Clinical Survey of Minimally Invasive Ponto Surgical Technique (MIPS)

N/ACompletedNCT03281967

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 Implant in patients indicated and counselled for Bone Anchored Hearing System.

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)

University Medical Center St Radboud

Nijmegen, Netherlands

Outcomes

Primary Outcomes

Numbness (sensibility) around surgery area

The primary objective of the study is to investigate the difference in numbness around implant after MIPS procedure (test, this investigation) and a surgery with soft tissue preservation (control, from a previous study, C47) for implanting Oticon Medical implants and abutments. Two different sensibilities will be tested by means of a broken wooden cotton swab/bud (q-tip): gnostic (with cotton side) and vital (with broken, sharp wooden side) sensibility. The measurement locations will be standardized at specific positions from surgery location, and the same location (with respect to the surgery site) will be used for sensibility measurement for each patient visit. Both the area (diameter in cm) and the degree (scale form 0 (no complaints) to 10 (maximum complaints)) will be monitored. Additionally, patients' subjective sensibility judgment around surgery area on a scale of 0-10 will be recorded.

Time frame: 6 months post surgery

Secondary Outcomes

Time needed for surgery

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

Time frame: At surgery

Unplanned visit

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

Time frame: 36 months

Adverse Events

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

Time frame: 36 months

Pain perception by patient

Investigate and compare patient perceived pain. For pain measurement, the patient is asked if pain around the implant is present. If it's present, duration is assessed (more or less than 6 weeks present). In addition, increase of pain is assessed during manipulation of the abutment (tightening of or tapping on the abutment). The patient is asked to score the perceived pain on a scale of 0-10; with 0 being no pain at all and 10 being the highest pain the patient had ever experienced.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.