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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01738490
First Posted: November 30, 2012
Last Update Posted: September 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Oticon Medical
November 28, 2012
November 30, 2012
September 1, 2017
June 2012
June 2014   (Final data collection date for primary outcome measure)
  • ISQ (Implant Stability Quotient) [ Time Frame: Surgery (0 days) ]
    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.
  • 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 ]
Same as current
Complete list of historical versions of study NCT01738490 on ClinicalTrials.gov Archive Site
  • Time of minimum ISQ (Implant stability quotient) [ Time Frame: 0, 7, 14, 21 and 28 days after surgery ]
    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.
  • ISQ (Implant stability quotient) gradient [ Time Frame: 0, 7, 14, 21 and 28 days, 6 weeks, 12weeks, 6 months after surgery ]
    ISQ (implant stability quotient) per time unit gives a measure of osseointegration speed.
  • Skin condition according to Holgers score [ Time Frame: 7 days after surgery ]
    Holgers score is a standardized scale to clinically assess skin condition around a percutaneous implant
  • 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 (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).
  • Glasgow Benefit Inventory Questionnaire [ Time Frame: 12 months after surgery ]
  • Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire [ Time Frame: Before surgery ]
    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).
  • 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 ]
    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.
  • Glasgow Health Status Inventory (GHSI) questionnaire [ Time Frame: 6 months after surgery ]
  • Glasgow Health Status Inventory (GHSI) questionnaire [ Time Frame: 36 months after surgery ]
Same as current
Not Provided
Not Provided
 
Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant
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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Deafness
  • Hearing Loss
  • Hearing Loss, Conductive
  • Hearing Disorders
  • Ear Diseases
  • Otorhinolaryngologic Diseases
Device: Bone anchored hearing implant
Other Names:
  • Ponto implant
  • Bone anchored hearing aid
  • 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.
    Intervention: Device: Bone anchored hearing implant
  • 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.
    Intervention: Device: Bone anchored hearing implant
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
December 2016
June 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01738490
C33
No
Not Provided
Plan to Share IPD: No
Oticon Medical
Oticon Medical
Not Provided
Principal Investigator: Myrthe KS Hol, MD, PhD University Medical Center St Radboud, Nijmegen, The Netherlands
Oticon Medical
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP