Clinical Study of Minimally Invasive Ponto Surgical Technique (MIPS) - Design Iteration

Oticon Medical25 enrolled

Overview

The objective of the study is to compare the outcomes after a surgical procedure with minimally invasive Ponto surgery (MIPS, test group) and tissue preservation surgery (control) for placing Oticon Medical Ponto implants and abutments.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bone Conduction Deafness Unilateral Deafness Middle Ear Deafness Mixed Hearing Loss

Interventions

Minimally Invasive Ponto SurgeryDEVICE

Minimally Invasive Ponto surgery is used for hearing rehabilitation using Ponto Wide Implants in patients indicated and counselled for Bone Anchored Hearing Systems.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years or older. * Patient indicated for an ear level bone anchored sound processor. * Healthy bone quality to allow for 4mm implant insertion. Exclusion Criteria: * Intraoperative switch to an alternative surgical technique * Patients undergoing re-implantation (on the side being included in the study) * Previous participation in the C47 study. * Inability to participate in follow-up. * Psychiatric disease in the medical history. * Mental disability. * Presumed doubt, for any reason, that the patient will be able to show up on all follow-ups. * Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus. * Patients with natural skin height of \>12mm (as there will be additional skin reduction needed)

Locations (1)

Radboud University Medical Center

Nijmegen, Netherlands

Outcomes

Primary Outcomes

Numbness (sensibility) around the implant

Total numbness around the implant will be assessed as a combination of gnostic and vital sensibility.

Time frame: 6 months post surgery

Secondary Outcomes

Length of surgery

Compare the surgical time between test (this investigation) and control group (previous investigation, C47).

Time frame: At surgery

Unplanned visits

Investigate and compare the number of unplanned visits, including unplanned surgical procedures and other treatments for the test (this investigation) and control group (previous investigation, C47).

Time frame: 36 months

Adverse skin reactions

Investigate and compare the rate of adverse skin reactions using the Holgers Scale.

Time frame: 36 months

Adverse skin reactions

Investigate and compare the rate of adverse skin reactions using the IPS scale.

Time frame: 36 months

Pain perception by patient

Investigate and compare pain using a visual analogue scale 0-10

Time frame: 36 months

Implant survivability

Investigate and compare implant survivability in terms of reported implant loss.

Time frame: 36 months

Implant stability as measured with resonance frequency analysis, RFA.

Investigate and compare implant stability. Implant stability is monitored by measuring the implant stability quotient when following up on patients. Stability will be reported as implant stability quotient (ISQ).

Data from ClinicalTrials.gov

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