Surgical Technique Guide

Transcription

1 Surgical Technique Guide

2 Minimally Invasive, Intramedullary Device For Distal Radius Fragility Fractures The Sonoma WRx Wrist Fracture Repair Device is flexible, inserting easily through a small incision over the radial styloid. This procedure preserves surrounding tendons and neurovascular structures, which can allow for pain-free early mobilization. Once activated, the device becomes rigid and proximal grippers engage the IM cortex. Locking cortical screws capture bone fragments and buttress the subchondral surface. With a less traumatic device footprint than volar plates, and earlier range of motion than with casting, this device is ideal for patients with fragility fractures Curved Hub Design with Intramedullary Fixation WAVIBODY Technology Proximal and distal 5mm or 6mm options ACTIVLOC grippers engage use flexible WAVIBODY bone upon implant activation Technology to conform to to provide solid foundation patient s unique anatomy. for fracture fixation. Locking Cortical Screws 2.7mm screws lock into implant providing a solid fixation of fragments and 3-dimensional subchondral support. 1

3 The Sonoma WRx Outrigger is designed to optimize Proximal and Buttress Screw placement by allowing visualization of their trajectories using K-Wires before activating the device grippers and finalizing the device s position in the IM canal. WRx Outrigger K-Wire Visualization The Outrigger Guide incorporates K-Wires to visualize screw trajectories in AP fluoro views to optimize implant position. Provisional Fixation K-Wires can be driven through provisional fixation holes, maintaining implant positioning and preventing countersinking when actuating the implant grippers. Parallax Elimination The Outrigger is designed to eliminate X-ray parallax and gauge the true position of the screws. When the Outrigger ball is in the hoop in the AP fluoro view, the view will be straight down and the screw trajectory true. 2

4 STEP 1 Patient Positioning and Fracture Reduction Use of a folded towel bolster placed beneath the wrist can aid in initial fracture reduction. Traction can be applied using finger traps and a 5-10 lb. weight suspended from the table, or by use of a traction tower. K-Wires and/or reduction clamps can be used to achieve anatomical reduction. The Sonoma WRx device procedure may be performed with the surgeon either seated or standing. If standing is preferred, the procedure may be performed with the patient s hand in the lateral position with the radial styloid up. Careful attention should be paid to achieving anatomical volar tilt. 3

5 Surgical Technique Guide 2 ND Dorsal Compartment 1 ST Dorsal Compartment Dorsal Radius Volar Ulna STEP 2 Establish Entry Point Make a 2-3cm incision, centered over the radial styloid. Bluntly dissect through the subcutaneous tissue to the periosteum between the first and second dorsal extensor compartments to expose the radial styloid. Incise the first dorsal compartment extensor retinaculum and free the tendons completely. Use a self-retaining retractor to displace the EPB tendon in a dorsal direction, and the APL tendon in a volar direction, while protecting the branch of the superficial radial nerve. B A 4

6 STEP 3 Preparing the Intramedullary Canal Use C-Arm WRx Overlay Template to establish proper entry point on the distal radial styloid, just proximal to the scaphoid fossa. Drive 1.6mm K-Wire under fluoroscopy from entry point. Confirm position and angle. K-Wire should be centered in lateral view, just below subchondral bone. Or alternatively use the 2mm Drill Bit and create a pilot hole 10mm deep. At the established entry point, introduce the 3mm S-Shaped Awl perpendicular to the bone (90 ), just distal to the subchondral bone. Confirm the Awl entry position and anatomical alignment of fracture in both AP and Lateral views. Use gentle +/- 30 rotating motions to advance the 3mm Awl across the fracture and into the IM canal. The Awl is adequately seated when it reaches the midline of the IM canal and the handle is flush against the patient s thumb. 5

7 Surgical Technique Guide STEP 3 Preparing the Intramedullary Canal (Cont.) Introduce the 5.5mm S-Shaped Awl to further widen the canal. Implant Diameter Selection: If the 5.5mm Awl tip transitions into the IM canal with noticeable resistance, select the smaller 5mm diameter 5470 Sonoma WRx Implant. If the 5.5mm Awl tip passes with relative ease into the IM canal, use the larger 6mm diameter 6470 Sonoma WRx Implant. If the 6470 Sonoma WRx Implant is to be used, introduce the 7.0mm S-Shaped Awl to further widen the IM canal. Use clinical judgment to select the appropriate Sonoma WRx Implant size for the patient s need. 6

8 STEP 4 Reaming the IM Canal Insert the J-Tip Guide Wire into the IM canal and across the reduced fracture. Verify fracture reduction and Guide Wire position in both AP and lateral views. Reamer Assembly: Insert the back end (non J-Tip) of the Guide Wire into the distal end of the 5.0mm Cannulated Reamer such that the flexible shaft extends outside the curved sheath. Retract the flexible shaft fully into the curved sheath prior to inserting Reamer into bone. Advance the entire Cannulated Reamer assembly over the Guide Wire, under manual control or power. Ream the IM canal to the appropriate depth as indicated by the marking on the Reamer shaft. Remove the Cannulated Reamer assembly and the Guide Wire from the IM canal prior to device implantation. 7

