Page 121 - ENT IMPLANTS CATALOGUE IMPLANTS ORL
P. 121

incudomalleolar joint or incus luxation. The goal of this study was to assess   Published: Laryngoscope, 2009 Dec; 119(12): 2421-7
          the admissible range of forces at the long process of the incus that would   DOI: 10.1002/lary.20641
          be tolerable before damaging the structures and to compare them with the
          forces occurring during surgery.                    Objectives/Hypothesis: The aim of the study was to gain the first clini-
                                                              cal experience with a new titanium clip prosthesis in stapes surgery, and to
          Methods: Load-deflection curves in the lateral-medial and anterior-poste-  compare this model with its predecessor. We placed particular emphasis on
          rior direction were measured in 9 freshly frozen or fresh temporal bones.   the practicability of fixing the prosthesis to the long process of the incus and
          The force was measured with a load cell, and displacement was taken from   on the postoperative improvement in hearing. Study Design: Retrospective
          the encoder information of the electrically driven translation stage on which   chart review.
          the load cell was mounted. The long process of the incus was coupled to the
          load cell via a customized needle. We also monitored with video recordings   Methods: The study included 23 patients who had a CliP Piston à Wengen
          for visual confirmation of findings.                fitted and 21 patients with a Soft CliP Piston (both from Kurz Medizintech-
                                                              nik, Dusslingen, Germany). Air and bone conduction were tested preoper-
          Results:  The rupture force at which the middle ear was found to be severe-  atively and 5 to 6 weeks after surgery in all patients, as well as after about
          ly injured was 894 (724-1018) mN in the anterior-posterior direction and   1 year in a subgroup.
          695 (574-771) mN in the lateral-medial direction. Micro-ruptures occurred
          at forces around 568 (469-686) mN in the anterior-posterior direction and   Results: We found a mean air-bone gap of 8.5 +/- 5.2 dB in the frequen-
          in the lateral-medial direction at 406 (254-514) mN. Short-term maximum   cies 0.5, 1, 2, and 3 kHz for the patients with a CliP Piston à Wengen at
          forces of 1,321 (1,051-1,533) mN were measured in the anterior-posterior   follow-up audiometry after an average of 31 days, and of 6.4 +/- 3.7 dB for
          direction and 939 (726-1,132) mN in the lateral-medial direction.  11 patients after 412 days. The corresponding figures for patients with Soft
                                                              CliP Pistons were 8.9 +/- 4.1 dB after 44 days, and 6.3 +/- 5.6 dB for 10
          Conclusion: Rupture forces of the incudomalleolar joint could be defined   patients after 419 days. There were no statistically significant differences.
          with high accuracy. These results were used to calculate risks of incus lux-  All the prostheses were implanted without difficulty.
          ation or subluxation during stapes surgery. Compared with the use of clip
          and SMA prostheses, the risk of damage from a crimping procedure is sig-  Conclusions: The two stapes prostheses studied gave good early audiometric
          nificantly higher.                                  results that showed no difference. After a short learning period, both could be
                                                              pushed onto the long process of the incus with similar ease, although subjec-
                                                              tively the new design of the Soft CliP seemed to adapt better to the different
          Diagnostic Findings in Stapes Revision Surgery -    diameters of the process and took up less space in the middle ear.
          A Retrospective of 26 Years
          Schimanski G., Schimanski E., Berthold M. R.        Stapes surgery: First experiences with the
                                                                          ®
                                                              new Soft-CliP  Piston
          Published: Otology & Neurotology: April 2011 - Volume 32(3): 373-383
          DOI: 10.1097/MAO.0b013e3182096da1                   Brase C., Zenk J., Wurm J., Schick B., Iro H., Hornung J.
          Objectives: The aim of the study is to obtain a detailed overview of the   Published: HNO 2009:57(509-513). (German)
          revision findings after stapes operations and to draw conclusions on a stapes   DOI: 10.1007/s00106-009-1899-y
          prosthesis that can be recommended.
                                                              Background: The first hearing results with a new stapes prosthesis with
          Study Design: Retrospective case series. Setting: Tertiary otologic referral   clip function (Soft-CliP  piston) are presented.
                                                                              ®
          center.
                                                              Patients and Methods: This new prosthesis was used in 15 patients (mean
          Methods: Approximately 12,000 middle ear operations within a period of   age 45.2 years; range 21-63 years) undergoing routine stapes surgery. Soft-
          26 years were evaluated. The findings of the revisions were classified into   CliP  piston prostheses with a shaft diameter of 0.4 mm and a length rang-
                                                                 ®
          surgeon related, prosthesis related, and other causes.   ing from 4.25 mm to 5.5 mm were used. Postoperative audiological testing
                                                              and measurement of the air-bone gap were performed after an average of
          Results: Three hundred forty-three stapes revisions were done. Many differ-  47.3 days and compared with the preoperative values.
          ent prostheses were found: the most common were Schuknecht prostheses
          and Teflon platinum, gold, and titanium pistons. Polyethylene strut, Teflon   Results:  The median observed postoperative air-bone gap (ABG) was
          wire pistons, Shea (Teflon) pistons, and other techniques, such as columel-  8.33 dB ±4.16 dB. All patients had less than 20 dB ABG and in 53.3% of
          la or malleovestibulopexy, were rarely found. There are specific findings   cases was less than 10 dB. The operating time showed a clear difference
          correlating to certain prostheses: Schuknecht prostheses were too short in   between the left (66.5 min ±37.79 min) and right ears (47.2 min ±11.08 min).
          50% of the revisions (surgeon related), Teflon platinum caused necrosis or
          arrosion of the long incudal process (prostheses related) in 69%, and gold   Discussion: This new prosthesis design greatly facilitates a very difficult
          caused reparative granuloma sometimes combined with necosis of the incus   step in stapes surgery, the prosthesis fixation to the incus. The first postop-
          in 70% (prostheses related). There was no specific diagnostic finding with   erative hearing results are very promising but long-term results in a larger
          titanium pistons, neither surgeon nor material related.   group of patients are still pending.

          Conclusion: An analysis of revision findings over an extended observation
          period can enable middle-ear surgeons to improve their surgical techniques   Development of a new CliP-Piston prosthesis for the Stapes
          and to select the best suited prosthesis. Self-fabricated stapes prostheses
          (e.g., Schuknecht) do not conform to required quality standards and should   Schimanski G., Steinhardt U., Eiber A.
          not be used. GoPi, which is no longer available, and TPlPi showed prosthe-
          sis-related diagnostic findings. The titanium prostheses used by the authors   Published: Proceedings of the 4th International Symposium. Zurich, Swit-
          have proven to be excellently compatible and can therefore be recommend-  zerland, 27 - 30 July 2006. Middle Ear Mechanics in Research and Otology:
          ed as safe stapes prostheses.                       pp. 237-245. DOI: 10.1142/9789812708694_0032
                                                              275 inserted Clip-Pistons type “ à Wengen” within three years revealed dif-
          First Experience With a New Titanium Clip Stapes Prosthesis   ficulties in 14.5% of the cases. In those cases it was necessary to make ad-
          and a Comparison With the Earlier Model Used in Stapes   justments to the clip shape (plastic deformation) before insertion due to the
          Surgery                                             individual dimension of the long incudal process. During 100 middle ear
                                                              surgeries the cross sections of the long incudal processes where the clip is
          Hornung J. A., Brase C., Bozzato A., Zenk J., Iro H.  attached was measured. This resulted in data hitherto unknown. By virtue

                                                                           www.instrumentarium.ca
                                                                                                               15
   116   117   118   119   120   121   122   123   124   125   126