Overview

This trial is active, not recruiting.

Conditions conductive hearing loss, mixed hearing loss, single sided deafness
Sponsor Oticon Medical
Collaborator Statistiska konsultgruppen
Start date February 2014
End date October 2017
Trial size 25 participants
Trial identifier NCT02064478, C47

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Ponto implant installed using a tissue preservation surgical technique
Ponto implant installed using a classical technique with skin thinning

Primary Outcomes

Measure
Numbness around implant, specifically mean Total sensibility
time frame: 36 months after surgery

Secondary Outcomes

Measure
Length of surgery
time frame: At surgery
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
Mild/Adverse skin reaction
time frame: 0-6 months
Skin condition according to Holgers
time frame: 7 days after surgery
Postoperative complications
time frame: 7 days to 6 months
Proportion of patients with complete wound healing at first surgical visit
time frame: 7 days
Glasgow Benefit Inventory (GBI) scores
time frame: 3 months
Glasgow Health Status Inventory (GHSI) scores
time frame: Baseline (before surgery)
Abbreviated profile of hearing aid benefit (APHAB) scores
time frame: Baseline (before surgery)
Mean hours of use of the sound processor
time frame: 0-6 months
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
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
Bone conduction (BC) in-situ audiometric thresholds
time frame: 6 months
Bone conduction (BC) audiometric threshold
time frame: 6 months
Mean total sensibility around implant
time frame: Baseline (before surgery)
Implant stability quotient (ISQ)
time frame: At surgery
Time to implant loss
time frame: 0-36 months
Patient and Observer scar assessment score
time frame: 21 days post surgery
Mild/Adverse skin reaction
time frame: 0-12 months
Mild/Adverse skin reaction
time frame: 0-36 months
Skin condition according to Holgers
time frame: 21 days
Skin condition according to Holgers
time frame: 12 weeks
Skin condition according to Holgers
time frame: 6 months
Skin condition according to Holgers
time frame: 1 year
Skin condition according to Holgers
time frame: 2 years
Skin condition according to Holgers
time frame: 3 years after surgery
Postoperative complications
time frame: 7 days to 12 months
Postoperative complications
time frame: 7 days to 36 months
Glasgow Benefit Inventory (GBI) scores
time frame: 12 months
Glasgow Health Status Inventory (GHSI) scores
time frame: 6 months
Glasgow Health Status Inventory (GHSI) scores
time frame: 36 months
Abbreviated profile of hearing aid benefit (APHAB) scores
time frame: 6 months
Abbreviated profile of hearing aid benefit (APHAB) scores
time frame: 36 months
Mean hours of use of the sound processor
time frame: 0-36 months
Mean total sensibility around implant
time frame: 21 days
Mean total sensibility around implant
time frame: 6 months
Mean total sensibility around implant
time frame: 12 months
Mean total sensibility around implant
time frame: 36 months
Implant stability quotient (ISQ)
time frame: 7 days post surgery
Implant stability quotient (ISQ)
time frame: 21 days post surgery
Implant stability quotient (ISQ)
time frame: 12 weeks post surgery
Implant stability quotient (ISQ)
time frame: 6 months post surgery
Implant stability quotient (ISQ)
time frame: 12 months post surgery
Implant stability quotient (ISQ)
time frame: 24 months post surgery
Implant stability quotient (ISQ)
time frame: 36 months post surgery
Patient and Observer scar assessment score
time frame: 6 months
Patient and Observer scar assessment score
time frame: 12 months
Patient and Observer scar assessment score
time frame: 36 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Clinical Survey of Oticon Medical Ponto Implants and a Surgical Technique With Tissue Preservation
Principal investigator Myrthe KS Hol, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Oticon Medical.