CLS Brevius Stem with Kinectiv Technology

Transcription

1 CLS Brevius Stem with Kinectiv Technology The Next Chapter in 27 Years of CLS Spotorno Stem History: Flexibility

2 2 CLS Brevius Stem with Kinectiv Technology Product Information Introduction Through independent leg length, offset and version control, CLS Brevius Stem with Kinectiv Technology offers the intraoperative flexibility surgeons need to reconstruct the personalized kinematics of their patients. Its core design is based on the original CLS Spotorno Hip Stem showing excellent clinical history with a survival rate of 95% at 20 years 1. Optimized stem length also supports surgeons in preserving more bone and facilitates less invasive surgery. The Kinectiv Technology is unique to Zimmer and addresses leg length and offset restoration by offering five length options, in 4mm increments ( 8mm, 4mm, +0mm, +4mm, and +8mm). This is possible by featuring a scope of strong modular straight, anteverted and retroverted necks (4 to 10 ) to be used in conjunction with a +0mm femoral head only, making the whole system very easy to use.

3 CLS Brevius Stem with Kinectiv Technology Product Information 3 CLS Brevius Stem with Kinectiv Technology Proven and safe technologies Design based on CLS Spotorno Stem Kinectiv Technology: material and design for a safe technology Excellent clinical heritage Personalized Kinematics Proven and safe technologies Personalized Kinematics Broad patient matching Optimized range of motion Simplicity More conserving Simplicity Independent adjustments of leg length, offset and version Easy-to-use instruments More conserving Distal stem shortening Modular necks

4 4 CLS Brevius Stem with Kinectiv Technology Product Information Proven and safe Technologies Design based on CLS Spotorno Hip Stem Proven and safe technologies Ribs in the Proximal Region Large contact area for osseointegration Increased primary and rotational stability Protasul 64WF Grit-blasted osteophilic titanium alloy Excellent osseointegration Three-Dimensional Taper and Trapezoid Cross-Section Proximal transmission of the loads Quick stem stabilization Excellent primary and rotational stability

5 CLS Brevius Stem with Kinectiv Technology Product Information 5 Excellent clinical results of CLS Spotorno Stem Through over 25 years of clinical history, and in numerous published studies, the CLS Spotorno Hip Stem has demonstrated excellent stability and osseointegration. The latest results show excellent long-term results with a cumulative survival rate at 21 years of 96,71% 3. Independent registry data such as the Swedish National Hip Arthroplasty Register has also documented the very high survivale rate of the CLS Spotorno Hip Stem. Proven and safe technologies Clinical Performance of CLS Spotorno Stem Author No of cases Mean Revision for Revision for Additional information Follow-up aseptic any reason/ in years loosening Survival rate Aldinger P.R THAs 17 95% 90% Patients under 55 y.o Follow-up up to 20 years Aldinger P.R hips 17 94% 88% Mean age of 57 years Follow-up up to 20 years Survival rate remained unchanged at 20 years Terré R THAs 17.9 n/a 96.71% Survivale rate at 21 years was 96,71% Müller L hips 17 n/a 98.8% Patients mean age was 65 years 100% survivale with non-traumatic loosening as an endpoint Aldinger P.R hips 12 95% 92% Mean age of 57 years Original THA performed by 23 surgeons Aldinger P.R hips 12 98% 97% Young patients under the age of 55 years Breusch S hips 11 96% 94% In all hips previous proximal intertrochanteric osteotomy had been performed with an average of 12 years before conversion to THA with CLS Spotorno Stem Siebold R hips % 95.6% The mean age at surgery was 55.2 years CLS Spotorno Hip Stem: Excellent survival rate at 16 years (all diagnoses and all reasons for revision) Percent not reoperated (%) Red curve = change of cup Blue curve = change of stem , 16y = 93.1% ( ), n = 1, , 16y = 97.5% ( ), n = 1, years postoperatively Source: Swedish Hip Arthroplasty Register, Annual Report 2008, Shortened Version,

