Zimmer® Nexel™ Total Elbow Surgical Technique Zimmer® Nexel™ Total Elbow Surgical Technique Table of Contents PAGE Indications / Contraindications ............................1 Pre-Operative Considerations ...............................2 Surgical Technique Summary ................................3 SECTION 1. Surgical Preparation and Exposure 5 2. Humeral Preparation 7 3. Ulnar Preparation 12 4. Trial Reduction 16 5. Component Implantation 17 6. Final Assembly 23 7. Closure 25 8. Postoperative Management 26 9. Poly Revision 27 10. Component Removal 29 Zimmer® Nexel™ Total Elbow Surgical Technique Device Description This device is a total elbow prosthesis designed for use with bone cement. It is available in sizes 4, 5 and 6, in left and right configurations. The Ulnar and Humeral Components are manufactured from Tivanium® (Ti-6Al-4V) alloy. The Ulnar Component has a porous coating of Ti-6Al-4V plasma spray and is curved to facilitate implantation. The Humeral Component has a porous coating of Ti-6Al-4V plasma spray and has an anterior flange to accommodate a bone graft. The Axle-Pin and Humeral Screws are manufactured from Zimaloy® (Co-Cr-Mo) alloy. Vitamin E highly cross-linked ultra-high molecular weight polyethylene (Vivacit-E®) bearings prevent metal-to-metal articulating contact. Note: Size 4, 5 and 6 are numerical relative descriptions of the available girths of the Implant stems. 4,5 and 6 do not imply or equate to a dimension. 4 does not equal 4 mm, and so on. Ulnar Bearing Ulnar Eye Humeral Screws Axle-Pin Plasma Spray Ulnar Component Ulnar Bearing Humeral Component Humeral Bearing Plasma Spray Anterior Flange Zimmer® Nexel™ Total Elbow Surgical Technique Indications / Contraindications INDICATIONS CONTRAINDICATIONS ® ™ Indications for use include: Use of the Zimmer Nexel Total Elbow is contraindicated in patients with: • Elbow joint destruction which significantly compromises the activities of daily living • Currently active, or history of repeated, local infection at the surgical site • Post-traumatic lesions or bone loss contributing to elbow instability • Paralysis or dysfunctional neuropathy involving the elbow joint • Ankylosed joints, especially in cases of bilateral ankylosis from causes other than active sepsis • Significant ipsilateral hand dysfunction • Advanced rheumatoid, post-traumatic, or degenerative • Excessive scarring of the skin or soft tissue that could arthritis with incapacitating pain prevent adequate soft tissue coverage • Instability or loss of motion when the degree of joint or soft • Daily activities that would subject the device to significant tissue damage precludes reliable osteosynthesis stress (i.e., heavy labor, torsional stress, and/or competitive sports) • Acute comminuted articular fracture of the elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus Relative contraindications include: • Revision arthroplasty • Distant foci of infection (e.g. genitourinary, pulmonary, skin [chronic lesions or ulcerations], or other sites). In cases of Caution: This device is intended for cemented use only distant infection, the foci of infection should be treated prior to, during and after surgery. • Ancient prior sepsis 1 Zimmer® Nexel™ Total Elbow Surgical Technique Pre-Operative Considerations Axis of Flexion M L • For those inexperienced in the technique of elbow arthroplasty, training with a cadaver specimen(s) is recommended to appreciate the soft tissue implications of the technique. • Be aware of existing shoulder pathology; assess shoulder stiffness, avoid forceful rotation. • Avoid overlapping cement mantles and/or interference between shoulder and elbow humeral stems, and/or a short cement gap between shoulder and elbow humeral stems as Fig. 0.0 these are known fracture risks. Posterior View • Understand if a revision length stem is to be used and assess/accommodate for the amount of anterior bowing of the humerus on the lateral pre-operative radiographs. • To address flexion contracture, consider counter sinking the Humeral Component to the extent that does not produce a Axis of Flexion fracture of the medial condyle. L M • For proper orientation of the humeral component, understand the humeral osseous landmarks establishing the axis of flexion of the elbow. Medially, the landmark is a point at the anterior/inferior aspect of the medial condyle. Laterally, the landmark is the center of the capitellum (Fig. 0.0-0.2). Fig. 0.1 Recommended Power for Surgery Anterior View • Bur for opening ulnar canal. • Microsagittal saw for removing trochlea. Center of Rotation • Power with high-speed attachment for trephine; 1000 rpm’s minimum. P A • Power with reamer attachment for ulnar reamers. • Oscillating saw blade for making verticle humeral cuts using cut guide; 1.27mm blade width and ~3” long. Fig. 0.2 Lateral View 2 Zimmer® Nexel™ Total Elbow Surgical Technique Surgical Technique Summary Dashed line denotes top of Implant Axis of Flexion A A Fig. 2.1 Fig. 2.3 Fig. 2.4 Use saw or ronguers to remove trochlea and Use