Overview

This trial is active, not recruiting.

Conditions deafness, hearing loss, hearing loss, conductive, hearing disorders, ear diseases, otorhinolaryngologic diseases
Treatment bone anchored hearing implant
Sponsor Oticon Medical
Start date June 2012
End date June 2014
Trial size 60 participants
Trial identifier NCT01738490, C33

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.

More specifically the primary objective of this clinical study is to test the hypothesis

- 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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Bone 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.
bone anchored hearing implant Ponto implant
(Other)
Bone 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.
bone anchored hearing implant Ponto implant

Primary Outcomes

Measure
ISQ (Implant Stability Quotient)
time frame: Surgery (0 days)
ISQ (Implant Stability Quotient)
time frame: 7 days after surgery
ISQ (Implant Stability Quotient)
time frame: 14 days after surgery
ISQ (Implant Stability Quotient)
time frame: 21 days after surgery
ISQ (Implant Stability Quotient)
time frame: 28 days after surgery
ISQ (Implant Stability Quotient)
time frame: 6 weeks after surgery
ISQ (Implant Stability Quotient)
time frame: 12 weeks after surgery
ISQ (Implant Stability Quotient)
time frame: 6 months after surgery
ISQ (Implant Stability Quotient)
time frame: 12 months after surgery
ISQ (Implant Stability Quotient)
time frame: 24 months after surgery
ISQ (Implant Stability Quotient)
time frame: 36 months after surgery

Secondary Outcomes

Measure
Time of minimum ISQ (Implant stability quotient)
time frame: 0, 7, 14, 21 and 28 days after surgery
ISQ (Implant stability quotient) gradient
time frame: 0, 7, 14, 21 and 28 days, 6 weeks, 12weeks, 6 months after surgery
Skin condition according to Holgers score
time frame: 7 days after surgery
Skin condition according to Holgers score
time frame: 14 days after surgery
Skin condition according to Holgers score
time frame: 21 days after surgery
Skin condition according to Holgers score
time frame: 28 days after surgery
Skin condition according to Holgers score
time frame: 6 weeks after surgery
Skin condition according to Holgers score
time frame: 12 weeks after surgery
Skin condition according to Holgers score
time frame: 6 months after surgery
Skin condition according to Holgers score
time frame: 12 months after surgery
Skin condition according to Holgers score
time frame: 24 months after surgery
Skin condition according to Holgers score
time frame: 36 months after surgery
Glasgow Benefit Inventory Questionnaire
time frame: 3 months after surgery
Glasgow Benefit Inventory Questionnaire
time frame: 12 months after surgery
Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire
time frame: Before surgery
Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire
time frame: 6 months after surgery
Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire
time frame: 36 months after surgery
Glasgow Health Status Inventory (GHSI) questionnaire
time frame: Before surgery
Glasgow Health Status Inventory (GHSI) questionnaire
time frame: 6 months after surgery
Glasgow Health Status Inventory (GHSI) questionnaire
time frame: 36 months after surgery

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: - 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.

Additional Information

Official title Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant
Principal investigator Myrthe KS Hol, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Oticon Medical.