ALIGN ® Surgical Technique Guide
22Pages

SURGICAL TECHNIQUE GUIDE RADIAL HEAD SYSTEM Miami Hand & Upper Extremity Institute Miami, Florida. skeletal dynamics' Innovation Based on Science

ELBOW LANDMARKS With the elbow flexed 900, palpate and mark the lateral epicondyle. Make an 8 -10cm line through the marked point. DISTAL ULNA LANDMARKS To identify the axis of forearm rotation, pronate the hand and flex the wrist. Palpate and mark the ulnar styloid, ulnar head and the direction of the shaft. Note: Use fluoroscopic imaging to verify proper landmark placement.

SUPERFICIAL EXPOSURE Make your incision. Make a longitudinal fascial incision over the center of the capitellum for the Kaplan approach. DEEP EXPOSURE Open the joint and gain access to the radial head. Limit distal dissection to protect the radial nerve.

HEAD SIZING Remove the radial head measure them using the Radial Head Sizing Tray. If between radial head sizes, select the smaller. TRIAL HEAD SELECTION Select the Trial Head that

PROVISIONAL NECK SIZING With the forearm pronated, select the radial neck length using the Neck Sizing Gauges. Neck Sizing Options: 0 Offset - 15mm 2 Offset - 17mm 4 Offset - 19mm 6 Offset - 21mm 8 Offset - 23mm Note: If between two lengths, always select the shortest sizing option. INITIAL NECK SIZING Use the Neck Sizing Gauge to select the level of the desired radial cut. Mark the radial neck just distal to the Neck Sizing Gauge.

ATTACHING BONE FORCEPS Secure the Bone Holding Forceps just distal to the marked radial neck. RESECTION Lift the radius with the Bone Holding Forceps, then make the radial neck cut. CAUTION: Protect the radial nerve. Note: The maximum defect that can be corrected is 23mm.

OPENING RADIAL CANAL Starting with the smallest Rasp, position the hand in pronation and insert the Rasp past the tuberosity in the direction of the radial styloid. Note: This will establish the trajectory for all subsequent Rasps. CANAL PREPARATION Insert each of the Rasps up to the etched depth mark. Continue broaching until cortical bone is encountered. Note: Each Rasp should be used as a broach. If the final Rasp used does not fully seat to the depth mark, a twisting motion can be used to ream. Note the size of the final Rasp used.

IDENTIFY PLANING LINE With the final Rasp fully seated, mark the highest spot. Note: This is the area to plane to ensure proper seating of the prosthesis. RASP REMOVAL To remove the Rasp, attach the Driver Extraction Tool to the Universal Handle and tap the striking plate.

NECK PLANING Prepare the resected end of the radius using the Planer. Note: Spin the Planer before contacting the bone surface, then advance it lightly. FINAL NECK SIZING With the forearm pronated, confirm the final radial neck length using the Neck Sizing Gauges. Note: If between two lengths, always select the shortest sizing option.

TRIAL STEM SELECTION Select the Trial Stem that corresponds to the final Rasp/Planer used and insert it into the prepared canal. TRIAL HEAD & NECK ASSEMBLY Assemble the Trial Head and Neck by threading the two components together. Thread the handle of the Neck Sizing Gauge into the Trial Head to facilitate loading onto the Trial Stem.

TRIAL VALIDATION Assemble the Trial Head and Neck into the Trial Stem. Reduce the joint and assess the sizing of the trial components by manipulating the elbow through its full range of motion. Note: Ensure that the joint has not been over-stuffed. FLUOROSCOPIC CONFIRMATION Confirm a proper fit using fluoroscopy, then remove the trial components.

PROSTHETIC STEM INSERTION With the forearm in pronation, use the Bone Holding Forceps to lift the radius out of the wound, then insert the Radial Stem implant into the canal. PROSTHETIC STEM IMPACTOR Insert the Stem Impactor laterally, then lower the handle until in-line with the stem. Impact the stem until the collar seats flush against the radius. Note: The notch on the Stem Impactor facilitates loading.

PROSTHETIC HEAD LOADING Side load the Radial Head implant onto the stem, then rotate it until the threads are positioned laterally. Note: Each Radial Head implant is packaged with its respective Lock Screw. HEAD ALIGNMENT TOOL ENGAGEMENT Remove the Bone Holding Forceps and secure the Head Alignment Tool to the Radial Head. The two tines of the Head Alignment Tool should engage the grooves of the Radial Head. Note: The Head Alignment Tool is used to control the position of the Radial Head. Head Alignment Tool engagement grooves

LOCK SCREW INSERTION Loosely thread the Lock Screw into the Radial Head. FOREARM GUIDE ASSEMBLY Keeping the Head Alignment Tool connected to the Radial Head, slide the rail of the Forearm Axis Jig into the handle until it snaps securely. With the elbow flexed and the forearm in neutral, adjust and lock the distal end of the Forearm Axis Jig to the marked fovea of the ulna.

INITIAL IMPLANT LOCKING Pronate the Head Alignment Tool ~200 - 300 from the neutral forearm position, then tighten the Lock Screw while providing countertorque. Warning: The Head Alignment Tool must be used when tightening the Lock Screw to provide the necessary counter-torque. Note: Positioning the Head Alignment Tool in 300 of pronation ensures the Lock Screw is at the center of the “safe zone”. FINAL IMPLANT LOCKING Use the torque indicating T-Handle Driver to ensure the minimal torque has been achieved. If desired, additional torque can be gained using the Universal Driver Handle....

IMPLANT VALIDATION Remove the Forearm Axis Guide assembly. Manipulate the elbow through its full range of motion to confirm final implant alignment. FLUOROSCOPIC CONFIRMATION Confirm final implant alignment using fluoroscopic imaging.

WOUND CLOSURE Repair soft tissues as needed, then close the incision.

ALIGN® - Radial Head System - Cat.# ALN-RHA-SYS Catalog Number Radial Heads (CoCr) (Lock Screw Included) Catalog Number

ALIGN®– Radial Head System ℞: For use by physicians only. Federal Law restricts this device to sale by or on the order of a physician. Failure to follow instructions may lead to patient injury. This package insert is designed to provide Instructions for Use of the ALIGN Radial Head System; it is not a reference to surgical techniques. Prior to use of the ALIGN Radial Head System the surgeon should become familiar with all information contained in this pamphlet. Symbols MATL: MATERIAL CoCr: MADE TI: TITANIUM ALLOY IN: QTY: SS, SST: STAINLESS STEEL DO NO REUSE (SINGLE USE ONLY) USE BY...