RapidSorb Resorbable Tacks. Resorbable Fixation System.

Transcription

1 RapidSorb Resorbable Tacks. Resorbable Fixation System. Fast Safe Resorbable Drill Press Fixed

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3 Table of Contents Introduction Overview 2 Indications and Contraindications 4 RapidSorb 5 Surgical Technique Insertion of Resorbable Tacks 6 Product Information Ordering Information 10 Bibliography 12 Warning This description alone does not provide sufficient background for direct use of the product. Instruction by a surgeon experienced in handling this product is highly recommended. Reprocessing, Care and Maintenance of Synthes Instruments For general guidelines, function control and dismantling of multi-part instruments, please refer to: Synthes 1

4 RapidSorb Resorbable Tacks. Resorbable Fixation System. Reliable fixation without tapping Fast No tapping Quick push-in insertion Automated tackdriver with adjustable insertion force Safe Retaining force is comparable with resorbable screws Higher stability compared with wires or sutures Push-out force remains for at least 8 weeks (see fig. 2 next page). Resorbable Artifact-free on x-ray film and MRI diagnosis No interference with radiotherapy No implant migration or growth restriction Resorption in about 1 year (RapidSorb) (see fig. 4 next page) Stability maintained during a minimum of 8 weeks during critical bone-healing phase (see fig. 2 next page). Fast The insertion of tacks allows a fast fixation of resorbable plates without the need of a threaded hole. This does not only reduce the insertion time, but also allows an easier handling without the chance to turn off the screw head. The insertion is facilitated by the use of the automated tackdriver which allows the insertion of the tack by means of a loaded spring while just pressing a trigger. Drill Press Fixed 2 Synthes RapidSorb Resorbable Tacks

5 Safe The resorbable implants are designed to maintain a stable fixation during the initial healing phase of the bone. The push out force is kept on a steady level for at least 8 weeks to keep the bone fragments and the plate in place. The RapidSorb tack has a minimal shear force of about 70 N (approx. 7 kg), which allows stable fixation of bone fragments in cranio-maxillofacial applications Fig.1 7 kg Push-out force, [N] In-vitro time, [weeks] Fig. 2: Course of push-out force tested under Laboratory conditions: Fixation remains for at least 8 weeks. Resorbable After an initial strength retention phase for at least 8 weeks of the resorbable implants, the healed bone can take over the function and the resorbable material is slowly degrading. RapidSorb shows, due to its fast resorbing characteristics, an early mass loss. The RapidSorb polymer is fully degraded in about 1 year [3,4]. Strength retention [%] RapidSorb Time in-vitro [ Weeks] Fig. 3: Course of implant shear strength in percentage of initial strength during degradation. Remaining implant mass, [%] [ Weeks] RapidSorb Fig. 4: Remaining implant mass during decomposition degradation. Synthes 3

6 Indications and Contraindications Indications The Synthes RapidSorb resorbable plate, screw and tack systems are used for bone fixation in the management of fractures or reconstructions of the craniofacial skeleton and as graft containment, soft tissue fixation, and fixation implants in other locations. The plates, screws and tacks should only be used in locations subject to low biomechanical loading, i.e. non-load bearing osteosynthesis exclusively. Examples of appropriate indications include: Trauma repair and reconstructive procedures in the mid facial area, maxilla and cranium. Containment of bone grafts or bone graft substitutes in other parts of the body in non-load bearing indications. Contraindications The Synthes RapidSorb Resorbable Fixation Systems should not be used in the following circumstances: Mandibular fractures subject to high biomechanical loading Resection of a mandibular tumor Any fracture outside the area of craniofacial surgery with load-bearing osteosynthesis situations Synthes Resorbable Fixation Systems are not indicated for use in load bearing and unstable indications for graft containment, soft tissue fixation, and fixation implants unless used in conjunction with appropriate osteosynthesis fixation systems Blood supply limitations or reduced blood circulation Insufficient quantity and quality of bone Active, acute, latent, potential or chronic infections Situations in which internal fixation is contraindicated for other reasons, e.g. in patients with bone disorders or lack of willingness to cooperate (e.g. alcoholism) Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation 4 Synthes RapidSorb Resorbable Tacks

7 RapidSorb The implants are made of poly (L-lactide-co-glycolide) 85:15. The resorption time has been shown to be about 1 year [3,4]. The implants have been designed to show minimal strength retention of 60% for at least 8 weeks. RapidSorb plates have an improved design with feathered edges to reduce palpability, a longitudinal groove for topside identification, improved countersinks for a lower profile and a straight edge design for higher strength. Compared to other fast degrading materials, the RapidSorb polymer has been chosen to support strength retention for at least 8 weeks while keeping the advantage of a fast degradation. Synthes 5

8 Surgical Technique 1 Select plates and tacks Instruments Water Bath System (230 V) Water Bath System (115 V) RapidSorb Implants S S S Tack 1.5 mm, RapidSorb, length 4 mm, sterile, pack of 2 units Tack 1.5 mm, RapidSorb, length 4 mm, sterile, pack of 4 units Tack 1.5 mm, RapidSorb, length 4 mm, sterile, pack of 10 units Select plates and tacks required for the corresponding indication. If substantial plate bending is required, contour the plates using the Synthes Water Bath System. 6 Synthes RapidSorb Resorbable Tacks

