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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Oticon Medical
ClinicalTrials.gov Identifier:
NCT01738490
First received: November 28, 2012
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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

Condition Intervention
Deafness
Hearing Loss
Hearing Loss, Conductive
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Device: Bone anchored hearing implant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant

Resource links provided by NLM:


Further study details as provided by Oticon Medical:

Primary Outcome Measures:
  • ISQ (Implant Stability Quotient) [ Time Frame: Surgery (0 days) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • ISQ (Implant Stability Quotient) [ Time Frame: 14 days after surgery ] [ Designated as safety issue: No ]
  • ISQ (Implant Stability Quotient) [ Time Frame: 21 days after surgery ] [ Designated as safety issue: No ]
  • ISQ (Implant Stability Quotient) [ Time Frame: 28 days after surgery ] [ Designated as safety issue: No ]
  • ISQ (Implant Stability Quotient) [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: No ]
  • ISQ (Implant Stability Quotient) [ Time Frame: 12 weeks after surgery ] [ Designated as safety issue: No ]
  • ISQ (Implant Stability Quotient) [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
  • ISQ (Implant Stability Quotient) [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
  • ISQ (Implant Stability Quotient) [ Time Frame: 24 months after surgery ] [ Designated as safety issue: No ]
  • ISQ (Implant Stability Quotient) [ Time Frame: 36 months after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time of minimum ISQ (Implant stability quotient) [ Time Frame: 0, 7, 14, 21 and 28 days after surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Skin condition according to Holgers score [ Time Frame: 21 days after surgery ] [ Designated as safety issue: No ]
  • Skin condition according to Holgers score [ Time Frame: 28 days after surgery ] [ Designated as safety issue: No ]
  • Skin condition according to Holgers score [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: No ]
  • Skin condition according to Holgers score [ Time Frame: 12 weeks after surgery ] [ Designated as safety issue: No ]
  • Skin condition according to Holgers score [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
  • Skin condition according to Holgers score [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
  • Skin condition according to Holgers score [ Time Frame: 24 months after surgery ] [ Designated as safety issue: No ]
  • Skin condition according to Holgers score [ Time Frame: 36 months after surgery ] [ Designated as safety issue: No ]
  • Glasgow Benefit Inventory Questionnaire [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire [ Time Frame: Before surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire [ Time Frame: 36 months after surgery ] [ Designated as safety issue: No ]
  • Glasgow Health Status Inventory (GHSI) questionnaire [ Time Frame: Before surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Glasgow Health Status Inventory (GHSI) questionnaire [ Time Frame: 36 months after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738490

Locations
Netherlands
University Medical Center St Radboud
Nijmegen, Netherlands, 6500
Sponsors and Collaborators
Oticon Medical
Investigators
Principal Investigator: Myrthe KS Hol, MD, PhD University Medical Center St Radboud, Nijmegen, The Netherlands
  More Information

No publications provided

Responsible Party: Oticon Medical
ClinicalTrials.gov Identifier: NCT01738490     History of Changes
Other Study ID Numbers: C33
Study First Received: November 28, 2012
Last Updated: February 14, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Oticon Medical:
Bone anchored hearing aid
Bone anchored implant
Implant stability
Wide diameter implant
Linear incision
Ponto

Additional relevant MeSH terms:
Deafness
Hearing Loss
Ear Diseases
Hearing Loss, Conductive
Otorhinolaryngologic Diseases
Hearing Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014