Original Investigation

Nylon Foil (Supramid) Orbital Implants in Pediatric Orbital Fracture Repair Peter J. Timoney, M.D., M.R.C.Ophth*, Mark Krakauer, M.D.†, Byron N. Wilkes, M.D.‡, H. B. Harold Lee, M.D.§, and William R. Nunery, M.D., F.A.C.S.†§ *Department of Ophthalmology, Oculofacial Plastic and Orbital Surgery, University of Kentucky; †Department of Ophthalmology, Oculofacial Plastic and Orbital Surgery, University of Louisville; ‡Department of Ophthalmology, Oculofacial Plastic and Orbital Surgery, University of Tennessee; and §Department of Ophthalmology, Oculofacial Plastic and Orbital Surgery, Indiana University

Purpose: To present the authors experience with the nylon foil (Supramid) implant as a safe and effective method to repair pediatric orbital wall fractures. Methods: A retrospective chart review of all pediatric patients (≤18 years) that underwent orbital wall fracture repair with an unsecured 0.4-mm Supramid implant between 2007 and 2010. Outcome variables were diplopia and surgical complications. This study was carried out with IRB approval. Results: A total of 59 orbits in 57 patients underwent orbital fracture repair using solely the 0.4-mm Supramid implant that were included in this retrospective chart review with the average age being 12 years. Trauma related to daily activities (42.1%) was the most frequent cause of orbital fractures. Eight patients (14.0%) had associated ocular/orbital injuries. Thirty-one patients (54.8%) were symptomatic at presentation with the most common presenting symptom being diplopia (n = 19, 33.3%). The most common fracture pattern sustained was combined orbital floor and medial wall fractures, which occurred in 21 patients (36.8%). Of the 3 patients (5.3%) that required immediate intervention due to extraocular muscle entrapment resulting in vasovagal responses, all returned to full and normal extraocular motility. There were 2 postoperative complications without any permanent sequelae; no patient developed postoperative enophthalmos recognizable by both physician and parents, and diplopia improved in all the 6 patients who suffered from immediate postoperative diplopia (10.7%). Conclusions: The nylon foil implant is a safe and effective method to repair pediatric orbital wall fractures given the low complication rate. (Ophthal Plast Reconstr Surg 2014;30:212–214)

A

dult orbital fracture repair is well detailed in the literature, but little is published regarding orbital fracture management in the pediatric population. Alloplastic implant materials have largely supplanted autogenous grafts as the

Accepted for publication October 9, 2013. Presented at the American Society of Ophthalmic Plastic and Reconstructive Surgery Spring Meeting, Aspen, Colorado June 2010 by Peter Timoney, Matthew Hauck, H. B. Harold Lee, William Nunery. The authors have no financial or conflict of interest to disclose. Address correspondence and reprint requests to Peter Timoney, M.D., Department of Ophthalmology, Kentucky Clinic, University of Kentucky, 740 South Limestone St., Lexington, Kentucky 40536. E-mail: peterjtimoney@ gmail.com DOI: 10.1097/IOP.0000000000000051

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primary choice in orbital fracture repair, due to the ease with which they are manipulated and inserted in the orbit and the sturdy support that they impart to the orbital tissue. There exist both porous and nonporous alloplastic implants. Nylon foil (Supramid) is a relatively inert nonporous implant that provides excellent and predictable structural support to the fractured orbital wall with no tissue incorporation. In this retrospective study, the authors present their experience with the repair of pediatric orbital fractures using the 0.4-mm Supramid implant and stress the importance of timely indicated surgical repair of such fractures to prevent both aesthetic and functional deficits.

