OsteoBridge IKA Intramedullary Knee Arthrodesis Fixation System. From the «BioBall Company» OsteoBridge Family

Transcription

1 From the «BioBall Company» OsteoBridge Family OsteoBridge IKA Intramedullary Knee Arthrodesis Fixation System The modular system for the fixation of the knee joint

2 01. OsteoBridge IKA The OsteoBridge IKA serves as a custom implant to fixate the knee after failed primary knee arthroplasty. Based on the OsteoBridge IDSF system, the OsteoBridge IKA modular segments are designed to be attached together to form a complete fixed knee implant using specially designed semicircular attachement shells that are clamped together to create a firm bridge at the joint. All components are manufactured from Ti-6Al-4V Titanium Alloy conforming to ASTM F-136. The intramedullary rods can be fixed with interlocking screws without or with bone cement. Clamping Screws Nail without Collar Angled Spacer Indications include: Failed total knee arthroplasty Limb salvage Oncology surgery Any other condition where there is little soft tissue or bony tissue available for support and arthrodesis is the treatment of choice 2

3 Advantages and System Structure The custom modularity of the system enables intraoperative adaption to the bone defect by using variable nail diameters and lengths Primary stability is achieved by pressfit Secondary stability is achieved with biological integration of the stems into the bone structure (osseointegration) stimulated by a brushed titanium surface Distal interlocking screws provide rotational stability By rotating the angled spacer, the surgeon may adjust both the extension/flexion and valgus/varus positioning of the joint Hollow spacer shells can be used as a carrier of antibiotics as well as bone graft Trial nails and a trial spacer for an intraoperative selection of implant components Cementless and cemented implantation possible Nail with Collar Interlocking Screws

4 02. Case Studies Axial knee replacement after meniscal resection with infection Fall resulting in patellectomy with arthrolysis preoperative Arthrodesis with chronic pain syndrome using OsteoBridge IKA postoperative

5 Condition after failed TKR with infection Temporary prosthesis Treatment with OsteoBridge IKA preoperative postoperative Condition after infection Temporary prosthesis using a carbon fiber rod Treatment with OsteoBridge IKA preoperative postoperative Merete Medical GmbH likes to thank Dr. med. I. Flesch, Berufsgenossenschaftliche Unfallklinik Tübingen, Germany; Prof. Dr. med. L. Rabenseifner, Stadtklinik Baden-Baden, Germany and Prof. Dr. med. A. H. Tiemann, Bergmannstrost Berufsgenossenschaftliche Kliniken Halle, Germany for the kind supply of the x-ray images.

6 04. OsteoBridge IKA Surgical Technique Preparation of the Intramedullary Canal and Implant Selection 1 Prepare the intramedullary canal by opening it with the manual awl or by drilling with flexible or rigid reamers (not included) to the desired diameter. The diameter varies depending on nail form and the principle of anchoring. Nail with Collar Nail Ø Reamer Size Cemented Reamer Size Cementless Ø 10 mm 14 mm 10 mm Ø 12 mm 16 mm 12 mm Ø 14 mm 18 mm 14 mm Ø 16 mm 20 mm 16 mm Nail without Collar Nail Ø Reamer Size Cemented Reamer Size Cementless Ø 14 mm 16 mm 12 mm Ø 16 mm 18 mm 14 mm Ø 18 mm 20 mm 16 mm 2 Most often after failed TKA the defect is trumpet shaped. In this case the nail with collar fits perfectly into the bone. The reamer (GA90021) can be used to shape the bone. The line on the reamer indicates the correct depth.

7 3 Under fluoroscopy 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. The leg should be shortened to facilitate walking. 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 To remove the trial nails use the extractor and slotted hammer. Insert the extractor into the proximal thread of the nail. 6 For a better recognition of the trial components and implants, the trial nails are labeled with diagrams of dice indicating the diameter of the nail. The diagram 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

8 Insertion of the Nails 1 Attention: Clamping length of 20 mm minimum 20 mm If the surgeon prefers to not use interlocking screws, the nails may be inserted and pressfit into the bone with the impactor. At least 20 mm clamping range has to remain outside the bone. 2 Locking Non-locking For cemented indications, cover sleeves must be placed over 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 4 mm larger than for cementless insertion (refer to the table on page 6). If the nail guiding/impacting instrument is not used, the covers GA90002 must be used when cementing the nails. 3 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 fitted into the slot and the locking screw screwed down until the nail is tightened to the nail guiding/impacting instrument.