6 6 CLS Brevius Stem with Kinectiv Technology Product Information History Since 1984 the CLS Spotorno Hip Stem, developed by Prof. Lorenzo Spotorno, has become one of the most successful implants 19. With more than stems* implanted globally, it has set standards in orthopedics and restored mobility to hundreds of thousands of patients. For the last 27 years, the CLS Spotorno Stem has been continuously evolving to improve patient care. Proven and safe technologies Official Introduction The CLS Spotorno Hip Stem was launched with patient safety as the top concern. To help surgeons in their decision-making process, a protocol was established based on the assessment of four clinical and radiological parameters: age, gender, osteoporosis and anatomy of the femur Changes to the Rib Structure were introduced to enhance stem penetration and reduce the risk of fissures Introduction of the 135 CCD angle giving surgeons more options for precise anatomical reconstruction Introduction of the 125 CCD angle to further expand the range of indications and better restore human anatomy. Over the long term, the CLS stems showed good osseous integration, excellent clinical results, and a low revision rate. Schreiner, et al: If only the stems revised for aseptic loosening are taken into account, a survival rate according to Kaplan-Meier of 95% is achieved ( ). This good survival rate, which even exceeds that achieved in older patients, is truly remarkable in such a young and active patient cohort. Aldinger, et al: * Data on file at Zimmer.

7 CLS Brevius Stem with Kinectiv Technology Product Information 7 12/14 12/ Standard neck (old) Standard neck (new) 2004 Adjustments to Neck and Taper help increase range of motion and reduce the risk for impingement Instrument Advancements Based on 25 years of experience, the instrumentation was refined to assist surgeons in precisely preparing the medullary canal. Excellent matching of rasps and implants, and the development of rasps with designated cutting and compression zones, enable excellent primary implant stability. Modular handles for MIS procedures are also available The CLS Brevius Stem with Kinectiv Technology is the next step in personalized patient care. Even in femoral deformities and in the hands of surgeons with differing levels of surgical training, the long-term results have been demonstrated to be outstanding. Aldinger, et al: With non-traumatic loosening as an endpoint, stem survival was 100% after 17 years. Müller L. et al.:

8 8 CLS Brevius Stem with Kinectiv Technology Product Information Kinectiv Technology: material and design for a safe technology Kinectiv Technology features 32 mo du lar necks for use with +0mm femoral head components only, to enable independent adjustments of leg length, offset and version. The system provides a wide range of head center locations with varus, valgus, anteverted, and retroverted head center solutions to help restore per so nalized kinematics. Titanium Kinectiv Neck Implants are made of titanium to achieve optimal very low fretting/corrosion wear debris and strength performance. Accelerated Corrosion Fatigue Mass Loss mg/10 million cycles 120% 100% 80% 60% 40% 20% 0 CLS Brevius Kinectiv Stem benchmark mass loss M/L Taper Kinectiv Stem Proven and safe technologies combined neck-stem mass loss combined head-neck mass loss Accelerated corrosion fatigue mass loss results of the CLS Brevius Stem with Kinectiv Technology (left) and the Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology (right) show comparable results. Head-neck mass loss refers to the mass loss of a standard +0 12/14 taper head-stem connection (CoCr-Ti). The bench mark line refers to the mass loss re sults of the marketed Zimmer 6 taper head-stem connection. Strength In clinical use since 2007, over Kinectiv Necks have been implanted*. To meet the same strength requirement as the Zimmer monoblock stems based on ISO and ASTM standards, Kinectiv Neck Implants feature a taper that is appreciably longer than that of other modular stems, use +0mm heads only and provide optimized version range to target a wide range of patient anatomies. Fatigue load (100%=acceptance criteria) 130% 120% 100% 80% 60% 40% 20% +11% +26% Minimum strength requirement of Zimmer monoblock stems 0 CLS Brevius Kinectiv size 5 Neck DD CLS Brevius Kinectiv size 20 Neck DD CLS Brevius Stem with Kinectiv Technology was tested using the same stringent strength requirement as Zimmer GmbH monoblock stems. Even the stem sizes showing the highest implant stress on finite element analysis surpass these requirements by 11% and 26%. Junction stability The Kinectiv Neck/Stem Junction demonstrates distraction forces that exceed those required to separate a typical 12/14 head/neck taper*. * Data on file at Zimmer.

