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

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 Overview

• Status: Completed
• Conditions: Unilateral Deafness; Bone Conduction Deafness; Mixed Hearing Loss; Middle Ear Deafness
• Intervention / Treatment: Device: Minimally Invasive Ponto Surgery

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands, 6525
    • Radboud University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Minimally Invasive Ponto Surgery; Surgical method for installation of a bone anchored hearing system for hearing rehabilitation	Device: Minimally Invasive Ponto Surgery; Minimally Invasive Ponto surgery is used for hearing rehabilitation using Ponto Wide Implants in patients indicated and counselled for Bone Anchored Hearing Systems.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numbness (sensibility) around the implant	Total numbness around the implant will be assessed as a combination of gnostic and vital sensibility.	6 months post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of surgery	Compare the surgical time between test (this investigation) and control group (previous investigation, C47).	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).	36 months
Adverse skin reactions	Investigate and compare the rate of adverse skin reactions using the Holgers Scale.	36 months
Adverse skin reactions	Investigate and compare the rate of adverse skin reactions using the IPS scale.	36 months
Pain perception by patient	Investigate and compare pain using a visual analogue scale 0-10	36 months
Implant survivability	Investigate and compare implant survivability in terms of reported implant loss.	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).	36 months
Surgical wound healing time	Investigate and compare healing time after surgery. Follow-up visits after surgery will assess the healing of wound. This will be a yes/no assessment to be answered by the attending physician. The investigators will also evaluate skin reactions and record any medications that were given to aid in skin healing.	36 months
Wound dehiscence	Investigate wound dehiscence size after surgery.	36 months
Quality of Life Assessment	Investigate and compare subjective benefit as measured by SSQ questionnaire.	36 months
Quality of Life Assessment	Investigate and compare subjective benefit as measured by YORK questionnaire.	36 months
Quality of Life Assessment	Investigate and compare subjective benefit as measured by APHAB questionnaire.	36 months
Quality of Life Assessment	Investigate and compare subjective benefit as measured by GBI questionnaire.	36 months
Quality of Life Assessment	Investigate and compare subjective benefit as measured by GHSI questionnaire.	36 months

Collaborators and Investigators

• Sponsor: Oticon Medical

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 7, 2018
• Primary Completion (ACTUAL): November 6, 2019
• Study Completion (ACTUAL): March 29, 2022

Study Registration Dates

• First Submitted: January 8, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (ACTUAL): January 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Conductive; Hearing Loss, Unilateral; Hearing Loss, Mixed Conductive-Sensorineural
• Other Study ID Numbers: C69

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No