Unilateral cleft nasal deformity is a clinical term referring to a nose

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1 ORIGINAL ARTICLE Assessment of Secondary Cleft Rhinoplasty Using Resorbable Plates at the Age of Primary School Arun K. Gosain, MD and Amir H. Fathi, MD Background: Secondary rhinoplasty after a cleft lip repair remains a significant challenge. We have developed a technique in which resorbable plates are used to support the cleft alar cartilage to minimize relapse. There are few guidelines by which one can objectively assess the outcome of cleft rhinoplasty over time. This study attempts to demonstrate a means by which the symmetry and form of the proposed rhinoplasty technique can be evaluated. Methods: Sixteen patients with unilateral cleft lip/palate repair had a secondary rhinoplasty performed at age 6 to 8 years, using a resorbable plate (resorption time, 2Y3 years) placed between the nasal lining and cleft alar cartilage to simulate the shape of the noncleft cartilage. Photographs were taken preoperatively and postoperatively. Median follow-up was 9.6 T 2.8 months. Various angles and ratios were measured to demonstrate outcomes, comparing preoperative to postoperative measures, and symmetry between cleft and noncleft sides. Results: Postoperatively, the angle between the horizontal axis, drawn across the alar base and tangent to the alar rim on both sides, was significantly altered (P G 0.001); both sides were closer to 60 degrees (mean, degrees), approximating the angle of the aesthetic norm. A measure of the angle between the horizontal axis and a line drawn from midpoint of axis to nasal tip was significantly closer to 90 degrees (P G 0.05). The shape of the affected nostril became more oval and symmetric relative to the unaffected side (P G 0.05). Angle between the horizontal axis and a line drawn through the widest point of each nostril was close to zero. (P G 0.001). The difference in nostril height between the cleft and noncleft sides was significantly decreased (P G 0.001). Conclusion: We have objectively evaluated the outcomes of our technique of secondary cleft rhinoplasty using resorbable plates for alar support. A careful geometric evaluation of preoperative and postoperative photographs can help determine the symmetry and overall quality of the result. These measures may help to evaluate long-term outcomes of cleft rhinoplasty over time. Key Words: Secondary cleft rhinoplasty, cleft nasal deformity, resorbable plates, photogrammetric analysis From the Department of Plastic Surgery, Case Western Reserve University School of Medicine, Cleveland, Ohio. Received February 6, Accepted for publication March 11, Address correspondence and reprint requests to Arun K. Gosain, MD, Department of Plastic Surgery, Case Western Reserve University, University Hospitals of Cleveland, MS 5044, Euclid Ave, Cleveland, OH 44106; arun.gosain@uhhospitals.org This article did not require any sources of funding. The authors declare that they had no financial interests or commercial associations during the course of this study. Copyright * 2009 by Mutaz B. Habal, MD ISSN: DOI: /SCS.0b013e3181b5d4c0 (J Craniofac Surg 2009;20: 1801Y1805) Unilateral cleft nasal deformity is a clinical term referring to a nose with residual deformity after primary unilateral lip and palate repair. 1 The complex three-dimensional nature of this anomaly involves skin, cartilage, vestibular lining, and skeletal platform. Correction of this deformity remains a challenging problem for reconstructive surgeons. 2 Growth increases the complexity of secondary cleft nasal correction. The nose undergoes a late growth spurt during puberty and early adolescence, and surgical intervention has the potential to interfere with this growth. Therefore, appropriate timing of repair is of paramount importance. We believe that secondary cleft nasal correction is often indicated at the age of primary school (ages 6Y8 years). At this age, patients social interactions increase significantly, and they begin to experience significant pressures from peers that form their selfimage. Although final rhinoplasty may still be required after the completion of nasal growth, we feel that secondary correction at this age is warranted to as to optimize the child s developing self-image. The optimal technique for providing support of the cleft alar cartilage at the age of primary school remains controversial. Millard 3 describes an alar lift to correct the unilateral cleft nasal deformity and recommends that this be done at the age of primary school and no earlier than age 5 years as the cartilage is felt to be too delicate to retain its position before this age. Whereas there has been an ongoing debate as to whether rhinoplasty performed before age 16 to 18 years causes long-term alteration in growth of the nose, Ortiz- Monasterio and Olmedo 4 have demonstrated that corrective rhinoplasty performed before puberty does not interfere with the long-term growth of the nose. However, other authors feel that definitive nasal surgery should be delayed as flattening of the alar cartilage will continue throughout adolescence, and the underlying maxillary deficiency cannot be corrected until skeletal growth is complete. 