METHODS A retrospective chart review was performed of all pediatric patients (18 years of age or less) who underwent orbital wall fracture repair with an unsecured 0.4-mm Supramid implant between July 2007 and October 2010 (Table). Medical records were reviewed to confirm the presence of an orbital fracture and to identify demographic information along with the mechanism of injury, any associated injuries, examination at presentation, and the postoperative clinical course. Fracture location was determined from radiologic studies and the operative report. This study was conducted in accordance with the guidelines of the Institutional Review Board. Orbital floor fractures were repaired using a lateral canthotomy and cantholysis with a transconjunctival approach. The inferior orbital rim periosteum was incised with a #15 blade and separated from bone with a periosteal elevator. Periosteum was not sutured, and the inferior palpebral conjunctiva was closed using interrupted 6-0 mild chromic gut sutures. Medial wall fractures were repaired with a medial orbitotomy technique that consisted of an approximately 1-cm vertical incision just anterior to the medial canthal tendon.1 The medial canthus was closed with a 4-0 polyglactin suture that engaged the medial periosteum, the medial canthal tendon, and the skin to prevent webbing. The skin was closed with interrupted 6-0 mild chromic sutures. Orbital roof fracture repair was approached through an upper eyelid crease incision. A 0.4mm Supramid implant was well positioned in each case, covering the entire fracture area after complete exposure of the fracture and elevation of all herniated orbital soft tissue in its normal anatomical location. No rigid or porous implants were used within the orbit, and the implants were not secured with sutures, rigid rim fixation devices, or adhesives. Combined orbital floor and medial wall fractures were repaired with a single 0.4-mm Supramid implant using a “­ wrap-around” technique.2 Follow up ranged from 1 to 21 months with the average follow up being 4.6 months. Thirty-six patients (63.2%) followed up for ≥ 3 months and 24 patients (42.1%) following up for ≥ 5 months. All but 1 patient returned for the first postoperative examination within the first week.

Ophthal Plast Reconstr Surg, Vol. 30, No. 3, 2014

Ophthal Plast Reconstr Surg, Vol. 30, No. 3, 2014

Nylon Foil (Supramid) Orbital Implants

Various patient characteristics Patient characteristics

Results

Number of patients/eyes Age range (y) Most frequent cause of orbital fractures Number of patients with associated ocular/orbital injury Patients with other associated facial fractures Mean time to surgery (d)

57/59 1–18 Trauma (42.1%) 8 (14%) 13 (22.8%) 6.7 d

RESULTS A total of 59 orbits in 57 patients, representing 28 right and 31 left orbits with 2 bilateral cases, who underwent orbital fracture repair using solely the 0.4-mm Supramid implant were included in this retrospective chart review. Surgical repair in 49 of the 57 patients (86%) was carried out within 2 weeks after the initial injury with the mean time between the sustained trauma and surgery being 6.7 days. Eight of the 57 patients (14%) underwent delayed surgical repair (up to 27 days postinjury) secondary to concomitant ocular and/or medical issues and delayed presentation. The age range of patients was 1 to 18 years of age with the average age being 12.0 years. The cause of the orbital fractures included trauma related to daily activities in 24 patients (42.1%), motor vehicle accidents in 16 patients (28.1%), assault related injuries in 10 patients (17.5%), and sports related injuries in 7 patients (12.3%). Four patients (7.0%) sustained orbital rim fractures that were reduced and plated with titanium plates, and 13 patients (22.8%) suffered other concomitant craniofacial fractures that were also repaired surgically (zygomaticomaxillary complex fractures: n = 7, LeForte fractures: n = 2, nasal fractures: n = 3, frontal bone fractures: n = 2, and mandibular fractures: n = 1). Eight patients (14.0%) had associated ocular/orbital injuries, which included hyphema (n = 2), commotio retinae (n = 2), traumatic ptosis (n = 1), traumatic optic neuropathy (n = 1), ruptured globe (n = 1), and an eyelid laceration (n = 1). Of the 57 patients, 21 patients (36.8%) sustained combined orbital floor and medial wall fractures, 20 patients (35.1%) sustained an isolated orbital floor fracture, 5 patients (8.8%) suffered an orbital roof fracture either isolated or associated with other facial fractures, 7 patients (12.3%) suffered an isolated medial wall fracture, and 7 patients (12.3%) sustained zygomaticomaxillary complex and floor fractures. In calculating preoperative and postoperative diplopia percentages (except in those requiring immediate intervention due to symptomatic extraocular muscle entrapment from trapdoor fractures), the patient suffering from a severely ruptured globe was omitted. Thirty-one patients (54.4%) were symptomatic at presentation with the most common presenting symptom being diplopia (n = 19, 33.9%), followed by pain on eye movement (n = 11, 19.3%). Six patients suffered from immediate postoperative diplopia (10.7%), which improved in all patients within a few weeks postoperatively with residual diplopia in 3 patients; 2 of these 3 patients displayed diplopia in extreme upgaze (present at their last recorded follow up; > 6 months), and another suffered from neurogenic damage. Of the 3 patients (5.3%) that required immediate intervention due to symptomatic extraocular muscle entrapment from trapdoor fractures, all returned to full and normal extraocular motility. One patient suffered from minimal lateral canthal dystopia that the patient and parents deemed cosmetically acceptable and did not proceed with any further surgical intervention. One patient did experience a retrobulbar hemorrhage within hours after medial wall fracture repair with Supramid implant placement that may have resulted from an episode of intensive postoperative vomiting. He underwent exploratory surgery in which the Supramid implant was removed and subsequently replaced 1 week later. He did not develop optic neuropathy or any signs of compartment syndrome. There were no intraoperative complications, and no patient developed recognizable postoperative enophthalmos in all reviewed

