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Lippincott Williams & Wilkins, Inc., Philadelphia 0 1999 The American Laryngological, Rhinological and Otological Society, Inc.

Case Study

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Auricular Rehabilitation With Bone-Anchored Titanium Implants

Jack J. Wazen, MD; Robert Wright, DDS; Regina B. Hatfield, DMD; Eric S. Asher, MAMS
Objective: To evaluate the effectiveness of the bone-anchoredtitanium implants i auricular reconn structions. Study Desigm Six patients who received implants for an auricular reconstruction were followed prospectively. Four patients had lost their ears to cancer, and the other two had congenital aural atresia. Methods: All patients were thoroughly evaluated by the reconstruction team, which included a surgeon, a prosthodontist, and a facial prosthetist. Three patients were evaluated audiologically for a bone-anchored hearing aid. Four patients received implants in a single-stageprocedure, and two underwent a two-stageprocedure. A gold bar with retaining clips was used to anchor the prosthetic ear in four patients, and magnets were used in the remaining two. Results: All six patients are completely satisfied with their reconstructions.No failures, extrusions, or bony complications were encountered. One patient had recurrent dermatitis, which subsided when his gold bar was replaced with magnets. Conclusion: Implanted under the guidance of an appropriate prosthetic team, bone-anchored titanium implants provide patients with a safe, reliable, adhesive-free method to anchor auricular prostheseswith recovery of their normal appearance. hryngoscope, lOfk623-627,1999
conditions or when the patient is perspiring. The patient must have good manual dexterity and motivation, since placement of an adhesive-retained prosthesis can be difficult without assistance. In addition, the adhesive causes rapid deterioration of the margins of the prosthesis. The ability to anchor such prostheses to the bony skeleton using bone-anchored titanium implants relieves the patient from the discomforts of adhesive application, increases the longevity of the prosthesis, and provides for a more secure and reproducible placement for patients lacking manual dexterity. The combination of bone-anchored implants with prosthetic rehabilitation offers the patient a nearly normal reconstructed appearance as well as more autonomy, freedom, and ease of placement.

MATERUJ.SAND METHODS
Five men requiring prosthetic rehabilitation for auricular defects underwent surgery for the insertion of titanium implants into the mastoid process, since this procedure was cleared by the U.S. Food and Drug Administration (FDA) in the summer of 1997. Another patient, as part of a study for bone-anchored hearing aids, received an implant in 1987 and is presented here as 10-year follow-up. Four patients had lost their ears because of cancer resection, and two patients had congenital microtidaural atresia. Two of the total of six patients had received postoperative radiation therapy before implantation. The radiation dosage to the mastoid area of both patients was 5,940 cGy. Three patients were fitted with a bone-anchored hearing aid. The patients received implants of the Branemark system manufactured by NobelBiocare (Gateberg, Sweden). The two-stage surgical technique, as previously described by Tjellstrom et al.,l.z was used in two patients. The remaining four surgeries were performed with a one-stage t e ~ h n i q u e . ~ Presurgical treatment planning with the prosthetic team is critical to success. Before implant surgery, a n impression and diagnostic wax pattern of the missing auricle are made and a transparent surgical template is prepared for use. This template ensures that the implants and retentive components are within the confines of the prosthetic ear. Ideally the patient should be referred to the prosthetic team before the ablative surgery. An impression of the diseased auricle can be obtained, as well as presurgical photographs, which facilitate the construction of the surgical template and final prosthesis. The maxillofacial prosthetic team is present at the surgery (prosthodontist and facial prosthetist) to offer suggestions on fixture placement and abutment selection. At least two implants are necessary to retain a n auricular prosthesis. The skin and

INTRODUCTION
The surgical reconstruction of auricular, nasal, and orbital defects remains a challenging task typically requiring multiple operations with oRen compromised aesthetic results. Until recently, the standard rehabilitative approach for patients who refused surgical reconstruction or were poor candidates for surgery has been with adhesive-retained prostheses. Although this is, and has been, an excellent rehabilitative technique, it is not without problems. The daily application of adhesives to the skin predisposes patients to frequent dermatitis. There are also retentive limitations with adhesives under humid
Presented at the Meeting of the Eastern Section of the American Laryngological, Rhinological and Otological Society, Inc., New York, New York, February 1, 1998. From the Department of OtolaryngologylHead and Neck Surgery (J.J.w.), and the Department ofMaxillofacia1 Prosthetics (R.w., R.B.H., E.s.A.), Columbia-Presbyterian Medical Center, New York, New York. Send Reprint Requests to Jack J. Wazen, MD, ColumbiaPresbyterian Medical Center, 161 Fort Washington Avenue, New York, NY 10032, U S A .

