Trial Outcomes & Findings for Wide Diameter Bone Anchored Implant Study (NCT NCT01671176)
NCT ID: NCT01671176
Last Updated: 2018-05-07
Results Overview
Holger's Scale is a 5 point that ranges from 0 - 4 scale that assesses skin reactions at the implant site where 0 means no reaction and 4 means excessive granulation, skin overgrowth, or scar formation requiring revision surgery
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
1 week, 3 weeks, 6 weeks, 3 months, 6 months and 12 months
Results posted on
2018-05-07
Participant Flow
Participant milestones
| Measure |
Wide Diameter Bone Anchored Implant
Intervention: Implantation of a wide diameter bone anchored auditory implant either 3 or 4 mm in length, into the skull on the side of the ear where intervention is intended in order to restore hearing. In the case of a conductive or mixed hearing loss, that side is chosen. In patients with unilateral, profound sensori-neural hearing loss the implant is implanted on that side but the sound is transmitted to the side with the normal hearing ear via bone conduction stimulation.
Wide diameter bone anchored implant: 4.5 mm wide diameter bone anchored implant
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Wide Diameter Bone Anchored Implant Study
Baseline characteristics by cohort
| Measure |
Wide Diameter Bone Anchored Implant
n=30 Participants
Intervention: Implantation of a wide diameter bone anchored auditory implant either 3 or 4 mm in length, into the skull on the side of the ear where intervention is intended in order to restore hearing. In the case of a conductive or mixed hearing loss, that side is chosen. In patients with unilateral, profound sensori-neural hearing loss the implant is implanted on that side but the sound is transmitted to the side with the normal hearing ear via bone conduction stimulation.
Wide diameter bone anchored implant: 4.5 mm wide diameter bone anchored implant
|
|---|---|
|
Age, Continuous
|
60.83 years
STANDARD_DEVIATION 16.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
|
Smoking status
yes
|
1 participants
n=5 Participants
|
|
Smoking status
no
|
29 participants
n=5 Participants
|
|
Diabetes
yes
|
3 participants
n=5 Participants
|
|
Diabetes
no
|
27 participants
n=5 Participants
|
|
Abutment length
6 mm
|
20 participants
n=5 Participants
|
|
Abutment length
9 mm
|
7 participants
n=5 Participants
|
|
Abutment length
12 mm
|
3 participants
n=5 Participants
|
|
Weight
|
76.72 kilogram
STANDARD_DEVIATION 19.61 • n=5 Participants
|
|
BMI
|
28.56 kilogram/M^2
STANDARD_DEVIATION 7.09 • n=5 Participants
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|
Height
|
163.79 centimeters
STANDARD_DEVIATION 8.89 • n=5 Participants
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PRIMARY outcome
Timeframe: 1 week, 3 weeks, 6 weeks, 3 months, 6 months and 12 monthsHolger's Scale is a 5 point that ranges from 0 - 4 scale that assesses skin reactions at the implant site where 0 means no reaction and 4 means excessive granulation, skin overgrowth, or scar formation requiring revision surgery
Outcome measures
| Measure |
Wide Diameter Bone Anchored Implant
n=30 Participants
Intervention: Implantation of a wide diameter bone anchored auditory implant either 3 or 4 mm in length, into the skull on the side of the ear where intervention is intended in order to restore hearing. In the case of a conductive or mixed hearing loss, that side is chosen. In patients with unilateral, profound sensori-neural hearing loss the implant is implanted on that side but the sound is transmitted to the side with the normal hearing ear via bone conduction stimulation.