9 CLS Brevius Stem with Kinectiv Technology Product Information 9 Very promising results with Kinectiv Technology Initial promising results have been published on Kinectiv Technology in a 2-year follow-up multicenter study conducted on 634 patients 12. Thanks to its wide range of head center locations, the Kinectiv Technology allows surgeons to more accurately and easily reconstruct patient anatomy. Its design offers enough flexibility in leg length, offset, version and taper geometry to address a wide range of patient morphologies while meeting strength requirement that surpass Zimmer internal requirement 12. Proven and safe technologies There were no complications related to the femoral implant, no fractures of a stem or modular neck, and no dissociations of the head-neck junction. Duwelius, et al: The broad head center opportunities allow preoperative planning to fit the stem in the femo ral anatomy. This reduces the need to make significant adjustments to stem size to fit the patient to the implant. Duwelius, et al:

10 10 CLS Brevius Stem with Kinectiv Technology Product Information Personalized Kinematics Broad patient matching Clinical experience shows that there are significant anatomical variations between patients, and between men and women, in head center location as well as in size and shape of the medullary canal. When using traditional implants with very limited neck-shaft angle options, these differences can make size selection and head center placement challenging, which may force surgeons to make compromises. The CLS Brevius Stem with Kinectiv Technology helps the surgeon address a broad range of patient anatomies by providing a wide range of head center locations which allows for less bone sacrificing neck cuts. Personalized Kinematics Leg Length (mm) Leg Length (mm) Male Female CLS Brevius Stem with Kinectiv Technology +0mm head centers Offset (mm) Offset (mm) Patient head center data 11 Kinectiv Technology head centers

11 CLS Brevius Stem with Kinectiv Technology Product Information 11 Optimized range of motion Reduced neck geometry and independent version adjustments after stem implantation facilitate optimal stem position based on the patient s proximal femoral anatomy and help reduce the risk of femoral fracture 12 and com ponent impingement while potentially decreasing alterations to cup position Optimized version without compromising stem orientation Personalized Kinematics Reduced neck geometry Stem: non modular, straight neck Disadvantage: cannot adjust for version following stem implantation Stem: modular, anteverted neck Advantage: optimized version following stem implantation Straight neck with neck impingement Anteverted neck resolves neck impingement Example of a straight neck impinging in flexion, abduction and external rotation. Example of an anteverted neck resolving neck impingement in the same flexion, abduction and external rotation.

12 12 CLS Brevius Stem with Kinectiv Technology Product Information Simplicity Independent adjustment of leg length, offset and version Modular necks, exclusive use of +0 heads, and a grid pattern of head centers allow for independent adjustment of leg length, offset and version following stem implantation, enabling optimization of soft tissue tension which help minimize risk of dislocation Simplicity Optimize version without compromising stem orientation Adjust leg length without affecting offset Adjust offset without affecting leg length Easy-to-use instruments The Kinectiv Neck Provisional Trays have been designed to simplify intraoperative independent adjustments of leg length, offset and version. Their layout mimics the template of head centers so that one simply needs to select the neck provisional that matches the templated head center location. Head center grids located on the tray corners correspond to the head center options shown on the templates. Modular provisional necks also allow intraoperative flexibility where adjustments can be made during trial reduction to achieve ideal personal kinematics. They facilitate intraoperative handling by offering: Alpha and alpha-numeric characters to match provisional necks to implants Gold and silver locking rings to distinguish between standard and ante- retroverted Kinectiv Neck Provisionals Letter Leg length and offset can both be adjusted for left and right THA using the same provisional tray. Locking ring Leg length and version are etched next to each neck to ease intraoperative handling.

13 CLS Brevius Stem with Kinectiv Technology Product Information 13 More conserving Distal shortening by 20%, compared to the CLS Spotorno Hip Stem, promotes less invasive surgery and con serves valuable bone. Intraoperative handling is further facilitated by Kinectiv Technology as the neck implant is inserted after the stem body. Because there is no neck to interfere with cup placement, the stem can be inserted first. This gives the additional benefit to potentially decrease blood loss and save valuable operating time. More conserving CLS Spotorno Hip Stem CLS Brevius Stem with Kinectiv Technology 20%

14 14 CLS Brevius Stem with Kinectiv Technology Product Information Rasps and Handles The design of the CLS Brevius Kinectiv Rasps is based on the same design of the CLS Spotorno Rasps, with 5 different working zones. Bone substance is removed only when it is absolutely necessary, and compressed in the remaining areas where primary stability needs to be increased. Zone 1: Cutting edges on the medial/lateral sides. Cancellous bone on the anterior/posterior sides is only compressed, while being simultaneously prepared for the sharp ribs. Zone 2: Metaphyseal part with cutting edges on all sides because in this zone the rasp body can can come into contact with cortical bone due to femoral antecurvature. Zone 3: Morphology of femur changes from oval to round cross section. Here, the cutting edges of the rasp affect mainly the sharp edges. Zone 4: Contact between implant and bone is avoided thanks to distal oversizing of the rasp. Zone 5: Centralization tip. A full range of straight and offset rasp handles support surgeons in their traditional and MIS approaches.

