Intraoperative feasibility of patient individual positioning and guiding jigs for cochlear implantation.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00025035

Enrollment

Registered

2021-04-13

Start date

2021-04-15

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H90

Interventions

Group 1: Mini-stereotactic frame 1 screw

Eligibility

Sex/Gender

All

Age

18 Years to 88 Years

Inclusion criteria

Inclusion criteria: CI surgery planned, age 18-88, male/female

Exclusion criteria

Exclusion criteria: - Revision surgery - Previous illness or condition that had required a mastoidectomy previously - For probands that do not meet the inclusion criteria - Acute infection in the middle ear or mastoid

Design outcomes

Primary

Measure	Time frame
Assessment of whether planning based on radiological image data and the subsequent production and attachment of the intraoperative, patient-specific jig can be carried out successfully.	—

Secondary

Measure	Time frame
most important secondary endpoint (s): - (Subjective) assessment of the fixation of the mini stereotaxic frames. Examination of the accuracy: - Control of the patient-specific guide hole made in the template by means of a straight "test rod" (e.g. puncture needle) or drill bit, verification via image recording under the surgical microscope: - a) Can a test rod (after conventional mastoidectomy) or a drill bit be passed through the facial recess? Measurement of the diameter across the axis of the guide hole in the facial recess. This would correspond to the critical passage of a later minimally invasive drilling. - b) Can the planned target point, the round window on the cochlea, be reached with the guided test rod/needle or with a drill bit? - c) Successful performing the minimally invasive drilling without the need to revert to the conventional surgical procedure. - Objective evaluation of the fixation of the mini stereotaxic frame based on an optical determination of the distance to a reference marker (also screwed to the bone). An unintentional subsequent movement of the screwed mini stereotaxic frame (e.g. inadequate hold of the bone screw (s)) can be measured and evaluated.	—

Measure

Time frame

most important secondary endpoint (s): - (Subjective) assessment of the fixation of the mini stereotaxic frames. Examination of the accuracy: - Control of the patient-specific guide hole made in the template by means of a straight "test rod" (e.g. puncture needle) or drill bit, verification via image recording under the surgical microscope: - a) Can a test rod (after conventional mastoidectomy) or a drill bit be passed through the facial recess? Measurement of the diameter across the axis of the guide hole in the facial recess. This would correspond to the critical passage of a later minimally invasive drilling. - b) Can the planned target point, the round window on the cochlea, be reached with the guided test rod/needle or with a drill bit? - c) Successful performing the minimally invasive drilling without the need to revert to the conventional surgical procedure. - Objective evaluation of the fixation of the mini stereotaxic frame based on an optical determination of the distance to a reference marker (also screwed to the bone). An unintentional subsequent movement of the screwed mini stereotaxic frame (e.g. inadequate hold of the bone screw (s)) can be measured and evaluated.

—

Countries

Germany

Contacts

Public ContactRolf Salcher

Medizinische Hochschule Hannover

salcher.rolf@mh-hannover.de+49 511 5322469

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026