下载文档原格式
人工膝关节置换术手术步骤人工膝关节置换手术假体类型：初次保留交叉韧带型(PRIMARY CRUCIATE-RETAINING TKR)设计上，带有后唇衬垫可用于PCL功能正常的情况。
PCL紧张时，需行松解。
初次交叉韧带加强型(PRIMARY CRUCIATE-SUPPTEMENTING TKR)使用曲线型衬垫可加大接触面，加强功能上过度松弛的PCL，适应较大的匹配性。
初次交叉韧带替代型(PRIMARY CRUCIATE-SUBSTITUTING TKR)在胫骨衬垫中央加入一个聚乙烯突起，可充当已不存在的PCL作用。
相应的股骨假体使用前后向切骨及斜面切骨，与PCL保留型假体相同，在准备女子的植入点不行翻修术时，允许改变。
全膝关节置换翻修假体(REVISION TKR)胫骨衬垫的几何形状考虑到在翻修和复杂的初次置换时，替代PCL和MCL，选择统一型式的胫骨、股骨干、衬垫，实际上是为翻修留有余地。
该系统提供三种级别限制，满足各种翻修需要：稳定型、限制型或TC3型。
RICHARD D．SCOTT,M．D．SCOTT,M．D．THOMAS S．THORNHILL,M．D．CHITRANJANS．RANAWAT,M．D．AssociatcClinical Professor of Orthopuedic Surgery，Harvard Chairman,Deparlhment of OrthopaedK Surgery, Clinical Professor of Orthopaedic Surgery Medical School Harvard Medical School Cornell Medical CollegeOrthopacdic Surgeon,Ncw England Baptist Orhupacdic Surgeon，New England Baptist Dirtctor, Orthopaedic SurgeryHospital and Brigham and Women’s Hospital Hospital center for Total Joint ReplacementBoston, Massachusetts Boston, Massachusctts Lenox Hill HospitalNew Y ork, New York术前计划(PREOPERATIVE PLANNING)拍全长下肢x线片，确定力学及解剖轴。
通过同品种医疗器械临床试验或临床使用获得的数据进行的分析评价报告- GKS prime系列假体- 1 -目录1同品种医疗器械判定.......................................................................................................... - 4 -1.1申报产品概述 ............................................................................................................ - 8 -1.1.1基本原理 .......................................................................................................... - 8 -1.1.2 结构组成 ......................................................................................................... - 9 -1.1.3主要原材料 .................................................................................................... - 15 -1.1.4 主要生产工艺 ............................................................................................... - 15 -1.1.5适用范围 ........................................................................................................ - 16 -1.1.6、使用方法 ..................................................................................................... - 16 -1.2同品种产品的概述 .................................................................................................. - 17 -2评价路径............................................................................................................................ - 23 -3分析评价............................................................................................................................ - 24 -3.1非临床研究资料 ....................................................................................................... - 24 -3.1.1研究概述- 24 -3.1.2同类型产品概述 ............................................................................................ - 31 -3.2非临床研究报告-与同品种产品差异性能分析..................................................... - 32 -3.2.1金属胫骨托部件循环疲劳试验 .................................................................... - 34 -3.2.2GKS Prime Flex CR胫骨垫片的耐久性和变形性的ASTM F2777测试... - 34 -3.2.3胫骨与股骨头之间的接触压力与面积 ........................................................ - 35 -3.2.4GKS Prime Flex活动平台胫骨衬垫接触压力最差状况的分析和磨损性能验证 .................................................................................................. - 38 -3.2.5小结 .......................................................................................................... - 40 -3.3申报产品临床文献和数据收集分析资料 .............................................................. - 41 -3.3.1资料搜集方法 ................................................................................................ - 41 -3.3.2数据 .......................................................................................................... - 42 -3.3.3效果 .......................................................................................................... - 45 -3.4关节登记机构的数据 .............................................................................................. - 48 -3.4.1GKS PRIME 假体.......................................................................................... - 48 -3.4.2GKS PRIME Flex系列膝关节假体............................................................... - 54 -3.5总结 .......................................................................................................................... - 63 -3.6参考文献 .................................................................................................................. - 64 -4同品种医疗器械临床文献和/或经验数据分析............................................................... - 70 -4.1Pubmed数据库临床数据筛选................................................................................. - 73 -4.1.1与GKS prime Flex拥有类似特征的假体的固定方法有关科学文献中看到的临床效果 .................................................................................. - 73 -4.1.2与GKS PRIME假体类似的活动板假体在科学出版物中的临床效果..... - 75 -4.1.3固定支座人工全膝+十字韧带保留型........................................................ - 76 -4.1.4本产品同类型固定轴承全膝关节的存活率和临床效果 ............................ - 80 -4.1.5插入物的磨损 ................................................................................................ - 84 -4.2中国知网数据库临床数据筛选 .............................................................................. - 86 -5结论.................................................................................................................................... - 89 -参考文献............................................................................................................................... - 91 -文献检索和筛选方案........................................................................................................... - 93 -文献检索和筛选报告........................................................................................................... - 97 -1同品种医疗器械判定近年来，随着老龄化人口的增加和人们日常活动的增加等诸多因素的影响，在膝关节假体的置换数量在逐年的增加。
