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T2 Arthrodesis Nailing System

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T2 Arthrodesis Nailing System T2 Arthrodesis Nailing System Operative Technique 1 Knee Arthrodesis Nailing System Contributing Surgeons Stephen Incavo MD University of Vermont Department of Orthopaedics & Rehabilitation Burlington/Vermont, USA Prof. Dr. Dr. Gunther O. Hofmann Chief of Surgical Services Medical Director of Halle Trauma Center Halle, Germany Director of Trauma Department Friedrich-Schiller-University Jena, Germany This publication sets forth detailed recommended procedures for using Stryker Osteosynthesis devices and instruments. It offers guidance that you should heed, but, as with any such technical guide, each surgeon must consider the particular needs of each patient and make appropriate adjustments when and as required. A workshop training is required prior to first surgery. All non-sterile devices must be cleaned and sterilized before use. Follow the instructions provided in our reprocessing guide (L24002000). Multi-component instruments must be disassembled for cleaning. Please refer to the corresponding assembly/ disassembly instructions. See package insert (L22000007) for a complete list of potential adverse effects, contraindications, warnings and precautions. The surgeon must Reference discuss all relevant risks, including 1. Incavo S., Lily J. ,Churchill the finite lifetime of the device, with Bartlett C., Arthrodesis of the Knee: the patient, when necessary. Experience with Intramedullary Nailing. Journal of Arthroplasty Warning: 15 (7) 871−876, 2000 All bone screws referenced in this document here are not approved 2. Hofmann G.O., Therapeutische for screw attachment or fixation Optionen bei persistierendem to the posterior elements Kniegelenkinfekt, Trauma (pedicles) of the cervical, Berufskrankheit 5 (2003), 221−224 thoracic or lumbar spine. 2 Contents Page 1. Introduction 4 Implant Features 4 Instrument Features 4 2. Indications, Precautions & Contraindications 5 Indications 5 Precautions 5 Relative Contraindications 5 3. Technical Details 6 System Specifications 6 4. Operative Technique 7 Pre-operative Planning 7 Patient Positioning 7 Knee Incision 7 Hip Incision and Entry Point 7 Reaming 8 Nail Assembly 8 Nail Insertion Preparation 9 Nail Insertion 10 Guided Locking Mode (via Targeting Device) 11 Static Locking 12 Apposition/Compression Locking Mode 14 Freehand Distal Locking 15 Ordering Information – Implants 16 Ordering Information – Instruments 17 3 Introduction The T2 Nailing System represents In addition to the T2 Femoral, Tibial, Stryker´s latest and most com- and Humeral Nailing Systems, prehensive development of the original Stryker developed the T2 Arthrodesis intra-medullary principles presented Nail to provide treatment of Knee by Prof. Gerhard Küntscher in 1940. Arthrodesis. Stryker has created a new generation Through the development of a locking nail system, bringing together common, streamlined and intuitive all the capabilities and benefits of surgical approach, both in principle separate nailing systems to create a and in detail, the T2 Arthrodesis Nail single, integrated surgical resource for offers significantly increased speed fixation of long bones. and functionality for the treatment of Knee Arthrodesis as well as simpli- fying the training requirements for all personnel involved. Implant Features Instrument Features The T2 Arthrodesis Nail is the The T2 Arthrodesis Nail is inserted realization of strong biomechanical with the existing T2 Basic Set, Long intramedullary stabilization using together with the Femur Indication small caliber cannulated implants for Set. internal fixation of long bones. Note: The design of the T2 Arthrodesis The core instruments of the T2 Nail features a unique curvature system provide the platform for which incorporates both femur all current and future Stryker antecurvature and knee valgus bend. Nailing Systems, thereby reducing This design dictates the need for both complexity and inventory. left and right implants providing Refer to the T2 Femoral Nailing an improved fit for each patient’s System Operative Technique individual needs. All T2 Arthrodesis (REF B1000004) and T2 Tibial Nail implants are made of Type II Nailing System Operative anodized titanium alloy (Ti6Al4V) Technique (REF B1000005) for for enhanced biomechanical and more detailed system protocols. biomedical performance. All implants are provided in sterile packaging. 