S H O U L D E R Solutions by Tornier Aequalis TM Pyrocarbon humeral head SURGICAL TECHNIQUE Aequalistm Pyrocarbon Humeral Head surgical technique
Aequalis TM Pyrocarbon humeral head surgical TECHNIQUE Aequalistm Pyrocarbon Humeral Head
contents 1. implant p. 4 2. intended use p. 5 3. indications p. 5 4. contra-indications known to date p. 5 5. positioning and fixation of final implant p. 6 6. trials and closure p. 8 7. size range p. 9 8. INSTRUMENTATION p. 10 Aequalis TM Pyrocarbon Humeral Head - Surgical Technique - UDOT151 3
surgical technique 1. IMPLANT The Aequalis Pyrocarbon Humeral Head is an articular implant assembled with a metallic taper (CoCr). The Aequalis Pyrocarbon Humeral Head is available in 6 sizes and 2 offsets: HEAD SIZE LOW OFFSET HIGH OFFSET 39 x 14 1,5 3,5 41 x 15 1,5 3,5 43 x 16 1,5 3,5 46 x 17 1,5 4 48 x 18 1,5 4 50 x 16 1,5 4 The Aequalis Pyrocarbon Humeral Head is compatible only with the Aequalis Ascend Flex Stems. Aequalis TM Pyrocarbon Humeral Head - Surgical Technique - UDOT151 4
surgical technique 2. intended use This system is intended to be used to partially replace the shoulder joint in primary treatment or during revision. 3. Indications The Aequalis Pyrocarbon Humeral Head associated with the Aequalis Ascend Flex stem is indicated for use as a replacement of deficient humeral head joints disabled by: Rheumatoid arthritis with pain, Non-inflammatory degenerative joint diseases (osteoarthritis, avascular necrosis) Correction of functional deformity Fractures of the humeral head, Post-traumatic osteoarthritis, Revision of other implants if bone stock is sufficient. The Aequalis Pyrocarbon Humeral Head shoulder prosthesis combined with the Aequalis Ascend Flex stem, are to be used only in patients with an intact or reconstructable rotator cuffs and if the native glenoid surface is intact or sufficient, where they are intended to increase mobility, stability, and relieve pain. 4. Known contraindications to date Absolute contraindications with shoulder arthroplasty: Active local or systemic infection, sepsis, or osteomyelitis, Insufficient bone stock to support implants in the humeral epiphysis, Insufficient bone stock or excessive deformation of the native glenoid to allow normal functioning of the glenohumeral joint, Poor bone quality leading to the risk of considerable migration of the prosthesis and/or to the risk of the fracture of the humerus or glenoid. Relative contraindications related to shoulder arthroplasty: Patient not cooperative or patient suffering from neurological disorders and unable to follow the recommendations of the healthcare professional, Metabolism disorders that could compromise bone formation, Osteomalacia, Distant foci of infections that could spread to the site of the implant, Rapid destruction of the joint, marked bone loss, or bone resorption apparent on the X-ray, Known allergy or suspected allergy to the materials, Pregnant women. All the following steps are identical to those described in the surgical technique of the Aequalis Ascend Flex: Approach, bone preparation, trials, size selection and implant selection (refer to the surgical technique of the Aequalis Ascend Flex). Specific instrumentation is required for the implantation of the final Aequalis Pyrocarbon Humeral Head. WARNING: Do not handle the Aequalis Pyrocarbon Humeral Head using metallic instruments. Aequalis TM Pyrocarbon Humeral Head - Surgical Technique - UDOT151 5
surgical technique 5. POSITIONING AND FIXATION OF FINAL IMPLANT UNCEMENTED STEM (PTC) NOTE: To avoid repeated impactions on the Aequalis Pyrocarbon Humeral Head, the final humeral stem must first be placed in the humerus before assembly of the head using the Specific Compactor. The final Humeral Stem (size and diameter determined during trials) is assembled with the Trial Compactor. Insert the stem in the humerus controlling its retroversion and then advance the Compactor until the Depth Stop rests flush on the resected surface of the humerus. Once the stem is correctly positioned, the Manual Planer Reamer may be used to grant perfect flushness of the resection relative to the stem: In the case of trans-osseous sutures for subscapularis reinsertion, the Manual Planer Reamer of the Aequalis Pyrocarbon Humeral Head must be used. Assemble the T-Handle from the Aequalis Ascend Flex instrumentation with the correct Aequalis Pyrocarbon Humeral Head Manual Planer Reamer. Place the Reamer Tip (blue part) into the taper of the Stem. The Manual Planer Reamer is asymmetric. In order to protect the transosseous sutures for subscapularis reinsertion; the Manual Planer Reamer is used backwards and forwards. corresponding sizes of stems and planners 1/2/3 SMALL 4/5/6 MEDIUM 7/8 LARGE NOTE: The surgeon should inspect the implant tapers and articular surfaces for debris or blemishes before assembly. The tapers should be clean and dry for assembly. The humeral head should be assembled with the final stem using clean gloves. Orient the selected size Aequalis Pyrocarbon Humeral Head onto the stem with the previously determined rotation. Adjust the Head rotation until the best coverage is achieved. Apply pressure to temporarily hold the Humeral Head in this position. Aequalis TM Pyrocarbon Humeral Head - Surgical Technique - UDOT151 6
