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1、CORAIL SYSTEM,1,强生狂关节置换与假体设计,CORAIL SYSTEM DESIGNERSARTRO GROUP FOUNTED IN 1981,2,强生狂关节置换与假体设计,1984 TITAN stem launched钛合金柄上市 1985 Clinical trails of TITAN / HA临床试验 1986 1st implantation of the CORAIL stem 第一个假体柄植入体内 1996 FDA approval FDA 通过 2005 Corail AMT,HISTORICAL RECORD历史回顾,3,强生狂关节置换与假体设计,CORAI
2、L DESIGN PRINCIPL设计原理,SURFACE TREATMENT 表面处理 RANGE OF IMPLANTS 假体尺寸 SURGICAL TECHNIQUE 外科技术 CLINICAL RESULTS 临床结果,4,强生狂关节置换与假体设计,RELIABLE PRIMARY STABILITY 可靠的初始稳定性 LONG TERM BIOLOGICAL FIXATION 长期的生物固定 PROXIMAL LOAD TRANSFER 近端负荷传导,CORAIL DESIGN PRINCIPLES设计原理,5,强生狂关节置换与假体设计,CORAIL DESIGN PRINCIPLE
3、S设计原理,6,强生狂关节置换与假体设计,FEMORAL HEADS 股骨头 Alumina (Biolox Forte)氧化铝 Tribological properties摩擦学属性 Compatible with alumina or cobalt chrome liners 与氧化铝或钴铬内衬匹配,CORAIL DESIGN PRINCIPLES设计原理,7,强生狂关节置换与假体设计,Straight stem 直柄 Thin distal tip 远端较细,CORAIL DESIGN PRINCIPLES设计原理,8,强生狂关节置换与假体设计,135 neck angle 颈干角 1
4、2/14 Morse taper锥度 Progressive offset 偏心距逐渐扩大,CORAIL DESIGN PRINCIPLES设计原理,9,强生狂关节置换与假体设计,四边形横截面 轴向及旋转稳定性,CORAIL DESIGN PRINCIPLES设计原理,10,强生狂关节置换与假体设计,Double taper geometry gives stero-stability 双锥度设计提供 立体稳定性,CORAIL DESIGN PRINCIPLES设计原理,11,强生狂关节置换与假体设计,Progressive horizontal macrostructure on the p
5、roximal stem 柄的近端逐渐扩大的横行结构,CORAIL DESIGN PRINCIPLES设计原理,12,强生狂关节置换与假体设计,Horizontal proximal macrostructure 近端横行结构 Size 9 = 11 grooves沟 Size 20 = 21 grooves沟,CORAIL DESIGN PRINCIPLES设计原理,13,强生狂关节置换与假体设计,Vertical distal macrostructre 远端垂直结构,CORAIL DESIGN PRINCIPLES设计原理,14,强生狂关节置换与假体设计,Optional collar
6、for calcar loading 股骨距负荷-带领,不带领,CORAIL DESIGN PRINCIPLES设计原理,15,强生狂关节置换与假体设计,HYDROXYAPATITE Bioactive coating 生物活性涂层,CORAIL DESIGN PRINCIPLES设计原理,16,强生狂关节置换与假体设计,BONE COMPOSITION骨组成,ORGANIC PHASE 有机期 30% collagen胶元, specific proteins特殊蛋白质 MINERAL PHASE 矿物质期 60% carbonated apatite 碳酸磷灰石 WATER 水 10,17
7、,强生狂关节置换与假体设计,HYDROXYAPATITE羟基磷灰石,Chemical Formula化学分子式 Ca10 (PO4)6 (OH)2 Similar to the mineral phase of human bone 与人类骨的矿物质期相似 Biocompatible, non resorbable 生物相容,不可吸收 Osteo-conductive properties 骨传导性,18,强生狂关节置换与假体设计,NON TOXIC无毒 NON INFLAMMATORY不引起炎症反应 NON ALLERGIC无过敏反应 NON CARCINOGENIC 不引起癌症,HYDRO
8、XYAPATITE,19,强生狂关节置换与假体设计,Coating thickness涂层厚度 = 150m Coatings 200m risk of delamination 脱层的危险,HYDROXYAPATITE,20,强生狂关节置换与假体设计,ADVANTAGES优点 Increased bone ingrowth 增加骨内生 No fibrous tissue interposition 无纤维组织插入 Gap filling 孔隙充填,HYDROXYAPATITE,21,强生狂关节置换与假体设计,New bone formation 新骨形成 HA coating HA涂层 Me
9、tal 金属,HYDROXYAPATITE,NO FIBROUS TISSUE INTERPOSITION 无纤维组织插入,22,强生狂关节置换与假体设计,HYDROXYAPATITE,Why is Corail fully coated ? 为何全涂层? Long term stability长期的稳定性 Biological seal against wear debris生物性封闭,以抵抗磨屑 No distal granulomas 没有远端肉芽肿,23,强生狂关节置换与假体设计,LONG TERM STABILITY长期稳定性“The complete absence of femo