5,6 Therefore, many patients will require definitive cleft rhinoplasty after skeletal maturation is complete. 6 Cartilage grafts placed at primary school age may therefore become obsolete should completion rhinoplasty be required after completion of skeletal growth. In addition, harvest of septal cartilage at primary school age would preclude the possibility of reharvest of this donor site as a source of nonscarred graft at a later age. To address this issue, we have developed a technique in which resorbable plates are used to support the cleft alar cartilage during rhinoplasty performed at primary school age to minimize relapse. The aims of the current study were to (1) describe our technique for primary cleft rhinoplasty at primary school age using resorbable plates and (2) demonstrate a means by which the symmetry and form of the proposed rhinoplasty technique can be evaluated. METHODS A total of 16 patients, 10 boys and 6 girls with unilateral cleft lip and nasal deformity, were included in this study. All patients operated on by the senior author who underwent secondary cleft rhinoplasty at primary school age and had placement of resorbable The Journal of Craniofacial Surgery & Volume 20, Supplement 2, September

2 Gosain and Fathi The Journal of Craniofacial Surgery & Volume 20, Supplement 2, September 2009 plates to support the affected alar cartilage were included in the study group. Mean age was 6 years, raging from 4 to 8 years. Patients were regularly monitored for a mean follow-up period of 9.6 T 2.8 months (mean T SEM), with the range of 20 days to 2 years postoperatively. A control group consisting of 16 children with no cleft lip or nasal deformity aged 6 to 8 years was also studied to confirm that the measurement technique demonstrated nasal symmetry in control subjects. Surgical Technique All patients in the study group had primary repair of the cleft nasal deformity at the time of primary lip repair. The secondary rhinoplasty is performed between 4 and 8 years of age to minimize psychosocial pressure. Using a transcolumellar stair-step incision, an open rhinoplasty technique is used to approach the alar cartilages (Fig. 1, top left). Many patients have restriction of vestibular lining that contributes to alar stenosis and diminished airflow through the affected nostril. This is addressed with a Z-plasty, using the constricted alar web as a guide for placing the central axis of the BZ[ (Fig. 1, top right). Bilateral infracartilaginous extensions provide access to the caudal border of the lower lateral cartilage. Both alar cartilages are dissected free on the cutaneous surface. The alar cartilage on the affected side is completely freed from the overlying skin envelope and underlying vestibular skin, providing complete mobilization of the affected alar cartilage (Fig. 1, bottom left). Thereafter, the adjacent fibrous soft tissue is completely removed, and the cartilage is trimmed using the unaffected side as the reference guide. A malleable metal template is then fashioned as a mirror image of the unaffected alar cartilage, and the resorbable plate is then fashioned to simulate the template; the resorbable plate is cut identical to the template and allowed to passively assume the shape of the template FIGURE 2. Secondary rhinoplasty is completed by trimming redundant skin from the alar rim (left, blue line), followed by support with a silastic nasal splint used for at least 3 months postoperatively (right). in the hot water bath. The plate is then placed beneath the affected alar cartilage and sutured to the cartilage with 5-0 Prolene suture (Ethicon, Somerville, NJ) and actively positioned to support and render it symmetric to the unaffected side (Fig. 1, bottom right). Symmetry of the alar dome in height and width is crucial in the positioning of alar cartilage-resorbable plate complex. The plate is sandwiched between vestibular mucosa and alar cartilage, thereby preventing collapse of the alar cartilage. As previously mentioned, in cases in which there is stenosis of the vestibular lining, Z-plasty FIGURE 1. Technique for secondary cleft rhinoplasty done at primary school age using resorbable plates, performed in a 6-year-old boy after right unilateral cleft lip and nose correction done at infancy. See Surgical Technique for detailed explanation FIGURE 3. Six-year-old boy for whom surgical technique has been demonstrated is shown preoperatively (above) and 1 year postoperatively (below) after secondary cleft rhinoplasty and revision cheiloplasty. * 2009 Mutaz B. Habal, MD

