Conductive Hearing LossC50NCT02438618
Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants
A study testing Surgery for Ponto bone anchored hearing aids in people with Conductive Hearing Loss and Unilateral Partial Deafness, run by Oticon Medical at 1 site in Netherlands.
Trial summary
The objective of this study is to make a comparison between two surgical techniques used when implanting a Ponto bone anchored hearing system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conductive Hearing Loss, Unilateral Partial Deafness, Mixed Conductive-sensorineural Hearing Loss
- What is being tested?
- Surgery for Ponto bone anchored hearing aids
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Dec 2014to 18 Nov 2018
- 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
- Adult patient, i.e. ≥ 18 years of age
- Eligible for the Ponto system
Who cannot join
- Known history of immunosuppressive disease
- Use of systemic immunosuppressive medication
- Receiving bilateral bone anchored hearing system
- Relevant dermatological diseases as judged by the investigator
- Not being able to finish the study, for example because of failure to complete the questionnaires
- Participating in another study with medical aids or medication
- When there is no suitable implantation-site for the 4 mm implant during surgery because of insufficient bone quality.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to make a comparison between two surgical techniques used when implanting a Ponto bone anchored hearing system.
- Conditions
- Conductive Hearing Loss, Unilateral Partial Deafness, Mixed Conductive-sensorineural Hearing Loss
- Being tested
- Surgery for Ponto bone anchored hearing aids
- Medical subject headings
- Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery for Ponto bone anchored hearing aidsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive punch technique | Experimental | New surgical technique for Ponto bone anchored hearing implants Receives: Procedure: Surgery for Ponto bone anchored hearing aids |
| Hultcrantz technique | Other | Standard surgical technique for bone anchored hearing implants Receives: Procedure: Surgery for Ponto bone anchored hearing aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of inflammation (Holgers index ≥ 2)
Measured: 3 months post surgery
Secondary outcomes (16)
Presence of dehiscence after surgery (Noted in a binary fashion (present/not present))
Measured: 3 months post surgery
Visual Analogue Scale (VAS) pain scale > 6 (Noted on a scale from 0 - 10)
Measured: 3 months post surgery
Loss of sensibility (Measured in mm outwards from the abutment)
Measured: 3 months post surgery
Soft tissue overgrowth (mm)
Measured: 3 months post surgery
Extrusion rate (number of implants lost)
Measured: 3 months post surgery
Implant stability quotient (ISQ) measurements (ISQ units 1-100)
Measured: 3 months post surgery
Surgical time (minutes)
Measured: 3 months post surgery
Wound healing time (time to reach healed)
Measured: 3 months post surgery
Holgers index ≥ 2 at any time point
Measured: 24 months post surgery
Presence of dehiscence after surgery (present/not present)
Measured: 24 months post surgery
Visual Analogue Scale (VAS) pain scale > 6 (Noted on a scale from 0 - 10)
Measured: 24 months post surgery
Loss of sensibility (Measured in mm outwards from the abutment)
Measured: 24 months post surgery
Soft tissue overgrowth (mm)
Measured: 24 months post surgery
Extrusion rate (number of implants lost)
Measured: 24 months post surgery
Implant stability quotient (ISQ) measurements (ISQ units 1-100)
Measured in ISQ units (1-100)
Measured: 24 months post surgery
Cosmetic result (10 point scale)
Scored using a 10-point scale and are compared to the healthy, normal contralateral situation
Measured: 24 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study start2 Dec 2014
- Primary completion20 Dec 2016
- Study completion18 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Conductive Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Stokroos, Professor, Principal investigator, Maastricht University Medical Centre (MUMC+)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438618
- Sponsor's protocol ID
- C50
- Acronym
- C50
- Status last verified
- Aug 2019
- First submitted
- 21 Apr 2015
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Strijbos RM, Straatman LV, Stegeman I, Holmberg M, Johansson ML, Stokroos RJ. Health Economic Cost Analysis for Percutaneous Bone Conduction Devices: The Minimally Invasive Ponto Surgery Versus Linear Incision Technique with Tissue Preservation. Otol Neurotol. 2023 Aug 1;44(7):709-717. doi: 10.1097/MAO.0000000000003939. Epub 2023 Jun 29.
PubMed 37400140Strijbos RM, Straatman LV, Calon TGA, Johansson ML, de Bruijn AJG, van den Berge H, Wagenaar M, Eichhorn E, Janssen M, Jonhede S, van Tongeren J, Holmberg M, Stokroos R. Long-Term Outcomes of the Minimally Invasive Ponto Surgery vs. Linear Incision Technique With Soft Tissue Preservation for Installation of Percutaneous Bone Conduction Devices. Front Neurol. 2021 Feb 24;12:632987. doi: 10.3389/fneur.2021.632987. eCollection 2021.
PubMed 33716934Calon TG, van Hoof M, van den Berge H, de Bruijn AJ, van Tongeren J, Hof JR, Brunings JW, Jonhede S, Anteunis LJ, Janssen M, Joore MA, Holmberg M, Johansson ML, Stokroos RJ. Minimally Invasive Ponto Surgery compared to the linear incision technique without soft tissue reduction for bone conduction hearing implants: study protocol for a randomized controlled trial. Trials. 2016 Nov 9;17(1):540. doi: 10.1186/s13063-016-1662-0.
