Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant

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

Study Overview

• Status: Completed
• Conditions: Otorhinolaryngologic Diseases; Ear Diseases; Hearing Loss; Hearing Disorders; Deafness; Hearing Loss, Conductive
• Intervention / Treatment: Device: Bone anchored hearing implant

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands, 6500
    • University Medical Center St Radboud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Wide diameter implant; 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.	Device: Bone anchored hearing implant; Other Names: Ponto implant; Bone anchored hearing aid
Other: Control group; 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.	Device: Bone anchored hearing implant; Other Names: Ponto implant; Bone anchored hearing aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ISQ (Implant Stability Quotient)	ISQ (implant Stability Quotient) is a measurement scale for use with the Resonance Frequency Analysis (RFA) method of determining implant stability. The measurement is made using the Osstell Mentor equipment (Osstell, Sweden) with SmartPegs. ISQ values range from 1 to 100, the higher the score the higher the stability. The highest and lowest score obtained from perpendicular measurements will be registered.	Surgery (0 days)
ISQ (Implant Stability Quotient)		7 days after surgery
ISQ (Implant Stability Quotient)		14 days after surgery
ISQ (Implant Stability Quotient)		21 days after surgery
ISQ (Implant Stability Quotient)		28 days after surgery
ISQ (Implant Stability Quotient)		6 weeks after surgery
ISQ (Implant Stability Quotient)		12 weeks after surgery
ISQ (Implant Stability Quotient)		6 months after surgery
ISQ (Implant Stability Quotient)		12 months after surgery
ISQ (Implant Stability Quotient)		24 months after surgery
ISQ (Implant Stability Quotient)		36 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of minimum ISQ (Implant stability quotient)	Implant stability can be seen as a combination of mechanical stability, which is the result of compressed bone holding the implant tightly in place, and biological stability, which is the result of new bone forming at the site of implantation and osseointegration. Mechanical stability is generally high immediately after implant placement and is decreasing with time. Biological stability, on the other hand, is non-existent immediately after placement and increases with time. The final stability level for an implant is the sum of the two. There is likely to be an initial decrease in stability followed by a subsequent increase as the implant becomes biologically stable. ISQ (implant Stability Quotient) is a measurement scale for use with the Resonance Frequency Analysis (RFA) method of determining implant stability.	0, 7, 14, 21 and 28 days after surgery
ISQ (Implant stability quotient) gradient	ISQ (implant stability quotient) per time unit gives a measure of osseointegration speed.	0, 7, 14, 21 and 28 days, 6 weeks, 12weeks, 6 months after surgery
Skin condition according to Holgers score	Holgers score is a standardized scale to clinically assess skin condition around a percutaneous implant	7 days after surgery
Skin condition according to Holgers score		14 days after surgery
Skin condition according to Holgers score		21 days after surgery
Skin condition according to Holgers score		28 days after surgery
Skin condition according to Holgers score		6 weeks after surgery
Skin condition according to Holgers score		12 weeks after surgery
Skin condition according to Holgers score		6 months after surgery
Skin condition according to Holgers score		12 months after surgery
Skin condition according to Holgers score		24 months after surgery
Skin condition according to Holgers score		36 months after surgery
Glasgow Benefit Inventory Questionnaire	Glasgow Benefit Inventory Questionnaire (GBI) 18-item, post-surgical questionnaire given to patients. The GBI measures the change in health status produced by surgical interventions (here, "health status" is the general perception of well-being, including total psychological, social, and physical well being).	3 months after surgery
Glasgow Benefit Inventory Questionnaire		12 months after surgery
Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire	The APHAB is a 24-item self-assessment inventory in which patients report the amount of trouble they are having with communication or noises in various everyday situations. Benefit is calculated by comparing the patient's reported difficulty in the unaided condition with their amount of difficulty when using amplification. The APHAB produces scores for 4 subscales: Ease of Communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV).	Before surgery
Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire		6 months after surgery
Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire		36 months after surgery
Glasgow Health Status Inventory (GHSI) questionnaire	The Glasgow Health Status Inventory is an 18 item questionnaire. It assesses health state, by measuring the effect of a health problem on the quality of life of a person. It allows cross-comparison among many health conditions, among different health interventions, and among demographic and cultural subgroups.	Before surgery
Glasgow Health Status Inventory (GHSI) questionnaire		6 months after surgery
Glasgow Health Status Inventory (GHSI) questionnaire		36 months after surgery

Collaborators and Investigators

• Sponsor: Oticon Medical
• Investigators: Principal Investigator: Myrthe KS Hol, MD, PhD, University Medical Center St Radboud, Nijmegen, The Netherlands

Publications and helpful links

General Publications

• 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. Erratum In: Eur Arch Otorhinolaryngol. 2016 Jan;273(1):113-4.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: November 28, 2012
• First Submitted That Met QC Criteria: November 28, 2012
• First Posted (Estimate): November 30, 2012

Study Record Updates

• Last Update Posted (Actual): November 27, 2017
• Last Update Submitted That Met QC Criteria: November 23, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Ponto; Bone anchored hearing aid; Implant stability; Linear incision; Wide diameter implant; Bone anchored implant
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Sensation Disorders; Hearing Loss; Deafness; Hearing Disorders; Hearing Loss, Conductive; Ear Diseases; Otorhinolaryngologic Diseases
• Other Study ID Numbers: C33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO