Maestro. Wrist Radial Fracture System. Surgical Technique. Knees Hips Extremities Cement and Accessories PMI Trauma Technology

Transcription

1 Maestro Wrist Radial Fracture System Surgical Technique Knees Hips Extremities Cement and Accessories PMI Trauma Technology

2 One Surgeon. One Patient. Over 1 million times per year, Biomet helps one surgeon provide personalized care to one patient. The science and art of medical care is to provide the right solution for each individual patient. This requires clinical mastery, a human connection between the surgeon and the patient, and the right tools for each situation. At Biomet, we strive to view our work through the eyes of one surgeon and one patient. We treat every solution we provide as if it s meant for a family member. Our approach to innovation creates real solutions that assist each surgeon in the delivery of durable personalized care to each patient, whether that solution requires a minimally invasive surgical technique, advanced biomaterials or a patient-matched implant. When one surgeon connects with one patient to provide personalized care, the promise of medicine is fulfilled.

3 Maestro Wrist Radial Fracture System Figure 1 Preoperative Planning and Positioning Use the templates provided to conduct preoperative planning. Identify approximate sizes for each of the following components: Radial fracture body Radial stem Capitate stem Carpal plate Carpal head Radial and ulnar screws Pre-operative radiographs from multiple angles (anteriorposterior, medial-lateral, etc.) should be taken. Estimate the amount of distal radius to be taken and approximate the distal radial fracture body that will be utilized. This surgical technique and postoperative care regimen are utilized by Andrew Palmer, M.D. Biomet, as the manufacturer of this device, does not practice medicine and does not recommend this device or technique. Each surgeon is responsible for determining the appropriate device and technique to utilize on each individual patient. If it appears that the radial resection is large and standard sizing appears insufficient, other options should be identified preoperatively and made available at the time of the operation. Position the patient supine, with the extremity placed comfortably on a hand table. Apply the pneumatic tourniquet to the upper arm and exsanguinate with an Esmarch bandage. Administer general or regional anesthesia and antibiotics, dependent upon surgeon preference. Inflate the pneumatic tourniquet. Incision and Approach Perform total wrist arthroplasty through a dorsal incision slightly radial to the center of the hand and wrist and extending 3 4 cm proximal to the distal radius to halfway up the third metacarpal (Figure 1). 1

4 Maestro Wrist Radial Fracture System Figure 2 Figure 3 Dissect directly to the dorsal retinaculum without excessive undermining. Palpate Lister s Tubercle and open the third dorsal extensor compartment, exposing the extensor pollicis longus (EPL) tendon (Figure 2). Mobilize the EPL proximally and distally and displace it radially. Expose the dorsal wrist capsule and make a longitudinal capsular incision extending from the distal radius to the base of the third metacarpal. Dissect sharply against the underlying radius and carpus, and elevate the overlying extensor compartments radially and ulnarward without violating their undersurface. It is also recommended to elevate and protect the first dorsal compartment tendons and the brachioradialis off the radius. Use Homan or large Gelpi retractors to displace the ulnar capsule and extensor tendons ulnarward and the radial capsule and radial wrist extensors, EPL and first compartment tendons radially, exposing the distal radius, the radioulnar joint capsule, the entire carpus and the metacarpal bases (Figure 3). 2

5 Figure 4 Radial Preparation and Resection Position the radial resection guide on the radius. Slide the guide distally until the distal curved portion contacts the carpal articulation (Figure 4). Pin the guide into the radius using one or more.062" K-wires. 3

6 Maestro Wrist Radial Fracture System Figure 5 Modestly distract the wrist (Figure 5). Approximately 2 3 mm of joint separation should be possible between the radial resection guide and the proximal carpal row. If this is not the case, adjust the radial resection guide accordingly until proper distraction is achieved. Insert additional K-wires through the proximal holes of the guide as needed for stability. Make a final resection through the most distal slot where bone would be removed. Remove K-wires, and radial resection guide. Note: The radial resection guide slots match the three heights of the fracture body. 4

