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Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant

Primary Purpose

Deafness, Hearing Loss, Hearing Loss, Conductive

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Bone anchored hearing implant
Sponsored by
Oticon Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deafness focused on measuring Bone anchored hearing aid, Bone anchored implant, Implant stability, Wide diameter implant, Linear incision, Ponto

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
  • Bone thickness at the implant site of at least 4 mm

Exclusion Criteria:

  • Longer abutment (>6mm) required
  • 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.

Sites / Locations

  • University Medical Center St Radboud

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Wide diameter implant

Control group

Arm Description

Bone anchored hearing implant For the wide diameter arm (test group), the Ponto wide implant (diameter 4,5mm, length 4mm) and abutment 6mm developed by Oticon Medical AB (Gothenburg, Sweden) will be installed.

Bone anchored hearing implant For the control group, the previous generation Ponto implant (diameter 3,75mm, length 4mm) and 6mm abutment (Oticon Medical AB, Gothenburg, Sweden) will be installed.

Outcomes

Primary Outcome Measures

ISQ (Implant Stability Quotient)
ISQ (implant Stability Quotient) is a measurement scale for use with the Resonance Frequency Analysis (RFA) method of determining implant stability. The measurement is made using the Osstell Mentor equipment (Osstell, Sweden) with SmartPegs. ISQ values range from 1 to 100, the higher the score the higher the stability. The highest and lowest score obtained from perpendicular measurements will be registered.
ISQ (Implant Stability Quotient)
ISQ (Implant Stability Quotient)
ISQ (Implant Stability Quotient)
ISQ (Implant Stability Quotient)
ISQ (Implant Stability Quotient)
ISQ (Implant Stability Quotient)
ISQ (Implant Stability Quotient)
ISQ (Implant Stability Quotient)
ISQ (Implant Stability Quotient)
ISQ (Implant Stability Quotient)

Secondary Outcome Measures

Time of minimum ISQ (Implant stability quotient)
Implant stability can be seen as a combination of mechanical stability, which is the result of compressed bone holding the implant tightly in place, and biological stability, which is the result of new bone forming at the site of implantation and osseointegration. Mechanical stability is generally high immediately after implant placement and is decreasing with time. Biological stability, on the other hand, is non-existent immediately after placement and increases with time. The final stability level for an implant is the sum of the two. There is likely to be an initial decrease in stability followed by a subsequent increase as the implant becomes biologically stable. ISQ (implant Stability Quotient) is a measurement scale for use with the Resonance Frequency Analysis (RFA) method of determining implant stability.
ISQ (Implant stability quotient) gradient
ISQ (implant stability quotient) per time unit gives a measure of osseointegration speed.
Skin condition according to Holgers score
Holgers score is a standardized scale to clinically assess skin condition around a percutaneous implant
Skin condition according to Holgers score
Skin condition according to Holgers score
Skin condition according to Holgers score
Skin condition according to Holgers score
Skin condition according to Holgers score
Skin condition according to Holgers score
Skin condition according to Holgers score
Skin condition according to Holgers score
Skin condition according to Holgers score
Glasgow Benefit Inventory Questionnaire
Glasgow Benefit Inventory Questionnaire (GBI) 18-item, post-surgical questionnaire given to patients. The GBI measures the change in health status produced by surgical interventions (here, "health status" is the general perception of well-being, including total psychological, social, and physical well being).
Glasgow Benefit Inventory Questionnaire
Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire
The APHAB is a 24-item self-assessment inventory in which patients report the amount of trouble they are having with communication or noises in various everyday situations. Benefit is calculated by comparing the patient's reported difficulty in the unaided condition with their amount of difficulty when using amplification. The APHAB produces scores for 4 subscales: Ease of Communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV).
Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire
Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire
Glasgow Health Status Inventory (GHSI) questionnaire
The Glasgow Health Status Inventory is an 18 item questionnaire. It assesses health state, by measuring the effect of a health problem on the quality of life of a person. It allows cross-comparison among many health conditions, among different health interventions, and among demographic and cultural subgroups.
Glasgow Health Status Inventory (GHSI) questionnaire
Glasgow Health Status Inventory (GHSI) questionnaire

Full Information

First Posted
November 28, 2012
Last Updated
November 23, 2017
Sponsor
Oticon Medical
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1. Study Identification

Unique Protocol Identification Number
NCT01738490
Brief Title
Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant
Official Title
Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The overall aim of the study is to investigate the Ponto wide implant considering; initial implant stability, stability over time, skin reaction and long term success when loaded at 3 weeks post surgery. Patients' quality of life improvements following implantation will also be surveyed. More specifically the primary objective of this clinical study is to test the hypothesis The new Ponto wide diameter implant offers increased implant stability measured as ISQ (implant stability quotient) compared to the previous generation Ponto implant. And the secondary objective is to Investigate when in time implant stability is the lowest as the initial mechanical stability is gradually replaced by biological stability

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness, Hearing Loss, Hearing Loss, Conductive, Hearing Disorders, Ear Diseases, Otorhinolaryngologic Diseases
Keywords
Bone anchored hearing aid, Bone anchored implant, Implant stability, Wide diameter implant, Linear incision, Ponto