3 The Journal of Craniofacial Surgery & Volume 20, Supplement 2, September 2009 Cleft Rhinoplasty at Primary School Age continued for up to 6 months should the patient tolerate it. Stent use in the latter 3 months can be decreased to nighttime only if the patient prefers not to wear it during the day. Photographs of 2 patients who have completed this regimen are shown (Figs. 3 and 4). FIGURE 4. A 7-year-old boy in whom photogrammetric measurements are demonstrated is shown preoperatively (above) and 1 year postoperatively (below) after secondary cleft rhinoplasty and revision cheiloplasty. release of the vestibular mucosa is critical to retaining the augmented configuration of the alar cartilage. At conclusion of the procedure, the nasal skin is redraped to its normal anatomic position. The soft triangle is assessed, and any redundant skin on the affected side is trimmed to restore symmetry to the alar rim. The skin to be excised is demonstrated by the blue dotted line in Figure 2, left. We use a Porex nasal stent (Porex Surgical, Newton, GA) sized to match the unaffected nostril to help retain shape of the lining and repositioned alar rim (Fig. 2, right). The stent is not sutured in place but is held in place with tape across the external wings. The family is instructed as to how to remove the stent for cleaning, and it is recommended that the stent be worn continuously for the first 3 months, and its use Photogrammetric Measurements Accuracy and reliability of the photogrammetry of the face (indirect anthropometry) is well described by Farkas. 7 It is anthropometry adapted for quantification of surface features from standard photographs. We used the same principles in our study. Life-size frontal, lateral, and basilar views were obtained for all patients in preoperative and postoperative visits. Basilar views were obtained by tilting the patient s head back to bring the dome to the level of eyebrows, above the canthi. These views were used to identify the craniofacial landmarks. 8,9 Photograph requisition conditions were meticulously evaluated in each visit, to maintain the consistency. The photogrammetric analysis performed for each patient is demonstrated in Figure 5 (left). Two main axes were used as the basis of our measurements: (1) horizontal axis (H): line drawn as a tangent across the nostril floor bilaterally and (2) vertical axis (V): line drawn perpendicular to horizontal axis passing through the middle of the columellar base. The following angles and ratios were measured for each patient on preoperative and postoperative basilar view photographs, making measurements both on the affected and the unaffected sides: (1) Alar rim angle (ar): the angle between the horizontal axis and a line drawn tangent to the alar rim. The ideal angle is identical between the affected and the unaffected sides. (2) Columellar axis angle (ca): the angle between the horizontal axis (H) and a line drawn through the columellar axis. The columellar axis (ca) was defined as a line connecting the pronasale to the subnasale. The ideal angle is 90 degrees. (3) Nostril width angle (nw): the angle between the horizontal axis and a line drawn through the widest point of each nostril. The ideal angle is 0 degrees. (4) Nostril height difference (nd): the height difference (in millimeters) between the apex of the affected and unaffected nostrils. The ideal difference in nostril height is 0 mm. (5) Nostril shape: nostril height (L) and width (W) were measured Ton both sides and divided by the correction factor previously described. The ideal measure would be equivalence in nostril shape between the affected and unaffected sides of the nose. Photographs analyzed were taken preoperatively and at least 6 months postoperatively. Measurements made 1 year postoperatively FIGURE 5. Photogrammetric measurements are illustrated in the boy shown in Figure 4 taken preoperatively (left) and 1 year postoperatively (right). Measurements are described in Photogrammetric Measurements. * 2009 Mutaz B. Habal, MD 1803

4 Gosain and Fathi The Journal of Craniofacial Surgery & Volume 20, Supplement 2, September 2009 TABLE 1. Descriptive and Statistical Analysis of Normal Noses (Mean T SEM) Measurement (Mean T SEM) Alar Rim angle (right) 58.9 T 0.8 Alar Rim angle (left) 60.6 T 0.8 Columellar Axis angle 89 T 0.4 Nostril Width angle 0.8 T 0.3 Nostril Shape (right) 1.7 T 0.1 Nostril Shape (left) 1.6 T 0.1 Nostril Height difference (mm) 0.8 T 0.2 See text (BPhotogrammetric Measurements[) for explanation of measurements used for each calculation. BSEM[ = Standard Error of the Mean. on the illustrative patient demonstrate marked improvement in nasal symmetry (Fig. 5, right). Method Errors The method errors were assessed for intraobserver variance, photograph consistency, and reliability. To minimize intraobserver variance, alar rim angle on the affected side was measured twice, 2 weeks apart by the same observer on all samples. The measurements were analyzed by correlation analysis. A correction factor was used to eliminate magnification error and subtle variation between preoperative and postoperative photographs. Statistical analysis of preoperative and postoperative tip height measurements indicated no significant changes. Therefore, the ratio of preoperative nasal tip height to postoperative nasal tip height was used as the correction factor. In addition to photometric measurements, a panel of 5 people evaluated the preoperative and postoperative photographs. This panel consisted of a board-certified plastic surgeon, 2 plastic surgery