Wide Diameter Bone Anchored Implant Study

• Sponsor: Oticon Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01671176
• Collaborator: (none)
• Enrollment: 30
• Locations: 2
• Arm: 1
• Duration (Months): 30
• Patients Per Site: 15
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

To assess implant stability, implant loss, adverse skin reactions, and Quality of Life Benefit following implantation of the Ponto 4.5mm Wide Diameter implant. Secondary: to determine the feasibility of fitting the sound processor 3 weeks after surgical implantation, and to investigate if the type of skin reactions following implantation could be related to the demographic data of subjects and the type of surgical technique used

Condition or Disease	Intervention/Treatment	Phase
Conductive Hearing Loss; Conductive and Sensori-neural Hearing Loss in the Same Ear; Unilateral, Profound Sensori-neural Hearing Loss	Device: Wide diameter bone anchored implant	N/A

Detailed Description

Bone-anchored hearing systems have been an amplification choice for conductive, mixed, and profound, unilateral, sensorineural hearing loss for over three decades. So far, about 75,000 patients worldwide have received this surgical intervention (bone-anchored hearing system), since its first successful implantation in 1977. In 2009, Oticon Medical, LLC launched its bone-anchored hearing system called Ponto. In just over two years, the Ponto has been successfully implanted in over 3,000 patients by leading otolaryngologists and neurotologists in 18 countries worldwide.

The Ponto implant has previously been available with a 3.75mm diameter and comes in two lengths: 3mm and 4mm. Anew Ponto implant that is 4.5mm wide in diameter is now available in both 3mm and 4mm lengths. This Wide Diameter implant is designed to maximize bone-to-implant contact area and enhance implant stability which can potentially allow loading of the sound processor as early as 3 weeks after surgery. The abutment screw incorporates external threads at the screw head to make it possible to connect a SmartPeg (Osstell, Goteborg, Sweden) for stability measurements. All Ponto implants have the same universal implant-abutment interface. Therefore, they are fully compatible with existing instruments and abutments. Two new countersinks have been developed for the new Ponto Wide Diameter implant. The drill size of the countersink is 3.80mm. It is marked with a "W" to separate them from existing drills. All products are CE-marked and cleared for the US market by the FDA.

Objectives The present study will attempt to show that the Ponto 4.5mm Wide Diameter implant has similar or better outcomes in terms of Quality of Life (QoL) benefit; implant extrusion and revision surgery when compared to the 3.75mm diameter implant. Secondary objectives to be studied will include adverse skin reactions, the feasibility of fitting the sound processor three weeks after surgical implantation, and investigation to see if the type of skin reactions observed following implantation could be related to the demographic data of subjects or the type of surgical technique used.

Study Design This study is a prospective, multicenter study of subjects' demographic and implant data. Subjects will be enrolled at two US sites.

Subject Population Twenty adult subjects 18 years or older will be included in the study from each participating partner site.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Clinical Study of the Oticon Medical Ponto 4.5mm Wide Implant
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm

Intervention/Treatment

Other: 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.

Device: Wide diameter bone anchored implant; 4.5 mm wide diameter bone anchored implant; Other Names: Oticon Medical Ponto Pro Oticon Medical Ponto Pro Power Osstell ISQ

Outcome Measures

Primary Outcome Measures

1. Holger's Scale [1 week, 3 weeks, 6 weeks, 3 months, 6 months and 12 months]

   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

2. Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane [At surgery, 1 week, 3 weeks, 6 weeks, 12 weeks, 6 months and 12 months]

   Presently, 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• conductive, mixed or single sided deafness

• 18 years of age or older

Exclusion Criteria:

• younger than 18 years of age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Silverstein Institute	Sarasota	Florida	United States	34239
2	Michigan Ear Institute	Farmington Hills	Michigan	United States	48833

