to be tightened with the torque limiting screwdriver in the given order. 3. 2.! IMPORTANT! Repeat this precedure 3 times to re-tighten the screws! Outside Then the 4 outer clamping screws have to be tightened in the defined order. 7. 6. 5. 8. Repeat the whole procedure 3 times! Merete Medical GmbH Alt-Lankwitz 102 12247 Berlin Germany Phone: +49 (0)30-77 99 80-0 Fax: +49 (0)30-77 99 80-177 Mail: service@merete.de www.merete.de 17
OsteoBridge Knee Arthrodesis surgical technique 5 When using a spacer with the length of 20 mm or 30 mm of the Extended System it has to be positioned onto the clamping area of the nail without collar and screwed in place. Do not clamp the spacer onto the tapered part of the nail. ATTENTION: The part of the nail left outside of the bone has to have a length of 40-50 mm! 20 mm 40-50 mm 6 When using a spacer with the length of 40 mm to 70 mm of the Extended System PLUS this spacer has to be assembled between the spacer connector and the nail only after the angled spacer is fully mounted. 18
OsteoBridge Family OsteoBridge Family OsteoBridge Diaphysis The modular diaphyseal endoprosthesis for the long term stabilisation of segmental bone defects and bone resections in humerus, femur and tibia Product Forecast Development in Progress OsteoBridge Resection Hip Prosthesis OsteoBridge Metaphysic Supply Merete Medical GmbH Alt-Lankwitz 102 12247 Berlin Germany Phone: +49 (0)30-77 99 80-0 Fax: +49 (0)30-77 99 80-177 Mail: service@merete.de www.merete.de 19
Merete Medical GmbH Alt-Lankwitz 102 12247 Berlin Germany Phone: +49 (0)30 77 99 80-0 Fax: +49 (0)30 76 68 03 61 service@merete.de www.merete.de ENOA 09-2009 All rights reserved. Cover: corellio Fotolia.de