7 Figure 6 Figure 7 Radial Reaming and Sizing After resection, fully flex the wrist to allow visualization of the volar radius. Strip the pronator quadratus muscle to the approximate volar flange elevation while being careful not to harm the volar anatomy. Insert the trial, making sure to slide the flange directly onto the palmar radius against the volar cortex, beneath the pronator quadratus muscle, volar innervation and vascular structures (Figure 6). If the radial body overhangs the resected dorsal radius or does not cover the entire cortical surface, change trial size to match the outer cortex as closely as possible. Note: It is important to match the sigmoid notch of the radius and the ulnar head. The ulnar head should not sit distal to the distal fracture body. Place a K-wire sleeve through the center hole of the appropriate size trial radial body, and ensure the flange remains against the volar aspect of the distal radius. Introduce a K-wire through the sleeve into the radial canal (Figure 7). Confirm central position of the K-wire with fluoroscopy. If necessary, change the radial body size to achieve central canal placement and cortical contact with the flange. 5

8 Maestro Wrist Radial Fracture System Figure 8 Figure 9 Note: It is preferred that the flange be placed in contact with the volar cortex of the radius and any gap that does exist be filled with autograft or other bone substitute to help stabilize the component. Remove the radial trial from the resected radius, place the cannulated drill bit over the K-wire and drill to a depth of 70 mm (Figure 8). Utilize fluoroscopy to confirm depth, if necessary. Remove the K-wire and drill bit and ream with a 4.5 mm x 60 mm reamer until flutes are inserted flush with the resected surface (Figure 9). Utilizing fluoroscopy, sequentially ream until the reamer fills the intramedullary canal and cortical chatter is achieved. Note the size of the last reamer used for trialing. 6

9 Figure 10 Figure 11 Radial Trial Selection Thread the 60 mm stem trial that matches the last reamer used into the trial radial body used in centering the k-wire. This will ensure a proper fit for assessing range of motion (ROM). Note: The final radial stem implant will be one size smaller than the trial used to allow room for the cement mantle. Place the flange in contact with the anterior cortex of the radius with the stem centered in the intramedullary canal (Figure 10). Use the radial fracture body impactor and handle to impact trials until the base of the fracture body trial is flush with the resected radius. Articulate the radial trial component with the intact carpus and assess range of motion (figure 11). Flexion/extension and radial/ulnar deviation should be evaluated. Check freedom of motion and stability to determine that the correct implant size has been chosen. If motion is limited, resect more bone from the radius or choose a shorter fracture body. Final stability is best judged after replacing the carpus, articulating the carpal component with the fracture body and capsular closure. If the wrist appears unstable at this time, use a larger carpal head or taller radial fracture body. Next remove the fracture body trials and approach the carpus. 7

10 Maestro Wrist Radial Fracture System Figure 12 Figure 13 Carpal Resection With the capitate and the proximal aspect of the third metacarpal exposed to facilitate alignment, position the carpal resection guide so the proximal apex of the guide allows visualization and subsequent resection of 2 3 mm of the capitate head (Figure 12). Orient the guide parallel to the longitudinal axis of the third metacarpal and insert two.062" K-wires through the guide (Figure 13). Place the first wire at the level of the capitate neck and the second in the metaphysis of the third metacarpal. If properly placed, the ulnar wing of the guide should line up closely with the midcarpal articulation between the triquetrum and hamate, while the radial wing bisects the scaphoid in its distal third. 8

11 Figure 14a Figure 14 Figure 15 Insert the carpal resection guide handle to help stabilize the carpal guide during resection. Keeping the saw blade flush against the four edges of the carpal resection guide, cut through the scaphoid, capitate head, edge of the hamate and triquetrum (Figure 14 and 14a). Remove the carpal resection guide and K-wires (Figure 15). 9

12 Maestro Wrist Radial Fracture System Figure 15 Figure 16 Carpal Canal Preparation Use a knife and ronguer to remove the proximal carpus and remaining distal scaphoid fragments (Figure 15). Insert a K-wire into the center of the capitate at the apex of resection. Confirm positioning with the aid of fluoroscopy. Place the 6 mm cannulated capitate reamer over the K-wire and carefully ream the center of the capitate without cracking the cortical walls (Figure 16). Use fluoroscopy to determine the reamer placement, depth and size within the capitate. Insert the flutes and stem until they near the distal surface of the capitate. Determine the appropriate size trial capitate stem by using the blue and green depth marks at the proximal margin of the capitate and fluoroscopic confirmation of the position of the reamer. If only the flutes are inserted past the articular surface, the silver trial is used. Use a 7.5 mm capitate reamer for large capitates.* *Requires a cement mantle. 10