9 2 Drill the first hole Instruments Handle, medium, with Mini Quick Coupling Drill Bit 1.5 mm with Stop, for Resorbable Tacks, length 45/4 mm, for J-Latch Coupling or Drill Bit 1.5 mm with Stop, for Resorbable Tacks, length 52/4 mm, for Hexagonal Coupling 1.5 mm 1.6 mm Drill the hole with the drill bit matching the diameter of the respective tack. A 1.5 mm tack with its 1.6 mm outer diameter and 1.3 mm core diameter is designed to anchor securely in a hole drilled with a 1.5 mm drill bit. Synthes 7

10 Surgical Technique 3 Pick up tack Instrument Tackdriver, self-holding, for Resorbable Tacks or Tackdriver, automatic, self-holding Self-holding tackdriver: Lightly press the tip of the tackdriver onto the tack; if the tack is not picked up immediately, gentle movements back and forth will help anchor the tack securely. 8 Synthes RapidSorb Resorbable Tacks

11 4 Insert the tack Instrument Tackdriver, self-holding, for Resorbable Tacks or Tackdriver, automatic, self-holding Insert the tack through the plate into the predrilled hole and fix with slight pressure. When using the tackdriver with the holding sleeve, the holding sleeve must be retracted before the tack is fixed completely. Place the first tack on the mobile fragment. Repeat steps 2 to 4 for the other tacks. Note: The insertion of the tacks requires the application of axial pressure which can lead to fragment shifting or, in extreme cases, to bone damage. Careful assessment of the indication is therefore essential, and a risk-benefit analysis must be performed by the surgeon in each case. 5 Emergency fixation Instruments Handle, medium, with Mini Quick Coupling Tap for Resorbable Cortex Screws 2 mm, self-drilling Screwdriver Shaft 2.0, cruciform, with Holding Sleeve, for Mini Quick Coupling For emergency fixation, the inserted tack and existing hole can be over-drilled by using a 2.0 mm self-drilling tap and a 2.0 mm screw can be inserted. Synthes 9

12 Ordering Information Instrument tray insert for tacks Resorbable Tack System Insert for Instrument Tray for Resorbable Tacks Mini Module for Instrument Tray for Resorbable Tacks Instruments Handle, medium, with Mini Quick Coupling Drill Bit 1.5 mm with Stop, for Resorbable Tacks, length 45/4 mm, for J-Latch Coupling Drill Bit 1.5 mm with Stop, for Resorbable Tacks, length 52/4 mm, for Hexagonal Coupling Tackdriver, self-holding, for Resorbable Tacks Tackdriver, automatic, self-holding Water Bath System (230V) Water Bath System (115V) Instruments for Emergency Fixation Handle, medium, with Mini Quick Coupling Tap for Resorbable Cortex Screws 2 mm, self-drilling Screwdriver Shaft 2.0, cruciform, with Holding Sleeve, for resorbable fixation system, for Mini Quick Coupling 10 Synthes RapidSorb Resorbable Tacks

13 RapidSorb Implants S S S Tack 1.5 mm, RapidSorb, length 4 mm, sterile, pack of 2 units Tack 1.5 mm, RapidSorb, length 4 mm, sterile, pack of 4 units Tack 1.5 mm, RapidSorb, length 4 mm, sterile, pack of 10 units Synthes 11

14 Bibliography 1 Kleinsasser NH, Wild PJ, Perez Alvarez JC, et al. (2007) Extrusion forces of resorbable tacks and titianium screws in laryngeal chondrosynthesis. Eur Arch Otorhinolaryngol 264(4): Al-Shukun J, Törnwall J, Lindqvist C, et al. (2006) Bioresorbable Poly-L/DL-lactide (P[L/DL]LA 70/30) plates are reliable for repairing large inferior orbital wall bony defects: a pilot study. Am Assoc Oral Maxillofac Surg 64: Landes CA, Ballon A, Roth C. (2006) In-patient versus in vitro degradation of P(L/DL)LA and PLGA. J Biomed Mater Res B Appl Biomater 76B: Landes CA, Ballon A, Roth C. (2006) Maxillary and mandi - bulary osteosyntheses with PLGA and P(L/DL)LA implants:a 5-year inpatient biocompatibility and degradation experience. Am Soc Plast Surg 117(7): Landes CA, Kriener S, Menzer M, et al. (2003) Resorbable plate osteosynthesis of dislocated or pathological mandibular fractures: a prospective clinical trial of two amorpohous L-/DL-Lactide Copolymer 2-mm Miniplate Systems. Am Soc Plast Surg 111(2): Landes CA, Kriener S, Menzer M. (2003) Resorbable plate osteosynthesis of sagittal split osteotomies with major bone movement. Am Soc Plast Surg 111(6): Synthes RapidSorb Resorbable Tacks

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16 Synthes GmbH Eimattstrasse 3 CH-4436 Oberdorf All technique guides are available as PDF files at Ö öAA{ä SE_ AA /2009 Synthes, Inc. or its affiliates All rights reserved Synthes and RapidSorb are trademarks of Synthes, Inc. or its affiliates