cases. In those patients that had Hertel measurements performed, preoperative and postoperative assessments were similar.

DISCUSSION Facial fractures are uncommon injuries in the pediatric population,3–5 and orbital fractures represent 3% to 45% of all pediatric facial fractures.4–10 Frequently referenced causes of pediatric craniofacial fractures are falls and motor vehicle accidents.4,6,8–10 This case series correlates closely with trauma related to daily activities, leading to orbital fractures in 24 patients (42.1%), and motor vehicle accidents being the cause of the fracture in 16 patients (28.1%). The orbital floor was involved in 71.9% of the pediatric fractures in this case series, which is in agreement with several published series that describe the frequent involvement of the orbital floor in pediatric orbital fractures.11,12 The published data on the location of orbital fractures in children vary greatly. These findings are in contrast with an orbital fracture series published by Koltai et al.10 in which orbital roof fractures were more common. Pneumatization of the frontal sinuses, which is incomplete below 7 years of age, dissipates the energy absorbed by head trauma and therefore decreases the risk of orbital roof fractures in adults. With the average patient age being 12 years, frontal sinus pneumatization along with an increase in facial size may lead to an increased incidence of orbital floor fractures as seen in this retrospective study. Ocular injury is common in the setting of adult orbital fractures with scant published reports documenting the incidence of concomitant ocular injuries in pediatric orbital fracture patients. In this case series, 8 patients (14%) had a concurrent ocular/orbital injury. In the adult population, there continues to be some controversy over the benefit of acute repair of pure orbital fractures versus observing for several weeks until the resolution of periorbital edema to determine whether surgical repair is warranted. The pediatric population may benefit from early orbital fracture surgical repair.13,14 Eighty-six percent of these patients underwent surgical fracture repair within 2 weeks, and on review of this data, fracture repair occurring within 2 weeks of the initial insult leads to a very favorable clinical outcome. Most patients presented early, and therefore, the fracture repair when indicated was performed in a timely manner. Those patients that did present late had excellent outcomes. The authors believe in timely orbital fracture repair if indicated to restore the globe to a normal position and full ocular motility along with lessening the risks of cicatrix on surgical repair. These results are consistent with previous published reports that incorporated a broader age range. Nunery et al.2 reported that 81.6% of patients underwent surgical fracture repair of combined orbital floor and medial wall fractures with Supramid within 5 to 10 days. Park et al.15 demonstrated the effectiveness of Supramid in orbital fracture repair when the median interval between date of injury and surgical repair was 8 days (age range, 3–80 years). Pediatric cases demonstrating clinical muscle entrapment, whereby an extraocular muscle is incarcerated in a “trapdoor” fracture with possible consequential ischemia and subsequent loss of muscle function, require immediate fracture repair, and with such timely surgical intervention, these cases exhibit excellent clinical outcomes. The 3 patients (5.3%) in this case series demonstrating clinical muscle entrapment did not develop any postoperative compromise of extraocular motility. They expected >3 patients to present with clinical muscle entrapment given that orbital floor trapdoor fractures with muscle and soft tissue incarceration are the most common type of orbital fractures in children (27.8%–93%).16 This complication rate in this pediatric case series was 3.4% (2/59 orbits). The case of a postoperative retrobulbar

