TM UCP STEM Surgical Protocol

Transcription

1 UCP TM STEM Surgical Protocol

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3 Table of Contents Surgical Protocol Device... Preoperative Planning and Templating... Femoral Osteotomy... Femoral Canal Accessing... Canal Broaching... Trial Reduction... Stem Insertion... Stem Impaction... Femoral Head Impaction... Stem Specifications... I Order Information Femoral Head Accessory Head Trial Stem Trial & Instrument Safety statement- UCP Stem... 17

4 Device UCP Stem is designed with clinically proven philosophies to reproduce excellent outcomes. Cement friendly profile, including polished surface and tri-tapered geometry, reduce shear stress on cement. Collarless design and various insertion depth options allow surgeon to balance leg length with ease. The stem is made by CoCrMo material to provide strong fatigue strength. UCP stem is available with offset variants and stem length options to deal with a wide variety of clinical challenges. 12/14 Morse taper is compatible with CoCrMo metal head and BIOLOX delta ceramic head Various leg length adjustment option Available in both Standard and high offset option to better restore joint biomechanics Tri-tapered design to increase torsional stability and to reduce stresses on cement mantle Mirror-polished surface finish to protect cement from breakage Made by CoCrMo to provide strong fatigue strength Revision long stem option: 180, 210, and 230 mm long stem options indicate for proximal bone loss cases Specially designed centralizer allow stem creeping to stable position Cement Restrictor *BIOLOX delta is the registry trademark of Ceramtec AG. 1

5 Preoperative Planning and Templating Preoperative planning is essential for determining the optimized stem size, neck resected level and the appropriate neck length. Making an accurate femoral component selection begins with thorough radiographic evaluation of the involved femur: a full anteroposterior (A/P) view and lateral view. The A/P radiographic image should include bilateral hip joints to help the evaluation of the affected side. These radiographies provide the estimation of leg length inequality, femoral offset, and center of rotation to reconstruct hip biomechanics. UCP stem templates with 15% magnification are offered in accordance with the common enlargement of x-ray image. UCP stem is designed to obtain immediate geometrical stability depended on medial and lateral cortex contact. Templating the prosthesis size which best fits the metaphyseal canal is recommended. Standard and high offset options are available for all stem sizes. High offset provides femoral lateralization, increasing stem offset while maintains leg length. Also, multiple head offsets are offered for the adjustment of neck length. The final determination of implant options should be taken into account including the acetabular cup position, cup size and center of rotation of the acetabulum. Femoral Osteotomy Place the UCP Resection Guide aligned with the long axis of the femoral canal. Determine the neck resection level by measuring preoperatively determined distance above the lesser trochanter or by measuring the distance from the tip of the greater trochanter to the shoulder of the stem. The cutting line can be marked by using the electrocautery, then complete the femoral neck resection with a power saw. 2

6 Femoral Canal Accessing Create the canal entry point at the piriformis fossa through modular Femoral Cutting Chisel. Place the cutting chisel laterally to remove the trochanteric bone which ensure neutral placement of subsequent broach and stem. Advance the UCP Start Reamer to the femoral canal with different depths based on the size of stem selected. There are two indicating grooves on the start reamer, the inferior (for #0) and superior (for #1-5) represent proper reaming depths. Ensure the correct reamer alignment within the femoral shaft axis. #1 - #5 #0 3

7 Canal Broaching Attach the smallest size of UCP Broach to Broach Handle, start broaching procedure along the axis of the femur and maintain proper orientation of the broach. Lateralization during broaching procedure is critical to ensure neutral placement of broach and implant. Sequentially enlarge the broach size until the templating size is met. Make sure the broach is advanced to proper depth, the second (from the top) depth indicating hole on the broach should seat in line with the neck resection surface. The UCP broach is designed to provide 2 mm cement mantle proximally and distally, and additional 2 mm mantle in the proximal medial part. The broach is 15 mm longer than the corresponding implant, which is the space designed for cement restrictor. Canals of #3, 210 mm and 230 mm long stem can be prepared through the #3, 180 mm broach. Cement Mantle A 2 2 A 4 2 A - A cross section B B B - B cross section Unit: mm 15 4