10、ral endosteal cortical osteolysis in spite of the abundance of particles is reassuring. The explanation may be that the extensive HA coating of the stem seals the whole interface and blocks the passage of particles.” 虽然有大量的磨损颗粒,但没有股骨骨内膜的皮质骨溶解。原因可能是广泛的HA涂层封闭了所有的交界面阻止了微粒的通道。 Rokkum et al JBJS Vol 81B,
11、 1999,HYDROXYAPATITE,24,强生狂关节置换与假体设计,Prevention of thigh pain大腿痛的防止 No fibrous tissue distally远端没有纤维组织 No distal micromotion没有远端微动 Minimise thigh pain 最小化大腿痛New bone formation,HYDROXYAPATITE,25,强生狂关节置换与假体设计,From Corail to Corail AMT,26,强生狂关节置换与假体设计,Articul / eze Mini Taper: AMT,Thinner neck更薄的颈部设计 =
12、 Improved range of motion 更大的活动度,27,强生狂关节置换与假体设计,Polished taper 抛光的锥部 Better resistance to PE wear 减少PE磨损,Articul / eze Mini Taper: AMT,28,强生狂关节置换与假体设计,Mini taper短小的锥部 12/14 Improved range of motion 更大的ROM No skirt effect无假裙现象,Articul / eze Mini Taper: AMT,29,强生狂关节置换与假体设计,Thinner neck更薄的颈部设计 Ellipti
13、co-trapezoidal shape 2 flat surfaces Frontal (向位): 12 mm Sagittal (矢向位): 9.15 mm,Articul / eze Mini Taper: AMT,30,强生狂关节置换与假体设计,New impaction hole新打入孔,Articul / eze Mini Taper: AMT,31,强生狂关节置换与假体设计,Standard range,KS Available sizes: (new) 8; 9; 10; 11; 12; 13; 14; 15; 16; 18; 20 Without collar outside
14、 of France NSA: 135 Indications: Primary THR; Revision stage 1 and 2,32,强生狂关节置换与假体设计,Articul / eze Heads,Cobalt chrome-22.225 mm: +4medium +7 long,33,强生狂关节置换与假体设计,Cobalt chrome: 28 mm:+1.5short neck +5medium (standard) +8.5long +12extra long,Articul / eze Heads,34,强生狂关节置换与假体设计,Articul / eze Range,Ce
15、ramic: 28 mm, 36mm:+1.5 short neck +5 medium (Standard) +8.5 long 32 mm:+1short neck+5 medium (Standard)+9long,35,强生狂关节置换与假体设计,97.7% Survivorship at 10 years 89% of patients without thigh pain (大腿痛) 0.8% stress shielding Gr. III 应力遮挡 JP Vidalain and the Artro Group International Corail Conference, 1
16、998,CORAIL Clinical results,36,强生狂关节置换与假体设计,100% Survivorship in 100 cases after 5 years 0 % Thigh pain大腿痛 0 % Stress shielding应力遮挡 0 % migration移动 Rokkum et al Journal of Arthroplasty Vol.14, 1999,CORAIL Clinical results,37,强生狂关节置换与假体设计,NORWEGIAN HIP REGISTER 99.5% Survivorship in 1117 cases at 4.5
17、 years Havelin L et al JBJS Vol. 77-B, 1995,CORAIL Clinical results,38,强生狂关节置换与假体设计,IN PATIENTS UNDER 50 years 99.1% Survivorship in 119 cases after 10 years Vidalain JP et al European Hip Society, 1998,CORAIL Clinical results,39,强生狂关节置换与假体设计,IN PATIENTS UNDER 55 years 94.4% Survivorship in 1039 cas
18、es after 6 years Havelin L et al JBJS Vol.79-B, 1997,CORAIL Clinical results,40,强生狂关节置换与假体设计,95.1% Survivorship in 5,130 cases at 15 yearsThe Norwegian Arthroplasty Register,1987-2004, 2005,迄今为止最成功生物型股骨假体,Clinical Heritage Documented,41,强生狂关节置换与假体设计,FEATURE QUADI-LATERAL CROSS SECTION 横截面四边形,BENEFIT
19、 ACCURATE ROTATIONAL STABILITY 精确的旋转稳定性,CORAIL,42,强生狂关节置换与假体设计,FEATURE MACROSTRUCTURE (横行,纵行)结构,BENEFIT INCREASE THE SURFACE FOR BONE / IMPLANT CONTACT BY 15 % 增加骨与假体接触面积15,CORAIL,43,强生狂关节置换与假体设计,FEATURE HORIZONTAL MACROSTRUCTURE 横行结构 PROGRESSIVE 逐渐增大,BENEFIT TO PREVENT STEMSUBSIDENCE 避免假体下沉 TO OPTI
