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

Primary Purpose

Bone Conduction Deafness, Unilateral Deafness, Middle Ear Deafness

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Minimally Invasive Ponto Surgery
Sponsored by
Oticon Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Conduction Deafness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Radboud University Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Minimally Invasive Ponto Surgery

Arm Description

Surgical method for installation of a bone anchored hearing system for hearing rehabilitation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Length of surgery
Compare the surgical time between test (this investigation) and control group (previous investigation, C47).
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).
Adverse skin reactions
Investigate and compare the rate of adverse skin reactions using the Holgers Scale.
Adverse skin reactions
Investigate and compare the rate of adverse skin reactions using the IPS scale.
Pain perception by patient
Investigate and compare pain using a visual analogue scale 0-10
Implant survivability
Investigate and compare implant survivability in terms of reported implant loss.
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).
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.
Wound dehiscence
Investigate wound dehiscence size after surgery.
Quality of Life Assessment
Investigate and compare subjective benefit as measured by SSQ questionnaire.
Quality of Life Assessment
Investigate and compare subjective benefit as measured by YORK questionnaire.
Quality of Life Assessment
Investigate and compare subjective benefit as measured by APHAB questionnaire.
Quality of Life Assessment
Investigate and compare subjective benefit as measured by GBI questionnaire.
Quality of Life Assessment
Investigate and compare subjective benefit as measured by GHSI questionnaire.

Full Information

First Posted
January 8, 2019
Last Updated
April 19, 2022
Sponsor
Oticon Medical
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1. Study Identification

Unique Protocol Identification Number
NCT03807713
Brief Title
Clinical Study of Minimally Invasive Ponto Surgical Technique (MIPS) - Design Iteration
Official Title
Clinical Study of Minimally Invasive Ponto Surgical Technique (MIPS) - Design Iteration
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 7, 2018 (Actual)
Primary Completion Date
November 6, 2019 (Actual)
Study Completion Date
March 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oticon Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Conduction Deafness, Unilateral Deafness, Middle Ear Deafness, Mixed Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minimally Invasive Ponto Surgery
Arm Type
Other
Arm Description
Surgical method for installation of a bone anchored hearing system for hearing rehabilitation
Intervention Type
Device
Intervention Name(s)
Minimally Invasive Ponto Surgery
Intervention Description
Minimally Invasive Ponto surgery is used for hearing rehabilitation using Ponto Wide Implants in patients indicated and counselled for Bone Anchored Hearing Systems.
Primary Outcome Measure Information:
Title
Numbness (sensibility) around the implant
Description
Total numbness around the implant will be assessed as a combination of gnostic and vital sensibility.
Time Frame
6 months post surgery
Secondary Outcome Measure Information:
Title
Length of surgery
Description
Compare the surgical time between test (this investigation) and control group (previous investigation, C47).
Time Frame
At surgery
Title
Unplanned visits
Description
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
Title
Adverse skin reactions
Description
Investigate and compare the rate of adverse skin reactions using the Holgers Scale.
Time Frame
36 months
Title
Adverse skin reactions
Description
Investigate and compare the rate of adverse skin reactions using the IPS scale.
Time Frame
36 months
Title
Pain perception by patient
Description
Investigate and compare pain using a visual analogue scale 0-10
Time Frame
36 months
Title
Implant survivability
Description
Investigate and compare implant survivability in terms of reported implant loss.
Time Frame
36 months
Title
Implant stability as measured with resonance frequency analysis, RFA.
Description
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).
Time Frame
36 months
Title
Surgical wound healing time
Description
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.
Time Frame
36 months
Title
Wound dehiscence
Description
Investigate wound dehiscence size after surgery.
Time Frame
36 months
Title
Quality of Life Assessment
Description
Investigate and compare subjective benefit as measured by SSQ questionnaire.
Time Frame
36 months
Title
Quality of Life Assessment
Description
Investigate and compare subjective benefit as measured by YORK questionnaire.
Time Frame
36 months
Title
Quality of Life Assessment
Description
Investigate and compare subjective benefit as measured by APHAB questionnaire.
Time Frame
36 months
Title
Quality of Life Assessment
Description
Investigate and compare subjective benefit as measured by GBI questionnaire.
Time Frame
36 months
Title
Quality of Life Assessment
Description
Investigate and compare subjective benefit as measured by GHSI questionnaire.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myrthe Hol, MD, PhD
Organizational Affiliation
Radboud UMC, Department of Otorhinolaryngology. The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Medical Center
City
Nijmegen
ZIP/Postal Code
6525
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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