1、CORAIL SYSTEM CORAIL SYSTEM DESIGNERSARTRO GROUP FOUNTED IN 1981 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 AMTHISTORICAL RECORD历史回顾CORAIL DESIGN PRINCIPL设计原理SURFACE TREATMENT表面处理RANGE O
2、F IMPLANTS假体尺寸SURGICAL TECHNIQUE外科技术CLINICAL RESULTS临床结果 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CORAIL DESIGN PRINCIPLES设计原理FEMORAL HEADS 股骨头Alumina(Biolox Forte)氧化铝Tribological properties摩擦学属性Compatible with
3、 alumina or cobalt chrome liners 与氧化铝或钴铬内衬匹配CORAIL DESIGN PRINCIPLES设计原理Straight stem直柄Thin distal tip远端较细CORAIL DESIGN PRINCIPLES设计原理135 neck angle 颈干角12/14 Morse taper锥度Progressive offset 偏心距逐渐扩大CORAIL DESIGN PRINCIPLES设计原理 四边形横截面 轴向及旋转稳定性CORAIL DESIGN PRINCIPLES设计原理Double taper geometry gives ste
4、ro-stability 双锥度设计提供 立体稳定性CORAIL DESIGN PRINCIPLES设计原理Progressive horizontal macrostructure on the proximal stem柄的近端逐渐扩大的横行结构CORAIL DESIGN PRINCIPLES设计原理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Vertical distal macrostructre 远端垂直结构COR
5、AIL DESIGN PRINCIPLES设计原理 Optional collar for calcar loading 股骨距负荷-带领，不带领CORAIL DESIGN PRINCIPLES设计原理HYDROXYAPATITE Bioactive coating 生物活性涂层CORAIL DESIGN PRINCIPLES设计原理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
6、%HYDROXYAPATITE羟基磷灰石Chemical Formula化学分子式 Ca10(PO4)6(OH)2Similar 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 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HYDROXYAPATITE Coating thickness涂层厚度 =150m C
7、oatings 200mrisk of delamination 脱层的危险HYDROXYAPATITEADVANTAGES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 New bone formation 新骨形成 HA coating HA涂层 Metal 金属HYDROXYAPATITENO FIBROUS TISSUE INTERPOSITION 无纤维组织插入HYDROXYAPATITE Why is Corail full
8、y 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LONG TERM STABILITY长期稳定性“The complete absence of femoral endosteal cortical osteolysis in spite of the abundance of particles is reassuring.The explanation may be that the extensive HA
9、 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,1999HYDROXYAPATITEPrevention 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
10、腿痛New bone formationHYDROXYAPATITEFrom Corail to Corail AMTArticul/eze Mini Taper:AMTThinner neck更薄的颈部设计=Improved range of motion更大的活动度 Polished taper 抛光的锥部 Better resistance to PE wear 减少PE磨损Articul/eze Mini Taper:AMT AMT taperOld taperMini taper短小的锥部 12/14 Improved range of motion 更大的ROM No skirt
11、effect无假裙现象Articul/eze Mini Taper:AMTThinner neck更薄的颈部设计 Elliptico-trapezoidal shape 2 flat surfaces Frontal(向位):12 mm Sagittal(矢向位):9.15 mmArticul/eze Mini Taper:AMT New impaction hole新打入孔Articul/eze Mini Taper:AMTStandard range:KS Available sizes:(new)8;9;10;11;12;13;14;15;16;18;20 Without collar
12、outside of France NSA:135 Indications:Primary THR;Revision stage 1 and 2Articul/eze HeadsCobalt chrome-22.225 mm:+4medium+7 longCobalt chrome:28 mm:+1.5 short neck+5medium(standard)+8.5 long+12 extra long Articul/eze HeadsArticul/eze RangeCeramic:28 mm,36mm:+1.5 short neck +5 medium(Standard)+8.5 lo
13、ng 32 mm:+1short neck+5 medium(Standard)+9long97.7%Survivorship at 10 years89%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,1998CORAIL Clinical results100%Survivorship in 100 cases after 5 years0%Thigh pain大腿痛0%Stres