8 Trial Reduction Disassemble the broach handle and leave the final broach in place. UCP stem offer standard and high offset options to better restore joint stability and kinematics. Select the ideal Standard or High Trial and assemble it onto the broach. Perform trial reduction using Femoral Head Trial with desired diameter and neck length. With the collarless design of UCP stem, leg length adjustment can be manipulated easily. UCP stem offers 4 leg adjustment options through different insertion depths, including -5, 0, +5 and +10 mm. If shortening of the leg length is required, further advanced the broach until the top indication hole seat in line with the neck resection surface. On the other hand, extension of the leg length can be achieved by moving the broach upward to third (+5 mm) or fourth (+10 mm) depth indication hole. With the help of UCP Locating Pin, the broach can seat properly. 1 st (-5mm) Shortening of the leg length by 5mm 3 rd (+5mm) Extend the leg length by 5mm 2 nd (0mm) Regular broaching depth 4 th (+10mm) Extend the leg length by 10mm UCP Locating Pin 5

9 Mark the Calcar bone at the position of depth indicating hole, this would be the reference to guide proper stem position during implantation. If 210 or 230 mm stem is selected, specially designed long stem trials are available to performed trial reduction.the stem trial is the same dimension as real implant. Use UCP locating pin to place stem trial in ideal position during trial reduction. Reference mark 6

10 Canal Sizing After trial reduction, retrieve the broach from the canal. Assemble the Canal Sizer with Non-Ratcheting Handle. Sequential sizing the canal should be carried out to the proper indicated depth according to selected stem size. The last size of Canal Sizer which passed through the isthmus is the ideal size. Attach the ideal size cement restrictor to the UCP Restrictor Inserter. Introduce the restrictor by tapping with hammer until indicating depth is achieved. Remove the inserter and leave the restrictor in place. Introduce Bone Cement Proper Irrigation, lavage and dry the femoral canal before introduce bone cement. The bone cement is introduced in low viscosity state. Cement is injected in a retrograde fashion to gradually fill the canal. 7

11 Implantation The size-matched UCP centralizer was packed together with UCP cement restrictor. Fit the centralizer with UCP stem, The centralizer can fit with all sizes of UCP stems. Use the Quick Connect Holder to firmly attach the UCP stem and advance it to the depth that is decided during trial reduction. The depth indicator on the stem should align with the mark on the Calcar bone and sit in line with the neck resection surface. Pressurize the stem into bone cement while removing excessive cement. Until cement is polymerized, disengage the quick connect holder from UCP stem. Femoral Head Impaction A final trial reduction may be performed if desired to re-evaluate stability and leg length by using the femoral head trials. After the appropriate femoral head size has been determined, place it onto the cleaned and dried taper with manual twist. Using the Femoral Head Impactor, engage the head with several gentle taps until it is firmly set. 8

12 Stem Specifications 130 Stem Length Metal Head Size Stem Length 28,32,36 mm Standard, # Standard, # Standard, # Standard, # Standard, # Standard, # High, # High, # High, # High, # High, # High, # Long stem, # Long stem, # Long stem, # Long stem, # BIOLOX delta BIOLOX delta Head Size *BIOLOX delta is the registry trademark of Ceramtec AG. 28 mm 32, 36, 40 mm 32 mm 36, 40 mm -2.5 mm +1 mm +4 mm -3 mm +1 mm +5 mm Stem Length Standard, # Standard, # Standard, # Standard, # Standard, # Standard, # High, # High, # High, # High, # High, # High, # Long stem, # Long stem, # Long stem, # Long stem, #

13 Special Order Items Order Information Standard Catalog No UCP stem, #0 UCP stem, #1 UCP stem, #2 UCP stem, #3 UCP stem, #4 UCP stem, #5 High Catalog No UCP stem, high offset, #0 UCP stem, high offset, #1 UCP stem, high offset, #2 UCP stem, high offset, #3 UCP stem, high offset, #4 UCP stem, high offset, #5 Long Stem Catalog No UCP stem, CCM, long stem, #2, 180mm UCP stem, CCM, long stem, #3, 180mm UCP stem, CCM, long stem, #3, 210mm UCP stem, CCM, long stem, #3, 230mm 10

14 Femoral Head Metal Head Catalog Number ø 28 mm ø 28 mm ø 28 mm ø 28 mm ø 28 mm ø 28 mm ø 32 mm ø 32 mm ø 32 mm ø 32 mm ø 32 mm ø 32 mm ø 36 mm ø 36 mm ø 36 mm ø 36 mm ø 36 mm ø 36 mm + 10 BIOLOX delta Ceramic Head Catalog Number ø 28 mm S ø 28 mm + 1 M ø 28 mm + 4 L ø 32 mm - 3 S ø 32 mm + 1 M ø 32 mm + 5 L ø 32 mm + 8 XL ø 36 mm - 3 S ø 36 mm + 1 M ø 36 mm + 5 L ø 36 mm + 9 XL ø 40 mm - 3 S ø 40 mm + 1 M ø 40 mm + 5 L ø 40 mm + 9 XL *BIOLOX delta is the registry trademark of Ceramtec AG. 11