20、MISE PROXIMAL LOAD TRANSFER 优化近端负荷传导,CORAIL,44,强生狂关节置换与假体设计,FEATURE VERTICAL MACROSTRUCTURE 纵行结构,BENEFIT TO IMPROVE ROTATIONAL STABILITY 改善旋转稳定性,CORAIL,45,强生狂关节置换与假体设计,FEATURE HYDROXYAPATITE COATING HA涂层,BENEFIT GREATER SHEAR STRENGTH OF IMPLANT 假体的剪力增大 INCREASED BONE ONGROWTH 增加骨表面增长,CORAIL,46,强生狂关
21、节置换与假体设计,FEATURE HYDROXYAPATITE COATING HA涂层,BENEFIT NO FIBROUS TISSUE INTERPOSITION 没有纤维组织插入 GAP FILLING 空隙封闭,CORAIL,47,强生狂关节置换与假体设计,FEATURE FULL HA COATING 完全的HA涂层,BENEFIT NO THIGH PAIN 没有大腿痛 BARRIER TO THE INGRESS OF WEAR DEBRIS 阻止磨屑进入,CORAIL,48,强生狂关节置换与假体设计,FEATURE 21 YEAR EXPERIENCE 21年经验,BENEF
22、IT OVER 130,000 IMPLANTATIONS 假体植入 CLINICAL RESULTS,CORAIL,49,强生狂关节置换与假体设计,FEATURE SURGICAL TECHNIQUE 外科技术,BENEFIT EASY & REPRODUCIBLE 容易,可重复性强 NO CONTRA-INDICATIONS 没有禁忌症,CORAIL,50,强生狂关节置换与假体设计,CORAIL - Positioning 产品定位,Key selling points宣传要点 Superior Design 上乘的设计 Proximal Loading and Fully HA Coat
23、ed近端负重及HA全涂层 21 Years of Clinical Heritage21年的临床验证 130 000 implantations Easy Surgical Technique手术技术简单 Stems for all surgeons 满足各种需求 Perfect fit for MI适合于MI手术,51,强生狂关节置换与假体设计,Simple and comprehensive instrumentation 简单易操作的工具,CORAIL Surgical technique,52,强生狂关节置换与假体设计,Simple procedure简单的手术步骤 One step
24、broaching (non agressive)一步扩髓腔(不锋利) No prior reaming of the canal不先进行扩髓 Preserving cancellous bone保护松质骨 Living bony mantle respected and compacted 有活力的松质骨得到重视并压实,CORAIL Surgical technique,53,强生狂关节置换与假体设计,STEP 1 Neck resection at 45 45度颈部截骨 Level determined during preop planning 术前计划决定截骨水平,CORAIL Sur
25、gical technique,54,强生狂关节置换与假体设计,STEP 2 Proximal compaction before broaching 锉髓腔前近端松质骨压实 No distal reaming 远端不扩髓 Cancellous bone is preserved 保护松质骨,CORAIL Surgical technique,55,强生狂关节置换与假体设计,Canal Finder股骨探髓,Canal probe establish a direct pathway to the medullary canal 髓腔探棒找到正确髓腔位置,靠后外侧,紧贴梨状窝进入,找到正确髓腔
26、位置,中立位进入,避免内翻,56,强生狂关节置换与假体设计,STEP 3 Progressive broaching until complete stability is achieved 进行性扩髓直到获得完全的稳定性,CORAIL Surgical technique,57,强生狂关节置换与假体设计,STEP 4 Calcar milling 锉平台,CORAIL Surgical technique,58,强生狂关节置换与假体设计,STEP 5 Trial reduction with trial neck segment 试模颈进行试模复位,CORAIL Surgical techn
27、ique,59,强生狂关节置换与假体设计,STEP 6 Definitive implant insertion 确定的假体插入,CORAIL Surgical technique,60,强生狂关节置换与假体设计,STEP 7 Proximal bone compaction in the remaining gaps to establish a complete seal between implant & cortex 残留间隙处近端骨压实以建立完全的假体与皮质骨的空隙封闭,CORAIL Surgical technique,61,强生狂关节置换与假体设计,STEP 8 Femoral
28、head impaction 股骨头打入,CORAIL Surgical technique,62,强生狂关节置换与假体设计,Anteversion 前倾,Anteversion by first broach control 前倾角由第一把髓腔锉来控制,髓腔锉尽量靠后靠外,避免假体内翻,63,强生狂关节置换与假体设计,Getting The Correct Implant Size获得正确的假体尺寸,When the last broach is rotationally stable 当最后的锉在旋转时取得稳定时,建议最后锉打击至截骨面下12mm,64,强生狂关节置换与假体设计,Avoid early impaction 避免过早的打压,Corail Insertion 假体植入,65,强生狂关节置换与假体设计,Corail In
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