PubMed 27829464
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants
- ClinicalTrials.gov ID
- NCT02438618
- Acronym / sponsor ID
- C50 / C50
- Conditions
- Conductive Hearing Loss, Unilateral Partial Deafness, Mixed Conductive-sensorineural Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2014 (actual)
- Primary completion
- 20 Dec 2016 (actual)
- Study completion
- 18 Nov 2018 (actual)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to make a comparison between two surgical techniques used when implanting a Ponto bone anchored hearing system.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive punch technique | Experimental | Procedure: Surgery for Ponto bone anchored hearing aidsNew surgical technique for Ponto bone anchored hearing implants |
| Hultcrantz technique | Other | Procedure: Surgery for Ponto bone anchored hearing aidsStandard surgical technique for bone anchored hearing implants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patient, i.e. ≥ 18 years of age
- Eligible for the Ponto system
Key exclusion criteria (7 listed)
- Known history of immunosuppressive disease
- Use of systemic immunosuppressive medication
- Receiving bilateral bone anchored hearing system
- Relevant dermatological diseases as judged by the investigator
- Not being able to finish the study, for example because of failure to complete the questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery for Ponto bone anchored hearing aids | Procedure or surgery | Hultcrantz technique, Minimally invasive punch technique |
Primary outcome
Incidence of inflammation (Holgers index ≥ 2)
Time frame: 3 months post surgery
16 secondary outcomes
Presence of dehiscence after surgery (Noted in a binary fashion (present/not present))
Time frame: 3 months post surgery
Visual Analogue Scale (VAS) pain scale > 6 (Noted on a scale from 0 - 10)
Time frame: 3 months post surgery
Loss of sensibility (Measured in mm outwards from the abutment)
Time frame: 3 months post surgery
Soft tissue overgrowth (mm)
Time frame: 3 months post surgery
Extrusion rate (number of implants lost)
Time frame: 3 months post surgery
Implant stability quotient (ISQ) measurements (ISQ units 1-100)
Time frame: 3 months post surgery
Surgical time (minutes)
Time frame: 3 months post surgery
Wound healing time (time to reach healed)
Time frame: 3 months post surgery
Holgers index ≥ 2 at any time point
Time frame: 24 months post surgery
Presence of dehiscence after surgery (present/not present)
Time frame: 24 months post surgery
Visual Analogue Scale (VAS) pain scale > 6 (Noted on a scale from 0 - 10)
Time frame: 24 months post surgery
Loss of sensibility (Measured in mm outwards from the abutment)
Time frame: 24 months post surgery
Soft tissue overgrowth (mm)
Time frame: 24 months post surgery
Extrusion rate (number of implants lost)
Time frame: 24 months post surgery
Implant stability quotient (ISQ) measurements (ISQ units 1-100)
Time frame: 24 months post surgery
Cosmetic result (10 point scale)
Time frame: 24 months post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
- Derived from this study: PubMed 37400140Strijbos RM, Straatman LV, Stegeman I, Holmberg M, Johansson ML, Stokroos RJ. Health Economic Cost Analysis for Percutaneous Bone Conduction Devices: The Minimally Invasive Ponto Surgery Versus Linear Incision Technique with Tissue Preservation. Otol Neurotol. 2023 Aug 1;44(7):709-717. doi: 10.1097/MAO.0000000000003939. Epub 2023 Jun 29.
- Derived from this study: PubMed 33716934Strijbos RM, Straatman LV, Calon TGA, Johansson ML, de Bruijn AJG, van den Berge H, Wagenaar M, Eichhorn E, Janssen M, Jonhede S, van Tongeren J, Holmberg M, Stokroos R. Long-Term Outcomes of the Minimally Invasive Ponto Surgery vs. Linear Incision Technique With Soft Tissue Preservation for Installation of Percutaneous Bone Conduction Devices. Front Neurol. 2021 Feb 24;12:632987. doi: 10.3389/fneur.2021.632987. eCollection 2021.
- Derived from this study: PubMed 27829464Calon TG, van Hoof M, van den Berge H, de Bruijn AJ, van Tongeren J, Hof JR, Brunings JW, Jonhede S, Anteunis LJ, Janssen M, Joore MA, Holmberg M, Johansson ML, Stokroos RJ. Minimally Invasive Ponto Surgery compared to the linear incision technique without soft tissue reduction for bone conduction hearing implants: study protocol for a randomized controlled trial. Trials. 2016 Nov 9;17(1):540. doi: 10.1186/s13063-016-1662-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Stokroos, Professor principal investigator
Maastricht University Medical Centre (MUMC+)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery for Ponto bone anchored hearing aids in people with Conductive Hearing Loss and Unilateral Partial Deafness, 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 2 inclusion and 7 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 3 Sep 2019. 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?
Incidence of inflammation (Holgers index ≥ 2) (time frame: 3 months post surgery). 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 NCT02438618, which also lists 3 linked publications.
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 3 Sep 2019.