Centinel Spine PRODISC C VIVO Manual

Cervical disc prosthesis to restore disc height and maintain segmental motion

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PRODISC

C VIVO

Cervical disc prosthesis to restore

disc height and maintain segmental

motion.

SURGICAL TECHNIQUE

Table of Contents

Summary of Contents for Centinel Spine PRODISC C VIVO

Page 1 PRODISC ® C VIVO Cervical disc prosthesis to restore disc height and maintain segmental motion. SURGICAL TECHNIQUE...
Page 2 Image intensiﬁer control Warning This description alone does not provide sufﬁcient background for direct use of Centinel Spine products. Instruction by a surgeon experienced in handling these products is mandatory. Processing, Reprocessing, Care and Maintenance For general guidelines, function control and dismantling of multi-part...
Page 3: Table Of Contents
TABLE OF CONTENTS prodisc C Vivo INTRODUCTION Kinematics Intended Use, Indications and Contraindications SURGICAL TECHNIQUE Surgical Technique Multi-Level Cases Removal Procedure PRODUCT INFORMATION Implants Instruments Pre-Cleaning Instructions BIBLIOGRAPHY prodisc C Vivo Surgical Technique Centinel Spine...
Page 4: Prodisc C Vivo
• UHMWPE on CoCrMo alloy articu- lation Ball and socket articulation • Permits a physiological range of motion in flexion/extension, rotation, and lateral bending • Allows for restoration of anatomi- cal balance • Resists shear forces Centinel Spine prodisc C Vivo Surgical Technique...
Page 5: Kinematics
16.9° Lateral bending The physiological range of motion in lateral bending is restored. 360º Axial rotation The axial rotation is limited by the anatomical structures and not by the prosthesis. prodisc C Vivo Surgical Technique Centinel Spine...
Page 6: Intended Use, Indications And Contraindications
• Systemic and metabolic diseases • Any medical and surgical conditions precluding the beneﬁts of spinal surgery • Foreign body sensitivity to the implant materials • Pregnancy • Severe obesity (Body Mass Index above 40) Centinel Spine prodisc C Vivo Surgical Technique...
Page 7: Surgical Technique
Determine the median line using image intensiﬁ er control and make a permanent midline mark on the superior and inferior vertebral bodies, e.g. using an osteotome or electro cauterization. prodisc C Vivo Surgical Technique Centinel Spine...
Page 8 This assembly secures parallel- ism of the retainer screws and the vertebral endplates of the operated level. Avoid using the retainer to distract the segment. For proper distraction refer to Step 4 on page 7. Centinel Spine prodisc C Vivo Surgical Technique...
Page 9 Remove as much disc material as possible to allow the verte- bral distractor tips to be placed as posteriorly as possible into the intervertebral space. Mild predistraction with the retainer can be applied to support disc removal. prodisc C Vivo Surgical Technique Centinel Spine...
Page 10 • Ensure the cartilageous tissue is removed from the endplates. Cartilageous tissue may hinder osseo- integration of the implant and reduce the fixation strength. Centinel Spine prodisc C Vivo Surgical Technique...
Page 11 Ensure that the shaft is fully screwed in before use. Align the trial implant with the midline and advance it under image intensiﬁ er control into the disc space by tapping it cautiously. prodisc C Vivo Surgical Technique Centinel Spine...
Page 12 • Avoid kyphotic position of the corresponding segment. Note: • Do not unscrew stop more than 4mm or contact to trial implant may be lost. Use next size trial implant instead. Centinel Spine prodisc C Vivo Surgical Technique...
Page 13 • Pull the implant en-bloc out of the packaging tray. Optionally, the stop can be attached to the implant holder. Note: The prodisc C Vivo implants are not designed to be used with bone cement. prodisc C Vivo Surgical Technique Centinel Spine...
Page 14 If the correct position of the implant is conﬁrmed using im- age intensiﬁer, release the retainer and apply slight compres- sion with the retainer. Slight compression from the retainer will help the spikes on the implant to penetrate into the ver- tebral bodies. Centinel Spine prodisc C Vivo Surgical Technique...
