Clinical Survey of Oticon Medical Ponto Implants and a Surgical Technique With Tissue Preservation

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Oticon Medical
Sponsor:
Collaborator:
Statistiska konsultgruppen
Information provided by (Responsible Party):
Oticon Medical
ClinicalTrials.gov Identifier:
NCT02064478
First received: February 14, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

A bone anchored hearing system is used to improve hearing for patients with e.g. conductive/mixed hearing loss or single sided deafness.

With this type of system, a titanium implant is installed in the temporal bone, where it osseointegrates, i.e. integrates with the bone. An abutment (also in titanium) is attached to the implants and penetrates the skin. The sound processor (hearing aid) is then connected to the abutment, and can be attached and removed by the patient via a snap-coupling. This type of system has been successfully implanted in more than 100.000 patients. Recently, a simplified surgical procedure, where no skin thinning around the abutment is made, was approved. The results after using this installation technique, here called soft tissue preservation, are the focus of this study.

The objective of the study is to compare the outcomes after a surgical procedure with soft tissue preservation (test) and a surgery with soft tissue reduction (control) for placing Oticon Medical Ponto implants and abutments. The main hypothesis is that patient numbness around the implant is less in the test group compared to the control group.


Condition
Conductive Hearing Loss
Mixed Hearing Loss
Single Sided Deafness

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Clinical Survey of Oticon Medical Ponto Implants and a Surgical Technique With Tissue Preservation

Resource links provided by NLM:


Further study details as provided by Oticon Medical:

Primary Outcome Measures:
  • Numbness around implant, specifically mean Total sensibility [ Time Frame: 36 months after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of surgery [ Time Frame: At surgery ] [ Designated as safety issue: No ]
  • Sum of number of unplanned visits, revision surgeries, medications related to implant, and other treatments requiring medical staff per patient [ Time Frame: 0-6 months ] [ Designated as safety issue: No ]
  • Mild/Adverse skin reaction [ Time Frame: 0-6 months ] [ Designated as safety issue: No ]
    Adverse skin reaction is defined as a Holgers score ≥ 2 at least one follow-up visit, including unplanned visits, during the analysis period Holgers score is a standardized score of skin reactions around a bone anchored hearing implant.

  • Skin condition according to Holgers [ Time Frame: 7 days after surgery ] [ Designated as safety issue: No ]
    Holgers score is a standardized score of skin reactions around a bone anchored hearing implant.

  • Postoperative complications [ Time Frame: 7 days to 6 months ] [ Designated as safety issue: No ]

    Including

    • Bleeding or hematoma
    • Flap necrosis
    • Wound dehiscence
    • Other (description)

  • Proportion of patients with complete wound healing at first surgical visit [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Glasgow Benefit Inventory (GBI) scores [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Glasgow Health Status Inventory (GHSI) scores [ Time Frame: Baseline (before surgery) ] [ Designated as safety issue: No ]
  • Abbreviated profile of hearing aid benefit (APHAB) scores [ Time Frame: Baseline (before surgery) ] [ Designated as safety issue: No ]
  • Mean hours of use of the sound processor [ Time Frame: 0-6 months ] [ Designated as safety issue: No ]
  • Sum of number of unplanned visits, revision surgeries, medications related to implant, and other treatments requiring medical staff per patient [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]
  • Sum of number of unplanned visits, revision surgeries, medications related to implant, and other treatments requiring medical staff per patient [ Time Frame: 0-36 months ] [ Designated as safety issue: No ]
  • Bone conduction (BC) in-situ audiometric thresholds [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Bone conduction (BC) audiometric threshold [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measured with B-71

  • Mean total sensibility around implant [ Time Frame: Baseline (before surgery) ] [ Designated as safety issue: No ]
  • Implant stability quotient (ISQ) [ Time Frame: At surgery ] [ Designated as safety issue: No ]
  • Time to implant loss [ Time Frame: 0-36 months ] [ Designated as safety issue: No ]
  • Patient and Observer scar assessment score [ Time Frame: 21 days post surgery ] [ Designated as safety issue: No ]
  • Mild/Adverse skin reaction [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]
    Adverse skin reaction is defined as a Holgers score ≥ 2 at least one follow-up visit, including unplanned visits, during the analysis period

  • Mild/Adverse skin reaction [ Time Frame: 0-36 months ] [ Designated as safety issue: No ]
    Adverse skin reaction is defined as a Holgers score ≥ 2 at least one follow-up visit, including unplanned visits, during the analysis period