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wide diameter implant
Arm Type
Other
Arm Description
Bone anchored hearing implant For the wide diameter arm (test group), the Ponto wide implant (diameter 4,5mm, length 4mm) and abutment 6mm developed by Oticon Medical AB (Gothenburg, Sweden) will be installed.
Arm Title
Control group
Arm Type
Other
Arm Description
Bone anchored hearing implant For the control group, the previous generation Ponto implant (diameter 3,75mm, length 4mm) and 6mm abutment (Oticon Medical AB, Gothenburg, Sweden) will be installed.
Intervention Type
Device
Intervention Name(s)
Bone anchored hearing implant
Other Intervention Name(s)
Ponto implant, Bone anchored hearing aid
Primary Outcome Measure Information:
Title
ISQ (Implant Stability Quotient)
Description
ISQ (implant Stability Quotient) is a measurement scale for use with the Resonance Frequency Analysis (RFA) method of determining implant stability. The measurement is made using the Osstell Mentor equipment (Osstell, Sweden) with SmartPegs. ISQ values range from 1 to 100, the higher the score the higher the stability. The highest and lowest score obtained from perpendicular measurements will be registered.
Time Frame
Surgery (0 days)
Title
ISQ (Implant Stability Quotient)
Time Frame
7 days after surgery
Title
ISQ (Implant Stability Quotient)
Time Frame
14 days after surgery
Title
ISQ (Implant Stability Quotient)
Time Frame
21 days after surgery
Title
ISQ (Implant Stability Quotient)
Time Frame
28 days after surgery
Title
ISQ (Implant Stability Quotient)
Time Frame
6 weeks after surgery
Title
ISQ (Implant Stability Quotient)
Time Frame
12 weeks after surgery
Title
ISQ (Implant Stability Quotient)
Time Frame
6 months after surgery
Title
ISQ (Implant Stability Quotient)
Time Frame
12 months after surgery
Title
ISQ (Implant Stability Quotient)
Time Frame
24 months after surgery
Title
ISQ (Implant Stability Quotient)
Time Frame
36 months after surgery
Secondary Outcome Measure Information:
Title
Time of minimum ISQ (Implant stability quotient)
Description
Implant stability can be seen as a combination of mechanical stability, which is the result of compressed bone holding the implant tightly in place, and biological stability, which is the result of new bone forming at the site of implantation and osseointegration. Mechanical stability is generally high immediately after implant placement and is decreasing with time. Biological stability, on the other hand, is non-existent immediately after placement and increases with time. The final stability level for an implant is the sum of the two. There is likely to be an initial decrease in stability followed by a subsequent increase as the implant becomes biologically stable. ISQ (implant Stability Quotient) is a measurement scale for use with the Resonance Frequency Analysis (RFA) method of determining implant stability.
Time Frame
0, 7, 14, 21 and 28 days after surgery
Title
ISQ (Implant stability quotient) gradient
Description
ISQ (implant stability quotient) per time unit gives a measure of osseointegration speed.
Time Frame
0, 7, 14, 21 and 28 days, 6 weeks, 12weeks, 6 months after surgery
Title
Skin condition according to Holgers score
Description
Holgers score is a standardized scale to clinically assess skin condition around a percutaneous implant
Time Frame
7 days after surgery
Title
Skin condition according to Holgers score
Time Frame
14 days after surgery
Title
Skin condition according to Holgers score
Time Frame
21 days after surgery
Title
Skin condition according to Holgers score
Time Frame
28 days after surgery
Title
Skin condition according to Holgers score
Time Frame
6 weeks after surgery
Title
Skin condition according to Holgers score
Time Frame
12 weeks after surgery
Title
Skin condition according to Holgers score
Time Frame
6 months after surgery
Title
Skin condition according to Holgers score
Time Frame
12 months after surgery
Title
Skin condition according to Holgers score
Time Frame
24 months after surgery
Title
Skin condition according to Holgers score
Time Frame
36 months after surgery
Title
Glasgow Benefit Inventory Questionnaire
Description
Glasgow Benefit Inventory Questionnaire (GBI) 18-item, post-surgical questionnaire given to patients. The GBI measures the change in health status produced by surgical interventions (here, "health status" is the general perception of well-being, including total psychological, social, and physical well being).
Time Frame
3 months after surgery
Title
Glasgow Benefit Inventory Questionnaire
Time Frame
12 months after surgery
Title
Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire
Description
The APHAB is a 24-item self-assessment inventory in which patients report the amount of trouble they are having with communication or noises in various everyday situations. Benefit is calculated by comparing the patient's reported difficulty in the unaided condition with their amount of difficulty when using amplification. The APHAB produces scores for 4 subscales: Ease of Communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV).
Time Frame
Before surgery
Title
Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire
Time Frame
6 months after surgery
Title
Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire
Time Frame
36 months after surgery
Title
Glasgow Health Status Inventory (GHSI) questionnaire
Description
The Glasgow Health Status Inventory is an 18 item questionnaire. It assesses health state, by measuring the effect of a health problem on the quality of life of a person. It allows cross-comparison among many health conditions, among different health interventions, and among demographic and cultural subgroups.
Time Frame
Before surgery
Title
Glasgow Health Status Inventory (GHSI) questionnaire
Time Frame
6 months after surgery
Title
Glasgow Health Status Inventory (GHSI) questionnaire
Time Frame
36 months after surgery

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 Bone thickness at the implant site of at least 4 mm Exclusion Criteria: Longer abutment (>6mm) required 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myrthe KS Hol, MD, PhD
Organizational Affiliation
University Medical Center St Radboud, Nijmegen, 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
Citations:
PubMed Identifier
25790770
Citation
Nelissen RC, den Besten CA, Mylanus EA, Hol MK. Stability, survival, and tolerability of a 4.5-mm-wide bone-anchored hearing implant: 6-month data from a randomized controlled clinical trial. Eur Arch Otorhinolaryngol. 2016 Jan;273(1):105-11. doi: 10.1007/s00405-015-3593-x. Epub 2015 Mar 20. Erratum In: Eur Arch Otorhinolaryngol. 2016 Jan;273(1):113-4.
Results Reference
result

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Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant

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