15 Accessory Catalog No UCP Centralizer and Cement Restrictor, OD UCP Centralizer and Cement Restrictor, OD UCP Centralizer and Cement Restrictor, OD UCP Centralizer and Cement Restrictor, OD UCP Centralizer and Cement Restrictor, OD UCP Centralizer and Cement Restrictor, OD 18 12

16 Head Trial Metal Head Trial Catalog Number RB ø 28 mm RB ø 28 mm RB ø 28 mm RB ø 28 mm RB ø 28 mm RB ø 28 mm RB ø 32 mm RB ø 32 mm RB ø 32 mm RB ø 32 mm RB ø 32 mm RB ø 32 mm RB ø 36 mm RB ø 36 mm RB ø 36 mm RB ø 36 mm RB ø 36 mm RB ø 36 mm + 10 BIOLOX delta Ceramic Head Trial Catalog Number RB ø 28 mm S RB ø 28 mm + 1 M RB ø 28 mm + 4 L RB ø 32 mm - 3 S RB ø 32 mm + 1 M RB ø 32 mm + 5 L RB ø 32 mm + 8 XL RB ø 36 mm - 3 S RB ø 36 mm + 1 M RB ø 36 mm + 5 L RB ø 36 mm + 9 XL RB ø 40 mm - 3 S RB ø 40 mm + 1 M RB ø 40 mm + 5 L RB ø 40 mm + 9 XL 13 *BIOLOX delta is the registry trademark of Ceramtec AG.

17 Special Order Items Trials Catalog Number UCP StemTrial, 210 mm UCP StemTrial, 230 mm Instruments Catalog Number Femoral Head Extractor Catalog Number RA Femoral Head Remover Catalog Number Anteversion Handle Catalog Number Quick Connect Holder 14

18 Instruments Catalog Number Straight Broach Handle Catalog Number Femoral Cutting Chisel Catalog Number RA Femoral Head Impactor Catalog Number Universal Handle Catalog Number Caliper Catalog Number UCP Locater Pin Catalog Number Non-Ratcheting handle 15

19 Instruments Catalog Number UCP restrictor inserter Catalog Number UCP neck resection guide Catalog Number UCP start reamer Catalog Number UCP broach, # UCP broach, # UCP broach, # UCP broach, # UCP broach, # UCP broach, # UCP broach, #2, 180mm UCP broach, #3, 180mm Catalog Number UCP neck trial, standard UCP neck trial, high offset Catalog Number UCP canal sizer / reamer, 10 mm UCP canal sizer / reamer, 12 mm UCP canal sizer / reamer, 14 mm UCP canal sizer / reamer, 16 mm UCP canal sizer / reamer, 18 mm Catalog Number UCP stem case, # UCP stem case, #2 16

