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Clinical Survey of Minimally Invasive Ponto Surgical Technique (MIPS)

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

  • University Medical Center St Radboud

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 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.

Secondary Outcome Measures

Time needed for surgery
Compare the surgical time between test (this investigation) and control group (previous investigation, C47).
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).
Adverse Events
Investigate and compare the rate of adverse skin reactions using the Holgers Scale and the IPS scale.
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.
Implant survivability
Investigate and compare implant survivability. Implant survivability is monitored by following upon patients and recording implant losses if and when they occur. The investigators do not expect multiple patients to have an implant loss. However, this may happen due to different reasons. The investigators would track the circumstances under which the implant loss occurred and the time between implant installation and loss.
Implant stability as measures by Implant stability quotient.
Investigate implant stability.
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 using the Holgers Scoring Scheme and record any medications that were given to aid in skin healing.
Quality of Life Assessment
Investigate and compare subjective benefit as measured by APHAB, GBI and GHSI questionnaires.
Aesthetic Assessment
Investigate and compare scar assessment by surgeon and patient (POSAS).

Full Information

First Posted
August 31, 2017
Last Updated
March 2, 2021
Sponsor
Oticon Medical
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1. Study Identification

Unique Protocol Identification Number
NCT03281967
Brief Title
Clinical Survey of Minimally Invasive Ponto Surgical Technique (MIPS)
Official Title
Clinical Survey of Minimally Invasive Ponto Surgical Technique (MIPS)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 9, 2017 (Actual)
Primary Completion Date
June 13, 2018 (Actual)
Study Completion Date
December 21, 2020 (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 Implant in patients indicated and counselled for Bone Anchored Hearing System.
Primary Outcome Measure Information:
Title
Numbness (sensibility) around surgery area
Description
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 Outcome Measure Information:
Title
Time needed for surgery
Description
Compare the surgical time between test (this investigation) and control group (previous investigation, C47).
Time Frame
At surgery
Title
Unplanned visit
Description
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
Title
Adverse Events
Description
Investigate and compare the rate of adverse skin reactions using the Holgers Scale and the IPS scale.
Time Frame
36 months
Title
Pain perception by patient
Description
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.
Time Frame
36 months
Title
Implant survivability
Description
Investigate and compare implant survivability. Implant survivability is monitored by following upon patients and recording implant losses if and when they occur. The investigators do not expect multiple patients to have an implant loss. However, this may happen due to different reasons. The investigators would track the circumstances under which the implant loss occurred and the time between implant installation and loss.
Time Frame
36 months
Title
Implant stability as measures by Implant stability quotient.
Description
Investigate implant stability.
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 using the Holgers Scoring Scheme and record any medications that were given to aid in skin healing.
Time Frame
36 months
Title
Quality of Life Assessment
Description
Investigate and compare subjective benefit as measured by APHAB, GBI and GHSI questionnaires.
Time Frame
36 months
Title
Aesthetic Assessment
Description
Investigate and compare scar assessment by surgeon and patient (POSAS).
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
University Medical Center St Radboud
City
Nijmegen
ZIP/Postal Code
6500
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Survey of Minimally Invasive Ponto Surgical Technique (MIPS)

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