Clover Staple. Surgical Technique

Transcription

1 Clover Staple Surgical Technique

2 Contents Product The BioPro Clover Staple is a permanent implant that removes minimal cross-sectional fusion area, allows easy radiographical monitoring and may permit early mobilization. Table of contents Indications & Contraindications 1 Implant Specifications 2-3 Instrument Specifications 4-5 Surgical Technique 6-12 Implant Ordering 13 Replacement Instrument Ordering Contact information Website: info@bioproimplants.com orders@bioproimplants.com Phone: (810) Fax: (810) Address: 2929 Lapeer Rd, Port Huron, MI 48060

3 Indications & Contraindications Indications for use: 1. Fragment and osteotomy fixation and joint arthrodesis of the hand and foot bones. Contraindications: 1. Comminuted bone surface which would mitigate against staple placement 2. Pathologic conditions of bone such as osteopenia which would impair the ability to securely fix the staple. 3. Foreign body sensitivity to metals including nickel. Where material sensitivity is suspected, appropriate tests should be made prior to implantation. Warning Immobilization in addition to this internal fixation until bone healing is complete should be achieved by routine methods (casting, splints, etc.) Reduction of the site should be achieved and maintained prior to implanting the staple. The compressive force of the staple closing should not be relied upon to achieve closure or reduction of the fracture line. Care and Caution Staples should be stored at 75ºF (24 C) or less. Staples should be cooled to 75ºF (24 C) prior to removing from the shipping block. Placing staples at -5 F (-20 C) while still in the polyethylene retainer, will return staples to original position. 1

4 Implant Specifications The Clover Staple is manufactured from Nitinol, a memory alloy. Nitinol is approximately 50% nickel (Ni) and 50% titanium (Ti) and was developed by the Naval Ordinance Lab (NOL). The alloy s unique properties allow the staple full activation at body temperature. A A The clover shaped design utilizes strategically placed bends that pull the legs of the staple towards the center of the device upon activation. This will create a constant compressive force on the fusion site. B B The Clover Staple is only 1mm thick, allowing minimal bone removal to recess the staple below the dorsal surface. Material Top Dimension (mm) Leg Length (mm) (available for every top dimension) 3-LEG STAPLE 10 x 8 14 x x 16 Nitinol A x B 4-LEG STAPLE 10 x 8 14 x x 16 10, 12.5, 15 10, 12.5, 15 2

5 Implant Specifications Open design The Clover Staple s open center design allows for easy monitoring of the fusion site via x-ray after implantation. Barbed legs The Clover Staple features teeth on the legs to prevent staple back-out. Activation temperature When exposed to patient body temperature, the staple will activate, creating 4-6 lbs of constant compressive force. 3

6 Instrument Specifications Color coded instruments allow for easy identification between staple sizes. Staple pushers Staple positioners Burr guides Also included in both instrument kits (ref 19678/19543) are (1) AO quick connect burr cutter, (3) drill guides, (1) impactor handle, (2) impactor tips and (1) depth gauge. Burr cutter Drill guide Impactor handle & tips Depth gauge 4

7 Instrument Specifications Instrument kits Two instrument kits are available (ref 19678/19543), one for 3-leg staples and one for 4-leg staples. Each kit contains all the necessary instruments for implantation. 3-Leg Instrument Kit (ref 19678) 4-Leg Instrument Kit (ref 19543) Drill bits Drill bits are not contained in the instrument kits, but are sterile packed and sent along with the sterile Clover Staple inventory. (ref 18960) 5

