Clinical trial NCT01738490: Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant
Official title: Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deafness
Hearing Loss
Hearing Loss, Conductive
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Keywords: Bone anchored hearing aid
Bone anchored implant
Implant stability
Wide diameter implant
Linear incision
Ponto
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2012-11-30
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


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:

* 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.

Primary outcomes:
measure: ISQ (Implant Stability Quotient)
timeFrame: Surgery (0 days)
measure: ISQ (Implant Stability Quotient)
timeFrame: 7 days after surgery
measure: ISQ (Implant Stability Quotient)
timeFrame: 14 days after surgery
measure: ISQ (Implant Stability Quotient)
timeFrame: 21 days after surgery
measure: ISQ (Implant Stability Quotient)
timeFrame: 28 days after surgery
measure: ISQ (Implant Stability Quotient)
timeFrame: 6 weeks after surgery
measure: ISQ (Implant Stability Quotient)
timeFrame: 12 weeks after surgery
measure: ISQ (Implant Stability Quotient)
timeFrame: 6 months after surgery
measure: ISQ (Implant Stability Quotient)
timeFrame: 12 months after surgery
measure: ISQ (Implant Stability Quotient)
timeFrame: 24 months after surgery
measure: ISQ (Implant Stability Quotient)
timeFrame: 36 months after surgery
Secondary outcomes:
measure: Time of minimum ISQ (Implant stability quotient)
timeFrame: 0, 7, 14, 21 and 28 days after surgery
measure: ISQ (Implant stability quotient) gradient
timeFrame: 0, 7, 14, 21 and 28 days, 6 weeks, 12weeks, 6 months after surgery
measure: Skin condition according to Holgers score
timeFrame: 7 days after surgery
measure: Skin condition according to Holgers score
timeFrame: 14 days after surgery
measure: Skin condition according to Holgers score
timeFrame: 21 days after surgery
measure: Skin condition according to Holgers score
timeFrame: 28 days after surgery
measure: Skin condition according to Holgers score
timeFrame: 6 weeks after surgery
measure: Skin condition according to Holgers score
timeFrame: 12 weeks after surgery
measure: Skin condition according to Holgers score
timeFrame: 6 months after surgery
measure: Skin condition according to Holgers score
timeFrame: 12 months after surgery
measure: Skin condition according to Holgers score
timeFrame: 24 months after surgery
measure: Skin condition according to Holgers score
timeFrame: 36 months after surgery
measure: Glasgow Benefit Inventory Questionnaire
timeFrame: 3 months after surgery
measure: Glasgow Benefit Inventory Questionnaire
timeFrame: 12 months after surgery
measure: Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire
timeFrame: Before surgery
measure: Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire
timeFrame: 6 months after surgery
measure: Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire
timeFrame: 36 months after surgery
measure: Glasgow Health Status Inventory (GHSI) questionnaire
timeFrame: Before surgery
measure: Glasgow Health Status Inventory (GHSI) questionnaire
timeFrame: 6 months after surgery
measure: Glasgow Health Status Inventory (GHSI) questionnaire
timeFrame: 36 months after surgery
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: University Medical Center St Radboud
Study officials:
affiliation: University Medical Center St Radboud, Nijmegen, The Netherlands
name: Myrthe KS Hol, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nelissen RC, den Besten CA, Mylanus EA, Hol MK. Stability, survival, and tolerability of a 4.5-mm-wide bone-anchored hearing implant: 6-month data from a randomized controlled clinical trial. Eur Arch Otorhinolaryngol. 2016 Jan;273(1):105-11. doi: 10.1007/s00405-015-3593-x. Epub 2015 Mar 20.