NEOCIF NEOCIF -SL

Transcription

1 At Biomet, engineering excellence is our heritage and our passion. For over 25 years, through various divisions worldwide, we have applied the most advanced engineering and manufacturing technology to the development of highly durable systems for a wide variety of surgical applications. NEOCIF NEOCIF -SL To learn more about this product, contact your local Biomet Sales Representative today. All trademarks are the property of Biomet, Inc. or one of its subsidiaries unless otherwise indicated. PEEK-Optima is a registered trademark of Invibio Ltd. (Thornton Cleveleys, United Kingdom) Not available for sale in the United States Distributed & Manufactured by: Biomet Spain Orthopaedics, S.L. Islas Baleares, 50 Fuente del Jarro, Valencia 46988, Spain T: +34 (0) F: +34 (0) es.biometspain@biomet.com

2 Surgical Technique NEOCIF NEOCIF -SL Manufactured From NEOCIF and NEOCIF -SL are intersomatic cervical cages designed to match the anatomical contour of the cervical spine The devices eliminate the need for structural autologous graft and provides superior stability Global Edition

3 Contents Introduction... Page 1 Design Features... Page 2 Instruments... Page 3 Surgical Technique... Page 4 Product Information... Page 9 Closure and Post-Operative Care... Page 11 Implant Removal... Page 11 Indications for Use... Page 12 Contraindications... Page 12 Warnings... Page 13 Sterilization Recommendations... Page 13 Further Information... Page 14 DISCLAIMER This publication and all content, artwork, photographs, names, logos and marks contained in it are protected by copyright, trademarks and other intellectual property rights owned by Biomet Spain Orthopaedics S.L. or its affiliates or licensed to Biomet Spain Orthopaedics S.L. or its affiliates. This brochure must not be used, copied or reproduced in whole or in part for any purposes other than marketing by Biomet Spain Orthopaedics S.L. or its authorised representatives. Any other purposes are prohibited. Biomet Spain Orthopaedics S.L. does not practice medicine and does not recommend any particular orthopaedic implant or surgical technique for use on a specific patient. The surgeon who performs any implant procedure is responsible for determining and utilising the appropriate techniques for implanting prosthesis in each individual patient. Biomet Spain Orthopaedics S.L. is not responsible for selection of the appropriate orthopaedic implant or surgical technique, nor does it advocate a particular technique to be utilised on an individual patient.

4 Introduction NEOCIF and NEOCIF -SL are intersomatic cervical cages designed to match the anatomical contour of the cervical spine. The devices eliminate the need for structural autologous graft and provides superior stability. The implants are constructed of polyetheretherketone (PEEK), a biocompatible and radiolucent plastic material for optimal visualization. Both implants have aggressive textures on the superior and inferior surfaces and are available with titanium marker to aid with visualization on x-ray. The central graft chamber of these cages have been designed to contain either autologous bone or synthetic bone substitutes. The large surface area of these openings exposed the biologic material they contain to the adjacent endplate, facilitating graft integration and thereby promoting fusion of the vertebral bodies. The NEOCIF system is available in two configurations: 1. NEOCIF is a spinal spacer made of polyetheretherketone (PEEK), a radiolucent material. The structural design supports the anterior cervical spine while optimizing the fusion environment through an open and load-sharing design. In addition, the system features three strategically placed titanium fixation pins for enhanced stabilization. 2. NEOCIF -SL is a spinal spacer made of polyetheretherketone (PEEK), a radiolucent material. The structural design is identical to the NEOCIF cage, but does not offer the titanium fixation spikes. Biomet is committed to providing options due to surgical preferences and patient selection. Both NEOCIF and NEOCIF -SL have a central instrumentation case for implantation of the device. Furthermore, both version of NEOCIF and NEOCIF -SL are available in two footprints and an array of heights to match the interbody space. 1

5 Design Features PEEK-OPTIMA features an elastic modulus between cortical and cancellous bone (3.6 GPa), providing immediate load-bearing capacity and biocompatibility. The material is radiolucent and allows for a visual assessment of fusion via x-ray, MRI and CT scan. Plating is recommended in cases of traumatic instability or whenever severe kyphotic misalignment has to be corrected. Rigid Teeth Surfaces with retentive teeth provide a secure cage fixation to the endplates. Visualization The titanium markers provide reference points to access the 3-dimensional positioning of the cage, both peri and postoperatively via x-ray. Open Design Implants Dimensions AP x HA Core Volume (cc) 13 x x x x x x x x x x x x The central core offers maximum filling volume for bone or granular bone substitute (up to 0.75cm 3 ). The goal is a faster and more complete bony ingrowth. 2

6 Instruments Graft Table Compactor Simple and user friendly instrumentation Insertion Instrument Trials Distractor Graft Table Temporary Pins 3

