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years after the initial procedure. Otological microscope findings and audio- Objective: To describe a new titanium clip prosthesis for partial ossicular
logical measurement data were evaluated for the analysis. The quality of life reconstruction with a micro ball joint in the headplate for compensation of
was evaluated based on the Glasgow Benefit Inventory. The objective of the tympanic membrane displacements.
study was to find information on the long-term hearing results (air-bone gap
before and after operation), the seating of the prosthesis, the rate of revision Patients: Laboratory experiments followed by 18 consecutive patients.
operations, protrusions and extrusions, and patient satisfaction.
Interventions: A micro ball joint was implemented into a headplate of ti-
Results: 30 patients were recruited and the average follow-up was 64 tanium middle ear prosthesis. First, the new prosthesis was tested in the
months. The validated analysis of quality of life showed an improvement; laboratory in temporal bone experiments. Second, the new prosthesis was
protrusions or extrusions were documented in isolated cases. The sound clinically installed in 18 patients.
transmission component - measured over frequencies 0.5-4 kHz - was re-
duced pantonally from an average of 21 dB to 10.2 dB. Outcome Measures: Results of laser Doppler vibrometry and force mea-
surements in the laboratory experiments, analysis of a questionnaire, and
Conclusion: This study demonstrates that the results remain stable over preoperative and postoperative pure tone audiometry.
the long term and in contrast to other methods of chain reconstruction the
sound conduction component is reliably reduced. This was also the first Results: The frictional resistance in the joint was measured to be 12 mN
time that a validated measurement procedure could be used to show that that should allow for adequate mobility under physiologic conditions. The
the subjective quality of life of patients is positively affected over the long effective sound transmission of the prosthesis was demonstrated by laser
term. Reconstruction of the ossicle chain with titanium CliP® Prostheses Doppler vibrometry. Intraoperatively, the installation of the prosthesis was
is now an established procedure. always straightforward with headplate prosthesis shaft angles between 60
and 90 degrees. Postoperatively, pure tone audiometry revealed satisfying
hearing results with a remaining average air-bone gap of 18.2 dB over the
Experience With the Use of a Partial frequencies 500, 1,000, 2,000, and 3,000 Hz. No signs of prosthesis disloca-
Ossicular Replacement Prosthesis With a Ball-and-Socket tion were discovered within the follow-up period of approximately 6 months.
Joint Between the Plate and the Shaft
Conclusion: The experimental data show that the new modified prosthesis
Birk S., Brase C., Hornung J. headplate fulfills the requirements necessary for sound transmission. The
joint allows the plate to follow movements of the tympanic membrane. This
Published: Otol Neurotol 2014; 35(7) :1248-1250 characteristic in conjunction with the proven clip design ensure for optimal
DOI: 10.1097/MAO.0000000000000383 prosthesis placement and effectiveness.
Background: In the further development of alloplastic prostheses for use in
middle ear surgery, the Dresden and Cologne University Hospitals, working
together with a company, introduced a new partial ossicular replacement CLIP PARTIAL PROS THESIS DRESDEN TYPE
prosthesis in 2011. The ball-and-socket joint between the prosthesis and the
shaft mimics the natural articulations between the malleus and incus and be-
tween the incus and stapes, allowing reaction to movements of the tympanic Short and Long-Term Outcomes of Titanium Clip Ossiculoplasty
membrane graft, particularly during the healing process.
Kahue Ch. N., O’Connnell B. P., Dedmon M. M.,
Study Design: Retrospective evaluation Haynes D. S., Rivas A.
Methods: To reconstruct sound conduction as part of a type III tym- Published: Otolo Neurotol 2018; 39(6): e453-e460
panoplasty, partial ossicular replacement prosthesis with a ball-and-socket DOI: 10.1097/MAO.0000000000001795
joint between the plate and the shaft was implanted in 60 patients, with
other standard partial ossicular replacement prosthesis implanted in 40 Objective: To report short (~4 mo) and long-term (>12 mo) audiometric
patients and 64 patients. Pure-tone audiometry was carried out, on av- outcomes following ossiculoplasty using a titanium clip partial ossicular
erage, 19 and 213 days after surgery. Results of the partial ossicular reconstruction prosthesis.
replacement prosthesis with a ball-and-socket joint between the plate
and the shaft were compared with those of the standard prostheses. Methods: Case series at a single tertiary referral center reviewing 130 pe-
diatric and adult patients with conductive hearing loss (CHL) secondary to
Results: Early measurements showed a mean improvement of 3.3 dB in the chronic otitis media (n = 121, 93%) or traumatic ossicular disruption (n = 9,
air-bone gap (ABG) with the partial ossicular replacement prosthesis with a 7%) who underwent partial ossiculoplasty from January 2005 to December
ball-and-socket joint between the plate and the shaft, giving similar results 2015 with the CliP prosthesis.
than the standard implants (6.6 and 6.0 dB, respectively), but the differences
were not statistically significant. Later measurements showed a statistically Results: At both short and long-term follow-up, postoperative air-bone
significant improvement in the mean ABG, 11.5 dB, compared with 4.4 dB gap (ABG) was significantly improved (18 dB HL, IQ range 13–26,
for one of the standard partial ossicular replacement prosthesis and a ten- p < 0.0001 and 18 dB HL, IQ range 13–29, p = 0.0002, respectively)
dency of better results to 6.9 dB of the other standard prosthesis. when compared with preoperative values (29 dB HL, IQ range 19–37). No
significant change in ABG was noted when comparing short and long-term
Conclusions: In our patients, we achieved similarly good audiometric intervals (18 versus 18 dB HL, p = 0.44). Fifty seven percent of cases
results to those already published for the partial ossicular replacement (51/89) achieved a long-term ABG less than or equal to 20 dB at the time
prosthesis with a ball-and-socket joint between the plate and the shaft. of their last follow-up. The extrusion and displacement rates were 1.5%
Intraoperative fixation posed no problems, and the postoperative com- (2/130), and 0.8% (1/130), respectively. There were no cases of iatrogenic
plication rate was low. sensorineural hearing loss.

Conclusions: Partial ossiculoplasty with the titanium CliP produces good
Titanium Clip Ball Joint: hearing outcomes with a favorable safety profile. At long-term follow-up
A Partial Ossicular Reconstruction Prosthesis (minimum of 12 mo), median ABG was 18 dB and remained stable when
compared with short-term follow-up. The majority of patients had success-
Beutner D., Luers J. C., Bornitz M., Zahnert T., ful long-term results, with 57% of patients achieving an ABG is less than or
Hüttenbrink K.-B. equal to 20 dB. Low rates of extrusion (1.5%) and prosthesis displacement
off the stapes (0.8%) support the long-term stability of the CliP prosthesis
Published: Otol Neurotol. 2011; 32 (4) : 646-9 in the middle ear.
DOI: 10.1097/MAO.0b013e318213867a

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