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Early results with semisynthetic total ossicular replacement prosthesis
Otolaryngology–Head and Neck Surgery (2010) 143, 307-308
CLINICAL TECHNIQUES AND TECHNOLOGY
Early results with semisynthetic total ossicular replacement prosthesis Giuseppe Malafronte, MD, Avellino, Italy No sponsorships or competing interests have been disclosed for this article.
T
he objective of this article is to describe a new semisynthetic total ossicular prosthesis (ssTORP). The ssTORP is obtained by assembling a synthetic shaft with an autolog cartilage head. To make the shaft, we used an adjustable-length stapedotomy prosthesis made of platinum and polytetrafluoroethylene (PTFE) (7 mm in total length and 0.4 mm in diameter). The base of the hook is cut. In this way, a shaft made of platinum and PTFE, 4 mm in length and 0.4 mm in diameter, is obtained. It represents an artificial stapes superstructure. The shaft is supplied with a blunt platinum tip 1 mm in length and 0.2 mm in diameter. The blunt tip is completely inserted into the cartilage head of the prosthesis. The PTFE base of the shaft is positioned on the footplate. The head of the prosthesis can be made from one, two, or three blocks of tragal cartilage. This cartilage is ideal because it is flat and usually 1 mm thick. The 5-mm long ssTORP has a head made of one square block of tragal cartilage. The surgeon judges the size fitting on the basis of each individual case. The perichondrium is left on both sides of the cartilage block. In the middle of the block, just in the perichondrium, a small hole is made using an insulin needle. The blunt tip of the shaft is inserted into the perichondrium hole. By exerting a slight force on the shaft, the tip penetrates completely into the cartilage, fixing the shaft firmly into the cartilage block. The 6 –mm-long ssTORP has a head made from two blocks of cartilage. A double cartilage block is obtained by taking a rectangle (2 ⫻ 5 mm) from the tragal cartilage. The perichondrium is left on both cartilage sides. The cartilage is cut in half, avoiding transection of the perichondrium on the opposite side. A small hole is made in the perichondrium in the middle of the block. Next, the blunt tip of the shaft is inserted into the cartilage block. The cartilage is then folded back on itself with the intact perichondrium layer doubled between the two cartilage blocks. This acts as a hinge, keeping the blocks from slipping. The obtained 6 –mm-long ssTORP is positioned between the tympanic membrane and the footplate (Fig 1A). The 7–mm-long ssTORP is obtained by assembling a triple cartilage block with a shaft (Fig 1B).
The average time to take cartilage and to prepare the ssTORP is approximately five minutes.
Patients and Methods Thirty-five patients underwent an ssTORP ossiculoplasty from January 2007 to December 2007. Four patients had an inadequate follow-up and were excluded from the study, which left 31 patients for consideration. Of these, 22 were female, and nine were male. The mean age was 36 years. In 15 cases, the ssTORP ossiculoplasty (48.3%) was performed during a onestage tympanoplasty with canal wall down mastoidectomy; in eight cases (25.8%), it was performed during a planned second stage tympanoplasty with canal wall down mastoidectomy; and in eight cases (25.8%), the total chain reconstruction was performed during a tympanoplasty without mastoidectomy. The 5–mm-long ssTORP was used in three cases (9.6%). The 6 –mm-long ssTORP was used in 27 cases (87.09%). The 7–mm-long ssTORP was used in one case (3.2%). The audiometric data were first obtained two and six months after surgery, and thereafter at least once a year. For all patients, the last audiogram was obtained in November 2009. The average postoperative follow-up was 31 months (range, 24-34 months). A successful reconstruction was defined as a postoperative air bone gap less than or equal to 20 dB. Calculation of hearing results was in accordance with the American Academy of Otolaryngology–Head and Neck Surgery 1995 guidelines.1 Patients were fully informed concerning ssTORP ossiculoplasty, and they gave their written informed consent after a discussion of the alternatives, which included ossiculoplasty with traditional TORP. The S.G. Moscati Hospital Ethical Committee approved the study.
Results At the end of follow-up, none of the cases had worsening of bone conduction. There were no cases of prosthesis extrusion or dislocation. Success rate air bone gap ⱕ 20 dB occurred in 74.4 percent of cases.
Received February 23, 2010; revised April 27, 2010; accepted May 3, 2010.
0194-5998/$36.00 © 2010 American Academy of Otolaryngology–Head and Neck Surgery Foundation. All rights reserved. doi:10.1016/j.otohns.2010.05.001
308
Otolaryngology–Head and Neck Surgery, Vol 143, No 2, August 2010 perform both stapes surgery and total ossicular chain reconstruction is a very practical possibility. In conclusion, these encouraging short-term outcomes, in a limited series of patients at a single institution, justify further comparative studies to determine the role of the new device versus existing, more established alternatives.
Acknowledgments The author thanks Filosa Barbara, MD, for collecting clinical data for this article, and Infante Mafalda, audiometrist, for her contribution collecting audiometric data for this article.
