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Humeral Nailing System

Humeral Nailing System
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Humeral Nailing System

Product catalog summary
Overview: The document provides comprehensive instructions for the T2 Humeral Nailing System by Stryker Osteosynthesis, focusing on the stabilization of humeral fractures. It highlights the necessity of surgeon discretion and patient-specific adjustments, recommending workshop training before initial use.
Specifications: The T2 Humeral Nail is designed for temporary stabilization of various humeral fractures, including shaft fractures, non-unions, and pathological fractures. Available in diameters of 7-9mm and lengths of 140-320mm, the system includes fully and partially threaded locking screws, end caps, and a range of instruments coded by procedure type.
Indications and Contraindications: Indications include humeral shaft fractures and malalignments. Precautions involve infection, compromised vascularity, and obesity. Contraindications include interference with anatomical structures and certain mental or neuromuscular disorders. The system is not evaluated for MR environments.
Pre-operative Planning: Emphasizes the importance of pre-operative radiographic evaluation to determine nail length and diameter, considering the apposition/compression feature of the nail.
Operative Techniques:
  • Antegrade Technique: Details patient positioning, incision, entry point preparation, and nail insertion, including unreamed and reamed methods.
  • Locking Options: Offers static, dynamic, and advanced locking modes with detailed steps for each using the Target Device.
Warnings: Stryker bone screws are not approved for attachment to the posterior elements of the spine. All non-sterile devices must be cleaned and sterilized before use, following the reprocessing guide.
Contributing Surgeons: Lists contributing surgeons from various institutions, highlighting their expertise in trauma and orthopedic surgery.
Procedures:
  • Static Locking Mode: Involves drilling through the first cortex and reading screw length directly from the drill.
  • Static Oblique Locking Mode: Utilizes the Tissue Protection Sleeve assembly for screw insertion.
  • Freehand Distal Locking: Requires visualization of a perfectly round locking hole with the C-Arm.
  • Dynamic Locking Mode: Allows for controlled dynamic locking for stable fractures.
  • Apposition/Compression Locking Mode: Provides active mechanical apposition/compression.
  • Advanced Locking Mode: Offers additional fixation by inserting a Fully Threaded Locking Screw.
  • Nail Removal: Describes the elective procedure for nail removal, emphasizing the sequence of screw extraction.
Patient Positioning and Incision:
  • Patients are positioned on a radiolucent table in either prone or lateral decubitus position.
  • A posterior approach is used for incision, with detailed steps for accessing the distal humerus.
Techniques:
  • Unreamed Technique: Involves the use of a Smooth Tip Guide Wire for nail insertion without reaming.
  • Reamed Technique: Utilizes a Ball Tip Guide Wire and reaming in increments for precise nail placement.
Warnings and Recommendations:
  • Ensure the Tissue Protection Sleeve is flush with the cortex to maintain screw measurement accuracy.
  • Avoid drilling through the far cortex to prevent joint penetration.
  • Use image intensification to confirm screw position and length.
  • Handle Elastosil components with care to prevent blockage and bending.
  • Carefully select End Cap length to avoid impingement.
Introduction: Provides detailed instructions for the retrograde technique of inserting a T2 Humeral Nail, including specifications, procedures, and recommendations for ensuring proper alignment and stability.
Specifications:
  • The final reamer should be 1mm−1.5mm larger than the diameter of the nail.
  • The driving end of the 7mm nail is always 8mm.
  • X-Ray Templates should be used pre-operatively to determine the canal size radiographically.
Procedures:
  • Guide Wire Management: Use the Guide Wire Pusher to maintain the Guide Wire position during reamer shaft extraction.
  • Nail Selection and Insertion: The diameter of the selected nail should be 1mm smaller than the last reamer used.
  • Locking Modes: Includes Static Oblique, Static Transverse, Controlled Dynamic, and Advanced Locking Modes.
Recommendations:
  • Use image intensification to confirm screw position and length.
  • Ensure the Tissue Protection Sleeve is flush with the cortex to maintain screw measurement accuracy.
End Cap Insertion: After removing the Target Device, insert an End Cap to prevent bony ingrowth into the proximal threads of the nail.
Conclusion: Outlines the critical steps and considerations for the successful insertion and locking of a T2 Humeral Nail using the retrograde technique.
Operative Technique – Retrograde Technique:
  • Insertion and Fixation: Designed to allow for additional fixation by inserting a Fully Threaded Locking Screw.
  • Advanced Locking Mode: Follow the static locking procedure for inserting the second transverse Fully Threaded Locking Screw.
  • Nail Removal: Typically elective, with specific steps for removing the End Cap and Compression Screw.
Manufacturer and Distribution: Manufactured by Stryker Trauma GmbH in Germany and distributed by Stryker in the USA. Emphasizes the need for professional clinical judgment and training in product use.
Legal and Trademark Information: Stryker Corporation owns the trademarks Stryker and T2. The document includes a disclaimer about medical advice and product availability, and it is CE marked.
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Catalog excerpts

Humeral Nailing System-1

stryker Trauma & Extremities Operative Technique

 Open the catalog to page 1
Humeral Nailing System-2

Contributing Rupert Beickert, M. D. Senior Trauma Surgeon Murnau Trauma Center Murnau Germany Rosemary Buckle, M. D. Orthopaedic Associates, L. L. P. Clinical Instructor University of Texas Medical School Houston, Texas USA Prof. Dr. med.Volker Buhren Chief of Surgical Services Medical Director of Murnau Trauma Center Murnau Germany Michael D. Mason, D. O. Assistant Professor of Orthopaedic Surgery Tufts University School of Medicine New England Baptist Bone & Joint Institute Boston, Massachusetts USA This publication sets forth detailed recommended procedures for using Stryker Osteosynthesis...