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hemorrhage was likely due to intense postoperative emesis and did not result in any adverse outcomes, whilst the other complication was the lateral canthal dystopia that did not require revision. Other studies that stress the success of Supramid in orbital fracture repair have comparable complication rates. Nunery et al.2 demonstrated the efficacy of nonporous, nonsecured 0.4-mm Supramid implants in repairing combined orbital floor and medial wall fractures with a complication rate of 0% (102 orbits). Park et al.15 had a complication rate of 1.7% (3/181 cases) in their retrospective chart review of the use of Supramid in repairing orbital fractures. Custer et al.17 published a case series whereby 5 of 41 patients (12.2%) who underwent orbital fracture repair with the Supramid implant suffered complications (age range: 5.6–80.6 years, mean age: 27.0 years). Four of the 5 reported complications involved late capsular hemorrhage, which appeared 7.8 to 10 years after implant insertion. Custer also speculated “that the true incidence of late capsular hemorrhage or abscess is less than indicated by this study.” Custer et al.17 stated that patients with larger Supramid implants, previous orbital surgery, and an increased interval between trauma and fracture repair may be more likely to have implant-related complications. These issues do not appear to pertain to the pediatric population studied, and therefore, one could assume that the implant-related complications may be less than Custer et al.17 reported. Supramid implants have been used for orbital fracture repair since at least 1965.18 The use of nonporous alloplastic implants has been supplanted by porous alloplastic implants, which allow integration via fibrovascular ingrowth. This propensity for inducing fibrosis in the orbit and/or eyelid after orbital fracture repair may lead to orbital adherence syndrome with resultant restrictive diplopia and/or cicatricial eyelid malpositioning. The use of porous orbital implants in fracture repair has been well received due to their perceived excellent biocompatibility and low complication profile.19 Nonporous orbital implants are inert materials that provide structural support without tissue integration that are a safe and viable option.15 This desire to limit orbital adherence syndrome along with several reports2,15,20 demonstrating the efficacy of Supramid implants in orbital fracture repair affirm the recommendation to use nonporous implants for orbital fracture repair. No published reports to date have solely documented the use of Supramid implants for orbital fracture repair in the pediatric population. To this knowledge, this is the first report to document the use of nylon foil exclusively in the pediatric population. No complications secondary to Supramid implant selection have been observed in this case series. Three patients demonstrated persistent diplopia; 2 having diplopia in extreme upgaze, and another patient suffering from neurogenic diplopia. The use of a nonporous, nonreactive implant that is well fashioned to cover the entire fracture area, the lack of fixation, and the 0.4-mm thickness implant that conforms well to the orbital walls all contribute to the lack of persistent postoperative diplopia and enophthalmos observed in this pediatric population. They believe this 1 post surgical orbit hematoma was not attributable to the choice of implant but rather excessive postoperative vomiting. There are several limitations to this study given the age of the population studied. They had difficulty measuring enophthalmos due to the age of the average patient and their unwillingness to fully cooperate. The retrospective nature of this article

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did not afford them the opportunity to determine the ideal time period to repair pediatric orbit fractures. Another limitation is the absence of consistent and long-term follow up with the average follow up being 4.6 months. Given that this study is the first to review the use of nylon foil implants exclusively in the pediatric population, the authors find that the nylon foil implant is a safe and effective method to repair orbital wall fractures in pediatric patients, given the low complication rate associated with the implant. Due to the high prevalence of surgical intervention in pediatric orbital fractures, the authors stress the importance of timely indicated surgical repair and the sole use of a nonporous orbital implant for intraorbital fracture repair.