Author Information From the Department of Otolaryngology–Head and Neck Surgery, Azienda Ospedaliera S.G. Moscati Avellino, Avellino, Italy.
Figure 1 (A) Semisynthetic prosthesis 6-mm long and its position. (B) Semisynthetic prosthesis 7-mm long and its position. The straight arrow indicates the hinge of the perichondrium keeping the blocks from slipping; the curving arrows indicate the folding direction of blocks.
Corresponding author: Giuseppe Malafronte, MD, Unità operativa di otorinolaringoiatria, Azienda Ospedaliera S.G. Moscati Avellino, Viale Italia Avellino, Italia. E-mail address: [email protected].
Author Contribution Discussion In the recent past, most synthetic TORPs have been made of either hydroxyapatite or titanium. The head of the prosthesis is usually covered by a slice of tragal cartilage approximately 0.5 mm in thickness without perichondrium. In the short term, the extrusion rate of hydroxylapatite prostheses appears to be in the order of four to seven percent and, for titanium prostheses, around one to seven percent.2-4 All titanium extrusion resulted from resorption of the interposed slice cartilage. During the follow-up, extrusion of ssTORP occurred in no cases. The most likely reason for the high compatibility of the ssTORP is because of its head being made of one or more blocks of cartilage with perichondrium. The perichondrium left on both sides of the block improves nutrition, increases survival, preserves stiffness, and avoids the reabsorption of the head of the prosthesis.5 A short survey of the major medical equipment suppliers shows that the cost of the adjustable-length stapedotomy platinum-PTFE prosthesis is lower than that of the synthetic TORP. Moreover, the use of the same type of prosthesis to
Giuseppe Malafronte, substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data, drafting the article or revising it critically for important intellectual content, and final approval of the version to be published.
Disclosures Competing interests: None. Sponsorships: None.
References 1. Committee on Hearing and Equilibrium. Guidelines for the evaluation of results of treatment of a conductive hearing loss. Otolaryngol Head Neck Surg 1995;113:186 –7. 2. Schmerber S, Troussier J, Dumas G, et al. Hearing results with the titanium ossicular replacement prosthesis. Eur Arch Otorhinolaryngol 2006;263:347–54. 3. Coffey CS, Lee FS, Lambert PR. Titanium versus nontitanium prosthesis in ossiculoplasty. Laryngoscope 2008;118:1650 – 8. 4. Goldenberg RA. Hydroxylapatite ossicular replacement prosthesis: a four year experience. Otolaryngol Head Neck Surg 1992;106:261–9. 5. Malafronte G, Filosa B, Mercone F. A new double block ossiculoplasty: long-term results. Otol Neurotol 2008;29:531–3.
CLINICAL TECHNIQUES AND TECHNOLOGY
Early results with semisynthetic total ossicular replacement prosthesis Giuseppe Malafronte, MD, Avellino, Italy No sponsorships or competing interests have been disclosed for this article.
T
he objective of this article is to describe a new semisynthetic total ossicular prosthesis (ssTORP). The ssTORP is obtained by assembling a synthetic shaft with an autolog cartilage head. To make the shaft, we used an adjustable-length stapedotomy prosthesis made of platinum and polytetrafluoroethylene (PTFE) (7 mm in total length and 0.4 mm in diameter). The base of the hook is cut. In this way, a shaft made of platinum and PTFE, 4 mm in length and 0.4 mm in diameter, is obtained. It represents an artificial stapes superstructure. The shaft is supplied with a blunt platinum tip 1 mm in length and 0.2 mm in diameter. The blunt tip is completely inserted into the cartilage head of the prosthesis. The PTFE base of the shaft is positioned on the footplate. The head of the prosthesis can be made from one, two, or three blocks of tragal cartilage. This cartilage is ideal because it is flat and usually 1 mm thick. The 5-mm long ssTORP has a head made of one square block of tragal cartilage. The surgeon judges the size fitting on the basis of each individual case. The perichondrium is left on both sides of the cartilage block. In the middle of the block, just in the perichondrium, a small hole is made using an insulin needle. The blunt tip of the shaft is inserted into the perichondrium hole. By exerting a slight force on the shaft, the tip penetrates completely into the cartilage, fixing the shaft firmly into the cartilage block. The 6 –mm-long ssTORP has a head made from two blocks of cartilage. A double cartilage block is obtained by taking a rectangle (2 ⫻ 5 mm) from the tragal cartilage. The perichondrium is left on both cartilage sides. The cartilage is cut in half, avoiding transection of the perichondrium on the opposite side. A small hole is made in the perichondrium in the middle of the block. Next, the blunt tip of the shaft is inserted into the cartilage block. The cartilage is then folded back on itself with the intact perichondrium layer doubled between the two cartilage blocks. This acts as a hinge, keeping the blocks from slipping. The obtained 6 –mm-long ssTORP is positioned between the tympanic membrane and the footplate (Fig 1A). The 7–mm-long ssTORP is obtained by assembling a triple cartilage block with a shaft (Fig 1B).
The average time to take cartilage and to prepare the ssTORP is approximately five minutes.