9 Surgical Technique Guide STEP 5 Sonoma WRx Implant Insertion Confirm fracture reduction prior to inserting the Sonoma WRx Implant. Assemble the selected Sonoma WRx Implant to the blue WRx Outrigger using the Hub Attachment Tube (either the 5470 or 6470) and the Hub Attachment Screw (either 5470 or 6470). Insert the Sonoma WRx Implant into the entry hole and advance until the notch of the implant viewed in AP is slightly below the surface of the radial styloid. Use the WRx Outrigger to align and drill screws. To eliminate radiographic parallax, ensure the Dot is within the Circle in the AP view. To visualize the Buttress Screw position and trajectory, insert a 1.6mm K-Wire through the top Buttress Screw hole in the blue Outrigger. In AP view, ensure the Outrigger Dot is within the Circle. Adjust the proximal/distal position of the Sonoma WRx Implant until the Buttress Screw position, as indicated by the K-Wire, is just beneath the articular surface. 8

10 STEP 5 Sonoma WRx Implant Insertion (Cont.) To visualize the Proximal Screw position and trajectories, insert 1.6mm K-Wires through the Proximal Screw Trajectory holes. In AP view, ensure the Outrigger Dot is within the Circle. Confirm that the screws will not be in the fracture. Provisional Fixation: If desired, the Sonoma WRx Implant position can be provisionally maintained using 1.6mm K-Wires inserted through one of the center provisional fixation holes in the Outrigger. This will prevent the Sonoma WRx Implant shifting during actuation of the grippers. 9

11 Surgical Technique Guide STEP 5 Sonoma WRx Implant Insertion (Cont.) Activating Grippers: For 5470 device, insert the Flexible Actuation Driver with the YELLOW cap into the back of the Outrigger. For 6470 device, insert the Flexible Actuation Driver with the GREEN cap into the back of the Outrigger. Actuate the ActivLoc grippers by turning the Actuation Driver handle clockwise until the lines on the handle are collinear and resistance is felt. Confirm fixation via fluoroscopy and by gently pulling on the Outrigger attached to the Sonoma WRx Implant. Remove the Actuation Driver from the Sonoma WRx Implant. 10

12 STEP 6 Locking Screw Placement Proximal Screw Insertion (2.7mm cortical screws): Insert the External Sheath into the #1 or #2 hole in the Outrigger and advance the Sheath until it contacts bone. Insert the Drill Guide into the Sheath and align the keyways until flush. Using the 2.0mm Drill Bit, drill a pilot hole into the radius. Measure depth using the scale on the Drill Bit. Select a screw that is 2mm shorter than measured to allow for counter-sinking. Remove the Drill Guide, and insert the Screw Guide into the Sheath. Insert the screw into the Screw Guide. Use the 2.5mm Hex Bit attached to the Driver Handle to tighten the screw. Repeat for second Proximal Screw. Buttress Screw Insertion (2.7mm cortical screw): Remove the blue Outrigger from the Sonoma WRx Implant by rotating the Hub Attachment Screw counter-clockwise. Under fluoroscopic and direct visualization, drill a pilot hole with the 2.0 Drill Bit through the Buttress Screw hole in the Sonoma WRx Implant hub. Do not violate the Distal Radioulnar Joint (DRUJ). Measure the screw length with the Depth Gauge. Place the screw through the Buttress Screw hole inside the hub of the Sonoma WRx Implant and thread into the pilot hole. Use the 2.5mm Hex Bit and Driver Handle to tighten the screw. Ensure that the screw does not protrude into the DRUJ. The buttress screw is designed to support the subchondral bone and does not require bicortical fixation. 11

13 Surgical Technique Guide STEP 7 Final Evaluation and Closure Evaluate the fixation and deployment of the Sonoma WRx Implant in both AP and lateral radiographic views. Conclude the procedure by loosely approximating the first extensor retinaculum with absorbable suture and closing the incision. The physician may also elect to suture part of the first dorsal extensor retinaculum under the tendons to cover any protruding hardware. Apply appropriate cast or splint. STEP 8 Post-Operative Care Post-operative radiographs, casting, or splinting are at the surgeon s discretion. Proper adherence to post-operative rehabilitation guidelines should be emphasized to the patient to ensure minimal pain and to allow for requisite healing. STEP 9 Implant Removal Sonoma Orthopedic Products, Inc. recognizes that the reasons for removal are very diverse, as there are many factors for the physician to consider. Removal of such devices as the Sonoma WRx Implant is generally not considered less than weeks after surgery and only after radiographic healing can be verified. 12

14 NOTES 13

15 Surgical Technique Guide NOTES 14

16 Sonoma Orthopedic Products, Inc Westwind Blvd. Santa Rosa, California P: Fax: Sonoma Orthopedic Products, Inc. has made these technique guidelines available for informational purposes only and to illustrate the physician authors suggested treatment for an uncomplicated procedure. Proper surgical procedures and techniques are the responsibility of the surgeon, who must evaluate the appropriateness of the procedures described, based upon his/her own personal medical training, experience and the needs of the individual patient. Prior to the use of the Sonoma Orthopedic Products system, the surgeon should refer to the product instruction for use (IFU) for complete indications, warnings, precautions and contra indications. Package inserts are also available by contacting Sonoma Orthopedic Products, Inc. TM Trademarks and Registered Marks of Sonoma Orthopedic Products, Inc. MediTech Strategic Consultants B.V. Maastrichterlaan En Vaals The Netherlands Sonoma Orthopedic Products, Inc. All Rights Reserved USA Patents 7,846,162; 7,909,825; 7,914,533 and 7,942,875 USA and International Patents Pending LB-1151, Rev A