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00001665-201103000-0000800001665_2011_22_395_pietrzak_bioabsorbable_2editorial< 139_0_14_5 >Journal of Craniofacial Surgery© 2011 Mutaz B. Habal, MDVolume 22(2)March 2011pp 395-401First Bioabsorbable Fixation System in Craniofacial Surgery on the 15th Anniversary of Its US Utility[Special Editorials]Pietrzak, William S. PhD*†; Habal, Mutaz B. MD, FRCSC, FACS‡From the *Biomet, Inc, Warsaw, Indiana; †Department of Bioengineering, University of Illinois at Chicago, Chicago, Illinois; and ‡Tampa Bay Craniofacial Center, Tampa, Florida.Received December 1, 2010.Accepted for publication December 3, 2010.Address correspondence and reprint requests to William S. Pietrzak, PhD, Biomet, Inc, 56 E Bell Dr, Warsaw, IN 46582; E-mail: billsp@uic.eduAll trademarks herein are the property of Biomet, Inc, or its subsidiaries unless otherwise indicated. PDS® and Craniosorb® are trademarks of Johnson & Johnson Co. Poly Surgiclip® is a trademark of US Surgical Corp. FRP™ is a trademark of Macropore, Inc. Delta™ is a trademark of Stryker, Corp. CPS® is a trademark of Inion Ltd. Resorb-X™ is a trademark of KLS-Martin, LP. Biosorb™ is a trademark of Linvatec. Synthes® is a trademark of Synthes, Inc.The authors report no conflicts of interest.On a cold, gray weekend in March 1996, a group of pioneering craniofacial surgeons from around the country convened in northern Indiana to participate in a historic event: the release of the first commercially available bioabsorbable craniofacial fixation system in the United States. The system, under development for several years, had just received 510(k) clearance from the US Food and Drug Administration (FDA), and the time was ripe to present craniofacial surgeons with a new treatment option that was heretofore not available. One focus was also on its utility for craniofacial surgery in children. From these humble beginnings, the LactoSorb system (Biomet, Inc, Warsaw, IN) was born, has since evolved, flourished, and now coexists with several other bioabsorbable systems, which, collectively, are an essential part of the craniofacial surgeon's armamentarium. The authors, who participated with many others in the development of this system, commemorate its 15th anniversary by reflecting on its early beginnings, how the field has grown, and what may lie ahead.THE EARLY YEARS: 1991-1997Material SelectionBioabsorbable craniofacial fixation was a paradigm shift 15 years ago. Providing temporary internal fixation until healing occurred, with the implant gradually hydrolyzing and being metabolized until nothing remained, stood in stark contrast to the historical method of using permanent metal hardware, which, while effective, could require removal in certain situations.1-3 Indeed, the unique aspects of fixation of the growing pediatric cranium alone provided sufficient justification for bioabsorbable fixation in this region of the anatomy.4,5Although bioabsorbable fixation is commonplace today, it was in its infancy in the early 1990s.6-8 At that time, only a small number of orthopedic companies had bioabsorbable product offerings such as pins, screws, suture anchors, and tacks, with the predominant polymers being poly-l-lactic acid (PLLA), polyglycolic acid (PGA), or polydioxanone.9 In the orthopedic skeleton, PGA was found to have a high incidence of tissue reaction believed to be due to its rapid hydrolysis and local accumulation of acidic degradation products. Polydioxanone is the material from which PDS suture is made. Although high flexibility at body temperature is important for suture function, this property is not ideal for use in rigid internal fixation. A limited amount of craniofacial clinical work using PLLA devices had been reported in Europe in the early 1990s.10,11 However, late-stage inflammatory reactions were found several years after implantation because of the release of degradation-resistant polymer crystals.10 Consequently, it was important to start at the beginning and choose an appropriate material for the craniofacial skeleton.Custom synthetic bioabsorbable polymers are specialty products, and a great deal of chemical expertise and equipment are required for their large-scale synthesis. In the 1990s, only a few major companies, worldwide, had this capability. One was US Surgical Corporation (USSC, Norwalk, CT). US Surgical Corporation was a leader in laparoscopic surgery and developed, manufactured, and marketed several types of bioabsorbable sutures and devices. In 1991, Biomet entered into a joint development agreement with USSC, obtaining access to their spectrum of proprietary bioabsorbable polymer technology. Among the many formulations USSC developed, one, in particular, stood out. It was a patented copolymer of 82% PLLA and 18% PGA.12 This material had an extensive, nearly decade-long, clinical history in the form of a bioabsorbable ligating clip called the Poly Surgiclip.13 This material was trademarked as LactoSorb copolymer by Biomet. It retained approximately 70% of its initial strength for 6 to 8 weeks with complete mass loss within approximately 9 to 15 months. As a substantially amorphous (noncrystalline) copolymer, it was very biocompatible and seemed well suited for craniofacial indications.Early TestingAlthough the 82:18 PLLA/PGA copolymer already had an extensive clinical history and had passed tripartite biocompatibility testing required by the FDA,14 a series of animal studies