Wide diameter bone anchored implant: 4.5 mm wide diameter bone anchored implant
|
|---|---|
|
Holger's Scale
Holger score of 1 at 3 months
|
1 participants
|
|
Holger's Scale
Holger score of 2 at 3 months
|
0 participants
|
|
Holger's Scale
Holger score of 0 at 6 months
|
30 participants
|
|
Holger's Scale
Holger score 0 at 1 week
|
29 participants
|
|
Holger's Scale
Holger score of 1 at one week
|
0 participants
|
|
Holger's Scale
Holger score of 2 at one week
|
1 participants
|
|
Holger's Scale
Holger score of 0 at 3 weeks
|
29 participants
|
|
Holger's Scale
Holger score of 1 at 3 weeks
|
1 participants
|
|
Holger's Scale
Holger score of 2 at 3 weeks
|
0 participants
|
|
Holger's Scale
Holger score of 0 at 6 weeks
|
28 participants
|
|
Holger's Scale
Holger score of 1 at 6 weeks
|
2 participants
|
|
Holger's Scale
Holger score of 2 at 6 weeks
|
0 participants
|
|
Holger's Scale
Holger score of 0 at 3 months
|
29 participants
|
|
Holger's Scale
Holger score of 1 at 6 months
|
0 participants
|
|
Holger's Scale
Holger score of 2 at 6 months
|
0 participants
|
|
Holger's Scale
Holger score of 0 at 12 months
|
29 participants
|
|
Holger's Scale
olger score of 1 at 12 months 1
|
1 participants
|
|
Holger's Scale
Holger score of 2 at 12 months
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0 participants
|
PRIMARY outcome
Timeframe: At surgery, 1 week, 3 weeks, 6 weeks, 12 weeks, 6 months and 12 monthsPresently, the recommendations to load the sound processor on a bone anchored implant is 3 months (for adults). Using outcome measures, i.e., OSSTELL ISQ ranges from 0 -100 where 0 is least stable and 100 being the most stable.
Outcome measures
| Measure |
Wide Diameter Bone Anchored Implant
n=30 Participants
Intervention: Implantation of a wide diameter bone anchored auditory implant either 3 or 4 mm in length, into the skull on the side of the ear where intervention is intended in order to restore hearing. In the case of a conductive or mixed hearing loss, that side is chosen. In patients with unilateral, profound sensori-neural hearing loss the implant is implanted on that side but the sound is transmitted to the side with the normal hearing ear via bone conduction stimulation.
Wide diameter bone anchored implant: 4.5 mm wide diameter bone anchored implant
|
|---|---|
|
Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane
ISQ horizontal at one week
|
59.77 units on a scale
Standard Deviation 7.88
|
|
Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane
ISQ vertical at 12 weeks
|
61.97 units on a scale
Standard Deviation 5.91
|
|
Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane
ISQ vertical at 6 month
|
63.62 units on a scale
Standard Deviation 5.26
|
|
Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane
ISQ horizontal at 6 months
|
63.27 units on a scale
Standard Deviation 5.48
|
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Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane
ISQ vertical at 12 months
|
63.73 units on a scale
Standard Deviation 5.31
|
|
Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane
ISQ vertical at surgery
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58.43 units on a scale
Standard Deviation 8.01
|
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Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane
ISQ horizontal at surgery
|
58.58 units on a scale
Standard Deviation 7.42
|
|
Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane
ISQ vertical at one week
|
59.70 units on a scale
Standard Deviation 7.03
|
|
Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane
ISQ vertical at 3 weeks
|
60.53 units on a scale
Standard Deviation 7.14
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Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane
ISQ horizontal at 3 weeks
|
60.30 units on a scale
Standard Deviation 7.78
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|
Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane
ISQ vertical at 6 weeks
|
61.28 units on a scale
Standard Deviation 5.81
|
|
Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane
ISQ horizontal at 6 weeks
|
61.02 units on a scale
Standard Deviation 6.56
|
|
Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane
ISQ horizontal at 12 weeks
|
62.00 units on a scale
Standard Deviation 6.07
|
|
Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane
ISQ horizontal at 12 months
|
63.62 units on a scale
Standard Deviation 5.26
|
Adverse Events
Wide Diameter Bone Anchored Implant
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Wide Diameter Bone Anchored Implant
n=30 participants at risk
Intervention: Implantation of a wide diameter bone anchored auditory implant either 3 or 4 mm in length, into the skull on the side of the ear where intervention is intended in order to restore hearing. In the case of a conductive or mixed hearing loss, that side is chosen. In patients with unilateral, profound sensori-neural hearing loss the implant is implanted on that side but the sound is transmitted to the side with the normal hearing ear via bone conduction stimulation.
Wide diameter bone anchored implant: 4.5 mm wide diameter bone anchored implant
|
|---|---|
|
Skin and subcutaneous tissue disorders
Skin revision
|
3.3%
1/30
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place