TORNIER AEQUALIS ASCEND. Shoulder System SURGICAL TECHNIQUE

Transcription

1 TORNIER AEQUALIS ASCEND Shoulder System SURGICAL TECHNIQUE

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3 Table of Contents: Implant/Instrument Rationale...4 Indications & Contraindications...5 Surgical Technique Preoperative Planning and Patient Positioning...6 Humeral Exposure (Delto-Pectoral Approach)...7 Humeral Head Preparation and Resection...8 Sizing the Medullary Canal...9 Preparing the Metaphysis Distal Broaching Trialing Final Implantation Testing & Closure Rehabilitation Trialing Instrumentation Humeral Prep Instrumentation Humeral Stem Implants Humeral Head Implants

4 Implant/Instrument Rationale Humeral Stems The original titanium grit-blasted surface and a Pure Titanium Coating (PTC) option are available 9 stems ranging mm 3 angles of inclination per size Short stem design leverages sounding vs. reaming when preparing the bone for the implant to create a compacted layer surrounding the stem AEQUALIS ASCEND features a collarless design to facilitate removal if required Low profile lateral border avoids insertion of the supraspinatus tendon without sacrificing rotational stability Exceptional proximal press-fit with the flexibility to cement if needed Humeral Heads Anatomic progression throughout the entire range Infinite dialability 3 eccentric offset options to maximize anatomic adjustments: 1.5 mm, 3.5 mm, and 4.0 mm offset options Instrument Rationale Instrumentation has been designed to allow a precise, easy and reproducible implantation The sterilization case layout is organized by size to make it surgeon friendly during implantation Progressive metaphyseal sounders allow for an optimal primary fixation through bone compaction vs. removal Color coding for easy identification 4

5 Indications & Contraindications The AEQUALIS ASCEND Shoulder System consists of a humeral stem, a mating humeral head, and an optional polyethylene glenoid. The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The AEQUALIS ASCEND Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The AEQUALIS ASCEND Shoulder System is indicated for use as a replacement of shoulder joints disabled by: Rheumatoid arthritis with pain Noninflammatory degenerative joint disease (i.e. osteoarthritis and a vascular necrosis) Correction of functional deformity Fractures of the humeral head Traumatic arthritis Revision of other devices if sufficient bone stock remains* All components are single use. The humeral stem is intended for cemented or cementless use, while the all polyethylene glenoid is intended for cemented use only *This specific indication is not approved in the EU. Contraindications common to AEQUALIS ASCEND Shoulder System: Total joint replacement is contraindicated where there is: Active local or systemic infection, sepsis and osteomyelitis Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components Poor bone quality, such as osteoporosis, where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid Relative contraindications for shoulder arthroplasty: Uncooperative patient or patient with neurologic disorders who are not capable of following direction Osteoporosis Metabolic disorders which may impair bone formation Osteomalacia Distant foci of infections which may spread to the implant site Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram Note: All components are single use The humeral stem is intended for cemented or cementless use 5

6 Surgical Technique Pre-Operative Planning Pre-operative planning is performed utilizing x-ray templates on the frontal and sagittal views. Appropriate implant size and positioning is determined. The use of a CT scan or MRI is recommended to better determine the orientation of the glenoid, the quality of glenoid bone stock and to confirm the integrity of the rotator cuff. Scans are also used to determine the length of the humeral stem. Patient Positioning Position the patient in a beach chair position with the operative arm draped free. For optimal access, the patient should be positioned near the edge of the operating table such that the shoulder can be fully extended. A bump can be placed under the operative shoulder to stabilize the scapula. (Figure 1) Figure 1 6

7 Humeral Exposure Delto-Pectoral Approach (Figure 2) An incision is made from the tip of the coracoid along the delto-pectoral groove, slightly lateral to the axillary fold. The pectoralis major is identified. The deltoid and cephalic veins are retracted laterally to open the delto-pectoral groove. The coracoid process is identified. A Hohmann retractor is positioned behind the coracoid. Care should be taken to preserve the origin and insertion of the deltoid. The clavi-pectoral fascia is incised at the external border of the coraco-brachialis. The axillary nerve is then identified before opening the subscapularis. As the arm is externally rotated, the anterior and inferior capsule are released from the humerus to the glenoid. With adequate releases, the humeral head is then dislocated into the delto-pectoral interval by abduction of the arm and progressive external rotation and extension. In cases of severe restriction of external rotation (0 or less), it is recommended to release more of the upper pectoralis insertion. Figure 2 7

