Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant
1 other identifier
interventional
59
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 28, 2012
CompletedFirst Posted
Study publicly available on registry
November 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedNovember 27, 2017
November 1, 2017
2 years
November 28, 2012
November 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
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.
Surgery (0 days)
ISQ (Implant Stability Quotient)
7 days after surgery
ISQ (Implant Stability Quotient)
14 days after surgery
ISQ (Implant Stability Quotient)
21 days after surgery
ISQ (Implant Stability Quotient)
28 days after surgery
ISQ (Implant Stability Quotient)
6 weeks after surgery
ISQ (Implant Stability Quotient)
12 weeks after surgery
ISQ (Implant Stability Quotient)
6 months after surgery
ISQ (Implant Stability Quotient)
12 months after surgery
ISQ (Implant Stability Quotient)
24 months after surgery
ISQ (Implant Stability Quotient)
36 months after surgery
Secondary Outcomes (20)
Time of minimum ISQ (Implant stability quotient)
0, 7, 14, 21 and 28 days after surgery
ISQ (Implant stability quotient) gradient
0, 7, 14, 21 and 28 days, 6 weeks, 12weeks, 6 months after surgery
Skin condition according to Holgers score
7 days after surgery
Skin condition according to Holgers score
14 days after surgery
Skin condition according to Holgers score
21 days after surgery
- +15 more secondary outcomes
Study Arms (2)
Wide diameter implant
OTHERBone 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.
Control group
OTHERBone 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.
Interventions
Eligibility Criteria
You may qualify if:
- years or older
- Patient indicated for an ear level bone anchored sound processor
- Bone thickness at the implant site of at least 4 mm
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oticon Medicallead
Study Sites (1)
University Medical Center St Radboud
Nijmegen, 6500, Netherlands
Related Publications (1)
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.
PMID: 25790770RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Myrthe KS Hol, MD, PhD
University Medical Center St Radboud, Nijmegen, The Netherlands
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2012
First Posted
November 30, 2012
Study Start
June 1, 2012
Primary Completion
June 1, 2014
Study Completion
December 1, 2016
Last Updated
November 27, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share