13 Figure 17 Figure 18 Carpal Trial Selection Remove the reamer and K-wire from the capitate. Determine the trial carpal plate by the curvature and width of the proximal carpal surface and the size of the radial defect resulting from the removal of the scaphoid. Carpal plates are available in lengths of 37 mm and 43 mm, with three scaphoid augment options for each length. In most instances, there is a radial defect proximal to the base of the trapezoid, requiring one of the augmented carpal plates be used. The appropriate carpal plate should lie flush with the hamate and proximal capitate surfaces, and the scaphoid augment should hug the radial slope of the capitate and the base of the trapezoid. Assemble the previously chosen capitate stem to the appropriate carpal plate. Insert the assembled carpal plate and stem onto the proximal carpal surface and into the capitate using the insertion tool (Figure 17). When fitted correctly, the radial screw hole should lay straight below the second metacarpal, and the ulnar screw hole should be positioned so that an angled screw will be centered in the hamate. Any protruding bone that impedes congruous fit of the carpal plate should be trimmed. Continue trial fitting of the carpal plates with the predetermined capitate stem and radial augments until observation and fluoroscopy confirms satisfactory plate position, radial augment size and screw hole alignment. Place the previously assembled radial trials in to the radius. Place the standard carpal head onto the carpal plate (Figure 18). Flexion/extension and radial/ulnar deviation should be evaluated. Check freedom of motion and stability to determine that the correct implant size has chosen. If motion is limited, resect more bone from the radius or if possible, use a thinner carpal head or shorter radial fracture body. If the wrist appears unstable, use a larger (+2 or +4) carpal head or taller radial fracutre body. 11

14 Maestro Wrist Radial Fracture System Figure 19a Figure 19 Figure 20 Carpal Implant Insertion Assemble the appropriate capitate stem to the carpal plate using the assembly tool and driver (Figure 19). Inject bone cement into the cavities of the capitate. Insert the distal component by pressing the stem into the capitate and the plate against the distally resected carpus using the carpal impactor (Figure 19a). Select the appropriate drill guide (fixed or variable based upon screw preference), and connect the guide to the ulnar threaded hole of the carpal plate. Insert the K-wire sleeve into the drill guide and use fluoroscopy to assist in placement of the K-wire through the inner sleeve and into the bone (Figure 20). The pin should be directed obliquely into the central part of the hamate. 12

15 Figure 21 Figure 22 Once desired placement of the K-wire is found, remove the K-wire sleeve and place the cannulated drill bit over the K-wire (Figure 21). Drill depth is based upon desired screw length and confirmed with fluoroscopy. Screw length is based on drill depth referenced on the cannulated drill bit. Repeat process on the radial side, with the K-wire and drill inserted longitudinally through the trapezoid and into the second metacarpal. After both holes are drilled, insert the appropriate size ulnar and radial screws, making certain they are fully seated and locked into the carpal plate (Figure 22). 13

16 Maestro Wrist Radial Fracture System Figure 23 Figure 24 Place the carpal head onto the taper of the carpal plate and impact, ensuring the groove of the head is parallel with the length of the plate (Figure 23). Radial Implant Insertion Tighten the radial stem into the previously determined radial fracture body using the stem driver (Figure 24). Inject bone cement into the radial cavity. 14

17 Figure 25 Figure 26 Place the appropriate size radial implant into the prepared radius with the stem centered in the canal and the flange of the body flush along the outer volar aspect of the radius. Impact until the implant is fully seated (Figure 25). Insert graft between the flange and bone if needed. Joint Assessment Reduce the joint and reassess range of motion to ensure proper fit of the definitive implant (Figure 26). The joint should be stable while allowing freedom of motion in extension/flexion and radial/ulnar deviation. As with the trials, if motion is limited due to overstuffing of the joint, a smaller carpal head may be necessary. If the wrist seems unstable and the joint loose, a larger carpal head may be required. 15

