@article{ZahnertLoewenheimBeutneretal.2016,
  author    = {Zahnert, Thomas and L{\"o}wenheim, Hubert and Beutner, Dirk and Hagen, Rudolf and Ernst, Arneborg and Pau, Hans-Wilhelm and Zehlicke, Thorsten and K{\"u}hne, Hilke and Friese, Natascha and Tropitzsch, Anke and L{\"u}ers, Jan-Christoffer and Mlynski, Robert and Todt, Ingo and H{\"u}ttenbrink, Karl-Bernd},
  title     = {Multicenter Clinical Trial of Vibroplasty Couplers to Treat Mixed/Conductive Hearing Loss: First Results},
  series = {Audiology and Neurotology},
  volume    = {21},
  journal   = {Audiology and Neurotology},
  number    = {4},
  issn      = {1420-3030},
  doi       = {10.1159/000444616},
  url       = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-199129},
  pages     = {212-222},
  year      = {2016},
  abstract  = {Objective: To evaluate the safety and effectiveness of round window (RW), oval window (OW), CliP and Bell couplers for use with an active middle ear implant. Methods: This is a multicenter, long-term, prospective trial with consecutive enrollment, involving 6 university hospitals in Germany. Bone conduction, air conduction, implant-aided warble-tone thresholds and Freiburger monosyllable word recognition scores were compared with unaided preimplantation results in 28 moderate-to-profound hearing-impaired patients after 12 months of follow-up. All patients had previously undergone failed reconstruction surgeries (up to 5 or more). In a subset of patients, additional speech tests at 12 months postoperatively were used to compare the aided with the unaided condition after implantation with the processor switched off. An established quality-of-life questionnaire for hearing aids was used to determine patient satisfaction. Results: Postoperative bone conduction remained stable. Mean functional gain for all couplers was 37 dB HL (RW = 42 dB, OW = 35 dB, Bell = 38 dB, CliP = 27 dB). The mean postoperative Freiburger monosyllable score was 71\% at 65 dB SPL. The postimplantation mean SRT<sub>50</sub> (speech reception in quiet for 50\% understanding of words in sentences) improved on average by 23 dB over unaided testing and signal-to-noise ratios also improved in all patients. The International Outcome Inventory for Hearing Aids (IOI-HA)quality-of-life questionnaire was scored very positively by all patients. Conclusion: A significant improvement was seen with all couplers, and patients were satisfied with the device at 12 months postoperatively. These results demonstrate that an active implant is an advantage in achieving good hearing benefit in patients with prior failed reconstruction surgery.},
  language  = {en}
}
@article{BernhardKrumpholzKriegeretal.2022,
  author    = {Bernhard, Lukas and Krumpholz, Roman and Krieger, Yannick and Czempiel, Tobias and Meining, Alexander and Navab, Nassir and L{\"u}th, Tim and Wilhelm, Dirk},
  title     = {PLAFOKON: a new concept for a patient-individual and intervention-specific flexible surgical platform},
  series = {Surgical Endoscopy},
  volume    = {36},
  journal   = {Surgical Endoscopy},
  number    = {7},
  issn      = {0930-2794},
  doi       = {10.1007/s00464-021-08908-x},
  url       = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-307490},
  pages     = {5303-5312},
  year      = {2022},
  abstract  = {Background Research in the field of surgery is mainly driven by aiming for trauma reduction as well as for personalized treatment concepts. Beyond laparoscopy, other proposed approaches for further reduction of the therapeutic trauma have failed to achieve clinical translation, with few notable exceptions. We believe that this is mainly due to a lack of flexibility and high associated costs. We aimed at addressing these issues by developing a novel minimally invasive operating platform and a preoperative design workflow for patient-individual adaptation and cost-effective rapid manufacturing of surgical manipulators. In this article, we report on the first in-vitro cholecystectomy performed with our operating platform. Methods The single-port overtube (SPOT) is a snake-like surgical manipulator for minimally invasive interventions. The system layout is highly flexible and can be adapted in design and dimensions for different kinds of surgery, based on patient- and disease-specific parameters. For collecting and analyzing this data, we developed a graphical user interface, which assists clinicians during the preoperative planning phase. Other major components of our operating platform include an instrument management system and a non-sterile user interface. For the trial surgery, we used a validated phantom which was further equipped with a porcine liver including the gallbladder. Results Following our envisioned preoperative design workflow, a suitable geometry of the surgical manipulator was determined for our trial surgery and rapidly manufactured by means of 3D printing. With this setup, we successfully performed a first in-vitro cholecystectomy, which was completed in 78 min. Conclusions By conducting the trial surgery, we demonstrated the effectiveness of our PLAFOKON operating platform. While some aspects - especially regarding usability and ergonomics - can be further optimized, the overall performance of the system is highly promising, with sufficient flexibility and strength for conducting the necessary tissue manipulations.},
  language  = {en}
}