surgical technique NOTE: Never impact the Aequalis Pyrocarbon Humeral Head using the Aequalis Ascend Flex Impactor. Use the specific Pyrocarbon Head Impactor in order to impact the Pyrocarbon Head onto the stem. Choose the correct silicon tip that corresponds to the Pyrocarbon Head size. Choose the Impactor Tip Support that corresponds to the chosen silicon tip. Take the Spring Impactor. Screw the Impactor Tip Support on its extremity and place the silicon tip inside. Aequalis TM Pyrocarbon Humeral Head - Surgical Technique - UDOT151 7
surgical technique NOTE: Make sure the specific Aequalis Pyrocarbon Humeral Head Impactor is perfectly centered and fully in contact with the Pyrocarbon Head before impaction. The Spring Impactor is made of a spring that is activated thanks to the handle. It provides a precise amount of energy thus helps controlling the amount of energy that is delivered for impaction. It is necessary to activate and release the Spring Impactor 3 times to achieve the perfect Aequalis Pyrocarbon Humeral Head impaction onto the stem. cemented stem Final implants can be assembled on the back table using the specific Impactor mounted with the silicon tip that corresponds to the Aequalis Pyrocarbon Humeral Head size. NOTE: Do not impact the Aequalis Pyrocarbon Humeral head onto the stem with the Aequalis Ascend Flex Impactor. Make sure the Pyrocarbon Head Impactor is perfectly centered and fully in contact with the Pyrocarbon Head before impaction. The full implant is introduced manually into the humeral diaphysis with no impaction. Refer to Aequalis Ascend Flex Surgical Technique Back Table Assembly on page 27 for more details. 6. tests and closure Test the Pyrocarbon Head assembly onto the stem by pulling the head back. If the Pyrocarbon Head is not correctly impacted, clean head & stem tapers and repeat impaction steps. 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 onto 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. Aequalis TM Pyrocarbon Humeral Head - Surgical Technique - UDOT151 8
implants 7. size range Aequalis PYROCARBON HUMERAL HEADS* Reference Description Diameter Height Offset DWH039 Aequalis Pyrocarbon Humeral Head 39 mm 14 mm 1.5 mm DWH041 Aequalis Pyrocarbon Humeral Head 41 mm 15 mm 1.5 mm DWH043 Aequalis Pyrocarbon Humeral Head 43 mm 16 mm 1.5 mm DWH046 Aequalis Pyrocarbon Humeral Head 46 mm 17 mm 1.5 mm DWH048 Aequalis Pyrocarbon Humeral Head 48 mm 18 mm 1.5 mm DWH050 Aequalis Pyrocarbon Humeral Head 50 mm 16 mm 1.5 mm DWH139 Aequalis Pyrocarbon Humeral Head 39 mm 14 mm 3.5 mm DWH141 Aequalis Pyrocarbon Humeral Head 41 mm 15 mm 3.5 mm DWH143 Aequalis Pyrocarbon Humeral Head 43 mm 16 mm 3.5 mm DWH146 Aequalis Pyrocarbon Humeral Head 46 mm 17 mm 4 mm DWH148 Aequalis Pyrocarbon Humeral Head 48 mm 18 mm 4 mm DWH150 Aequalis Pyrocarbon Humeral Head 50 mm 16 mm 4 mm Low High * Available upon registration in countries. Aequalis TM Pyrocarbon Humeral Head - Surgical Technique - UDOT151 9
instrumentation 8. instrumentation The Aequalis Pyrocarbon Humeral Head is assembled onto the Aequalis Ascend Flex Stem. The Aequalis Ascend Flex instrumentation is necessary for the implantation of the Aequalis Pyrocarbon Humeral Head. 2 1 3 4 6 5 7 1 2 3 Reference MWF724 MWF720 MWF721 AEQUALIS Pyrocarbon humeral head instrumentation (YKAD238) Description Spring Impactor 39-43 Impactor Tip Support 46-50 Impactor Tip Support MWF739 Pyrocarbon Head Impactor Tip Dia 39 H 14 4 MWF741 Pyrocarbon Head Impactor Tip Dia 41 H 15 MWF743 Pyrocarbon Head Impactor Tip Dia 43 H 16 MWF746 Pyrocarbon Head Impactor Tip Dia 46 H 17 5 MWF748 Pyrocarbon Head Impactor Tip Dia 48 H 18 MWF750 Pyrocarbon Head Impactor Tip Dia 50 H 16 6 7 MWF725 MWF726 MWF727 MWF728 NCR238 YRAD238 Manual Planer Reamer Size S Manual Planer Reamer Size M Manual Planer Reamer Size L Reamer Tip Cover Tray Aequalis TM Pyrocarbon Humeral Head - Surgical Technique - UDOT151 10
notes Aequalis TM Pyrocarbon Humeral Head - Surgical Technique - UDOT151 11
US HEADQUARTERS Tornier, Inc. 10801 Nesbitt Ave South Bloomington, MN 55437 USA +1 952 426 7600 INTERNATIONAL HEADQUARTERS MANUFACTURER Tornier SAS 161 rue Lavoisier 38330 Montbonnot Saint-Martin France +33 (0)4 76 61 35 00 www.tornier.com Prior to using any Tornier device, please review the instructions for use and surgical technique for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use. 2015 Tornier, Inc. All rights reserved. Aequalis, Tornier et are trademarks or registered trademarks of Tornier in the U.S. and other countries. Aequalis TM Pyrocarbon Humeral Head - Surgical Technique - UDOT151