18 Maestro Wrist Radial Fracture System Figure 27a Figure 27 Figure 29 Head Extraction If the definitive carpal head must be removed after impaction onto the carpal plate, an extraction device is available (Figure 27 and 27a). Closure Close the wrist capsule and dorsal retinaculum using non-absorbable sutures (Figure 28). The EPL may be left repositioned radially or included in the repair of the retinaculum. A drain may be used at the surgeon s discretion. If the distal ulna was excised, carry out a strong, stabilizing capsular closure over the distal ulnar stump. Apply a sterile bulky dressing incorporating a palmar splint. Deflate the pneumatic tourniquet. Prior to removing the drapes and awakening the patient, use fluoroscopy to confirm the implant remains in a reduced position. Postoperative Care Encourage early finger motion. Remove the splint at one week and apply a cast or splint for an additional one to three weeks. Note: If the distal ulna was removed, splint the forearm in neutral rotation for three weeks before commencing rotational exercises. Remove any drains at 24 hours, and the dressing and sutures at days. If the distal ulna was preserved, utilize a short arm, removable splint to maintain the wrist in neutral. Encourage gentle active motion several times daily with the splint removed after 14 days. Begin more vigorous active and passive motion at one month, with the frequency of exercises and amount of passive force applied to the hand based on the patient s progress and at the surgeon s discretion. 16

19 Implants Product Part Number Description Size Radial Fracture Body Size 1 Radial Fracture Body Size 1 Radial Fracture Body Size 1 Radial Fracture Body Size 1 Radial Fracture Body Size 1 Radial Fracture Body Size 1 Radial Fracture Body Size 2 Radial Fracture Body Size 2 Radial Fracture Body Size 2 Radial Fracture Body Size 2 Radial Fracture Body Size 2 Radial Fracture Body Size 2 Radial Fracture Body Size 3 Radial Fracture Body Size 3 Radial Fracture Body Size 3 Radial Fracture Body Size 3 Radial Fracture Body Size 3 Radial Fracture Body Size 3 Tapered Carpal Plate Tapered Carpal Plate Tapered Carpal Plate Tapered Carpal Plate Tapered Carpal Plate Tapered Carpal Plate Tapered Carpal Plate Tapered Carpal Plate Radial Fracture Stem Radial Fracture Stem Radial Fracture Stem Radial Fracture Stem 12 mm Right 12 mm Left 16 mm Right 16 mm Left 20 mm Right 20 mm Left 12 mm Right 12 mm Left 16 mm Right 16 mm Left 20 mm Right 20 mm Left 12 mm Right 12 mm Left 16 mm Right 16 mm Left 20 mm Right 20 mm Left 9 mm x 37 mm 9 mm x 43 mm 9 mm x 37 mm with 6 mm augment 9 mm x 37 mm with 9 mm augment 9 mm x 37 mm with 12 mm augment 9 mm x 43 mm with 8 mm augment 9 mm x 43 mm with 11 mm augment 9 mm x 43 mm with 14 mm augment 4.5 mm x 60 mm 6.0 mm x 60 mm 7.5 mm x 60 mm 9.0 mm x 60 mm Poly Carpal Head Poly Carpal Head Poly Carpal Head STD +2 mm +4 mm Captitate Stem Captitate Stem Captitate Stem 4.75 mm Fixed Locking Screw 4.75 mm Fixed Locking Screw 4.75 mm Fixed Locking Screw 4.75 mm Fixed Locking Screw 4.75 mm Fixed Locking Screw 4.75 mm Fixed Locking Screw 4.75 mm Fixed Locking Screw 4.75 mm Fixed Locking Screw 6.0 x 12 mm 6.0 x 15 mm 6.0 x 18 mm 15 mm 20 mm 25 mm 30 mm 35 mm 40 mm 45 mm 50 mm 17

20 Maestro Wrist Radial Fracture System Implants Product Part Number Description Size Variable Locking Screw Variable Locking Screw Variable Locking Screw Variable Locking Screw Variable Locking Screw Variable Locking Screw Variable Locking Screw Variable Locking Screw 4.75 x 15 mm 4.75 x 20 mm 4.75 x 25 mm 4.75 x 30 mm 4.75 x 35 mm 4.75 x 40 mm 4.75 x 45 mm 4.75 x 50 mm Instruments Product Part Number Description Size Radial Fracture Trial Body Size 1 Radial Fracture Trial Body Size 1 Radial Fracture Trial Body Size 1 Radial Fracture Trial Body Size 1 Radial Fracture Trial Body Size 1 Radial Fracture Trial Body Size 1 Radial Fracture Trial Body Size 2 Radial Fracture Trial Body Size 2 Radial Fracture Trial Body Size 2 Radial Fracture Trial Body Size 2 Radial Fracture Trial Body Size 2 Radial Fracture Trial Body Size 2 Radial Fracture Trial Body Size 3 Radial Fracture Trial Body Size 3 Radial Fracture Trial Body Size 3 Radial Fracture Trial Body Size 3 Radial Fracture Trial Body Size 3 Radial Fracture Trial Body Size 3 12 mm Right 12 mm Left 16 mm Right 16 mm Left 20 mm Right 20 mm Left 12 mm Right 12 mm Left 16 mm Right 16 mm Left 20 mm Right 20 mm Left 12 mm Right 12 mm Left 16 mm Right 16 mm Left 20 mm Right 20 mm Left Radial Fracture Carpal Head Trial Radial Fracture Carpal Head Trial Radial Fracture Carpal Head Trial STD +2 mm +4 mm Poly Carpal Head Impactor Radial Fracture Body Impactor 18