were performed to ensure that fixation devices would retain sufficient strength long enough for healing to occur. These included studies of rabbit plate and screw cranial fixation,15-18 pig frontal and infra-orbital rim fixation using plates fixed to the bone with cyanoacrylate adhesive,19 dog diaphyseal and metaphyseal long bone screw fixation,20 and goat ligament to bone rivet fixation.21 All tissues healed uneventfully without a pronounced inflammatory response, with the implant material completely gone by approximately 9 to 15 months. In vitro studies were performed by placing devices in pH 7.4 buffer at 37°C for prescribed time intervals and then removing them and performing mechanical testing. Such testing demonstrated substantial strength retention for 6 to 8 weeks or longer.22,23System DevelopmentThe clinical system was initially developed with input from Dr Barry Eppley (Indianapolis, IN). Coincident with this, Biomet was developing a LactoSorb hand plating system that was very similar to the craniofacial system.24 As such, there was synergy between the orthopedic and craniofacial realms, so clinical input was available from multiple sources. The key was to have the bioabsorbable system mimic metal systems as much as possible to minimize the clinical learning curve and maximize acceptance. As such, many of the implants resembled their metal counterparts, that is, screws, geometric plates of various designs, and mesh panels. Specifically, the system included 1.5- and 2.0-mm plate/screw/mesh systems as well as 2.5-mm screws. The 2.5- and 2.0-mm screws could be used as emergency screws for the 2.0- and 1.5-mm systems, respectively. Also, instrumentation was taken directly from the Walter Lorenz Surgical (Jacksonville, FL, now Biomet Microfixation) metal fixation system and used as is, if possible, or modified as necessary for use with the LactoSorb system.Nevertheless, the significant material differences between bioabsorbable polymers and metals demanded some departure from metal technique. For instance, (1) it was necessary to provide a clinically friendly method to heat the plates to soften them for adaptation to bone. A water-activated chemical (calcium chloride) heat pack was developed for this purpose.9 The benefits included portability and no electrical requirements at the expense of a limited operating time. However, their low cost enabled multiple units to be used per procedure, if necessary. (2) The plates needed to be machined in a manner to be free of internal stresses or else they could distort when heated, making adaptation difficult. A machining cycle was developed to produce stress-free plates so that, on heating, they would remain dimensionally stable. (3) Bioabsorbable polymers have mechanical properties that are approximately 2 orders of magnitude less than those of metals. As such, it was important to maximize screw strength through thread design as well as polymer orientation. A buttress thread was used to increase the thread thickness and enhance strength (Fig. 1). Furthermore, the screws were machined from rod stock that had been "drawn" to orient the polymer chains in the direction of the screw long axis. This increased the tensile as well as the shear and bending strength of the screws. The appropriate draw ratio had to be established to maximize screw strength but not cause delamination of the polymer. Plate strength was enhanced by providing a ridge along the outer geometry to improve stiffness while minimizing mass, similar to the concept of an I-beam (Fig. 2). (4) Tapping is more of a necessity for bioabsorbable screws than for metal screws because the former do not possess the strength to be self-tapping in bone. Also, proper tapping technique is critical to maximize screw holding strength because bioabsorbable screws typically have a shallow thread depth. Finally, (5) it is important to not overtorque a bioabsorbable screw to avoid screw damage. The screw was designed to include an auxiliary break-off hex head such that, when the screw was fully seated, it would twist off (Fig. 1). Consequently, the twist-off torque had to be substantially greater than the screw insertion torque.FIGURE 1. LactoSorb craniofacial screw showing the buttress thread design and the breakaway auxiliary hex head.FIGURE 2. Representative LactoSorb plate showing the side ridges used to enhance stability and stiffness.Coincident with system development, patent work was undertaken, which covered aspects of implant design,25,26 heating and shaping implants,25,26 heat packs,27 and polymer processing.28First Clinical Use of the LactoSorb SystemEppley and Sadove18 performed the first clinical cases using the LactoSorb system, publishing their results in 1995. LactoSorb plates, 4 mm wide and 0.5 mm thick, were placed in 20 infants with craniosynostosis after osteotomies and repositioning. Because the development of the polymer screws was not yet complete at this time, metallic microscrews were used to attach a total of 231 plates to bone. At 12 months after surgery, no complications were noted. In addition to providing fixation to bone, the metallic screws also served as radiographic markers.510(k) SubmissionThere are 2 regulatory pathways to market a medical device in the United States. (1) If there is already a similar (predicate) device on the market, then a 510(k) application can be submitted to the FDA showing "substantial equivalence." On successful review by the FDA, the new