7 Surgical Technique Surgical Approach and Preparation The patient is positioned supine on the operative table with a folded towel beneath the intrascapular region to maintain the head in slight extension. The use of a head halter attached to an outrigger for traction may be helpful. If fluoroscopy is used, it can be utilized at this point to confirm positioning and check that desired vertebral levels can be adequately visualized. (See Fig. 1) Fig. 1 The standard anterior approach to the cervical spine is utilized. This can be through one of several incisions with the exposure typically medial to the carotid sheath and lateral to the trachea and esophagus. Adequate fascial plane release is important for optimal exposure. After identification of the disc space is confirmed with x-ray, preparation for anterior interbody fusion is commenced. (See Fig. 2) Fig. 2 4

8 Distraction Once the target area is confirmed with the image intensifier, Temporary Pin are screwed in with the pin inserter (Fig. 3 and Fig. 4), in the vertebrae above and below the disc to be removed. The sleeves of the Distractor are inserted onto the pins. Distraction of the vertebrae is provided by turning the wing nut clockwise. (Figs. 5 and 6) Fig. 4 Depending on the pathology to be treated, a single or multi-level discectomy can be carried out. Fig. 5 Fig. 3 Fig. 6 5

9 Surgical Technique (Continued) Discectomy and Decompression Cage Selection A complete discectomy should leave the adjacent vertebral endplates cleared from all the disc material and the cartilaginous layer. (Fig. 7) The appropriate NEOCIF trial cage is connected to the insertion instrument and the safety stop is adjusted. (Fig. 8) The trial is then introduced into the intervertebral space under fluoroscopy (Fig. 9, Fig. 10 and Fig. 11). Ensure the handle is positioned in the cranial position (see etching on instrument). The size of the trials correspond to the NEOCIF without fixation pins. NOTE: The trial should never be left in situ. Fig. 7 Fig. 10 Fig. 8 Fig. 11 Fig. 9 6

10 Packing the Cage Implant Insertion The selected NEOCIF cage is connected to the insertion instrument and placed on the Graft Table Compactor. Autologous bone or Biomet Bone Graft Substitutes may be used to fill the NEOCIF Cage. The Graft Table Compactor is used for this purpose (Fig. 12 and 13). The graft table has one of the two footprints in each side of the device. The NEOCIF cage is inserted into the disc space under fluoroscopy (Fig. 14 and Fig. 15). The Insertion Instrument has a preset depth feature to allow the surgeon placed the implant properly into the former disc space. The sleeve may be rotated 90 to engage the stop to the appropriate depth. To facilitate implantation of the NEOCIF, additional distraction of 1mm may be necessary to implant the device. Once the distraction is released, the fixation pins will adhere to the endplates. Fig. 12 Fig. 14 Fig. 15 Fig. 13 7

11 Surgical Technique (Continued) Postoperative Placement Compression and Closure A lateral and/or AP x-ray may be used to confirm placement of the NEOCIF cage (Fig 16). Once the implant is positioned appropriately, the implant holder can be disengaged. Releasing distraction and performing axial compression for the NEOCIF (Cyclops instrument as optional ref ) improves the penetration of the anchoring pins to the vertebral endplate. For the NEOCIF -SL, additional distraction and final compression with the Cyclops instrument may not be necessary. After removal of the distraction screws, the wound may be closed in layers. Fig. 16 8

12 Product Information Depth NEOCIF -SL Implants - Depth (mm) x Height (mm) Catalog # Description mm x 4mm Cage mm x 5mm Cage mm x 6mm Cage mm x 7mm Cage mm x 8mm Cage mm x 9mm Cage Height mm x 4mm Cage mm x 5mm Cage mm x 6mm Cage mm x 7mm Cage mm x 8mm Cage mm x 9mm Cage NEOCIF Implants - Depth (mm) x Height (mm) Catalog # Description mm x 4mm Cage mm x 5mm Cage mm x 6mm Cage mm x 7mm Cage mm x 8mm Cage mm x 9mm Cage mm x 4mm Cage mm x 5mm Cage mm x 6mm Cage mm x 7mm Cage mm x 8mm Cage mm x 9mm Cage 9

13 Product Information (Continued) Image not in actual size Instruments Catalog # Description Qty/Set NEOCIF Instrument Set 1 Includes: IQL Sterilization Case Insertion Instrument Graft Table Graft Table Compactor mm x 4mm Trial mm x 5mm Trial mm x 6mm Trial mm x 7mm Trial mm x 8mm Trial mm x 9mm Trial mm x 4mm Trial mm x 5mm Trial mm x 6mm Trial mm x 7mm Trial mm x 8mm Trial mm x 9mm Trial Cyclops Distractor** (Optional) Cyclops Pin Inserter** (Optional) Cyclops Temporary Pin** (Optional) ** The following instruments (Cyclops Cervical Plate System) can be used to achieve distraction/compression. - To be ordered separately - No room in the empty case (ref IQL) 10

