DARCO. Bow 2 Plate SURGIC AL TECHNIQUE

Transcription

1 DARCO Bow 2 Plate SURGIC AL TECHNIQUE

2 Contents 2 Preface 3 Chapter 1 4 Chapter Appendix Intended Use Indications/Contraindications Design Rationale Preoperative Planning Surgical Technique Osteotomy Plate Selection Plate Application Grafting and Closure Ordering Information DARCO Implants DARCO Instruments

3 Indications Contraindications INDICATIONS The DARCO Locking Bone Plate System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet, ankles and toes. The system can be used in both adult and pediatric patients. This implant should only be used with a DARCO plate and screw system. Combination with other implants or instruments is not permissible. CONTRAINDICATIONS No product specific contraindications. Proper surgical procedures and techniques are the responsibility of the medical professional. The following guidelines are furnished for information purposes only. Each surgeon must evaluate the appropriateness of the procedures based on his or her personal medical training and experience. Prior to use of the system, the surgeon should refer to the product package insert for complete warnings, precautions, indications, contraindications and adverse effects. Package inserts are also available by contacting the manufacturer. Contact information can be found on the back of this surgical technique and the package insert is available on the website listed. Please contact your local Wright representative for product availability. DARCO BOW Plate 2

4 Design Rationale Preface The DARCO BOW 2 Plate offers innovative, stable fixation to address proximal correction of Hallux Valgus (bunion) deformity. Advantages of Opening Wedge Osteotomy for correction of Hallux Valgus Maintenance of overall metatarsal length with minimal shortening. Combination of locked plate and intact lateral cortex creates a mechanically stable construct at the time of surgery. Minimal tissue irritation associated with low-profile proximal plating. Ability to make moderate to large intermetatarsal angular corrections. Advantages of fixation with the DARCO BOW 2 Locked Plate Low profile minimizes soft tissue irritation, and allows ease of contouring Fixed-angle 2.7mm locking screws for maximum stability Anatomically pre-contoured shape Interpositional wedge from 0-7mm allows customized correction 2 points of locked fixation on either side of osteotomy to resist rotational forces Titanium hardware for low tissue reactivity and less stress shielding 3 DARCO BOW Plate

5 Preoperative Planning Surgical Technique as described by Christopher F. Hyer, DPM; Greg Berlet, MD; Thomas Lee, MD; and Ernst Orthner, MD chapter 1 Weight-bearing radiographs are used to estimate the amount of correction desired- and thus, the correct BOW 2 Plate size. As a general rule, each 1 millimeter of spacer width creates degrees of intermetatarsal correction. For example- the 3mm BOW Plate will create degrees of correction. In addition to standard small-joint instrumentation, the following items should be planned for in the operating room: intra-operative fluoroscopy powered handpiece with k-wire driver, jacobs chuck and sagittal saw set of straight osteotomes bone graft substitute Chapter 1 Preoperative Planning 4

6 Surgical Technique chapter 2 Surgical Approach Plan a medial approach to the proximal 1st metatarsal along the dorsomedial aspect of the foot, medial to the EHL tendon course and just distal to the 1st tarsometatarsal (TMT) joint. Figure 1 A single extensile incision may be taken down distally to the 1st MPJ joint to allow for distal soft tissue work or a 2nd incision may be created as necessary. Create the skin incision, taking care to protect any overlying neurovascular structures. Carry the incision through the fascial layers and identify the periosteum of the metatarsal. Confirm the location of the 1st TMT joint either directly or using Flouroscopy; a 22g needle or ink pen may be used to mark the joint. Figure 2 Figure 1 Figure 2 5 Chapter 2 Surgical Technique

7 Osteotomy The planned osteotomy for the medial opening wedge is marked 15 mm distal to the 1st TMT. Figure 4 Perform the osteotomy in a medial to lateral direction with the sagittal saw. Figure 4 It is critical that the osteotomy is made perpendicular to the metatarsal shaft, and is only taken through about 70% of the metatarsal leaving the lateral cortical wall intact. Use a straight osteotome to gradually green-stick open the osteotomy, pivoting the distal metatarsal laterally and closing down the intermetatarsal angle. By levering the osteotome, the hinge may be opened in a gradual and controlled manner until the desired correction is achieved. Figure 5 Figure 4 Figure 5 Chapter 2 Surgical Technique 6