9 4 Interlocking the nails: The length of the nail and corresponding drill hole alignment is indicated on the side of the nail guiding/impacting instrument. The protection sleeve must be inserted into the corresponding drill hole of the guiding/impacting instrument, indicating the same length as the nail. The trocar peak center-punches a percutaneous drill hole. The trocar is removed and the drill sleeve inserted. 5 Use the Ø 4.5 mm drill bit to drill the interlocking hole. Then remove the drill sleeve. The depth gauge must be positioned to the bone through the protection sleeve. Push the small depth gauge measuring hook through the bone and hook the opposite cortical bone. Now the required length of the interlocking screw can be determined at the end of the depth gauge. Always measure up to the next available screw size. 6 Static interlocking Dynamic interlocking Insert the interlocking screw through the protection sleeve and tighten with the Merete screwdriver. All nails are provided with two drill holes for double interlocking. After inserting the screws remove the nail guiding/impacting instrument. Do not start locking the second nail until the first nail has been completely locked into position. Additional Information: To achieve dynamic compression of the nail postoperatively, the surgeon may remove the static interlocking screw after a few weeks. Please contact Merete for surgical guidance when the indication requires dynamic screw compression postoperatively.

10 Inserting and Fastening the Spacer 1 Position the lower half-shell carefully underneath the nails. Distract the leg to allow enough space to insert and position the spacer. A minimal clamping length of 20 mm must be maintained! The colored area must be entirely positioned inside the spacer. 4 guiding pins are then inserted into the four outside holes. Guided by the pins the upper half-shell can correctly be adjusted onto the lower half-shell. Support the knee bend to facilitate the correct positioning of the spacer. 20 mm 2 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. Parallel alignment

11 3 Replace the guiding pins with four more clamping screws that are tightened down slightly. Next tighten the screws firmly with the torque limiting screwdriver. The torque limiting screwdriver consists of two pieces that must be assembled before use (picture A). A 4 Inside First the 4 inner clamping screws must be tightened in the defined order. Outside Then the 4 outer clamping screws have to be tightened in the defined order. ATTENTION! IMPORTANT! Follow the steps to tighten correctly! Follow the instructions for the connection of the spacer with 8 clamping screws. 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 order as shown. IMPORTANT! Perform this sequence 3 times to tighten the screws! Before wound closure we strongly recommend covering the spacer with bone graft to enhance callus formation The tightening sequence must be performed at least 3 times!

12 Components of OsteoBridge IKA Custom angled Spacer, sterile Interlocking Screws, non-sterile Diameter 5 mm Length Length GB mm GB mm Length GB mm GB mm GB35020 GB mm 22 mm GB35034 GB mm 36 mm GB35048 GB mm 50 mm Diameter 40 mm, Angle 10 GB mm GB mm GB mm Length GB mm GB mm GB mm GA mm GB mm GB mm GB mm Intramedullary Nails with Collar, sterile Intramedullary Nails without Collar, sterile Diameter (mm) Ø =10 Ø =12 Ø =14 Ø =16 Diameter (mm) Ø =14 Ø =16 Ø =18 Length (mm) L = 110 GA11011 GA11211 GA11411 GA11611 L = 130 GA11013 GA11213 GA11413 GA11613 L = 150 GA11015 GA11215 GA11415 GA11615 Length (mm) L = 130 GA21413 GA21613 GA21813 L = 150 GA21415 GA21615 GA21815 L = 200 GA21420 GA21620 GA21820

13 Instruments Instrument Tray 1 GA Item Item 1 IKA Nail Guiding / Impacting Instrument GA Depth Gauge AI Protection Sleeve GB Manual awl 6/10 GA Guiding Pins GA Reamer GA Ø 4.5 mm Drill Sleeve GB Cover Sleeve (cement protection for nail) GA Trocar GB90102 Extractor GB mm Ruler AI Cover Sleeve (cement protection for nail to use with Nail Guiding/Impacting Instrument ) Distance Holder Ø 4.5 mm Drill Bit GA90025 GA90007 GB90245 Instrument Tray 2 GA Item Item 15 Slotted Hammer AI Torque Limiter with ¼ -coupling GA Hex. 5.0 Screwdriver (for Clamping Screws) GA Impactor GA Hex. 3.5 Screwdriver (for Interlocking Screws) AI Trial Spacer GA Hex. 3.5 Screwdriver with AO-coupling (for Interlocking Screws) GA Ø 5 mm Interlocking Screws length: mm GB GB Hex. 5.0 Screwdriver with ¼ -coupling (for Clamping Screws) GA90024

14 Implants Trial Implant Tray with 2 Trial Nails per Size GA91003 Trial Implant Tray with 2 Trial Nails per size GA91004