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periosteum are marked with methylene blue using a needle passed through the predrilled holes in the surgical template. An incision is made approximately 30 mm posterior to the opening of the expected position of the external auditory canal. The skin and subcutaneous tissue are elevated. The subcutaneous tissue and muscle are excised around the implant sites, thinning down the skin until it is almost transparent. Full-thickness skin grafts were initially used to ensure a thin, hairless skin around the implants. However, generous dissection of the subcutaneous tissue, including shaving off the hair follicles, works as well and eliminates the need for skin grafts. The implants are placed where the periosteum has been marked with methylene blue. This usually is approximately 20 mm from the external auditory canal opening. Implants are placed a t least 15 mm from each other, center to center. The details of the surgical technique were described in previous publications.1.2 Guide drills 3 and 4 mm long are first used to determine the length of the titanium screw to be used. A 4-mm implant is always preferable. The hole is then enlarged with a countersink, followed by tapping of the site a t a very slow speed with copious irrigation to prevent heat injury of the surrounding bone. The titanium implant is threaded in, also a t slow speed and high irrigation. The same technique is repeated for each of the implants. In one-stage procedures the abutments are passed through a punch hole in the overlying skin, the incision is closed, and a dressing is applied. If a two-stage procedure is preferred, the skin is closed over the titanium implants and the percutaneous attachment of the abutments is performed 3 months later, after completion of the osseointegration (Fig. 1). The type of retentive mechanism is based on the manual dexterity of the patient, the number of implants, the thickness of the antihelix of the auricular prosthesis, and patient desire. The most commonly used retention techniques are mechanical via the use of a gold bar with clips or magnetic retention. The use of a gold bar requires a minimum of two osseointegrated implants and a patient with a t least moderate manual dexterity. Magnets require a minimum of three bone-anchored implants. They may be used when there is limited space within the confines of the antihelix of the wax pattern, such as when the prosthesis requires a low profile, when the patient has low manual dexterity, or if the patient has poor hygiene. Magnets allow for better hygiene when cleaning the periabutment tissue and enhance ease of placement.

Four patients had reconstruction using a gold bar to fit under the antihelix of the wax pattern (Fig. 2). Two of these patients had previously worn adhesive-retained prostheses. The bar is cast in a gold dental alloy (Midas, Jelenko, Armonk, NY) and must be tried in the patient to verify an accurate fit. The remaining two patients had reconstruction with magnetically retained prostheses (Magna-Cap, Technovent Ltd., Leeds, U.K.). Both patients exhibited problems with manual dexterity; one of them had previously had reconstruction with a bar and clip prosthesis in 1987 but had developed a significant periabutment inflammatory response because of inability to clean adequately around the bar (Fig. 3). The patient is given verbal and written instructions regarding home care and is placed on a hygiene regimen using the appropriate aids such as superfloss, end-tufted brushes, cottontipped applicators, and proxybrushes. The patients are recalled for a follow-up examination every 3 months during the first year and every 6 months thereafter.

RESULTS
At the time of this writing, all six patients are using their bone-anchored prostheses with great satisfaction. There were no failures or rejections. Of the three boneanchored hearing aids placed, one patient is using the hearing aid in conjunction with his prosthesis, another has not purchased the hearing aid to this date, and the last no longer uses the device for aesthetic reasons. Patients who have had rehabilitation using the barclip method of retention have demonstrated no complaints with aesthetics or retention. Both patients who have had rehabilitation using magnetic retention have demonstrated ability to place and remove the prosthesis without difficulty. The patient who had secondary rehabilitation with magnets demonstrated virtually total elimination of periabutment inflammation because of enhanced ability to clean these tissues. All patients stated that they felt comfortable with their prosthesis and secure that their prosthesis will stay

Fig. 1. A. Implant sites approximately 20 mm from the center of the ear canal. Incision made 30 mm from canal. B Periosteum removed from implant . site. C. Thinning of the flap and removal of hair follicles. D Titanium im. plants and abutments exteriorized through punch holes in overlying skin. E. Bar in place.

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Fig. 2. A. Gold bar attached to two titanium implants. B Prosthetic ear in . place, clipped onto gold bar.

in place even in conditions of increased humidity or perspiration. This is especially relevant for two patients who had worn adhesive-retained prostheses in the past. These patients indicated that they felt more confident that they would not lose their prosthesis and that the prosthesis now felt more natural to them than their adhesiveretained prostheses.