8 Preparation & Technique Humeral Head Preparation Abduct and externally rotate the arm to expose the humeral head through the deltopectoral interval. Remove all osteophytes, using a rongeur or a curved osteotome, with a superiorly directed motion, to identify the exact capsular insertion at the anatomic neck. Humeral Head Resection To facilitate the cut, the cutting plane can be defined by: Marking the superior/lateral point (12 o clock position), inferior/medial (6 o clock position) points and the most anterior points (3 o clock for a right shoulder and 9 o clock for a left shoulder). Connecting these three points with a surgical pen or bovie will help identify the anatomic humeral neck prior to resection. (Figure 3) Figure 3 Use a saw blade to complete the humeral resection. (Figure 4) Figure 4 8

9 Sizing the Medullary Canal Using the Starter Awl, create a pilot hole 5 mm directly below the hinge point (or 7 mm below the top of the greater tuberosity as illustrated in Figure 5). Note that the Starter Awl should be inserted until the wide portion is below the level of the cut. Next, insert the Sounders incrementally through the pilot hole starting with the Size 1-3 and progressively increasing until contact is made with the cortical wall of the canal. (Figure 6) Note that the size of the canal is identified by directly reading the mark on the Sounder positioned at the edge of the cut. The size measured on the Sounder will determine the maximum stem size to be implanted. It is critical not to ream/broach over this size to prevent any risk of humeral fracture. Caution: The Sounders are not intended to cut cortical bone. As a result, a reaming motion should not be used when cortical contact is made. Figure 5 Figure 6 9

10 Preparing the Metaphysis With the final Sounder in place, select the Goniometer that corresponds to the Sounder size. Attach the Goniometer through the slots of the Sounder and slide it down until it rests flat on the humeral cut. (Figure 7) If necessary, the Sounder might be rotated to allow the Goniometer to rest perfectly flat on the cut. Record the angle marking on the Goniometer which aligns with the centerline of the Sounder. Note that angles will be marked with an A, B and C. If the reading is between two angles, the smallest angle should be chosen. In other words, if the reading is between A and B then the A angle should be selected. Next, select the corresponding Punch and impact it onto the Goniometer until the punch is fully seated. (Figure 8) The Punch will create the medial fin track mark that the broaches will follow to maintain the desired retroversion. Once the Punch is complete (Figure 9) then the entire assembly (Sounder, Goniometer and Punch) can be removed. Figure 7 Note: In case of poor bone quality, the Osteotome might be used instead of the Punch. The medial bone graft should be left in place unless extremely dense bone is encountered as this bone will later be used to help create the compacted layer of bone around the implant. Figure 8 Figure 9 10

11 Distal Broaching When possible begin with the Broach three sizes below the final Sounder reading. Assemble the Broach Pin by making sure that the Pin will be on the anterior part of the broach designated by an R for a right shoulder and an L for a left shoulder. Align the medial fin of the Broach with the track mark created by the Punch. (Figure 10) Impact the Broach until the Pin contacts the cut. (Figure 11) The Broach Pin should always remain parallel to the cut surface during impaction to maintain the desired retroversion. Broach sequentially up until satisfactory proximal fixation is achieved. Satisfactory proximal fixation can be assessed by a slight torque motion of the Broach. The Broach should not move within the proximal humerus during this test. Note: It is important not to use a Broach larger than the size measured by the Sounder to avoid risk of humeral fracture. Figure 10 Figure 11 11