Humeral Awl Reamer to open canal and Sequentially Rasp the canal; solid line needs access humeral canal. confirm readiness for Rasps. to align with the axis of flexion. Fig. 2.13 Do not start drill until pin in hole. Fully seat Trephine Stabilizer 2 Create notch 1 with rongeur Fig. 2.7 Fig. 2.11 Fig. 2.12 Anterior View Score the bone, and create rounded humeral Secure the Humeral Cut Guide by inserting Fully seat the Trephine Stabilizer until the marking cut by using the Trephine saw. the Pin, then make vertical cuts using aligns with the axis of Flexion (notch anterior oscillating saw. humerus), and finish the Trephine cut. Fig. 3.2 Bur Fig. 2.14 Fig. 3.1 Fig. 3.5 Assess Humeral bone preparation with Remove tip of the olecranon and open ulnar Prepare the distal ulna using Flexible Reamers, Provisional. canal with a bur. Solid followed by Cannulated, until marking aligns with chosen length Implant. 3 Zimmer® Nexel™ Total Elbow Surgical Technique Surgical Technique Summary Fig. 3.11 Flat of the Olecranon Fig. 3.7 Fig. 3.9 Fig. 4.1 Prepare the proximal ulna using sequential After using the Ulnar Bearing Clearance Reduce joint and perform a trial range of Rasps, until hole feature on Rasp aligns Template to confirm adequate clearance for motion. with axis of flexion. Implant, assess the ulnar preparation using the Ulnar Provisional. Fig. 5.1 Fig. 5.2 Fig. 5.4 Retrograde fill the ulnar canal with cement. Use Ulnar Stem Inserter to fully seat implant, Retrograde fill the humeral canal with cement. then remove Cement Diverter. Fig. 5.5 Fig. 6.4 Fig. 6.6 Insert bone graft under the anterior flange Partially reduce the joint with hand pressure, Bearings will be flush with top of Implant and use the Humeral Stem Inserter to fully then fully reduce it using the Articulation when fully seated, and Humeral Screws will seat the Implant. Inserter. (Alternate: Ulnar Bearing Tamp is thread in easily using Elbow Torque Driver. used with the triceps-on exposure.) 4 SECTION 1 Zimmer® Nexel™ Total Elbow Surgical Technique 1. Surgical Preparation and Exposure Ulnar Crest 1.1 Patient Preparation Ulnar Nerve • Position the patient. · Position patient in supine with a sandbag under Fig. 1.1 the scapula. Incision just lateral to medial epicondyle. · Place the arm across the chest. • Place a rolled towel under elbow. TECHNIQUE TIP 1.2 Flexor carpi A more midline positioned incision decreases the need for ulnaris m. elevating an extensive flap. Medial epicondyle 1.2 Incision • Make a straight incision approximately 15cm in length. · Center incision over the elbow joint just lateral to the Fig. 1.2 medial epicondyle and just medial to the tip of the olecranon (Fig. 1.1). Translocate ulnar nerve to subcutaneous tissue. Motor branch 1.3 Ulnar Nerve Protection of ulnar m. • Isolate the ulnar nerve. Sharpey’s fibers · Identify the medial aspect of the triceps mechanism. · Use ocular magnification and a bipolar cautery as necessary. • Mobilize the ulnar nerve to the first motor branch. • Very carefully translocate the nerve anteriorly into the subcutaneous tissue (Fig. 1.2). Note: Carefully protect the nerve throughout the remainder of Fig. 1.3 the procedure. Remove triceps from the proximal ulna. 5 SECTION Zimmer® Nexel™ Total Elbow Surgical Technique 1 1.4 The Bryan/Morrey Approach* The Bryan/Morrey approach is recommended for new and inexperienced users of the Nexel Total Elbow System. This approach employs a meticulous repair of the triceps that is detailed at the end of this surgical technique. Once experience is gained, other exposures (e.g., Triceps-On/Sparing) can be employed at the surgeon’s discretion. • Release the triceps (Fig. 1.3 previous page). · Make an incision over the medial aspect of the ulna. Fig. 1.4 · Elevate the ulnar periosteum along with the forearm fascia. Transpose the extensor mechanism laterally. • Expose distal humerus, proximal ulna and radial head (Fig 1.4) · Retract the medial aspect of the triceps along with the posterior capsule. · Remove the triceps from the proximal ulna by releasing the Sharpey’s fibers from their insertion · Further reflect the extensor mechanism laterally including the anconeus. · Transpose the entire extensor mechanism (triceps, ulnar periosteum, and anconeus) as a single soft-tissue sleeve Fig. 1.5 laterally. Release medial and lateral collateral ligaments. • Expose and dislocate the joint. · Release the medial and lateral collateral ligaments from Released LCL their humeral attachment (Fig. 1.5). Released MCL · Flex the elbow to disarticulate the ulna from the humerus (Fig. 1.6). Ulnar nerve · Externally rotate the forearm to allow further flexion and separation of the articulation. · Release the anterior capsule and contracted soft tissue Triceps from the distal humerus (Fig. 1.7). Fig. 1.6 TECHNIQUE TIP 1.4 Flex elbow to disarticulate ulna from humerus. A complete release of the soft tissues from the medial aspect of the distal humerus protects the medial epicondyle from fracture during flexion and manipulation of the forearm.