14 Closure and Post-Operative Care Implant Removal Closure After implantation of the NEOCIF Intersomatic Cage is complete, closure is performed in layers according to standard protocol. Radiographs should be taken during surgery to confirm appropriate placement of the implant prior to closing. Removal of the NEOCIF Intersomatic Cage is performed by reversing the order of the implant procedure. Attach the insertion instruments and remove implant. Postoperative Care Collar (soft or hard) immobilization may be used for comfort but also may be indicated given individual bone density and quality of fixation. This should be determined on an individual basis. Postoperative radiographs should be taken. 11

15 Indications for Use Contraindications NEOCIF and NEOCIF -SL anterior cervical intersomatic fusion cages are designed for the treatment of softand hard disc degenerative conditions, in combination with anterior cervical plates. Traumatic disc lesions and revision surgery for pseudarthrosis can also be addressed. a) Absolute contra indications 1. Infection or inflammation of the cervical spine 2. Distant infection sites, with potential hematogenous spread to the implant 3. Metastases of the cervical spine 4. Patients with an immature skeleton 5. Patients with neuromuscular diseases, limited available bone at the cervical spine b) Conditions that increase the risk of failure: 1. Patients with poor compliance 2. Severe osteoporosis: additional posterior cervical fixation may be required 3. Metabolic disorders of bone 4. Osteomalacia 5. Pathological obesity 6. Pregnancy 7. Senility, mental illness, alcoholism or drug abuse 8. Poor health conditions with regard to wound healing (e.g., skin ulceration, terminal diabetes mellitus, alcoholism, drug abuse, or malnutrition) 12

16 Warnings Sterilization Recommendations a) Mechanical resistance of the implant: NEOCIF and NEOCIF -SL intersomatic cages undergo exhaustive testing. Nevertheless, the implant is not intended to substitute healthy bone. The cage is designed as a primary fixation device while a solid bony fusion through the core of the implant will provide definitive stability. Regular check-ups are recommended following surgery. b) Correct implant selection: A correct selection of the implant size will increase the rate of excellent clinical results. A careful positioning of the implant is also crucial in order to achieve an adequate fixation to the vertebral endplates. c) Factors relating to patient selection: 1. Occupation or activity: if patient occupation or activity implies spinal over-exertion, the resulting forces may cause failure of fixation, the implant or both. If solid bony fusion is achieved, no limitation of activity is required. The implant is unable to restore functionality to the level found in healthy bone; false patient expectations should therefore be avoided. 2. Senility, mental illness or alcoholism: these conditions, among others, can cause the patient to ignore certain limitations and precautions regarding implant use, with the risk of failure or other complications. 3. Hypersensitivity to foreign bodies: should there be any suspicion of patient hypersensitivity to titanium or PEEK, the pertinent allergy testing must be performed prior to implant surgery. NEOCIF and NEOCIF -SL anterior cervical intersomatic fusion cages have been gamma-ray sterilized before being placed on the market, and in no case need resterilizing. The NEOCIF Intersomatic Cervical Cage System Surgical Technique is presented to demonstrate the surgical technique utilized by Lucas Papavero, MD. Biomet Spine, as the manufacturer of this device, does not practice medicine and does not recommend this product or any specific surgical technique for use on any individual patient. The surgeon who performs any implant procedure is responsible for determining the appropriate product(s) and utilizing the appropriate technique(s) for said implantation in each individual patient. 13

17 Further Information This brochure is presented to demonstrate the surgical technique utilized by Dr. L. Papavero. Biomet Spine, as the manufacturer and distributor of this device and/or implant and their surgical consultants do not recommend this or any other surgical technique for use on a patient. The surgeon who performs any implant procedure is responsible for determining and utilizing the appropriate techniques for implanting all allograft products in each patient. Biomet is not responsible for selection of the appropriate surgical technique to be utilized for an individual patient. For further information, please contact your local Biomet Distributor: Biomet Spine C/O Biomet Spain Orthopaedics SL Calle Islas Baleares No. 50 P.O. Box Fuente Del Jarro Valencia, Spain Phone: Fax: es.biometspain@biomet.com 14

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20 DISCLAIMER This publication and all content, artwork, photographs, names, logos and marks contained in it are protected by copyright, trademarks and other intellectual property rights owned by Biomet Spain Orthopaedics S.L. or its affiliates or licensed to Biomet Spain Orthopaedics S.L. or its affiliates. This brochure must not be used, copied or reproduced in whole or in part for any purposes other than marketing by Biomet Spain Orthopaedics S.L. or its authorised representatives. Any other purposes are prohibited. Biomet Spain Orthopaedics S.L. does not practice medicine and does not recommend any particular orthopaedic implant or surgical technique for use on a specific patient. The surgeon who performs any implant procedure is responsible for determining and utilising the appropriate techniques for implanting prosthesis in each individual patient. Biomet Spain Orthopaedics S.L. is not responsible for selection of the appropriate orthopaedic implant or surgical technique, nor does it advocate a particular technique to be utilised on an individual patient.