DISCUSSION
Conventional facial prosthetics has previously relied on the use of adhesives for retention. Jani and Schaaf4 and Chen et aL5 reported that many patients with facial prostheses did not wear them because of poor retention. The use of osseointegrated implants for facial prosthetics has been a significant advance in maxillofacial prosthetics. For a facial prosthesis to be successful, it must meet criteria of aesthetic acceptability, functional performance, biocompatibility, and desired retention.6 Pitfalls of the adhesive-retained prosthesis include skin irritation from the adhesives, unpredictability of retention, variability of positioning of the prosthesis, and poor hygiene attributable to the tackiness of the adhesive, as well as decreased life span of the prosthesis resulting in an increased number of remakes. The extraoral application of the Branemark titanium implant system for craniofacial rehabilitation and bone-anchored hearing aids has provided us with a safe, retentive, reproducible, adhesive-free attachment to such devices. A review of the U.S., Swedish, and Canadian experience with the titanium implants revealed a 97.5%success rate in nonirradiated patients with a 70%success rate in irradiated patient^.^^^ In a detailed analysis of titanium implants lost in irradiated tissues, Granstrom et al.9 reported that the adjunctive use of hyperbaric oxygen could reduce implant loss. Preoperative treatment with one 90minute dive to 2.5 ATA per day for 20 days, followed by 10 Laryngoscope 109: April 1999

more dives after implantation, is suggested. Our two irradiated patients have done very well with their implants, although they did not receive hyperbaric oxygen. We have preferred the single-stage technique in most of our patients. With one operation, preferably using general anesthesia, the titanium screws are implanted and the abutments are secured in place and exteriorized. No loading or instrumentation of the abutments is perfarmed before a t least a 3-month period during which the titanium binds to the bone through the process of osseointegration. Premature loading of the fixtures increases the chances of failure. Patients undergoing the single-stage procedure need to be well aware of the importance of avoiding any pressure or torque on the fixtures for fear of extrusion. They are advised to wear a protective mastoid type of dressing at bedtime. Patients who may not be able to care for the fixtures during the critical phase of osseointegration have implantation with the original twostage technique. The titanium implants are completely covered under the skin with no need for any wound care. The exteriorization and attachment of the abutments are performed 3 months later, using local anesthesia. Preparation of the prosthesis is begun 3 to 4 weeks later, upon complete healing of the surgical site. Patients with implants can undergo a computed tomography scan without difficulties (Fig. 4). Magnetic resonance images can be safely obtained after disconnecting the abutments from the titanium screws, a painless ofice procedure. The final appearance of the prosthesis is a function of the maxillofacial prosthetics team. Through a painstaking process of manufacturing and artistry, the auricular prostheses are made to look exactly like the opposite ear. The coloring is chosen to match the patients own complexion, including freckles and capillaries. Another prosthesis with
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Fig. 3. A. Magnets attached to three titanium implants and one implant for a bone-anchored hearing aid (BAHA). 6. Auricular prosthesis and BAHA in place. C. BAHA camouflaged within the hairline.

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CONCLUSION
The application of the Branemark titanium boneanchored implant system to extraoral maxillofacial rehabilitation has greatly enhanced the ultimate appearance of patients with such deficits. The advantages of this technique over the adhesive retention include the lack of dermatitis or allergic reactions induced by the adhesives, and a more secure and predictable placement of the prosthesis, particularly with perspiration and humidity. The normal appearance of the prostheses, securely anchored through a minimal surgical procedure, provides the patients with a reasonable alternative to conventional reconstructive surgery.

BIBLIOGRAPHY
1. Tjellstrom A, Rosenhall U, Lindstrom J, et al. Five-year experience with skin penetrating bone. Acta Otolaryngol 1983;95:568-575. 2. Tjellstrom A, Yontchev E, Lindstrom J, Branemark PI. Fiveyears experience with bone anchored auricular prosthesis. Otolaryngol Head Neck Surg 1985;93:366-372. 3. Tjellstrom A, Granstrom G. One-stage procedure to establish osseointegration: a zero to five years follow-up report. J Laryngol Otol 1995;109593-598. 4. Jani RM, Schaaf NG. An evaluation of facial prostheses. J Prosthet Dent 1978;39:546-550. 5. Chen MS, Udagama A, Drane J. Evaluation of facial prostheses for head and neck cancer patients. J Prosthet Dent 1981;46:538-544. 6. Lewis DH, Castleberry DJ. An assessment of recent advances in external maxillofacial materials. J Prosthet Dent 1980; 43~426-432. 7. Parel SM, Tjellstrom A. The United States and Swedish experience with osseointegration and facial prostheses. Int J Oral Implants 1991;6675-679. 8. Wolfaardt JF, Wilkes GH, Parel SM, Tjellstrom A. Craniofacia1 osseointegration: the Canadian experience. Znt J Oral Maxillofac Implants 1993;8:197-204. 9. Granstom G, Bergstrom K, Tjellstrom A, Branemark P. A detailed analysis of titanium implants lost in irradiated tissues. Znt J Oral Maxillofac Implants 1994;9:653-662.

Fig. 4. Computed tomography scan of temporal bones showing titanium implants and attached abutment for auricular prosthesis.

darker colors is frequently used in the summer months to match the patients tan. All of our patients are elated with their results. Their normal appearance is tremendously satisfying and has significantly enhanced their self-image,whether their deficit was congenital or acquired. Through minimal surgery, their rehabilitation is complete and they have regained their confidence in a society that does not look at them as different anymore.

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