21 Instruments Product Part Number Description Size Radial Stem Trial Radial Stem Trial Radial Stem Trial Radial Stem Trial Radial Reamer Radial Reamer Radial Reamer Radial Reamer Radial Reamer 4.5 X 60 mm 6.0 X 60 mm 7.5 X 60 mm 9.0 X 60 mm 4.5 X 60 mm 6.0 X 60 mm 7.5 X 60 mm 9.0 X 60 mm 10.5 X 60 mm Fracture Radial Resection Guide Right Fracture Body K-wire Sleeve Fracture Radial Resection Guide Left Pin Puller Carpal Resection Guide Resection Guide Handle 19

22 Maestro Wrist Radial Fracture System Instruments Product Part Number Description Size Resection Level Guide Radial Provisional Extractor Carpal Provisional Holding Forcep Implant Assembly Tool Carpal Plate Trial Carpal Plate Trial Carpal Plate Trial Carpal Plate Trial Carpal Plate Trial Carpal Plate Trial Carpal Plate Trial Carpal Plate Trial Capitate Stem Trial Capitate Stem Trial Capitate Stem Trial Tapered Carpal Plate Impactor 9 mm x 37 mm 9 mm x 43 mm 9 mm x 37 mm with 6 mm augment 9 mm x 37 mm with 9 mm augment 9 mm x 37 mm with 12mm augment 9 mm x 43 mm with 8 mm augment 9 mm x 43 mm with 11 mm augment 9 mm x 43 mm with 14 mm augment 6 x 12 mm 6 x 15 mm 6 x 18 mm Carpal Head Extractor Fixed Drill Guide Variable Drill Guide Screw Hex Driver Cannulated Capitate Reamer Cannulated Capitate Reamer 6.0 mm 7.5 mm 20

23 Instruments Product Part Number Description Size K-wire Sleeve Cannulated Drill Bit Hexalobular Driver Impactor Handle Ratcheting Handle K-Wire Pk x K-Wire Single.062 x Instrument Case 21

24 INDICATIONS Total Wrist Indications The Maestro Total Wrist and Maestro Wrist Fracture Replacement systems are indicated for use as a replacement of wrist joints disabled by pain, deformity and/or limited motion caused by: 1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Revision where other devices or treatments have failed. 4. Scapholunate Advanced Collapse (SLAC) and other functional deformities. 5. Trauma, including fractures of the distal radius and/or carpal bones. Carpal Hemiarthroplasty Indications The Maestro Carpal Hemiarthroplasty is indicated for use as a replacement of wrist joints disabled by pain, deformity and/or limited motion caused by: 1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Revision where other devices or treatments have failed. 4. Scapholunate Advanced Collapse (SLAC) and other functional deformities. 5. Trauma, including fractures of the carpal bones. The radial and carpal components are intended to be implanted with bone cement. CONTRAINDICATIONS Absolute contraindications include: infection, sepsis, and osteomyelitis. Relative contraindications include: 1) uncooperative patient or patients with neurologic disorders who are incapable of following directions, 2) osteoporosis, 3) metabolic disorders which may impair bone formation, 4) osteomalacia, 5) distant foci of infections which may spread to the implant site, 6) rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and/or 7) absent or insufficient wrist extensor tendons. The information contained in this package insert was current on the date this brochure was printed. However, the package insert may have been revised after that date. To obtain a current package insert, please contact Biomet at the contact information provided herein.

25 All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless otherwise indicated. This material is intended for the sole use and benefit of the Biomet sales force and Physicians only and is NOT intended for patient distribution. It is not to be redistributed, duplicated or disclosed without the express written consent of Biomet. For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert and the Patient Risk Information at P.O. Box 587, Warsaw, IN x Biomet Orthopedics biomet.com Form No. BIV REV051512