 Open the catalog to page 2
Humeral Nailing System-3

6. Operative Technique - Antegrade Technique 9 Patient Positioning and Fracture Reduction 9 Guided Locking Mode (via Target Device) 15 Static Locking Mode 16 Freehand Distal Locking 19 Dynamic Locking Mode 21 Apposition/Compression Locking Mode 22 Advanced Locking Mode 24 7. Operative Technique - Antegrade Technique 26 Guided Locking Mode (via Target Device) 32 Static Locking Mode 33 Freehand Proximal Locking 36 Dynamic Locking Mode 37 Apposition/Compression Locking Mode 38 Advanced Locking Mode 40

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Humeral Nailing System-4

Humerus Advanced Compression Screw (Diameter = 6mm) 4.0mm Fully Threaded Locking Screws L = 20−60mm 4.0mm Partially Threaded Locking Screws (Shaft Screws) L = 20−60mm End Caps Instrument Coding Symbol coding on the instruments indicates the type of procedure, and must not be mixed. Symbol Long instruments Triangular = Short instruments 3.5mm = Orange For 4.0mm Fully Threaded Locking Screws and for the second cortex when using 4.0mm Partially Threaded Locking Screws (Shaft Screws). 4.0mm = Grey For the first cortex when using 4.0mm Partially Threaded Locking Screws (Shaft Screws). Drills feature...

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Humeral Nailing System-5

Indications ' The T2 Humeral Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the humerus. ' The nails are inserted using an opened or closed technique and can be static, dynamic and compression locked. ' The subject and predicate devices are indicated for use in the humerus. ' Types of fractures include, but not limited to fractures of the humeral shaft, non-unions, malalignments, pathological humeral fractures, and impending pathological fractures. Precautions Stryker Osteosynthesis systems have not been evaluated for safety and use...

 Open the catalog to page 5
Humeral Nailing System-6

An X-Ray Template (1806-0003) is available for pre-operative planning. Thorough evaluation of pre-operative radiographs of the affected extremity is critical. Careful radiographic examination can help prevent intra-operative complications. If X-Rays show a very narrow intramedullary canal in the distal part of the humerus, retrograde humeral nailing is not possible. The proper nail length when inserted antegrade should extend from subchondral bone proximally, to 1cm above the olecranon fossa distally. The retrograde nail length is determined by measuring the distance from 1cm above the olecranon...

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Humeral Nailing System-7

Locking Options Static Mode oblique Static Mode transverse

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Humeral Nailing System-8

Locking Options Dynamic Mode Apposition/Compression Mode Advanced Locking Mode

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Humeral Nailing System-9

Operative Technique – Antegrade Technique Patient Positioning and Fracture Reduction The patient is placed in a semireclined “beach chair position” or supine on a radiolucent table. Patient positioning should be checked to ensure that imag­ ing and access to the entry site are possible without excessive manipulation of the affected extremity (Fig.  ). The 1 image intensifier is placed at the legside of the patient  the surgeon is positioned ; at the headside. Incision A small incision is made in line with the fibers of the deltoid muscle anterolateral to the acromion. The deltoid is split to...

 Open the catalog to page 9
Humeral Nailing System-10

Operative Technique – Antegrade Technique Entry Point The entry point is made with the Curved, cannulated Awl (1806-0040) (Fig. 3). The 2.5 × 800mm Ball Tip Guide Wire (1806-0083S) is then introduced through the awl under image intensification into the metaphysis, central to the long axis of the humerus. Alternatively, the optional Crown Drill (1806-2020) may be used over the K-Wire with Washer (1806-0051S) for entry point preparation. The K-Wire will help to guide the Crown Drill centrally (Fig. 3a). Then, the 3 × 285mm K-Wire (18060050S) is introduced under image intensification into the metaphysis,...

 Open the catalog to page 10
Humeral Nailing System-11

Operative Technique – Antegrade Technique Unreamed Technique If an unreamed technique is preferred, the nail may be inserted over the 2.2 × 800mm Smooth Tip Guide Wire (1806-0093S) (Fig. 4). Reamed Technique For reamed techniques, the 2.5 × 800mm Ball Tip Guide Wire (1806-0083S) is inserted across the fracture site. The Reduction Rod (1806-0363) may be used as a fracture reduction tool to facilitate Guide Wire insertion across the fracture site (Fig. 5). Reaming is commenced in 0.5mm increments until cortical contact is appreciated. Final reaming should be 1mm−1.5mm larger than the diameter of...

 Open the catalog to page 11
Humeral Nailing System-12

Note: • Humeral Nails cannot be inserted over the 2.5mm Ball Tip Guide Wire. The Ball Tip Guide Wire must be exchanged for the 2.2mm Smooth Tip Guide Wire prior to nail insertion. • Use the Teflon Tube (1806-0073S) for the Guide Wire exchange. When reaming is completed, the Teflon Tube (1806-0073S) should be used to exchange the Ball Tip Guide Wire (1806-0083S) with the Smooth Tip Guide Wire (1806-0093S) for nail insertion (Fig. 8 and 9). An unreamed technique can be considered in cases, where the medullary canal has the appropriate diameter. In these cases, the nail can be introduced over the...

 Open the catalog to page 12
Humeral Nailing System-13

Operative Technique – Antegrade Technique Nail Selection Transverse Compression Slot (Oblique or Dynamic) Hole Positions The X-Ray Template should be used pre-operatively to determine the canal size radiographically. This information may be utilized in conjunction with the clinical assessment of canal size as determined by the size of the last reamer used. The diameter of the selected nail should be 1mm−1.5mm smaller than the last reamer used. Length End of Guide Wire Ruler is the measurement reference Fig. 11 Nail length may be determined with the X-Ray Ruler (Fig. 10). The Guide Wire Ruler...

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