A monocenter, patient-blinded, randomized, parallel-group, non-inferiority study to compare cochlear implant receiver/stimulator device fixation techniques (COMFIT) with and without drilling in adults eligible for primary cochlear implantation.

BACKGROUND: During the cochlear implantation procedure, the receiver/stimulator (R/S) part of the implant is fixated to prevent postoperative device migration, which could have an adverse effect on the position of the electrode array in the cochlea. We aim to compare the migration rates of two fixation techniques, the bony recess versus the subperiosteal tight pocket without bony sutures. METHODS AND ANALYSIS: This single-blind randomized controlled trial will recruit a total of 112 primary cochlear implantation adult patients, eligible for implantation according to the current standard of practice. Randomization will be performed by an electronic data capture system Castor EDC, with participants block randomized to either bony recess or standard subperiosteal tight pocket in a 1:1 ratio, stratified by age. The primary outcome of this study is the R/S device migration rate; secondary outcomes include patient-experienced burden using the validated COMPASS questionnaire, electrode migration rate, electrode impedance values, speech perception scores, correlation between R/S migration, electrode array migration and patient complaints, assessment of complication rates, and validation of an implant position measurement method. Data will be collected at baseline, 1 week, 4 weeks, 8 weeks, 3 months, and 12 months after surgery. All data analyses will be conducted according to the intention-to-treat principle. DISCUSSION: Cochlear implantation by means of creating a tight subperiosteal pocket without drilling a bony seat is a minimally invasive fixation technique with many advantages. However, the safety of this technique has not yet been proven with certainty. This is the first randomized controlled trial that directly compares the minimally invasive technique with the conventional method of drilling a bony seat. TRIAL REGISTRATION: Netherlands Trial Register NL9698. Registered on 31 August 2021.

Reliability and Agreement of 3D Anthropometric Measurements in Facial Palsy Patients Using a Low-Cost 4D Imaging System.

The reliability (precision) and agreement (accuracy) of anthropometric measurements based on manually placed 3D landmarks using the RealSense D415 were investigated in this paper. Thirty facial palsy patients, with their face in neutral (resting) position, were recorded simultaneously with the RealSense and a professional 3dMD imaging system. First the RealSense depth accuracy was determined. Subsequently, two observers placed 14 facial landmarks on the 3dMD and RealSense image, assessing the distance between landmark placement. The respective intra- and inter-rater Euclidean distance between the landmark placements was 0.84 mm (±0.58) and 1.00 mm (±0.70) for the 3dMD landmarks and 1.32 mm (±1.27) and 1.62 mm (±1.42) for the RealSense landmarks. From these landmarks 14 anthropometric measurements were derived. The intra- and inter-rater measurements had an overall reliability of 0.95 (0.87 - 0.98) and 0.93 (0.85 - 0.97) for the 3dMD measurements, and 0.83 (0.70 - 0.91) and 0.80 (0.64 - 0.89) for the RealSense measurements, respectively, expressed as the intra-class correlation coefficient. Determined by the Bland-Altman analysis, the agreement between the RealSense measurements and 3dMD measurements was on average -0.90 mm (-4.04 - 2.24) and -0.89 mm (-4.65 - 2.86) for intra- and inter-rater agreement, respectively. Based on the reported reliability and agreement of the RealSense measurements, the RealSense D415 can be considered as a viable option to perform objective 3D anthropomorphic measurements on the face in a neutral position, where a low-cost and portable camera is required.