12 Trialing Humeral Stem(s): Assemble the Distal Humeral Trial to the Proximal Body. (Figure 12) The angle of the proximal body should be the same as the angle read on the Goniometer when preparing the metaphysis. The size of the distal stem should be the same size as the last Broach used. Figure 12 Once the dovetail is fully engaged, the assembly is secured by screwing the Lateral Fixation Screw with the 3.5 mm Hexagonal Screwdriver. (Figure 13) The assembly is then placed into the humerus with the trial inserter until it rests flush with the cut. Note that care should be taken to maintain the desired retroversion during the placement of the trial. Figure 13 Humeral Head(s): Select the appropriate humeral head size. The trial diameter and thickness should match the diameter and thickness of the humeral head resected to restore natural anatomy. Note that both Neutral and Offset Humeral Head Trials are available. The degree of offset will be determined by selecting the trial that maximizes cut coverage. Grasp the Humeral Head Trial with the Humeral Head Trial Clamp. Rotate it onto the trunion of the trial stem until the ideal coverage of the humeral resection is obtained. The Humeral Head Trial is then secured by a gentle impaction. (Figure 14) Figure 14 12

13 Final Implantation Insert the Humeral Extractor through the Humeral Head Trial and thread into the Proximal Humeral Trial. Remove the entire Humeral Trial Assembly with the Slap-Hammer in an axially-directed motion. Record the index marking on the inferior surface of the Humeral Trial Head, which is aligned to the lateral laser marking on the Proximal Humeral Trial. Place the chosen definitive monolithic Humeral Stem Implant (respecting the diameter and angle measured on the trial) into the impaction stand. Impact the selected size Humeral Head implant in the proper index orientation using the Humeral Head Impactor. Finally, insert the entire Implant Assembly into the prepared humerus while maintaining the established retroversion. Then impact the Implant until the Humeral Head is flush with the cut. (Figure 15) Figure 15 Note: The final standard stem is diametrically 1 mm larger than the Broach and the PTC stem is diametrically 2 mm larger than the Broach. In most cases this provides for a firm press-fit without the need for cement. The decision to use cement or a press-fit technique is based upon individual surgeon preference. In some instances, it may be necessary to use cement. 13

14 Testing & Closure After the joint has been washed and the prosthesis reduced, the stability and mobility of the shoulder are tested. The joint is closed by reinsertion of the subscapularis to the coraco-humeral ligament, and to the subscapular remnant, allowing slight slipping of the subscapularis upwards. The wound is closed in planes over an aspiration drain. Post-operatively the arm is immobilized in a simple sling. Humeral Extraction The short, collarless AEQUALIS ASCEND implant combined with the AEQUALIS ASCEND Anatomic Implant Extractor simplifies the removal process while preserving precious proximal bone stock for patient specific reversed prosthesis placement. Additionally, fixation independent of the distal canal reduces the need for humeral osteotomy upon removal. Collarless design allows for access to proximally fixed surface with osteotomes. Attachment for removal with AEQUALIS ASCEND Extractor* * Special Order Only - Reference catalog #SH6541 for the Ascend Anatomic Implant Stem Extractor 14

15 Rehabilitation Rehabilitation is essential and is responsible for at least 50% of the final result. Rehabilitation begins on the evening of surgery by removing the sling and actively moving fingers, wrist and elbow. If the patient desires, his/her arm may be left along the length of his/her body, putting no tension on the suture line. The following day, the patient begins active exercises of the fingers, wrist and elbow, assisted by a physiotherapist, 5 to 6 times daily, each for a few minutes duration. The patient is allowed to get out of bed with his/her arm in a sling. Once the drain is removed after 48 hours, the patient is encouraged to carry out brief pendular exercises throughout the day. The fundamental principle which guides rehabilitation, either in the operative center or as an outpatient, is maximal recovery of passive joint movement prior to any active motion. Passive elevation is begun by simple pendular movements followed rapidly by self-mobilization with the patient in the dorsal decubitus position, with elbow extended. This is helped by exhaling through the mouth, which adds a few degrees movement with each inspiration. It is preferable to perform a single smooth motion rather than repeated jerking movements. External rotation is performed using a stick, with the elbow against the body. Internal rotation is performed with the arm behind the back, helped by the other hand wherever possible. Rehabilitation sessions should not be more than 5 minutes long and should be performed ideally hourly throughout the day. The time required for purely passive rehabilitation varies depending on preoperative passive mobility. In the rare case that pre-operative mobility is present, the amplitude of movement generally recovers after 45 days and active movement may be possible. In this case a few minutes of active movement should be performed mornings and evenings exercising the joint in a swimming pool using arm movements for 10 to 15 minutes daily for 3 months. If a patient was highly restricted preoperatively (forward elevation less than 90 ), it should be understood that the total shoulder prosthesis is not a mobilizing procedure. It is unlikely the patient will recover passive elevation beyond 130 degrees. The patient should be asked to perform multiple daily passive stretching exercises and breast-stroke movement of his/her arms in a swimming pool throughout the first postoperative year, in order to obtain and maintain maximum mobility. Note: Desired rehabilitation protocols vary by surgeon. The surgeon, physical therapist and patient should play an active role in determining the appropriate recovery process. 15