15 CLS Brevius Stem with Kinectiv Technology Product Information 15 References 1 Aldinger P.R, et al: Uncemented Grit-Blasted Straight Tapered Titanium Stems in Patients Younger than Fifty-five Years of Age. Fifteen to Twenty-Year Results, J Bone Joint Surg Am. 2009;91: Aldinger P.R, et al: Survival of the Cementless Spotorno Stem in the Second Decade, Clin Orthop Relat Res (2009) 467: Terré R.A, et al: Estimated survival probability of the Spotorno total hip arthroplasty after a 15- to 21-year follow-up: one surgeon s results, Hip Int 2010; 20 (Suppl 7 ): S70 S78 4 Müller L., et al: Seventeen-year survival of the cementless CLS Spotorno stem, Arch Orthop Trauma Surg (2010) 130: Aldinger P.R, et al: A ten- to 15-year follow-up of the Cementless Spotorno stem, J Bone Joint Surg [Br] 2003;85-B: Aldinger P.R, et al: Cementless Spotorno tapered titanium stems. Excellent year survival in 141 young patients, Acta Orthop Scand 2003; 74 (3): Breusch S., et al: Ten-year results of uncemented hip stems for failed intertrochanteric osteotomy, Arch Orthop Trauma Surg (2005) 125: Siebold R., et al: Langzeitergebnisse mit dem zementfreien CLS-Schaft von Spotorno, Orthopäde : Schreiner, et al: Mid-term results of the cementless CLS stem. A 7- to 11-year follow-up study. Arch. Orthop. Trauma Surg 121: , Aldinger P.R, et al: The uncemented CLS Femoral Component Long-Term Results, Indications and Limitations, Akt Traumatol 2005; 35: Data from Mohamed Mahfouz, PhD, University of Tennessee Center for Musculoskeletal Research. Femoral Bone Atlas. 12 Duwelius P.J, et al: Clinical Results of a Modular Neck Hip System: Hitting the Bull s-eye More Accurately, Am J Orthop. 2010; 39 (10 suppl): Malik A, Maheshwari A, Dorr LD. Impingement with total hip replacement. J Bone Joint Surg. 2007;89: Shon WY, Baldini T, Peterson MG, Wright TM, Salvati EA. Impingement in total hip arthroplasty: a study of retrieved acetabular components. J Arthroplasty. 2005;20: D Lima DD, Urquhart AG, Buehler KO, Walker RH, Colwell CW. The effect of the orientation of the acetabular and femoral components on the range of motion of the hip at different head-neck ratios. J Bone Joint Surg. 2000;82-A: Iorio R, Healy WL, Warren PD, Appleby D. Lateral trochanteric pain following primary total hip arthroplasty. J Arthroplasty. 2006; 21: Bourne RB, Rorabeck CH. Soft tissue balancing the hip. J Arthroplasty. 2002: 17 (suppl 1): Biedermann R, Tonin A, Krismer M, Rachbauer F, Eibl G, Stöckl B. Reducing the risk of dislocation after total hip arthroplasty: the effect of orientation of the acetabular component. J Bone Joint Surg (Br). 2005;87-B: Swedish Hip Arthroplasty Register, Annual Report 2008, Shortened Version,

16 Disclaimer This documentation is intended exclusively for physicians and is not intended for laypersons. Information on the products and procedures contained in this document is of a general nature and does not represent and does not constitute medical advice or recommendations. Because this information does not purport to constitute any diagnostic or therapeutic statement with regard to any individual medical case, each patient must be examined and advised individually, and this document does not replace the need for such examination and/or advice in whole or in part. Please refer to the package inserts for important product information, including, but not limited to, contraindications, warnings, precautions, and adverse effects. Copyright 2011 by Zimmer GmbH Printed in Switzerland Subject to change without notice Contact your Zimmer representative or visit us at Lit.No Ed ZHUB +H /$110601F11T