device will be "cleared" for marketing. In general, a clinical study is not required but may be in certain situations. (2) If a predicate device does not exist, then the regulatory pathway is via Premarket Approval (PMA), which always involves a clinical study to show that the device is "safe and effective." Successful review by the FDA results in the device being "approved." Typically, the 510(k) route is simpler and quicker than the PMA route.It might be expected that because there was no bioabsorbable craniofacial system predicate device at the time, the PMA route would have been required. However, there were obviously metal systems being used that were similar in form and function to the LactoSorb system and had the same indications being sought for the latter. So showing that the LactoSorb system had similar initial (time zero) biomechanical properties to metal systems,22-24,29 with an appropriate strength loss profile,22,23 bolstered with in vivo fixation studies in animal models,15-21 showed strong similarity with 1.0- and 1.5-mm titanium systems from Walter Lorenz Surgical, Inc. In addition, an investigational device exemption was submitted to the FDA describing a randomized, controlled, clinical study comparing the LactoSorb system with these metal systems. This was approved, enabling the study to begin.A mutlticenter, randomized, investigational device exemption clinical study was initiated in November 1994 to investigate the fixation of midfacial fractures. The treatment population received the LactoSorb system, whereas the control population received fixation from the Lorenz 1.0- and 1.5-mm titanium systems. In all, 110 LactoSorb plates and 467 screws were implanted in 51 treatment patients (84.3% male; mean age, 33 y; range, 17-58 y) and 144 titanium plates and 646 screws were placed in 49 control patients (79.6% male; mean age, 32 y; range, 18-60 y). Patients were clinically assessed at 2 weeks and at 1, 3, and 6 months and radiographically at 2 weeks and 6 months. Six-month data were available for 36 LactoSorb and 38 metal patients. Radiographically, all fractures were stable, without displacement, in both groups at 6 months, or longer, without signs of nonunion. Fracture lines remained evident in both groups at 6 months. At 3 months, LactoSorb and metal devices were palpable in 49% and 55% of patients, respectively. At 6 months, however, these values were 11% and 63%, respectively. There were 5 complications in the LactoSorb group, namely: (1) 2-week wound dehiscence that resolved by 3 months after surgery; (2) erythema at 2.5 weeks that resolved by 1 month after surgery; (3) superficial wound infection at 4.5 months, which was treated with antibiotics and resolved after 48 hours; (4) deep infection at 3 weeks treated with irrigation and debridement, multiple tooth extractions, and antibiotics, which resolved by 3 months after surgery; and (5) wound dehiscence with a small granuloma that resolved after cauterization with silver nitrate and use of antibiotics. There were 3 complications in the metal group, namely: (1) a deep infection at 8 weeks requiring intravenous antibiotics and drainage, resolving at 3 months after surgery; (2) a deep infection at 5 months requiring revision surgery to remove the orbital floor implant; and (3) a superficial infection at 2 weeks requiring drainage and intravenous antibiotics for resolution. As the data indicate, essentially the same clinical results were obtained with both systems.The 510(k) (no. K955729) for the system was submitted on December 15, 1995, with the system cleared on February 14, 1996, with the following indications: 1. Comminuted fractures of the naso-ethmoidal infraorbital areas 2. Comminuted fractures of the frontal sinus wall 3. Trauma of the midface or craniofacial skeleton 4. Reconstructive procedures of the midface or craniofacial skeletonFrom a regulatory standpoint, this first 510(k) clearance was a milestone in that it established a predicate bioabsorbable craniofacial system that would help facilitate future submissions by Biomet, as well as those from other companies as they began their own forays into this type of technology.Product Rollout and the Circle of SurgeonsWhen introducing any new medical technology, it is always prudent to start with a limited release and then gradually expand to more users. This is because of considerations including (1) product availability, (2) distribution limitations, (3) training requirements, and, perhaps most importantly, (4) making sure that the product continues to function in the field as expected.The initial goal was to expand the system to 15 to 20 surgeons before full release. Through discussion with individual surgeons, it became apparent that although most, if not all, saw the utility of a bioabsorbable craniofacial system, some opted to wait until peer-reviewed publications documenting outcomes were available before they would use it clinically, whereas others expressed a desire to be among the first users, help the system evolve, and publish the results of their efforts. Although both approaches are valid, it was the latter group who formed the initial core, called the Circle of Surgeons. This was a heterogeneous group of MDs, DMDs, and DDSs with each surgeon bringing his own unique perspective to the table. All shared high enthusiasm for the technology and desired to take a careful, systematic, scientific approach to its use.The first Circle of Surgeons meeting