Clinical trial NCT02064478: Clinical Survey of Oticon Medical Ponto Implants and a Surgical Technique With Tissue Preservation
Official title: Clinical Survey of Oticon Medical Ponto Implants and a Surgical Technique With Tissue Preservation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Conductive Hearing Loss
Mixed Hearing Loss
Single Sided Deafness
Keywords: Bone anchored hearing implant
Bone anchored hearing device
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
Collaborators: name: Statistiska Konsultgruppen
First posted: 2014-02-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

Brief summary: 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.


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:

* 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

Primary outcomes:
measure: Numbness around implant, specifically mean Total sensibility
timeFrame: 36 months after surgery
Secondary outcomes:
measure: Length of surgery
timeFrame: At surgery
measure: Sum of number of unplanned visits, revision surgeries, medications related to implant, and other treatments requiring medical staff per patient
timeFrame: 0-6 months
measure: Mild/Adverse skin reaction
timeFrame: 0-6 months
measure: Skin condition according to Holgers
timeFrame: 7 days after surgery
measure: Postoperative complications
timeFrame: 7 days to 6 months
measure: Proportion of patients with complete wound healing at first surgical visit
timeFrame: 7 days
measure: Glasgow Benefit Inventory (GBI) scores
timeFrame: 3 months
measure: Glasgow Health Status Inventory (GHSI) scores
timeFrame: Baseline (before surgery)
measure: Abbreviated profile of hearing aid benefit (APHAB) scores
timeFrame: Baseline (before surgery)
measure: Mean hours of use of the sound processor
timeFrame: 0-6 months
measure: Sum of number of unplanned visits, revision surgeries, medications related to implant, and other treatments requiring medical staff per patient
timeFrame: 0-12 months
measure: Sum of number of unplanned visits, revision surgeries, medications related to implant, and other treatments requiring medical staff per patient
timeFrame: 0-36 months
measure: Bone conduction (BC) in-situ audiometric thresholds
timeFrame: 6 months
measure: Bone conduction (BC) audiometric threshold
timeFrame: 6 months
measure: Mean total sensibility around implant
timeFrame: Baseline (before surgery)
measure: Implant stability quotient (ISQ)
timeFrame: At surgery
measure: Time to implant loss
timeFrame: 0-36 months
measure: Patient and Observer scar assessment score
timeFrame: 21 days post surgery
measure: Mild/Adverse skin reaction
timeFrame: 0-12 months
measure: Mild/Adverse skin reaction
timeFrame: 0-36 months
measure: Skin condition according to Holgers
timeFrame: 21 days
measure: Skin condition according to Holgers
timeFrame: 12 weeks
measure: Skin condition according to Holgers
timeFrame: 6 months
measure: Skin condition according to Holgers
timeFrame: 1 year
measure: Skin condition according to Holgers
timeFrame: 2 years
measure: Skin condition according to Holgers
timeFrame: 3 years after surgery
measure: Postoperative complications
timeFrame: 7 days to 12 months
measure: Postoperative complications
timeFrame: 7 days to 36 months
measure: Glasgow Benefit Inventory (GBI) scores
timeFrame: 12 months
measure: Glasgow Health Status Inventory (GHSI) scores
timeFrame: 6 months
measure: Glasgow Health Status Inventory (GHSI) scores
timeFrame: 36 months
measure: Abbreviated profile of hearing aid benefit (APHAB) scores
timeFrame: 6 months
measure: Abbreviated profile of hearing aid benefit (APHAB) scores
timeFrame: 36 months
measure: Mean hours of use of the sound processor
timeFrame: 0-36 months
measure: Mean total sensibility around implant
timeFrame: 21 days
measure: Mean total sensibility around implant
timeFrame: 6 months
measure: Mean total sensibility around implant
timeFrame: 12 months
measure: Mean total sensibility around implant
timeFrame: 36 months
measure: Implant stability quotient (ISQ)
timeFrame: 7 days post surgery
measure: Implant stability quotient (ISQ)
timeFrame: 21 days post surgery
measure: Implant stability quotient (ISQ)
timeFrame: 12 weeks post surgery
measure: Implant stability quotient (ISQ)
timeFrame: 6 months post surgery
measure: Implant stability quotient (ISQ)
timeFrame: 12 months post surgery
measure: Implant stability quotient (ISQ)
timeFrame: 24 months post surgery
measure: Implant stability quotient (ISQ)
timeFrame: 36 months post surgery
measure: Patient and Observer scar assessment score
timeFrame: 6 months
measure: Patient and Observer scar assessment score
timeFrame: 12 months
measure: Patient and Observer scar assessment score
timeFrame: 36 months
Other outcomes:
measure: Skin height around abutment (in mm)
timeFrame: At surgery
measure: Skin height around abutment (in mm)
timeFrame: 7 days post surgery
measure: Skin height around abutment (in mm)
timeFrame: 21 days post surgery
measure: Skin height around abutment (in mm)
timeFrame: 12 weeks post surgery
measure: Skin height around abutment (in mm)
timeFrame: 6 months post surgery
measure: Skin height around abutment (in mm)
timeFrame: 12 months post surgery
measure: Skin height around abutment (in mm)
timeFrame: 36 months post surgery
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Centre
Study officials:
affiliation: Radboud University Medical Center
name: Myrthe KS Hol, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Emmanuel AM Mylanus, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: den Besten CA, Bosman AJ, Nelissen RC, Mylanus EA, Hol MK. Controlled Clinical Trial on Bone-anchored Hearing Implants and a Surgical Technique With Soft-tissue Preservation. Otol Neurotol. 2016 Jun;37(5):504-12. doi: 10.1097/MAO.0000000000000994.