16 Instruments Heads A9 B9 A8 A7 B8 B7 A6 A5 B6 B5 A4 A3 B4 B3 A2 A1 B2 B1 Humeral Trials Bottom Tray Label P/N Description A1 SH Trial Humeral Head 3.5 mm offset size 38x15 A2 SH Trial Humeral Head 3.5 mm offset size 40x15 A3 SH Trial Humeral Head 3.5 mm offset size 42x16 A4 SH Trial Humeral Head 3.5 mm offset size 44x17 A5 SH Trial Humeral Head 4 mm offset size 46x18 A6 SH Trial Humeral Head 4 mm offset size 48x19 A7 SH Trial Humeral Head 4 mm offset size 50x19 A8 SH Trial Humeral Head 4 mm offset size 52x20 A9 SH Trial Humeral Head 4 mm offset size 54x21 B1 SH Trial Humeral Head 1.5 mm offset size 38x15 B2 SH Trial Humeral Head 1.5 mm offset size 40x15 B3 SH Trial Humeral Head 1.5 mm offset size 42x16 B4 SH Trial Humeral Head 1.5 mm offset size 44x17 B5 SH Trial Humeral Head 1.5 mm offset size 46x18 B6 SH Trial Humeral Head 1.5 mm offset size 48x19 B7 SH Trial Humeral Head 1.5 mm offset size 50x19 B8 SH Trial Humeral Head 1.5 mm offset size 52x20 B9 SH Trial Humeral Head 1.5 mm offset size 54x21 16

17 Stems C D Humeral Trials Bottom Tray Label P/N Description C SH Proximal Humeral trial size 1-3 A C SH Proximal Humeral trial size 1-3 B C SH Proximal Humeral trial size 1-3 C C SH Proximal Humeral trial size 4-6 A C SH Proximal Humeral trial size 4-6 B C SH Proximal Humeral trial size 4-6 C C SH Proximal Humeral trial size 7-9 A C SH Proximal Humeral trial size 7-9 B C SH Proximal Humeral trial size 7-9 C D SH Distal Humeral trial size 1 D SH Distal Humeral trial size 2 D SH Distal Humeral trial size 3 D SH Distal Humeral trial size 4 D SH Distal Humeral trial size 5 D SH Distal Humeral trial size 6 D SH Distal Humeral trial size 7 D SH Distal Humeral trial size 8 D SH Distal Humeral trial size 9 17

18 A C D B H1 H2 H3 E G F Humeral Instruments Top Tray Label P/N Description A SH0762 Humeral Extractor B SH0768 Humeral Impaction Stand C Head Impactor Tip D Head Impactor Shaft E SH mm Modular Hex Driver F SH0799 Modular Trial Insertor G MWA103 Trial Head Clamp H1 SH Humeral Head Protector size 1-3 H2 SH Humeral Head Protector size 4-6 H3 SH Humeral Head Protector size