convened in Warsaw, IN, at Biomet's corporate headquarters for a weekend symposium in March 1996 (Fig. 3). The first day included presentations by corporate scientists, engineers, and regulatory personnel on basic bioabsorbable material science, animal studies, description of the system, and a summary of the clinical study and cleared indications. This was followed by presentations from surgeons who had participated in the clinical study, conveying their results and tips for using the system efficiently. Finally, several hours were spent in a multistation human head cadaver laboratory, where the new surgeons could learn the nuances of the system and gain hands-on experience. The next day, after the group had a chance to sleep on it, there were many excellent questions and issues that were raised and discussed. However, it was heartening that, in general, the surgeons felt that the system was well thought out, and there did not seem to be any major roadblocks to its release to them and moving forward. The session ended with the following conclusions: (1) bioabsorbable fixation would not supplant metallic fixation in the craniofacial skeleton, but rather, would complement it, and would be especially useful in pediatric craniofacial surgery; (2) new surgeons must be trained on the system before it would be released to them; (3) the Circle of Surgeons and corporate personnel would meet, as a group every 6 months or so to advance the technology and its utilization; and (4) in 1 year, the Journal of Craniofacial Surgery would publish an issue devoted to the clinical experience with the LactoSorb system.FIGURE 3. Surgeons attending the first Circle of Surgeons meeting and symposium in Warsaw, IN, March 1996. Back row (left to right): Louis N. Morales, Jr; Robert M. Kellman; N/A; Mark W. Ochs; Barry L. Eppley; Michael M. Mayer; Norman J. Cavanagh; Christopher M. Duma; Robert J. Wood; Steven M. Sullivan. Front row (left to right): Edward N. Ellis III, Myron R. Tucker, Mutaz B. Habal, Peter D. Waite, Dean M. Toriumi, Gregory C. Rinehart, Jay M. Pensler, Jeffrey A. Goldstein, Paul M. Glat.As the Circle members gained clinical experience, regional surgeon training workshops were set up across the county with 5 to 10 surgeons per workshop not uncommon. The workshops were set up as a mini version of the weekend symposium and lasted half a day. Critical to the workshops was to have a Circle surgeon participate. Owing to transportation and facilities issues, human cadaver heads were not used in these laboratories. Rather, pig heads were found to be an effective substitute. The laboratories were always the highlight of the workshops, with the attendees and presenters interacting and, in many ways, learning from each other. For example, the authors traveled to Miami in Fall 1996 and both gave the inaugural address for the surgeons there at the University of Miami under the leadership of the new chairman of plastic surgery, Dr Seth Thaller, who introduced the topic as a breakthrough in craniofacial skeletal fixation and a big leap to the future as he himself was one of the major researchers in the field of bioabsorbables.The Journal of Craniofacial Surgery (March 1997)One year after the initial symposium, the March 1997 (vol. 8, no. 2) issue of The Journal of Craniofacial Surgery published 8 clinical and 3 technical articles regarding the LactoSorb system.9,15,22,30-37 Altogether, this represented 149 patients, with more than half being pediatric. All surgeries were performed in the mid and upper craniofacial skeleton with the exception of 1 case of repair of a fractured mandible.31 Follow-up was typically 6 months (range, 2 d to 2 y). There were no fixation failures necessitating repeated surgery. Two cases of infection/redness/edema were noted, which resolved with antibiotics.31,35 One case did require repeated surgery because of a screw hex head being inadvertently left in situ.37 It was clear that the system was working as intended. Overall, these studies collectively provided excellent validation of the system.1998 TO PRESENTA great deal has occurred in the field of bioabsorbable craniofacial fixation over the years, which could easily fill the pages of an entire book. To look at the field at large, however, we will take the 30,000-ft view and briefly examine major trends.As relates to the LactoSorb system, there have been several enhancements with the addition of new plate and screw designs, heating and shaping equipment, instruments, and indications. As relates to the field as a whole, other changes are also evident.The clinical use of bioabsorbable craniofacial fixation has grown tremendously, 1 indication being the number of companies that now offer complete fixation systems in the United States. Table 1 lists some of these companies, with information about the type of material used and some of the implants. Note that many factors affect the degradation characteristics of these polymers so the values in Table 1 should be taken as representative and for comparison purposes only. It is apparent that (1) all materials are a combination of 2 or more types of α-hydroxy acid monomers, which reduces, or eliminates, crystallinity in the polymer and should lessen concern of inflammatory reactions as well as provide the ability to tailor the polymer to specific requirements; (2) strength retentions from weeks to months are cited, which should be sufficient for healing; and (3) mass loss occurs within 2 to 