8 Surgical Technique The following technique describes the use of the Four- Leg Clover Staple for a 4-Corner fusion. This technique can be applied for use of the Clover Staple for other intercarpal fusions including the Three-Leg Clover Staple for use on STT fusions. Step One: Make a dorsal incision between the 3rd and 4th compartments. Expose the radial and mid carpal joint and perform scaphoidectomy, osteophytosectomy and arthrolysis (Fig 1). Correct the malalignment of the first row (front and sagittal) of the carpus onto the second row. Important Note The removed bone should be denuded of cartilage and morselized to use later as bone graft. Important Note No fusion will work without adequate preparation of the joint surfaces. All cartilage must be removed and subchondral bone must be fenestrated or decorticated. Important Note Adequate cancellous surface is important for fusion, while retaining the normal contours facilitates accurate positioning of the carpals. Thorough irrigation should remove all cartilagenous debris. Cartilage is removed between all bones to be fused. For optimal fusion, use a small osteotome for the cartilage and a 1 or 2mm burr to decorticate the bone. Fig 1 6

9 Step Two: Reduce and pin the carpals with K-wires (Fig 2). Mini-C-arm can be used to assure the lunate and capitate are collinear on the lateral view. Typically K-wires provide adequate stability. Suggested wire placement: Triquetro-Lunate, Triquetro-Hamo-Capitate. Fig 2 Step Three: Use the burr guide or staple pusher to assess which size staple will obtain the best purchase in bone (Fig 3). Fig 3 7

10 Step Four: Position the appropriate size burr guide (Fig 4), ensuring it sits flush against the dorsal surface (Fig 5). Caution It is important to mount the burr guide as proximal as possible on the lunate to ensure proper leg placement in the lunate (Fig 6a). Due to the typical crescent shape of the lunate, mounting the guide too distal may result in a poor purchase of the lunate (Fig 6b). Fig 4 Fig 5 8 Fig 6a Fig 6b

11 Step Five: Secure the burr guide in place with (1.1mm) K-wires. A minimum of three K-wires is recommended for adequate stability (Fig 7). Important Note Slightly bend the wires outward to allow easier access to the center of the burr guide. Fig 7 Step Six: Utilizing the burr cutter in a low speed AO connection rotary hand piece, plane around the inside of the burr guide to create a recess for the Clover Staple, most importantly on the lunate. This will prevent impingement of the staple during dorsiflexion of the wrist (Fig 8). Caution The burr cutter can be an aggressive instrument. It is advised to burr each corner of the burr guide prior to planing around the guide. Important Note Ensure the planer bit is inserted straight so the collar rides along the planer guide. Insertion of the bit at an angle can leave bone ridges that will interfere with staple seating. Fig 8 9

12 Step Seven: Insert the appropriately sized drill guide into the burr guide (Fig 9) and drill the holes for the staple legs (Fig 10). Drill all holes bicortically to ensure sufficient depth. Important Note Drill bits are not contained in the instrument kits, but are packaged sterile and provided with the sterile Clover Staple inventory. Once all holes have been drilled, remove the drill guide. Fig 9 Fig 10 10

13 Step Eight: Before removing the burr guide, it is important to mark the drill holes. This can be accomplished in one of the following methods: 1. With a surgical marking pen 2. With an electro-cautery device Once the drill holes have been appropriately marked, remove the K-wires used to mount the burr guide. Measure the depth of each leg hole with the depth gauge and select the longest leg length staple that will not sit bicortical. (Fig 11). Fig 11 Important Note Ensure that the staple legs do not sit bicortical. This allows the legs to compress into the cancellous bone, ensuring the staple remains recessed within the carpals. Step Nine: Irrigate again and then place bone graft in all interstices. Use the appropriately sized staple pusher to push the Clover Staple approximately 5mm out of its protective shipping block (Fig 12). Slide the appropriately sized staple positioner between the staple and the shipping block (Fig 13). Important Note Always use the supplied Staple Positioners to handle the Clover Staple. Heat from hands can prematurely activate the staple. Fig 12 Fig 13 11