19 A B Humeral Instruments Bottom Tray Label P/N Description A SH Monolithic Broach size 1 A SH Monolithic Broach size 2 A SH Monolithic Broach size 3 A SH Monolithic Broach size 4 A SH Monolithic Broach size 5 A SH Monolithic Broach size 6 A SH Monolithic Broach size 7 A SH Monolithic Broach size 8 A SH Monolithic Broach size 9 B SH0715 Monolithic Broach Pin 19

20 A B D E G C F Humeral Instruments Top Tray Label P/N Description A SH0780 Modular Palm Handle B SH0779 Modular T-Handle(s) - 2 C SH0713 Modular Starter Awl D SH Distal Sounder size 1-3 D SH Distal Sounder size 4-6 D SH Distal Sounder size 7-9 D SH Distal Sounder size 2-4 D SH Distal Sounder size 5-7 E SH Proximal Punch size 1-3 E SH Proximal Punch size 4-6 E SH Proximal Punch size 7-9 F SH Goniometer/Punch Template size 1-3 F SH Goniometer/Punch Template size 4-6 F SH Goniometer/Punch Template size 7-9 G SH0798 Modular Osteotome 20

21 AEQUALIS ASCEND Reference Size Length Angle A 1A 66 mm 125º B 1B 66 mm 130º C 1C 66 mm 135º A 2A 70 mm 125º B 2B 70 mm 130º C 2C 70 mm 135º A 3A 74 mm 125º B 3B 74 mm 130º C 3C 74 mm 135º A 4A 78 mm 127.5º B 4B 78 mm 132.5º C 4C 78 mm 137.5º A 5A 82 mm 127.5º B 5B 82 mm 132.5º C 5C 82 mm 137.5º A 6A 86 mm 127.5º B 6B 86 mm 132.5º C 6C 86 mm 137.5º A 7A 90 mm 130º B 7B 90 mm 135º C 7C 90 mm 140º A 8A 94 mm 130º B 8B 94 mm 135º C 8C 94 mm 140º A* 9A 98 mm 130º B* 9B 98 mm 135º C* 9C 98 mm 140º * Special Order Only 21

22 AEQUALIS ASCEND PTC Reference Size Length Angle A 1A 66 mm B 1B 66 mm C 1C 66 mm A 2A 70 mm B 2B 70 mm C 2C 70 mm A 3A 74 mm B 3B 74 mm C 3C 74 mm A 4A 78 mm B 4B 78 mm C 4C 78 mm A 5A 82 mm B 5B 82 mm C 5C 82 mm A 6A 86 mm B 6B 86 mm C 6C 86 mm A 7A 90 mm B 7B 90 mm C 7C 90 mm A 8A 94 mm B 8B 94 mm C 8C 94 mm A* 9A 98 mm B* 9B 98 mm C* 9C 98 mm 140 * Special Order Only 22

23 AEQUALIS ASCEND Low Offset Humeral Heads Reference Size Length Angle mm 15 mm 1.5 mm mm 15 mm 1.5 mm mm 16 mm 1.5 mm mm 17 mm 1.5 mm mm 18 mm 1.5 mm mm 19 mm 1.5 mm mm 19 mm 1.5 mm mm 20 mm 1.5 mm mm 21 mm 1.5 mm AEQUALIS ASCEND High Offset Humeral Heads Reference Size Length Angle mm 15 mm 3.5 mm mm 15 mm 3.5 mm mm 16 mm 3.5 mm mm 17 mm 3.5 mm mm 18 mm 4.0 mm mm 19 mm 4.0 mm mm 19 mm 4.0 mm mm 20 mm 4.0 mm mm 21 mm 4.0 mm 23

24 1023 Cherry Road Memphis, TN Nesbitt Avenue South Bloomington, MN Proper surgical procedures and techniques are the responsibility of the medical professional. This material is furnished for information purposes only. Each surgeon must evaluate the appropriateness of the material based on his or her personal medical training and experience. Prior to use of any Tornier implant 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 Wright. Contact information can be found in this document and the package insert. and denote Trademarks and Registered Trademarks of Wright Medical Group N.V. or its affiliates Wright Medical Group N.V. or its affiliates. All Rights Reserved. CAW-2481 Rev C ECN Jun-2016