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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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

Detailed Summary:
Sponsor: Oticon Medical

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Oticon Medical

Dates:
Date Received: November 28, 2012
Date Started: June 2012
Date Completion:
Last Updated: April 7, 2017
Last Verified: April 2017