IconixIconix features Intellibraid Technology which creates a bunching effect using targeted compression zones within the implant sheath for optimal fixation.NanoTack TTAt 1.4mm, the NanoTackTT, is the smallest PEEK hard body anchor on the market.* The NanoTack TT is designed toexpand upon anchor deployment and offers two points of fixation.Shared instrumentationStryker’s 1.4mm instability anchor platform features the Iconix all-suture anchor and the NanoTack TT PEEK hard body suture anchor. The platform offers intraoperative key advantages by using a shared instrumentation set including straight, 12, 25 degree guides as well as a shared drill.This compatibility across the platform offers the surgeon versatility to intraoperatively select the anchor best suited for the patient and the repair while maintaining a very small footprint to preserve glenoid bone.The 1.4mm Iconix all suture anchor, featuring XBraid Tieable Tape, is impacted into the bone until the inserter The drill hole is prepared using a 1.4mm drill. The Iconix drill features self-centering technology which is designed to maintain the angle of the curvedguides while also mitigating the creation of metal shavings during drilling.1.4mm Instability Anchor PlatformSuture tails are uncleated and released and the inserter shaft is removed from the guide. Pull slowly and uniformly on the suture tails to deploy and set the Iconix anchor.Without SC technology With SC technologySTEP 1STEP 3STEP 2STEP 4One tail of the XBraid TT is retrieved out of the superior anterior portal. Using a Champion Slider, pass the XBraid TT through the capsule and labrum to restore a stable bumper effect and appropriate tension to the capsulolabral complex.The nitinol wire is retrieved through the superior anterior portal.STEP 5STEP 6Instabilitysurgical procedure Instabilitysurgical procedureThe XBraid TT is passed through the capsulolabral complex in a horizontal mattress pattern which may enable the surgeon to restore the tension anatomically while keeping the knot stack away from the chondral surface.Intraoperative versatilityThe 1.4 instability platform utilizes shared instrumentation between two implants which allows the surgeon intra operative versatility between an all suture anchor or a PEEK hard body anchor based on bone assessment.Following the preparation of the 1.4mm bone tunnel the Nanotack TT is malleted into the bone. The anchor isdeployed by pulling up on the two red tabs which deploys a proprietary distal soft eyelet to expand the anchor. Sutures are uncleated and the shaft is removed.STEP 9STEP 10The suture is threaded through the loop which is retracted and shuttled through the tissue.The XBraid TT is tied and the knot is carefully slid onto the neck of the glenoid on the outside or anterior aspect of the capsulolabral complex. The tails are cut using a Big Dog suture cutter, ensuring a tail remains.Note: XBraid TT is a tie-able tape with comparable knot stacks to a #2 suture. The custom braid is designed to not fold under tension.2STEP 7STEP 8The final anchor is placed in a horizontal mattress fashion to restore the anatomic position of the labrum.Instabilityordering information Champion Shoulder InstrumentsPart number234102102Big Dog Flush Suture Cutter 3910500729391050072439105007253910500730Knot Manipulator Full Loop 3910500738Penetrating Grasper 30 DegreePenetrating Grasper 45 Degree Description DescriptionIconix 1.4mm disposable drillIconix 1.4mm reusable drillIconix 12° guide for 1.4mm anchorSports MedicineThis document is intended solely for the use of healthcare professionals. A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. We do not dispense medical advice and recommend that surgeons be trained in the use of any particular product before using it in surgery.The information presented is intended to demonstrate Stryker’s products. A surgeon must always refer to the package insert, product label and/ or instructions for use, including the instructions for cleaning and sterilization (if applicable), before using any of Stryker’s products. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets.Please contact your representative if you have questions about the availability of Stryker’s products in your area.Stryker or its affiliated entities own, use, or have applied for the following trademarks or service marks: Iconix, NanoTack TT, Dri-Lok, Champion SlingShot, XBraid and Stryker. All other trademarks are trademarks of their respective owners or holders.The absence of a product, feature, or service name, or logo from this list does not constitute a waiver of Stryker’s trademark or other intellectual property rights concerning that name or logo.1000903516 Rev BCopyright © 2020 Stryker Stryker Sports Medicine5670 Greenwood Plaza Blvd, Ste 200 Greenwood Village, CO 80111 USA t: 866 596 2022References1. DHD140242. Test Report: DHFD12758。