Page 15 (blood/bone marrow). HO might be reduced when bone wax is used to close cavities in the bone (screw holes) and open bone surfaces after removal of anterior osteophytes.¹ ¹ See Barbagallo 2014 prodisc C Vivo Surgical Technique Centinel Spine...
Page 16: Multi-Level Cases
Insert the screws under image intensiﬁer control. Repeated image intensiﬁer control in AP direction will be necessary to ensure proper alignment of the disc prostheses. Centinel Spine prodisc C Vivo Surgical Technique...
Page 17: Removal Procedure
Note: The surface edged with “inside” must be oriented towards the center of the disc space with respect to the implant endplate being removed. prodisc C Vivo Surgical Technique Centinel Spine...
Page 18 Alternatively, the slotted mallet or slide hammer can be used to aid implant removal. The superior endplate of the implant can be removed using the remover clamps or alternatively suitable forceps. Centinel Spine prodisc C Vivo Surgical Technique...
Page 19: Implants
12/14/16/18 mm Panjabi 1991 Three different heights (5, 6, and 7 mm) allow adjustment to the indi- vidual dimensions of the patient’s disc. 4.2–7.5 mm 5 /6 /7 mm Yoganandan et al. 2001 prodisc C Vivo Surgical Technique Centinel Spine...
Page 20 Art. No. Height Art. No. Height 04.670.955S 5 mm 04.670.965S 5 mm 04.670.975S 5 mm 04.670.956S 6 mm 04.670.966S 6 mm 04.670.976S 6 mm 04.670.957S 7 mm 04.670.967S 7 mm 04.670.977S 7 mm Centinel Spine prodisc C Vivo Surgical Technique...
Page 21: Instruments
Screwdriver 03.820.111 Vertebral Body Retainer The vertebral body retainer is used to maintain the distraction achieved with the vertebral distractor. The retainer has a toggle-switch mechanism to maintain distraction as well as compression. prodisc C Vivo Surgical Technique Centinel Spine...
Page 22 03.820.102 12 mm 03.820.106 13 mm 03.820.103 14 mm 03.820.107 15 mm 03.820.104 16 mm 03.820.108 17 mm 03.820.105 18 mm 03.820.109 19 mm 03.820.110 Locking Nut 03.820.112 Vertebral Distractor Centinel Spine prodisc C Vivo Surgical Technique...
Page 23 Trial Implants Trial implants are used to deﬁ ne the correct size Depth [mm] of the implants (height, width and depth). Width [mm] prodisc C Vivo Surgical Technique Centinel Spine...
Page 24 Depth 16 mm Depth 18 mm Art. No. Height Art. No. Height 03.670.965 5 mm 03.670.975 5 mm 03.670.966 6 mm 03.670.976 6 mm 03.670.967 7 mm 03.670.977 7 mm 03.670.204 Holder for Trial Implants Centinel Spine prodisc C Vivo Surgical Technique...
Page 25 Art. No. Height 03.670.325 5 mm 03.670.326 6 mm 03.670.327 7 mm 03.670.201 Implant Holder, size M and MD 03.670.202 Implant Holder, size L and LD 03.670.203 Implant Holder, size XL and XLD prodisc C Vivo Surgical Technique Centinel Spine...
Page 26 Instruments 03.670.212 Stop for Implant Holder 03.670.213 Shaft for Implant Holder 03.820.113 Mallet 03.820.282 Slide Hammer for Cervical Spine 03.670.207 Positioner Centinel Spine prodisc C Vivo Surgical Technique...
Page 27 03.670.400 Remover Clamp, size M/MD 03.670.410 Remover Clamp, size L/LD 03.670.420 Remover Clamp, size XL/XLD prodisc C Vivo Surgical Technique Centinel Spine...
Page 28: Pre-Cleaning Instructions
Please note that the manual pre-cleaning method has to be performed for instruments and cases prior to automated cleaning. Please consider the following positions for the pre-cleaning process: Position 1 Position 2 Actuate in Position 2 Centinel Spine prodisc C Vivo Surgical Technique...
Page 29 For general guidelines, function control and dismantling of multi-part instruments, please contact your local sales repre-sentative or refer to: Reprocessing, Care and Maintenance of Centinel Spine Instruments www.centinelspine.com/prodisc_reprocessing.html prodisc C Vivo Surgical Technique Centinel Spine...
Page 30 Korinth MC (2008) Treatment of cervical degenerative disc versus caudal geometric center. Spine 33(1): E6–9 disease – current status and trends. Zentralbl Neurochir. 69(3): 113–24 Centinel Spine prodisc C Vivo Surgical Technique...
Page 32 Prodisc ® is a registered trademark of DePuy Synthes. www.centinelspine.com © 2018 Centinel Spine, LLC or its affiliates. All rights reserved. is a registered trademark of Centinel Spine ® LBL409 Rev 1 (01/2018) Centinel Spine, LLC. This publication is not intended for distribution in the USA.