  • Skin condition according to Holgers [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Skin condition according to Holgers [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Skin condition according to Holgers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Skin condition according to Holgers [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Skin condition according to Holgers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Skin condition according to Holgers [ Time Frame: 3 years after surgery ] [ Designated as safety issue: No ]
  • Postoperative complications [ Time Frame: 7 days to 12 months ] [ Designated as safety issue: No ]

    Including

    • Bleeding or hematoma
    • Flap necrosis
    • Wound dehiscence
    • Other (description)

  • Postoperative complications [ Time Frame: 7 days to 36 months ] [ Designated as safety issue: No ]

    Including

    • Bleeding or hematoma
    • Flap necrosis
    • Wound dehiscence
    • Other (description)

  • Glasgow Benefit Inventory (GBI) scores [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Glasgow Health Status Inventory (GHSI) scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Glasgow Health Status Inventory (GHSI) scores [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Abbreviated profile of hearing aid benefit (APHAB) scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Abbreviated profile of hearing aid benefit (APHAB) scores [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Mean hours of use of the sound processor [ Time Frame: 0-36 months ] [ Designated as safety issue: No ]
  • Mean total sensibility around implant [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Mean total sensibility around implant [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mean total sensibility around implant [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mean total sensibility around implant [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Implant stability quotient (ISQ) [ Time Frame: 7 days post surgery ] [ Designated as safety issue: No ]
  • Implant stability quotient (ISQ) [ Time Frame: 21 days post surgery ] [ Designated as safety issue: No ]
  • Implant stability quotient (ISQ) [ Time Frame: 12 weeks post surgery ] [ Designated as safety issue: No ]
  • Implant stability quotient (ISQ) [ Time Frame: 6 months post surgery ] [ Designated as safety issue: No ]
  • Implant stability quotient (ISQ) [ Time Frame: 12 months post surgery ] [ Designated as safety issue: No ]
  • Implant stability quotient (ISQ) [ Time Frame: 24 months post surgery ] [ Designated as safety issue: No ]
  • Implant stability quotient (ISQ) [ Time Frame: 36 months post surgery ] [ Designated as safety issue: No ]
  • Patient and Observer scar assessment score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Patient and Observer scar assessment score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Patient and Observer scar assessment score [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Skin height around abutment (in mm) [ Time Frame: At surgery ] [ Designated as safety issue: No ]
  • Skin height around abutment (in mm) [ Time Frame: 7 days post surgery ] [ Designated as safety issue: No ]
  • Skin height around abutment (in mm) [ Time Frame: 21 days post surgery ] [ Designated as safety issue: No ]
  • Skin height around abutment (in mm) [ Time Frame: 12 weeks post surgery ] [ Designated as safety issue: No ]
  • Skin height around abutment (in mm) [ Time Frame: 6 months post surgery ] [ Designated as safety issue: No ]
  • Skin height around abutment (in mm) [ Time Frame: 12 months post surgery ] [ Designated as safety issue: No ]
  • Skin height around abutment (in mm) [ Time Frame: 36 months post surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: February 2014
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Tissue preservation
Ponto implant installed using a tissue preservation surgical technique
Tissue reduction
Ponto implant installed using a classical technique with skin thinning

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients to be included are already planned for treatment with a bone anchored hearing aid at Radboud University Nijmegen Medical Centre (Nijmegen, The Netherlands).

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:

  • 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 >10 mm
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02064478

Contacts
Contact: Myrthe KS Hol, MD +31 24 36 14934 Myrthe.Hol@radboudumc.nl
Contact: Chrisje A den Besten +31 24 361 72 02 Chrisje.denBesten@radboudumc.nl

Locations
Netherlands
Radboud University Medical Centre Recruiting
Nijmegen, Netherlands, 6500 HB
Principal Investigator: Myrthe KS Hol, MD, PhD         
Sponsors and Collaborators
Oticon Medical
Statistiska konsultgruppen
Investigators
Principal Investigator: Myrthe KS Hol, MD, PhD Radboud University
Principal Investigator: Emmanuel AM Mylanus, MD, PhD Radboud University
  More Information

No publications provided

Responsible Party: Oticon Medical
ClinicalTrials.gov Identifier: NCT02064478     History of Changes
Other Study ID Numbers: C47
Study First Received: February 14, 2014
Last Updated: February 14, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Oticon Medical:
Bone anchored hearing implant
Bone anchored hearing device

Additional relevant MeSH terms:
Deafness
Hearing Loss
Hearing Loss, Conductive
Hearing Loss, Mixed Conductive-Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014