14 Once the Clover Staple has been removed from the shipping block with the staple positioner, insert it into the drill holes as far as possible and remove the Staple Positioner. Step Ten: Impact the staple flush with the planed surface (Fig 14). Activate the staple with a small amount of 98 F (37 ) or warm saline and remove the provisional wires. Confirm that no debris is in the radiocarpal joint. Gently assess motion; mini-c-arm can be beneficial to provide images of the maximum stable motion provided by the implant. Important Note It is advised to take a lateral x-ray at this point. The Clover Staple often appears to sit proud in a lateral view. An immediate post-op x-ray will help avoid confusion in the future. Fig 14 Step Eleven: Close the joint capsule in layers using your suture of choice. The extensor tendons should have remained within their compartment unless the Extensor Pollicis Longus is intentionally left out from the chosen approach. The skin is sutured closed. Fig 10 12

15 Implant Ordering ITEM # DESCRIPTION SIZE LEG LENGTH FOUR-LEG CLOVER STAPLE 10MM X 8MM 10MM FOUR-LEG CLOVER STAPLE 10MM X 8MM 12.5MM FOUR-LEG CLOVER STAPLE 10MM X 8MM 15MM FOUR-LEG CLOVER STAPLE 14MM X 12MM 10MM FOUR-LEG CLOVER STAPLE 14MM X 12MM 12.5MM FOUR-LEG CLOVER STAPLE 14MM X 12MM 15MM FOUR-LEG CLOVER STAPLE 18MM X 16MM 10MM FOUR-LEG CLOVER STAPLE 18MM X 16MM 12.5MM FOUR-LEG CLOVER STAPLE 18MM X 16MM 15MM THREE-LEG CLOVER STAPLE 10MM X 8MM 10MM THREE-LEG CLOVER STAPLE 10MM X 8MM 12.5MM THREE-LEG CLOVER STAPLE 10MM X 8MM 15MM THREE-LEG CLOVER STAPLE 14MM X 12MM 10MM THREE-LEG CLOVER STAPLE 14MM X 12MM 12.5MM THREE-LEG CLOVER STAPLE 14MM X 12MM 15MM THREE-LEG CLOVER STAPLE 18MM X 16MM 10MM THREE-LEG CLOVER STAPLE 18MM X 16MM 12.5MM THREE-LEG CLOVER STAPLE 18MM X 16MM 15MM ITEM # DESCRIPTION ø LENGTH CLOVER STAPLE DRILL BIT 1.5MM 18MM 13

16 3-Leg Replacement Instrument Ordering ITEM # DESCRIPTION CLOVER STAPLE 3-LEG COMPLETE KIT IMPACTOR HANDLE IMPACTOR TIP SM IMPACTOR TIP LG PUSHER 3 LEG 10X PUSHER 3 LEG 14X PUSHER 3 LEG 18X STAPLE POSITIONER 10X STAPLE POSITIONER 14X STAPLE POSITIONER 18X DRILL GUIDE 3 LEG 10X DRILL GUIDE 3 LEG 14X DRILL GUIDE 3 LEG 18X BURR GUIDE 3 LEG 10X BURR GUIDE 3 LEG 14X BURR GUIDE 3 LEG 18X BURR CUTTER DEPTH GAUGE WRIST STAPLE INSTRUMENT TRAY 14

17 4-Leg Replacement Instrument Ordering ITEM # DESCRIPTION CLOVER STAPLE 4-LEG COMPLETE KIT IMPACTOR HANDLE IMPACTOR TIP SM IMPACTOR TIP LG PUSHER 4 LEG 10X PUSHER 4 LEG 14X PUSHER 4 LEG 18X STAPLE POSITIONER 10X STAPLE POSITIONER 14X STAPLE POSITIONER 18X DRILL GUIDE 4 LEG 10X DRILL GUIDE 4 LEG 14X DRILL GUIDE 4 LEG 18X BURR GUIDE 4 LEG 10X BURR GUIDE 4 LEG 14X BURR GUIDE 4 LEG 18X BURR CUTTER DEPTH GAUGE WRIST STAPLE INSTRUMENT TRAY 15

18 Notes

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20 Lapeer Road Port Huron, MI MKT16 01