20 Safety Statement - UCP Stem System DESCRIPTION UNITED UCP Stem is intended to use in primary or revision hip arthroplasty. It is available in an array of styles and sizes to accommodate various hip surgical requirements. The UCP Stem is intended to be fixed only with the use of PMMA bone cement and should be used with centralizer and cement restrictor. UCP Stem may be used with UNITED metal or ceramic femoral heads except for Forte ceramic femoral heads. For total hip arthroplasty, UCP Stem may be used with UNITED acetabular liner and cup. For bipolar hip replacement, UCP Stem may be used with UNITED bipolar prosthesis. MATERIALS Forged Co-Cr-Mo Alloy ASTM F799 (Raw material: ASTM F1537/ ISO ) PMMA UHMWPE ASTM F648/ISO5834 Stem Centralizer Cement restrictor INDICATIONS 1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia. 2. Inflammatory degenerative joint disease such as rheumatoid arthritis. 3. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques. 4. Revision procedures where other treatments or devices have failed. 5. Patients suffering from disability due to previous fusion. 6. Patients with acute femoral neck fractures. This device is a single use implant and intended for cemented use only. CONTRAINDICATIONS 1. Any active or suspected latent infection in or about the hip joint. 2. Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care. 3. Bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis. 4. Obesity. An overweight or obese patient can produce loads on the prosthesis which can lead to failure of the fixation of the device or to failure of the device itself. 5. Patients who allergic to any material of the device. 6. Skeletal immaturity. POSSIBLE ADVERSE EFFECT 1. While the expected life of total hip replacement components is difficult to estimate, it is finite. These components are made of foreign materials placed within the body for the potential restoration of mobility or reduction of pain. However, due to the many biological, mechanical and physicochemical factors, which affect these devices but cannot be evaluated in vivo, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone. 2. Dislocation of the hip prosthesis can occur due to inappropriate patient activity, trauma or other biomechanical considerations. 3. Loosening of total hip components can occur. Early mechanical loosening may result from inadequate initial fixation, latent infection, premature loading of the prosthesis or trauma. Late loosening may result from trauma, infection, biological complications, including osteolysis, or mechanical problems, with the subsequent possibility of bone erosion and/or pain. 4. Fatigue fracture of femoral stems and/or fracture of ceramic heads occurred in a small percentage of cases. Stem/head fracture is more likely to occur in the heavy, physically active individual or when contralateral joint disability results in a disproportionate distribution of weight on the reconstructed joint. 5. Peripheral neuropathies, nerve damage, circulatory compromise and heterotopic bone formation may occur. 6. Serious complications may be associated with any total joint replacement surgery. These complications include, but are not limited to: genitourinary disorders; gastrointestinal disorders; vascular disorders, including thrombus; bronchopulmonary disorders, including emboli; myocardial infarction or death. 7. Intraoperative fissure, fracture, or perforation of the femur, acetabulum or trochanter can occur due to impaction of the component into the prepared femoral canal or acetabulum. Postoperative femoral or acetabular fracture can occur due to trauma, the presence of defects, or poor bone stock. 8. With all implant devices, asymptomatic, localized progressive bone resorption (osteolysis) may occur around the prosthetic components as a consequence of foreign-body reaction to the particulate matter of cement, metal and/or ceramic. Particulate is generated by interaction between components, as well as between components and bone, primarily through wear mechanisms of adhesion, abrasion and fatigue. Secondarily, particulate can also be generated by third-body wear. Osteolysis can lead to future complications, including loosening, necessitating the removal and replacement of prosthetic components. 9. Adverse effects may necessitate reoperation, revision, arthrodesis of the involved joint, Girdlestone and/or amputation of the limb. 10. Metal sensitivity reactions have been reported following joint replacement 11. Infections that include acute post-operative wound infection and later on deep wound sepsis. 12. Trochanteric nonunion, it usually associates with early weight bearing or improper fixation of the trochanter, when a transtrochanteric surgical approach is used. 13. Dislocations, subluxation, decreased range of motion, or lengthening or shortening of the femur caused by improper neck selection. 17

21 WARNINGS 1. This device should only be applied by qualified and specially trained surgeons who have the corresponding knowledge and experience in the field of hip joint replacement. The surgeon should thoroughly understand all aspects of the surgical procedure and limitations of the device. 2. Factors outside the control of UOC are not UOC s responsibility, including any modification after delivering to the hospitals and any mishandled pre-operation, intra-operation or post-operation. The operating surgeon shall be responsible for any negative effects and complications resulting from non-compliance with the user instructions, improper treatment of the material or an incorrect assessment of indications. 3. If the product does not meet the specifications, please immediately notify the supplier, and dilate the problems that occur. If possible, please return the product to the supplier. 4. Surgeon must inform the patient about the relative information of this device, including its effects and the possible risks during operation, possible post-surgical complications, as well as inspect the materials biocompatibility of the products used with this device. 5. Discard all damaged or mishandled implants. 6. Never reuse an implant, even though it may appear undamaged. Reuse of this product will cause the risk of cross infection and unpredictable health threat. 7. Bearing areas must always be clean and free of debris prior to assembly. 8. At time of assembly, machined taper surfaces must be clean and dry to ensure proper seating and assembly security. 9. Improper seating of the head may result in a discrepancy in neck length, component disassociation and/or dislocation. 10. UCP stem must be used with centralizer to ensure the designated function. 11. Contouring or bending of an implant may reduce its fatigue strength and cause failure under load. 12. Intra-operative preparation and implantation of a femoral stem component can result in cracks of the proximal femur. The application of prophylactic cerclage wiring to the proximal femur may aid in the prevention of femoral cracks, crack propagation or their displacement 13. Care should be taken not to cut through surgical gloves when handling any sharp-edged orthopedic device. 14. UOC strongly advises against the use of another manufacturer's tapered head, centralizer or acetabular component with any UOC femoral stem component. Any such use will negate the responsibility of UOC for the performance of the resulting mixed component implant. 15. Return all packages with flaws in the sterile barrier to the supplier. Do not resterilize. PRECAUTIONS PREOPERATIVE 1. Care must be taken to protect the components from being marred, nicked or notched as a result of contact with metal or abrasive objects. 2. Multiple sizes of implants should be prepared for surgery, including larger and smaller size. Preparation of special size implants also recommended. 3. Before clinical use, the surgeon should thoroughly understand all aspects of the surgical procedure and limitations of the device. 4. Screening should be considered for patients who are allergic to the material of implants. 5. Radiographic templates are available to assist in the preoperative prediction of component size and style. 6. Patients should be instructed in the limitations of the prosthesis, including, but not limited to, the impact of excessive loading through patient weight or activity, and be taught to govern their activities accordingly. If the patient is involved in an occupation or activity, which includes substantial walking, running, lifting, or muscle strain, the resultant forces can cause failure of the fixation, the device, or both. The prosthesis will not restore function to the level expected with normal healthy bone, and the patient should not have unrealistic functional expectations. 7. To inspect the red dot on package to make sure the product has been properly sterilized. 8. To check the label information, especially the size designation, is consistent with the device. INTRAOPERATIVE 1. The recommended trial components should be used for size determination, canal preparation evaluation, trial reduction and range of motion evaluation, thus preserving the integrity of the actual implants and their sterile packaging. 2. Appropriate selection, placement and fixation of the femoral stem and/or acetabular components are critical factors which affect implant service life. As in the case of all prosthetic implants, the durability of these components is affected by biologic, biomechanical and other extrinsic factors, which limit their service life. Accordingly, strict adherence to the indications, contraindications, precautions and warnings for this product is essential to potentially maximize service life. 3. Care must be taken to prevent paralytic sciatica for developmental dysplasia of the hip. Extra small femoral implants are usually required to fit its small and straight femur bone. 4. Demand of surgical skill is higher for the revision surgery. Long operation time will increase blood loss, chance of pulmonary embolism and wound hematoma. Common mistakes include improper exposure of femur bone, improper fixation of implant and inadequate removal of osteophyte. 5. For the revision surgery, the fixation of the original implant and cement should be carefully checked. When necessary replacement of the original implant should be considered. 6. Prevent surface of metal implant being marred. The implant cannot be reused in any condition because invisible change of stress inside implant may lead to deformation or fracture of the implant. 18