REFERENCES 1. Timoney PJ, Sokol JA, Hauck MJ, et al. Transcutaneous medial canthal tendon incision to the medial orbit. Ophthal Plast Reconstr Surg 2012;28:140–4. 2. Nunery WR, Tao JP, Johl S. Nylon foil “wraparound” repair of combined orbital floor and medial wall fractures. Ophthal Plast Reconstr Surg 2008;24:271–5. 3. McCoy FJ, Chandler RA, Crow ML. Facial fractures in children. Plast Reconstr Surg 1966;37:209–15. 4. Rowe NL. Fractures of the facial skeleton in children. J Oral Surg 1968;26:505–15. 5. Kaban LB, Mulliken JB, Murray JE. Facial fractures in children: an analysis of 122 fractures in 109 patients. Plast Reconstr Surg 1977;59:15–20. 6. McGraw BL, Cole RR. Pediatric maxillofacial trauma. ­Age-related variations in injury. Arch Otolaryngol Head Neck Surg 1990;116:41–5. 7. Thaller SR, Huang V. Midfacial fractures in the pediatric population. Ann Plast Surg 1992;29:348–52. 8. Posnick JC, Wells M, Pron GE. Pediatric facial fractures: evolving patterns of treatment. J Oral Maxillofac Surg 1993;51:836–44; discussion 844–5. 9. Hussain K, Wijetunge DB, Grubnic S, et al. A comprehensive analysis of craniofacial trauma. J Trauma 1994;36:34–47. 10. Koltai PJ, Amjad I, Meyer D, et al. Orbital fractures in children. Arch Otolaryngol Head Neck Surg 1995;121:1375–9. 11. Bansagi ZC, Meyer DR. Internal orbital fractures in the pediatric age group: characterization and management. Ophthalmology 2000;107:829–36. 12. Hatton MP, Watkins LM, Rubin PA. Orbital fractures in children. Ophthal Plast Reconstr Surg 2001;17:174–9. 13. Sires BS, Stanley RB Jr, Levine LM. Oculocardiac reflex caused by orbital floor trapdoor fracture: an indication for urgent repair. Arch Ophthalmol 1998;116:955–6. 14. Jordan DR, Allen LH, White J, et al. Intervention within days for some orbital floor fractures: the white-eyed blowout. Ophthal Plast Reconstr Surg 1998;14:379–90. 15. Park DJ, Garibaldi DC, Iliff NT, et al. Smooth nylon foil (SupraFOIL) orbital implants in orbital fractures: a case series of 181 patients. Ophthal Plast Reconstr Surg 2008;24:266–70. 16. Wei LA, Durairaj VD. Pediatric orbital floor fractures. J AAPOS 2011;15:173–80. 17. Custer PL, Lind A, Trinkaus KM. Complications of supramid ­orbital implants. Ophthal Plast Reconstr Surg 2003;19:62–7. 18. Rowning CW, Walker RV. The use of alloplastics in 45 cases of ­orbital floor reconstruction. Am J Ophthalmol 1965;60:684–99. 19. Rubin PA, Bilyk JR, Shore JW. Orbital reconstruction using porous polyethylene sheets. Ophthalmology 1994;101:1697–708. 20. Lee HB, Nunery WR. Orbital adherence syndrome second ary to titanium implant material. Ophthal Plast Reconstr Surg 2009;25:33–6.

© 2014 The American Society of Ophthalmic Plastic and Reconstructive Surgery, Inc.

Nylon foil (supramid) orbital implants in pediatric orbital fracture repair.

To present the authors experience with the nylon foil (Supramid) implant as a safe and effective method to repair pediatric orbital wall fractures...
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