University Medical Center St Radboud
Nijmegen, 6500, Netherlands
NCT Number: NCT01738490
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
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Nijmegen, 6500, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Ponto implant, Bone anchored hearing aid
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.
Time frame: 7 days after surgery
Time frame: 14 days after surgery
Time frame: 21 days after surgery
Time frame: 28 days after surgery
Time frame: 6 weeks after surgery
Time frame: 12 weeks after surgery
Time frame: 6 months after surgery
Time frame: 12 months after surgery
Time frame: 24 months after surgery
Time frame: 36 months after surgery
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.
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.
Time frame: 7 days after surgery
Holgers score is a standardized scale to clinically assess skin condition around a percutaneous implant
Time frame: 14 days after surgery
Time frame: 21 days after surgery
Time frame: 28 days after surgery
Time frame: 6 weeks after surgery
Time frame: 12 weeks after surgery
Time frame: 6 months after surgery
Time frame: 12 months after surgery
Time frame: 24 months after surgery
Time frame: 36 months after surgery
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).
Time frame: 12 months after surgery
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).
Time frame: 6 months after surgery
Time frame: 36 months after surgery
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.
Time frame: 6 months after surgery
Time frame: 36 months after surgery
Oticon Medical
Industry
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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