ALIGN ® Surgical Approach

ALIGN ® Surgical Approach

  • 1. ELBOW LANDMARKS
    With the elbow flexed 90°, palpate and mark the lateral epicondyle.
    Make an 8 -10cm line through the marked point.

  • 2. 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.

  • 3. SUPERFICIAL EXPOSURE
    Make your incision.
    Make a longitudinal fascial incision over the center of the capitellum for the Kaplan approach.

  • 4. DEEP EXPOSURE
    Open the joint and gain access to the radial head.
    Limit distal dissection to protect the radial nerve.

  • 5. HEAD SIZING
    Remove the radial head fragments; assemble and measure them using the Radial Head Sizing Tray.
    Note: If between radial head sizes, select the smaller.

  • 6. TRIAL HEAD SELECTION
    Select the Trial Head that corresponds to the native head.

  • 7. 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.

  • 8. 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.

  • 9. ATTACHING BONE FORCEPS
    Secure the Bone Holding Forceps just distal to the marked radial neck.

  • 10. 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.

  • 11. 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.

  • 12. 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.

  • 13. 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.

  • 14. RASP REMOVAL
    To remove the Rasp, attach the Driver Extraction Tool to the Universal Handle and tap the striking plate.

  • 15. 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.

  • 16. 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.

  • 17. TRIAL STEM SELECTION
    Select the Trial Stem that corresponds to the final Rasp/Planer used and insert it into the prepared canal.

  • 18. 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.

  • 19. 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.

  • 20. FLUOROSCOPIC CONFIRMATION
    Confirm a proper fit using fluoroscopy, then remove the trial components.

  • 21. 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.

  • 22. 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.

  • 23. 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.

  • 24. 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.

  • 25. LOCK SCREW INSERTION
    Loosely thread the Lock Screw into the Radial Head.

  • 26. 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.

  • 27. INITIAL IMPLANT LOCKING
    Pronate the Head Alignment Tool W 20°- 30° from the neutral forearm position, then tighten the Lock Screw while providing counter-torque.
    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 30° of pronation ensures the Lock Screw is at the center of the “safe zone”.

  • 28. 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.
    Warning: The Head Alignment Tool must be used when tightening the Lock Screw to provide the necessary counter-torque.

  • 29. IMPLANT VALIDATION
    Remove the Forearm Axis Guide assembly.
    Manipulate the elbow through its full range of motion to confirm final implant alignment.

  • 30. FLUOROSCOPIC CONFIRMATION
    Confirm final implant alignment using fluoroscopic imaging.

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