CERVICAL COMPRESSIVE STAPLE

Transcription

1 S U R G I C A L T E C H N I Q U E CERVICAL COMPRESSIVE STAPLE

2 Dear colleague, In cervical surgery anterior decompression/arthrodesis is currently by far the most used technique. The arthrodesis is obtained using a bone graft and is generally secured using a screwed osteosynthesis plate. Fitting this screwed plate is often fastidious, time consuming and sometimes dangerous, as the volume of the implant itself is sometimes considerable and may give rise to side effects. It exposes the patient to specific risks such as the material breaking or becoming detached, or serious visceral complications which sometimes require more surgery. The rigidity of some of these plates can cause stress shielding and delayed or absence of intersomatic fusion. We have developed a new system of anterior cervical anchoring that works by plastic deformation of a titanium implant resulting in a fixing of the mounting. We think that this procedure, by simplifying and securing vertebral osteosynthesis, will represent a fundamental step towards progress in the area of greater well-being for our patients. Follow the instructions and prepare yourself... to be really enthusiastic. We are always available for discussion or advice. Yours sincerely, Dr. P. Bernard Dr. V. Fiere Dr. O. Ricart

3 C E R V I C A L C O M P R E S S I V E S T A P L E List of implants reference numbers B B OPTION B B B OPTION B C-JAWS TM H: 15 x L: 12 mm C-JAWS TM H: 15 x L: 14 mm C-JAWS TM H: 15 x L: 17 mm C-JAWS TM H: 20 x L: 12 mm C-JAWS TM H: 20 x L: 14 mm C-JAWS TM H: 20 x L: 17 mm L H List of instruments reference numbers A Double square awl 20mm A C-JAWS TM P.I.C. (Prehensor Impactor Compressor) A Double square awl 15mm A C-JAWS TM cutter A C-JAWS TM extractor A C-JAWS TM Handle 3.5 mm Ø drill A C-JAWS TM Drilling guide A C-JAWS TM Handle 3.5 mm Ø drill (AO type) A Removable end stop for C-JAWS TM drill A : C-JAWS TM Final impactor A : Displaying case for C-JAWS TM 1

4 S U R G I C A L T E C H N I Q U E SUMMARY I. General description of the implant...3 II. Surgical procedure...4 II.1. Preparation of implantation site...4 II.2. Setting of the implant...7 II.3. Ablation of the implant...10 For general precautions and conditions of use, refer to C-JAWS TM Instructions for Use. 3 2

5 S U R G I C A L T E C H N I Q U E I. General description of the implant The implants are made in non-alloyed titanium T40 in accordance with the ISO and ASTM F67 standards. The range of implants is composed of different sizes identified by a color code based on mini-frame height. (Fig. 1). L Example: Fig.1 H Height (H) (mm) Arms length (L) (mm) Widening the implant body, bringing together its two arms, results in controlled intervertebral compression. Its arms are notched along the whole length of their internal surfaces for greater resistance to pull out. (Fig. 2) Distraction of body Before After Compression of arms Fig. 2 - Diagram of the cervical compressive mini frame showing how it works. 3

6 C E R V I C A L C O M P R E S S I V E S T A P L E II. Surgical procedure II.1. Preparation of implantation site IMPORTANT NOTES: 1 The surgeon must check the correct positioning of the cage. Its anterior edge must be seated in regards to the anterior cortex of the adjacent vertebrae. The cage must be re-positioned if necessary. 2 It is mandatory that the surgeon removes anterior osteophytes to allow a correct implantation as close as possible to the vertebral bodies. Selection of the double square awl The surgeon must choose the double square awl C-JAWS TM (15 mm or 20 mm, references A or A ) which allows the implantation of the staple in the cancellous bone.* 4 * An intra-operative X-ray or an image intensifier is recommended at this step.

7 S U R G I C A L T E C H N I Q U E Preparation of the holes The preparation of the holes will be done by using the double square awl (A or A ). It is advisable to implant the staple in the anterior midline of the vertebral bodies, close to the dense bony area of the vertebral endplates. IMPORTANT NOTES: 1 The surgeon must orientate the double square awl strictly parallel to the endplates to allow perpendicular insertion of the staple.* 2 The C-JAWS TM drill (A or A ) must be systematically used with or without its dedicated C-JAWS TM drilling guide (A ). The C-JAWS TM 3.5 mm drills (A and A ) require a removable end stop (A ) if they are being used without the C-JAWS TM drill guide (A ). * An intra-operative X-ray or an image intensifier is recommended at this step. 5

8 C E R V I C A L C O M P R E S S I V E S T A P L E How to use the new drills with the drill guide The drills A and A have a stop when they are used with the drill guide A A A Stop when used with drill guide 14mm length How to use the new drills without the drill guide If the surgeon doesn t want to use the drill guide, he can adapt the removable end stop A only with the C-JAWS drills A and A , in order to have a stop on the drill. The removable end stop A is screwed on the threaded part of the drill. 14mm length 6

9 S U R G I C A L T E C H N I Q U E II.2. Setting of the implant Holding The implant is gripped using the C-JAWS TM P.I.C. (Prehensor Impactor Compressor) A locked to its first catch. Impaction The staple must be implanted in the vertebral bodies using the previously made guiding holes. Final impaction is done with gentle taps on the P.I.C. until the staple is flush with the vertebral bodies. 7

10 C E R V I C A L C O M P R E S S I V E S T A P L E IMPORTANT NOTES: 1 The central part of the staple must be only distracted once its body is in contact with the anterior part of the vertebral bodies. This step can be eventually confirmed by an intra-operative X-Ray or an image intensifier. 2 In case of non-optimal implant impaction, the final impactor for C-JAWS TM (A ) can be used after staple impaction to optimize its positioning on the anterior part of the vertebral bodies. Impaction must be realized on each extremity on the staple body straight above its arms. 8

11 S U R G I C A L T E C H N I Q U E Distraction Once the cervical compressive staple is impacted, intersomatic compression is produced by distraction of the implant and will stabilize the implanted cage or bone substitute. This distraction occurs by tightening the arms of the C-JAWS TM P.I.C. (Prehensor Impactor Compressor) A to the end-stop. Before After IMPORTANT NOTES: After the distraction of the staple, it is no more possible to perform additional impaction. 9

12 C E R V I C A L C O M P R E S S I V E S T A P L E II.3. Ablation of the implant In case of ablation, the C-JAWS TM cutter (A ) will be used to cut each lateral part of the implant (Fig. 3). (Fig. 3) Then, the C-JAWS TM extractor A will remove the two parts of the implant (Fig. 4). (Fig. 4) 10

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14 Headquarters: MEDICREA 24 porte du Grand Lyon NEYRON - FRANCE Tél. +33 (0) Fax +33 (0) Sales administration: MEDICREA Technologies Z.I. Chef de Baie LA ROCHELLE - FRANCE Tél. +33 (0) Fax +33 (0) customerservice@medicrea.com CERVICAL COMPRESSIVE STAPLE Distributed by: Cleared by FDA - All rights reserved. Patent pending - Ref. C10D Dec 2007 MEDICREA TM Product developped by MEDICREA TM under NEW DEAL INTEGRA exlusive licence