3 years or less, so there should be no long-term consequences as can occur with permanent implants.TABLE 1. Summary of Bioabsorbable Craniofacial Fixation Systems in the United StatesTABLE 1. ContinuedOver the years, bioabsorbable fixation has become the dominant fixation mode for certain procedures such as reconstruction of the pediatric cranial vault.50,55 New bioabsorbable devices have been developed to address other applications such as orthognathic surgery56,57 and endoscopic brow lift fixation.58 Bioabsorbable distraction of the mandible and midface was not even contemplated 15 years ago but is available today.59,60 Although screws remain the most common method of attaching plates and meshes to bone, the tapping requirement has lead to the development and investigation of "tapless" devices such as bioabsorbable tacks61,62 and rivets.63 Aldana et al64 have described a tapless device that is ultrasonically welded to bone to provide plate fixation.By now, bioabsorbable fixation in the craniofacial skeleton has become relatively commonplace, hence some of the original sense of novelty and newness has subsided. Nevertheless, this technology has not reached the stage of being a commodity and, perhaps, never will. Each system from the various manufacturers offers different polymers, implant designs, and delivery systems and they are not interchangeable. As such, there is a continued need for surgeons not only to learn the features of the various systems in terms of available designs and instrumentation but also to fundamentally understand the differences in the various polymers available and how they interact with the body so that an informed clinical decision can be made.THE FUTUREIt is always difficult to prognosticate about future advances in medicine. As to the future of bioabsorbable craniofacial fixation, developments in material science will help fuel additional clinical applications, whereas new clinical needs will help drive materials development. It is not so much as a matter of which comes first because both will undoubtedly occur together.From the materials side, we may consider that all existing systems use "conventional" materials composed of polymers of α-hydroxy acids. As such, we may define "unconventional" materials as α-hydroxy acid-based polymers incorporating other materials or other types of polymers entirely. For instance, α-hydroxy acid-based polymers have been modified to provide increased strength through fiber reinforcement and incorporation of bioactive ceramics65 and to release antibiotics,66,67 antiosteolytic agents,68 or various humoral agents such as insulin-like growth factor 1 and recombinant human bone morphogenetic protein 2.69 Theoretically, these modifications could promote bone healing and reduce complications, thereby improving outcomes. Challenges would include making sure that these materials are amenable to standard manufacturing methods and that any bioactive properties would not diminish during implant processing and fabrication. Also, it would likely be more difficult to gain FDA clearance or approval for combination devices that contain drugs or bioactive agents. As regard non-α-hydroxy acid-based polymers, poly(ortho esters) have been around a long time and degrade by surface erosion rather than the bulk hydrolysis that the conventional materials undergo,70 but the benefits of this type of material for internal fixation must await further study. Finally, it is possible that future bioabsorbable fixation devices might not be based on polymers at all. For instance, magnesium-based metals biodegrade in the body and have been studied since the early 1900s, including a small amount of clinical use for osteosynthesis.71,72 Currently, there are no such systems on the market, but interest in this technology remains.Future developments do not necessarily depend on advancements in material technology but are sure to include refinements of current (conventional) technology in implant designs and new indications. In any event, the envelope is sure to expand considerably in the coming years. We can stress the fact that craniofacial bioabsorbable fixation is here to stay and will continue to flourish. Individual systems may come and go, but the principle of needing fixation only until the bone heals will remain and that is what such systems provide. Finally, the standard of care for craniofacial fixation in infants and children is bioabsorbable, and this is unlikely to change in the foreseeable future.CONCLUSIONSWe attempted to (1) cast the early development of the first FDA-cleared craniofacial bioabsorbable fixation system in a historical context, (2) look at developments that have occurred since then, especially as relates to standard of care for infants and children, and (3) speculated about the future. Of course, we can only be sure about the first two and must await the future to see what it brings. However, as engineers, scientists, and clinicians, it is up to us to create the vision and make it happen. The future lies in our hands and patients depend on it!ACKNOWLEDGMENTSThe authors acknowledge David R. Sarver for design and development work on the LactoSorb system and Mary L. Verstynen for guidance and direction in regulatory matters.REFERENCES1. Berryhill WE, Rimell FL, Ness J, et al. 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Anniversary of Its US UtilityPietrzak, William S. PhD; Habal, Mutaz B. MD, FRCSC, FACSSpecial Editorials222