22 7. Before wound closure, any bone fragment or bone cement should be removed from surgical site. Heterotopic bone, bone spurs or bone fragment may cause pain or limitation of activity for patients. 8. For patients who have rheumatoid arthritis and rely on steroid, prevention of penetration of femur bone or greater trochanter duo to osteoporosis is important. 9. The UOC Surgical Protocols provide additional procedural information. POSTOPERATIVE 1. It is very important for patients to receive care and instruction from surgeon postoperatively. Postoperative weight bearing should be gradually and should provide individual plan for each individual patient. 2. Reminding patient to prevent activities of large range of motion in hip joint (such as go to the toilet) independently. 3. When move the patient, it is important to provide support with the surgical site and prevent adding pressure on it. 4. Restoring muscle strength around hip joint and increase level of activity gradually. 5. Periodically X- ray examination to ensure the fixation of the implant and bone cement, and bone quality. 6. Usage of antibiotic should be considered to prevent infection. PACKAGING AND LABELING All implants should be accepted only if received by the hospital or surgeon with the factory packaging and labeling intact. STERILIZATION 1. All components have been sterilized by gamma radiation. 2. The packaging of all sterile products should be inspected for flaws in the sterile barrier before opening. In the presence of such a flaw, the product must be assumed nonsterile. Special trial prostheses are available to avoid having to open any aspect of the sterile package prior to component use. 3. Care should be taken to prevent contamination of the component. In the event of contamination, this product must be discarded. IMPORTANT FOR OPENED COMPONENTS If the package is opened, but the product is not used, the component must be discarded or returned to the supplier. SAFETY INFORMATION IN THE MAGNETIC RESONANCE (MR) ENVIRONMENT The UTF Stem has not been evaluated for safety and compatibility in the MR environment. The UTF Stem has not been tested for heating or migration in the MR environment INFORMATION For further information, please contact United Orthopedic Corporation No. 57, Park Ave. 2, Science Park, Hsinchu, 300, Taiwan. TEL: FAX: service@uoc.com.tw 19

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24 Office Taiwan 12F, No. 80, Sec. 1, Chenggong Rd, Yonghe Dist., New Taipei City 23452, Taiwan Tel: Fax: USA UOC USA Inc. 20 Fairbanks, Suite 173 Irvine, CA Tel: Fax: EU Representative mdi Europa GmbH Langenhagener Strasse 71, Langenhagen, Germany Tel: Fax: China United Medical Instrument Co. Ltd. 7F, No.1405, GongheXin Road, Shanghai, China Tel: Fax: All Rights Reserved, 2015 United Orthopedic Corp. 01PC-S-15-01