Patients and Methods Thirty-five patients underwent an ssTORP ossiculoplasty from January 2007 to December 2007. Four patients had an inadequate follow-up and were excluded from the study, which left 31 patients for consideration. Of these, 22 were female, and nine were male. The mean age was 36 years. In 15 cases, the ssTORP ossiculoplasty (48.3%) was performed during a onestage tympanoplasty with canal wall down mastoidectomy; in eight cases (25.8%), it was performed during a planned second stage tympanoplasty with canal wall down mastoidectomy; and in eight cases (25.8%), the total chain reconstruction was performed during a tympanoplasty without mastoidectomy. The 5–mm-long ssTORP was used in three cases (9.6%). The 6 –mm-long ssTORP was used in 27 cases (87.09%). The 7–mm-long ssTORP was used in one case (3.2%). The audiometric data were first obtained two and six months after surgery, and thereafter at least once a year. For all patients, the last audiogram was obtained in November 2009. The average postoperative follow-up was 31 months (range, 24-34 months). A successful reconstruction was defined as a postoperative air bone gap less than or equal to 20 dB. Calculation of hearing results was in accordance with the American Academy of Otolaryngology–Head and Neck Surgery 1995 guidelines.1 Patients were fully informed concerning ssTORP ossiculoplasty, and they gave their written informed consent after a discussion of the alternatives, which included ossiculoplasty with traditional TORP. The S.G. Moscati Hospital Ethical Committee approved the study.
Results At the end of follow-up, none of the cases had worsening of bone conduction. There were no cases of prosthesis extrusion or dislocation. Success rate air bone gap ⱕ 20 dB occurred in 74.4 percent of cases.
Received February 23, 2010; revised April 27, 2010; accepted May 3, 2010.
0194-5998/$36.00 © 2010 American Academy of Otolaryngology–Head and Neck Surgery Foundation. All rights reserved. doi:10.1016/j.otohns.2010.05.001
308
Otolaryngology–Head and Neck Surgery, Vol 143, No 2, August 2010 perform both stapes surgery and total ossicular chain reconstruction is a very practical possibility. In conclusion, these encouraging short-term outcomes, in a limited series of patients at a single institution, justify further comparative studies to determine the role of the new device versus existing, more established alternatives.
Acknowledgments The author thanks Filosa Barbara, MD, for collecting clinical data for this article, and Infante Mafalda, audiometrist, for her contribution collecting audiometric data for this article.
Author Information From the Department of Otolaryngology–Head and Neck Surgery, Azienda Ospedaliera S.G. Moscati Avellino, Avellino, Italy.
Figure 1 (A) Semisynthetic prosthesis 6-mm long and its position. (B) Semisynthetic prosthesis 7-mm long and its position. The straight arrow indicates the hinge of the perichondrium keeping the blocks from slipping; the curving arrows indicate the folding direction of blocks.
Corresponding author: Giuseppe Malafronte, MD, Unità operativa di otorinolaringoiatria, Azienda Ospedaliera S.G. Moscati Avellino, Viale Italia Avellino, Italia. E-mail address: [email protected].
Author Contribution Discussion In the recent past, most synthetic TORPs have been made of either hydroxyapatite or titanium. The head of the prosthesis is usually covered by a slice of tragal cartilage approximately 0.5 mm in thickness without perichondrium. In the short term, the extrusion rate of hydroxylapatite prostheses appears to be in the order of four to seven percent and, for titanium prostheses, around one to seven percent.2-4 All titanium extrusion resulted from resorption of the interposed slice cartilage. During the follow-up, extrusion of ssTORP occurred in no cases. The most likely reason for the high compatibility of the ssTORP is because of its head being made of one or more blocks of cartilage with perichondrium. The perichondrium left on both sides of the block improves nutrition, increases survival, preserves stiffness, and avoids the reabsorption of the head of the prosthesis.5 A short survey of the major medical equipment suppliers shows that the cost of the adjustable-length stapedotomy platinum-PTFE prosthesis is lower than that of the synthetic TORP. Moreover, the use of the same type of prosthesis to
Giuseppe Malafronte, substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data, drafting the article or revising it critically for important intellectual content, and final approval of the version to be published.
Disclosures Competing interests: None. Sponsorships: None.
References 1. Committee on Hearing and Equilibrium. Guidelines for the evaluation of results of treatment of a conductive hearing loss. Otolaryngol Head Neck Surg 1995;113:186 –7. 2. Schmerber S, Troussier J, Dumas G, et al. Hearing results with the titanium ossicular replacement prosthesis. Eur Arch Otorhinolaryngol 2006;263:347–54. 3. Coffey CS, Lee FS, Lambert PR. Titanium versus nontitanium prosthesis in ossiculoplasty. Laryngoscope 2008;118:1650 – 8. 4. Goldenberg RA. Hydroxylapatite ossicular replacement prosthesis: a four year experience. Otolaryngol Head Neck Surg 1992;106:261–9. 5. Malafronte G, Filosa B, Mercone F. A new double block ossiculoplasty: long-term results. Otol Neurotol 2008;29:531–3.