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OpenTrials
Completed

NCT Number: NCT01738490

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center St Radboud

Nijmegen, 6500, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bone anchored hearing implant

Device

Other names: Ponto implant, Bone anchored hearing aid

Primary outcomes

  1. 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.

  2. ISQ (Implant Stability Quotient)

    Time frame: 7 days after surgery

  3. ISQ (Implant Stability Quotient)

    Time frame: 14 days after surgery

  4. ISQ (Implant Stability Quotient)

    Time frame: 21 days after surgery

  5. ISQ (Implant Stability Quotient)

    Time frame: 28 days after surgery

  6. ISQ (Implant Stability Quotient)

    Time frame: 6 weeks after surgery

  7. ISQ (Implant Stability Quotient)

    Time frame: 12 weeks after surgery

  8. ISQ (Implant Stability Quotient)

    Time frame: 6 months after surgery

  9. ISQ (Implant Stability Quotient)

    Time frame: 12 months after surgery

  10. ISQ (Implant Stability Quotient)

    Time frame: 24 months after surgery

  11. ISQ (Implant Stability Quotient)

    Time frame: 36 months after surgery

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. Skin condition according to Holgers score

    Time frame: 14 days after surgery

  5. Skin condition according to Holgers score

    Time frame: 21 days after surgery

  6. Skin condition according to Holgers score

    Time frame: 28 days after surgery

  7. Skin condition according to Holgers score

    Time frame: 6 weeks after surgery

  8. Skin condition according to Holgers score

    Time frame: 12 weeks after surgery

  9. Skin condition according to Holgers score

    Time frame: 6 months after surgery

  10. Skin condition according to Holgers score

    Time frame: 12 months after surgery

  11. Skin condition according to Holgers score

    Time frame: 24 months after surgery

  12. Skin condition according to Holgers score

    Time frame: 36 months after surgery

  13. 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).

  14. Glasgow Benefit Inventory Questionnaire

    Time frame: 12 months after surgery

  15. 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).

  16. Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire

    Time frame: 6 months after surgery

  17. Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire

    Time frame: 36 months after surgery

  18. 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.

  19. Glasgow Health Status Inventory (GHSI) questionnaire

    Time frame: 6 months after surgery

  20. Glasgow Health Status Inventory (GHSI) questionnaire

    Time frame: 36 months after surgery

Sponsors and collaborators

Lead sponsor

Oticon Medical

Industry

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Nov 30, 2012
Registry last updated
Nov 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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