8 Plate Selection Select the appropriately sized BOW 2 plate. Remove the osteotome and wedge the plate spacer into the open osteotomy. Provisionally fix the plate to the bone using temporary fixation pins in the small plate holes. Figure 6 Ensure that the plate screw holes that are parallel set closest to the TMT joint. Figure 7 Verify placement of the plate and reduction of the IM angle fluoroscopically. It is imperative that the Locking Drill Guides are used to ensure proper hole preparation for locking screws. Freehand drilling by the surgeon is not recommended unless non-locking screw fixation is planned. Thread the Locking Drill Guide into whichever proximal screw location lies most flush to the bone. Use the 2.0mm Drill (P/N DC6106) to prepare the screw hole. Figure 8 Figure 6 Distal Proximal Figure 7 Figure 8 7 Chapter 2 Surgical Technique

9 Plate Application Screw length is determined using the drill and drill guide. Use the 2.0mm drill to penetrate through the proximal cortex and continue until the distal cortex is reached. Stop drilling just as the distal cortex of the first metatarsal is penetrated and take note of where the step in the drill meets the screw gauge on the guide. Figure 9 In general, bicortical fixation is not required with locking screw systems; however, it should be strongly considered if the lateral hinge of the osteotomy has been compromised. Typical screw lengths in the proximal metatarsal are between 18 and 22mm. Select the appropriate screw from the caddy and advance until flush with the plate. Next, select the distal screw hole that is most flush with the bone; thread in the Locking Drill Guide and repeat the above steps to place the appropriate screw. Figure 10 At this point the plate will be secured distally and proximally. Both Locking Drill Guides are then threaded into the two vacant screw locations; if necessary, they may be used as in-situ benders to contour the plate to the bone. Figure 11 Drill, measure, and place screws in the remaining holes as described above. Figure 9 Figure 10 Figure 11 Chapter 2 Surgical Technique 8

10 Grafting and Closure Filling the osteotomy void may be desirable according to surgeon judgment and patient circumstances. Capsulorrhapy of the medial MPJ and lateral release of the adductor tendon are performed as necessary. Fluoroscopy is used to confirm reduction and realignment of the hallux valgus and metatarsal primus varus deformities. Closure is performed in layers per the surgeon s preference. A soft dressing spica is applied to protect the soft tissue correction. The patient is allowed protected weightbearing in a surgical boot or shoe per the surgeon s normal protocol. Explant Information Removal of the plate may be performed by first extracting the plate screws using the tx-lock screwdriver (DC 4268) and then removing the plate from the bone. If the removal of the implant is required due to revision or failure of the device, the surgeon should contact the manufacturer using the contact information located on the back cover of this surgical technique to receive instructions for returning the explanted device to the manufacturer for investigation. 9 Chapter 2 Surgical Technique

11 Ordering Information Appendix Kit List Part No. Description Quantity DMFS-KITA DMFS-KIT1 Implant Kit Instrument Kit Locked Screws DC mm x 2.7mm 5 DC mm x 2.7mm 5 DC mm x 2.7mm 5 DC mm x 2.7mm 5 DC mm x 2.7mm 5 DC mm x 2.7mm 5 DC mm x 2.7mm 5 DC mm x 2.7mm 5 DC mm x 2.7mm 5 DC mm x 2.7mm 5 DC mm x 2.7mm 5 DC mm x 2.7mm 5 Non-Locked Screws DC mm x 2.7mm 2 DC mm x 2.7mm 2 DC mm x 2.7mm 2 DC mm x 2.7mm 2 DC mm x 2.7mm 2 DC mm x 2.7mm 2 DC mm x 2.7mm 2 DC mm x 2.7mm 2 DC mm x 2.7mm 2 DC mm x 2.7mm 2 DC mm x 2.7mm 2 DC mm x 2.7mm 2 Instruments and accessories DC 27 Box System tray assembly 1 DC 4125 Bending forceps 1 DC 4175 Drill guide 2 DC 4197 Forceps 1 DC Depth gauge 1 DC 4268 Screwdriver tx-lock 1 DC x 120mm drill bit 2 NO K-wire, single-trocar mm DARCO BOW Plate 10

12 Part No. Description Placement in Trays BOW 2 Opening Wedge Plate for Bunions DC BOW II PLATE 0MM DC B OW II PLATE 2MM DC BOW II PLATE 3MM DC BOW II PLATE 4MM DC BOW II PLATE 5MM DC BOW II PLATE 6MM DC BOW II PLATE 7MM UPS 2.7 General Purpose Plating System DC mm DC mm DC mm DC mm MPJ Fusion Plate DC S: 28mm, 4 holes, 2 compression slots DC M: 35mm, 6 holes 2 compression slots DC L: 45mm, 6 holes 2 compression slots S M L 11 DARCO BOW Plate

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