research fellows, a plastic surgery resident, and a layperson. The panelists rated the postoperative photographs relative to achieved symmetry on a scale of 1 to 10, 10 being the level of symmetry in a normal nose. To further validate these measures, basilar views were obtained from 16 randomly selected control subjects aged 4 to 8 years. The control subjects had no lip and/or nose deformity and had not undergone nasal surgery. Similar measures were made on these subjects to evaluate whether the measures described could adequately assess symmetry (Table 1). Statistical Analysis A 2-tailed paired t test was performed to compare preoperative and postoperative measurements after normalization with the correction factor. P G 0.05 was considered statistically significant. RESULTS The Pearson correlation test illustrated a highly significant intraobserver correlation for repeated measurements (r = , P G 0001). Having validated the reliability of the data, preoperative and postoperative measures were compared (Table 2). Duration from surgery to the postoperative photograph analyzed was 9.6 T 2.8 months (mean T SEM), with a maximum duration to postoperative photograph of 38 months. Comparable measures in agematched controls are provided in Table 1. No significant differences were noted between sides in the parameters measured in these agematched controls (P ). Analysis of the data indicates that there was a statistically significant improvement in nasal symmetry postoperatively. The mean 1804 alar rim angle went from 46.1 degrees preoperatively to 56.3 degrees postoperatively (P G 0.001); the mean alar rim angle in age-matched controls was 58.9 to 60.6 degrees, validating the ideal measure of 60 degrees. The mean columellar axis angle went from 80.6 degrees preoperatively to 86.3 degrees postoperatively (P G 0.05); the mean columellar axis angle in age-matched controls was 89 degrees, validating the ideal measure of 90 degrees. The mean nostril width angle went from 7.1 degrees preoperatively to 3.3 degrees postoperatively (P G 0.001); the mean nostril width angle in age-matched controls was 0.8 degrees, validating the ideal measure of 0 degrees, or parallel to the horizontal axis. Nostril shape measurement went from a mean of 0.8 to 1.2 on the affected side (P G 0.05), approximating the mean of the unaffected nostril of 1.1; the nostril shape on the affected side showed no significant change postoperatively, retaining the oval shape of the control nostrils (mean nostril shape of 1.6Y1.7). The mean nostril height difference went from 3.8 mm preoperatively to 1.4 mm postoperatively (P G 0.001); the mean nostril height difference in age-matched controls was 0.8 mm, validating the ideal of no difference in nostril height between sides. The panel s comparative and clinical assessment of preoperative and postoperative photographs revealed that the surgery rendered more symmetric and appealing noses. Overall outcomes score went from 3.7 T 0.4 (mean T SEM) preoperatively to 6.4 T 0.2 postoperatively. DISCUSSION There are 3 primary goals of the secondary rhinoplasty performed at primary school age: (1) to minimize or eliminate stigmata of the cleft nasal deformity, (2) to maintain or restore patency of the nasal airway when compromised by alar webbing or external valve collapse, and (3) to minimize interference with nasal growth and to avoid harvest of critical nasal tissues that will become obsolete with nasal growthvspecifically to maintain septal cartilage donor sites for final rhinoplasty after skeletal maturity if needed. A clear understanding of the pathologic anatomy of the deformity is essential to achieve satisfactory aesthetic and functional outcomes. Moreover, it must be distinguished from the primary nasal deformity of the unrepaired anomalies. Table 3 summarizes some common features of the unilateral cleft nasal deformity as described by Bardach and Cutting. 10,6 First successful utilization of biodegradable plates in oral and maxillofacial surgery field was reported in animal studies, and later on, in humans, they were modified for fixation purposes in orthognathic surgeries. 11,12 TABLE 2. Descriptive and Statistical Analysis of Anthropometric Changes (Mean T SEM) Preoperative Measurement Postoperative Measurement Alar rim angle: affected side 46.1 T T 2.4 G0.001 Alar rim angle: unaffected side 46.5 T T 2.3 G0.001 Columellar axis angle 80.6 T T 0.9 G0.05 Nostril width angle 7.1 T T 0.3 G0.001 Nostril shape: affected side 0.8 T T 0.2 G0.05 Nostril shape: unaffected side 1.0 T T Nostril height difference, mm 3.8 T T 0.3 G0.001 See Photogrammetric Measurements for explanation of measurements used for each calculation. Statistical analyses compare preoperative to postoperative measures. * 2009 Mutaz B. Habal, MD P