4 Indications, Precautions and Contraindication Indications Precautions Aseptic failed total knee arthro-plasty The T2 System has not been evaluated with or without bone loss for safety and compatibility in the MR • Failed external fixation, environment. nonunions and malunions The T2 System has not been tested • Periarticular fractures where for heating or migration in the MR repair is not possible environment. • Pathologic fractures, impending pathologic fractures and tumor resections • Pseudoarthrosis and correction osteotomy • Ipsilateral femur fractures • Open and closed femoral fractures Relative Contraindications The physician’s education, training and professional judgement must be relied upon to choose the most appropriate device and treatment. Conditions presenting an increased risk of failure include: • Any active or suspected latent • Implant utilization that would infection or marked local interfere with anatomical inflammation in or about the structures or physiological affected area. performance. • Compromised vascularity that • Any mental or neuromuscular would inhibit adequate blood disorder which would create an supply to the fracture or the unacceptable risk of fixation operative site. failure or complications in • Bone stock compromised by postoperative care. disease, infection or prior implan- • Other medical or surgical tation that can not provide conditions which would preclude adequate support and/or fixation the potential benefit of surgery. of the devices. • Material sensitivity, documented or suspected. • Obesity. An overweight or obese patient can produce loads on the implant that can lead to failure of the fixation of the device or to failure of the device itself. • Patients having inadequate tissue coverage over the operative site. 5 Technical Details System Specifications Two Nails, Left and Right 0mm Diameters: 11.5 & 13mm Lengths: 540 − 780mm in 40mm increments 32.5mm 35mm Compression Range: 45mm Total Length of Slot 15mm 47.5mm Less Screw Diameter (−) 5mm 60mm Maximum Movement of Screw 10mm Screws, End caps & Compression Screw (See Page 16 for complete description and catalog numbers) 75 mm 35 mm 25 mm 0 mm 6 Operative Technique Pre-operative Hip Incision and Entry Point Planning A skin incision is made beginning at the level of the Greater Trochanter Noting any deformity of the axis An X-Ray Template (1806-0011) is extending proximal and slightly of the tibial shaft, and using either available for pre-operative planning. posterior, in line with the Gluteus the Awl or Rigid Reamer over the Implant sizing is best determined Muscle, exposing the Piriformis K-Wire, open the anterior central using full length A/P and Lateral Fossa. Alternatively, the Tip of the medial aspect of the tibia using the X-Rays of both the affected and Greater Trochanter can be located tibial tubercle as a reference to the contralateral legs. C.T. Scan for canal by palpation, and a horizontal skin medullary canal. diameter and leg length may be useful. incision is made from the Greater The knee should be placed in 5−10˚ of Trochanter to the Iliac Crest. The Insert the 1250mm Ball Tip Guide flexion and 5˚ valgus. The leg should medullary canal is opened with the Wire (1806-1250S) from the hip be 1cm shorter than the opposite curved awl (1806-0040), or with a through the knee and advance into the side. This position allows for more 3×285mm K-Wire (1806-0050) and tibial shaft to the depth at which you normal gait and foot clearance during Ø12mm Rigid Reamer (1806-2014) want the nail to end. walking. combination. Ultimately, 1 cm of leg shortening The Guide Wire Ruler (1806-0022) is the goal, therefore in cases with Alternatively, a minimal skin incision features dedicated marks to identify more significant bone loss, additional of the hip region can be made if the the to be choosen nail length when flexion should be avoided to minimize femoral canal is reamed in retrograde using the 1250mm Guide Wire. additional shortening. fashion from the knee joint. To accomplish this, the 3×1250mm Caution: Ball Tip Guide Wire (1806-1250S) Use image intensification (A/P is advanced from the distal femoral and Lateral) for confirmation Nail Length canal proximally to the greater throughout each step. The nail length is surgeon dependent trochanteric / piriformis fossa region. with regards to the individual situation of the patient and with Warning: regards on how long the nail should Avoid the femoral neck. The extend into the Tibia. Guide Wire is then gently advanced through the cortex by gently tapping the strike plate on the Guide Wire Handle/ Chuck assembly. Fluoroscopic visualization is necessary for this Patient Positioning step. Once the Guide Wire exits the bone, it is retrieved through a Patient positioning is surgeon small skin incision made over the dependent. The patient may be tip of the Guide Wire. positioned supine (elevate the affected hip), lateral or semi-lateral on a radiolucent table. Use image intensification (A/P and Lateral) for confirmation throughout each step. Knee Incision A vertical skin incision is made extending from the femoral condylar region to the tibial tubercule, followed by a parapatellar capsular incision. In
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