AzTrials
AzTrials

DeafnessNCT01738490

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

A study testing Bone anchored hearing implant in people with Deafness and Hearing Loss, run by Oticon Medical at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Deafness, Hearing Loss, Hearing Loss, Conductive
What is being tested?
Bone anchored hearing implant
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteNetherlands
Study dates
Jun 2012to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • University Medical Center St Radboud

    Nijmegen, 6500

Other trials in Netherlands

About this study

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

Read more
  • 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
Being tested
Bone anchored hearing implant
Keywords
Bone anchored hearing aid, Bone anchored implant, Implant stability, Wide diameter implant, Linear incision, Ponto
Medical subject headings
Deafness, Hearing Loss, Hearing Loss, Conductive, Hearing Disorders, Ear Diseases, Otorhinolaryngologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bone anchored hearing implantDevice

    Also called Ponto implant, Bone anchored hearing aid

Study groups in NCT01738490
Study groupRoleWhat they receive
Wide diameter implantOtherBone 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.
Receives: Device: Bone anchored hearing implant
Control groupOtherBone 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.
Receives: Device: Bone anchored hearing implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Surgery (0 days)

  2. ISQ (Implant Stability Quotient)

    Measured: 7 days after surgery

  3. ISQ (Implant Stability Quotient)

    Measured: 14 days after surgery

  4. ISQ (Implant Stability Quotient)

    Measured: 21 days after surgery

  5. ISQ (Implant Stability Quotient)

    Measured: 28 days after surgery

  6. ISQ (Implant Stability Quotient)

    Measured: 6 weeks after surgery

  7. ISQ (Implant Stability Quotient)

    Measured: 12 weeks after surgery

  8. ISQ (Implant Stability Quotient)

    Measured: 6 months after surgery

  9. ISQ (Implant Stability Quotient)

    Measured: 12 months after surgery

  10. ISQ (Implant Stability Quotient)

    Measured: 24 months after surgery

  11. ISQ (Implant Stability Quotient)

    Measured: 36 months after surgery

Secondary outcomes (20)

  1. 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.

    Measured: 0, 7, 14, 21 and 28 days after surgery

  2. ISQ (Implant stability quotient) gradient

    ISQ (implant stability quotient) per time unit gives a measure of osseointegration speed.

    Measured: 0, 7, 14, 21 and 28 days, 6 weeks, 12weeks, 6 months after surgery

  3. Skin condition according to Holgers score

    Holgers score is a standardized scale to clinically assess skin condition around a percutaneous implant

    Measured: 7 days after surgery

  4. Skin condition according to Holgers score

    Measured: 14 days after surgery

  5. Skin condition according to Holgers score

    Measured: 21 days after surgery

  6. Skin condition according to Holgers score

    Measured: 28 days after surgery

  7. Skin condition according to Holgers score

    Measured: 6 weeks after surgery

  8. Skin condition according to Holgers score

    Measured: 12 weeks after surgery

  9. Skin condition according to Holgers score

    Measured: 6 months after surgery

  10. Skin condition according to Holgers score

    Measured: 12 months after surgery

  11. Skin condition according to Holgers score

    Measured: 24 months after surgery

  12. Skin condition according to Holgers score

    Measured: 36 months after surgery

  13. 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).

    Measured: 3 months after surgery

  14. Glasgow Benefit Inventory Questionnaire

    Measured: 12 months after surgery

  15. 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).

    Measured: Before surgery

  16. Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire

    Measured: 6 months after surgery

  17. Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire

    Measured: 36 months after surgery

  18. 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.

    Measured: Before surgery

  19. Glasgow Health Status Inventory (GHSI) questionnaire

    Measured: 6 months after surgery

  20. Glasgow Health Status Inventory (GHSI) questionnaire

    Measured: 36 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionJun 2014
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01738490
Sponsor's protocol ID
C33
Status last verified
Nov 2017
First submitted
28 Nov 2012
Last updated
27 Nov 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25790770

Questions about this trial

What is this clinical trial studying?

A study testing Bone anchored hearing implant in people with Deafness and Hearing Loss, run by Oticon Medical at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ISQ (Implant Stability Quotient) (time frame: Surgery (0 days)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01738490, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in