5 The Journal of Craniofacial Surgery & Volume 20, Supplement 2, September 2009 Cleft Rhinoplasty at Primary School Age TABLE 3. Features of Unilateral Cleft Nasal Deformity 1 The columella is shorter on the cleft side. 2 The base of the columella is deviated to the noncleft side. 3 The lateral crus of the lower lateral cartilage is longer on the cleft side. 4 The nasal tip is displaced in both the frontal and the horizontal planes. 5 The nasal tip is asymmetric. 6 The ala is flattened, resulting in horizontal orientation of the nostril. 7 The nostrils are asymmetric. 8 The entire nostril is retropositioned because of the deficiency in the underlying frame. 9 The base of the ala is displaced laterally and/or posteriorly and sometimes inferiorly. 10 The nasal floor is caudal on the cleft side. 11 A nasolabial fistula could be present. 12 The septum and anterior nasal spine are shifted toward the noncleft vestibule. 13 The nasal septum is deviated, resulting in a varying degree of nasal obstruction. 14 The inferior turbinate on the cleft side is hypertrophic. 15 The maxilla is hypoplastic on the cleft side. 16 The premaxilla and the maxillary segments are displaced. Biodegradable plates have been made of lactic and glycolic acid polymers that degrade by diffusion-controlled hydration, the products of which are taken up by macrophages and finally eliminated through the Krebs cycle. Recently, these polymers have been blended with trimethylene carbonate to increase their flexibility. Further bioengineering using highly orientated fibers in the longitudinal axis of the polyester has allowed the development of a biocompatible, bioresorbable material suitable for use in craniomaxillofacial surgery. 13,14 We have extended the use of these plates from support of the craniomaxillofacial skeleton to support of the alar cartilages when secondary cleft rhinoplasty is done at the age of primary school (ages 6Y8 years). Wong et al 15 first described the use of resorbable plates for support of the alar cartilages in primary cleft nasal repair performed during the first year of life. The present study is the first to report on the outcome of resorbable plates for secondary cleft nasoplasty. We feel this to be an excellent application of these biomaterials in soft tissue nasal surgery because it allows for cartilage support without harvesting native tissues that might be required for final cleft nasoplasty upon completion of skeletal growth. In the current study, we have used 0.75 Inion plates (Stryker, Kalamazoo, MI), with resorption time of 2 to 3 years. The plates were softened in a water bath, then contoured and cut to the desired shape and size according to the unaffected alar cartilage. In summary, the current study has used the following approach to correction of the cleft nasal surgery in the growing child: 1. Primary cleft nasal surgery is done during the first year of life, at time of the cleft lip repair. 2. Secondary cleft nasal surgery is done at the time of early grade school (6Y8 years old) should there be relapse after primary surgery. This is an age in which children are exposed to a broader social network and optimizing aesthetic appearance is paramount, although some children may still require a final rhinoplasty after skeletal growth is complete. When rhinoplasty is performed at the age of primary school, we feel it is important to minimize the harvest of septal cartilage so as not to impair further cartilage growth and to leave unscarred cartilage for the final rhinoplasty. We use resorbable plates to support the alar cartilage, selecting plates with a resorption time of 2 to 3 years. We have found this technique to provide adequate support to restore a normal nostril shape, as confirmed by photogrammetric measurements. In addition, we use a silastic nasal stent (Porex Surgical) to provide further support to the alar contour for 3 months postoperatively. We also avoid nasal osteotomies so as to avoid potential disturbance in skeletal growth, reserving osteotomies for the final rhinolasty if indicated. 3. Final cleft nasal surgery, if needed, is performed after completion of nasal growth (age 16 years). By following the protocol outlined, virgin septal cartilage remains for final grafting, and one does not need to dissect out obsolete pieces of cartilage graft that no longer fit the size of the adult nose. Nasal osteotomies, if required, are reserved until this age. The present study introduces a novel application of resorbable plates to support the affected alar cartilage during secondary cleft rhinoplasty performed at the age of primary school. Furthermore, we present a protocol for objective assessment of postoperative outcomes of cleft nasal surgery using standardized photographs taken preoperatively and postoperatively. Using this analytic technique, we have demonstrated that the operated noses return to normal as compared with the unaffected side in the unilateral cleft nasal deformity, as well as relative to a normal cohort of age-matched controls. REFERENCES 1. 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Poly(L-lactide) implants for repair of human orbital floor defects: clinical and magnetic resonance imaging evaluation of long-term results. J Oral Maxillofac Surg 1996;54:9Y Wong GB, Burvin R, Mulliken JB. Resorbable internal splint: an adjunct to primary correction of unilateral cleft lip-nasal deformity. Plast Reconstr Surg 2002;110:385Y391 * 2009 Mutaz B. Habal, MD 1805