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

Browse trials for

• Hearing Loss 1,092
• Deafness 609
• Ear Diseases 59
• Hearing Disorders 61
• Otorhinolaryngologic Diseases 51
• Hearing Loss, Conductive 76

Keywords

• Bone anchored hearing aid
• Bone anchored implant
• Implant stability
• Wide diameter implant
• Linear incision
• Ponto

Study arms

• 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
  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

Interventions

• DeviceBone anchored hearing implant

  Also known as: Ponto implant, Bone anchored hearing aid

Primary outcomes

1. 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.

   Time frame: Surgery (0 days)

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)

   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.

   Time frame: 0, 7, 14, 21 and 28 days after surgery

2. ISQ (Implant stability quotient) gradient

   ISQ (implant stability quotient) per time unit gives a measure of osseointegration speed.

   Time frame: 0, 7, 14, 21 and 28 days, 6 weeks, 12weeks, 6 months after surgery

3. Skin condition according to Holgers score

   Holgers score is a standardized scale to clinically assess skin condition around a percutaneous implant

   Time frame: 7 days after surgery

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

    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).

    Time frame: 3 months after surgery

14. Glasgow Benefit Inventory Questionnaire

    Time frame: 12 months after surgery

15. 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).

    Time frame: Before surgery

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

    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.

    Time frame: Before surgery

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

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. doi: 10.1007/s00405-015-3798-z. PubMed 25790770 ↗

Individual participant data

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