14、s shielding应力遮挡0%migration移动Rokkum et al Journal of Arthroplasty Vol.14,1999 CORAIL Clinical resultsNORWEGIAN HIP REGISTER 99.5%Survivorship in 1117 cases at 4.5 years Havelin L et al JBJS Vol.77-B,1995CORAIL Clinical resultsIN PATIENTS UNDER 50 years 99.1%Survivorship in 119 cases after 10 yearsVid
15、alain JP et al European Hip Society,1998CORAIL Clinical resultsIN PATIENTS UNDER 55 years 94.4%Survivorship in 1039 cases after 6 yearsHavelin L et al JBJS Vol.79-B,1997CORAIL Clinical results95.1%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
16、体Clinical Heritage DocumentedFEATUREQUADI-LATERAL CROSS SECTION 横截面四边形BENEFITACCURATE ROTATIONAL STABILITY 精确的旋转稳定性CORAIL FEATUREMACROSTRUCTURE（横行，纵行）结构BENEFITINCREASE THE SURFACE FOR BONE/IMPLANT CONTACT BY 15%增加骨与假体接触面积15%CORAIL FEATUREHORIZONTAL MACROSTRUCTURE 横行结构PROGRESSIVE逐渐增大BENEFITTO PREVENT
17、 STEMSUBSIDENCE避免假体下沉TO OPTIMISE PROXIMAL LOAD TRANSFER优化近端负荷传导CORAIL FEATUREVERTICAL MACROSTRUCTURE 纵行结构BENEFITTO IMPROVE ROTATIONAL STABILITY 改善旋转稳定性CORAIL FEATUREHYDROXYAPATITE COATING HA涂层BENEFITGREATER SHEAR STRENGTH OF IMPLANT假体的剪力增大INCREASED BONE ONGROWTH增加骨表面增长CORAIL FEATUREHYDROXYAPATITE CO
18、ATING HA涂层BENEFITNO FIBROUS TISSUE INTERPOSITION没有纤维组织插入GAP FILLING空隙封闭CORAIL FEATUREFULL HA COATING完全的HA涂层BENEFITNO THIGH PAIN没有大腿痛BARRIER TO THE INGRESS OF WEAR DEBRIS阻止磨屑进入CORAIL FEATURE21 YEAR EXPERIENCE21年经验BENEFITOVER 130,000 IMPLANTATIONS假体植入CLINICAL RESULTSCORAIL FEATURESURGICAL TECHNIQUE外科技
19、术BENEFITEASY&REPRODUCIBLE容易，可重复性强NO CONTRA-INDICATIONS没有禁忌症CORAIL 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 Coated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
20、 Perfect fit for MI适合于MI手术.Simple and comprehensive instrumentation 简单易操作的工具CORAIL Surgical technique Simple procedure简单的手术步骤 One step 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
21、 Surgical techniqueSTEP 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 Surgical techniqueSTEP 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 techniqueCanal Finder股骨探髓Canal probe esta
22、blish 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，找到正确髓腔位置，中立位进入，避免内翻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 techniqueSTEP 4 Calcar milling 锉平台CORAIL Surgical techniqueSTEP 5 Trial reduction with trial neck segment 试模颈进行试模复
23、位CORAIL Surgical techniqueSTEP 6 Definitive implant insertion 确定的假体插入CORAIL Surgical techniqueSTEP 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 techniqueSTEP 8 Femoral head impaction 股骨头打入CORAIL Surgic
24、al techniqueAnteversion 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12mmAvoid early impaction避免过早的打压Corail Insertion 假体植入Corail Insertion 假体植入用手将假体沿准备好的髓腔方向推入，避免假体和髓腔错误
25、对线Sepcial Case 特殊病例Young Male patients年轻男性病人Challenge（挑战）：usually you will find it is difficult to put the stem in.通常比较难以将柄植入Reason（原因）：This is because young male patients have higher chance for narrower canal(especially in the conjunction of metaphysis and diaphysis of the femur).这是由于很多年轻男性病人髓腔比较狭窄
26、（特别是在股骨干骺端连接处）Tips(小技巧）：ream a little bit at the distal part of the narrow canal to make sure we can choose a right Corail implant that can fully fit in proximal part of the femur.在远端髓腔狭窄处用细钻钻一下，确保我们可以选择一个完全匹配股骨近端的正确的假体We can use the Srom 6/7mm canal reamer to help us during the operation.我们可以使用S-Rom 工具中的6/7mm的髓腔钻CORAIL CASE REVIEW PRE-OP 9 YEARS2 WEEKSPostoperation Ideal X-ray术后好的X光片 Remained Cancellous Bone保留的松质骨CORAIL CASE REVIEWPRE-OP 8 YEARS3 MONTHS Thank You!Thank You!