Sponsors and Collaborators

• Oticon Medical

Investigators

• Principal Investigator: Jack Wazen, MD, Sarasota Ear Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Oticon Medical
• ClinicalTrials.gov Identifier: NCT01671176
• Other Study ID Numbers: Wide04262012
• First Posted: Aug 23, 2012
• Last Update Posted: May 7, 2018
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Oticon Medical: Wide diameter implant; ISQ; Ponto; Bone anchored implant
• Additional relevant MeSH terms: Hearing Loss; Deafness; Hearing Loss, Conductive; Retrocochlear Diseases; Hearing Loss, Sensorineural

Study Results

Participant Flow

Arm/Group Title	Wide Diameter Bone Anchored Implant
Arm/Group Description	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
Period Title: Overall Study
STARTED	30
COMPLETED	30
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Wide Diameter Bone Anchored Implant
Arm/Group Description	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 Participants	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.83 (16.07)
Sex: Female, Male (Count of Participants)
Female	22 73.3%
Male	8 26.7%
Region of Enrollment (participants) [Number]
United States	30 100%
Smoking status (participants) [Number]
yes	1 3.3%
no	29 96.7%
Diabetes (participants) [Number]
yes	3 10%
no	27 90%
Abutment length (participants) [Number]
6 mm	20 66.7%
9 mm	7 23.3%
12 mm	3 10%
Weight (kilogram) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram]	76.72 (19.61)
BMI (kilogram/M^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram/M^2]	28.56 (7.09)
Height (centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeters]	163.79 (8.89)

Outcome Measures

1. Primary Outcome

Title	Holger's Scale
Description	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
Time Frame	1 week, 3 weeks, 6 weeks, 3 months, 6 months and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wide Diameter Bone Anchored Implant
Arm/Group Description	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
Measure Participants	30
Holger score 0 at 1 week	29 96.7%
Holger score of 1 at one week	0 0%
Holger score of 2 at one week	1 3.3%
Holger score of 0 at 3 weeks	29 96.7%
Holger score of 1 at 3 weeks	1 3.3%
Holger score of 2 at 3 weeks	0 0%
Holger score of 0 at 6 weeks	28 93.3%
Holger score of 1 at 6 weeks	2 6.7%
Holger score of 2 at 6 weeks	0 0%
Holger score of 0 at 3 months	29 96.7%
Holger score of 1 at 3 months	1 3.3%
Holger score of 2 at 3 months	0 0%
Holger score of 0 at 6 months	30 100%
Holger score of 1 at 6 months	0 0%
Holger score of 2 at 6 months	0 0%
Holger score of 0 at 12 months	29 96.7%
olger score of 1 at 12 months 1	1 3.3%
Holger score of 2 at 12 months	0 0%

2. Primary Outcome

Title	Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane
Description	Presently, 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.
Time Frame	At surgery, 1 week, 3 weeks, 6 weeks, 12 weeks, 6 months and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wide Diameter Bone Anchored Implant
Arm/Group Description	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
Measure Participants	30
ISQ vertical at surgery	58.43 (8.01)
ISQ horizontal at surgery	58.58 (7.42)
ISQ vertical at one week	59.70 (7.03)
ISQ horizontal at one week	59.77 (7.88)
ISQ vertical at 3 weeks	60.53 (7.14)
ISQ horizontal at 3 weeks	60.30 (7.78)
ISQ vertical at 6 weeks	61.28 (5.81)
ISQ horizontal at 6 weeks	61.02 (6.56)
ISQ vertical at 12 weeks	61.97 (5.91)
ISQ horizontal at 12 weeks	62.00 (6.07)
ISQ vertical at 6 month	63.62 (5.26)
ISQ horizontal at 6 months	63.27 (5.48)
ISQ vertical at 12 months	63.73 (5.31)
ISQ horizontal at 12 months	63.62 (5.26)

Adverse Events

Arm/Group Title	Wide Diameter Bone Anchored Implant
Arm/Group Description	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
All Cause Mortality
	Wide Diameter Bone Anchored Implant
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Wide Diameter Bone Anchored Implant
	Affected / at Risk (%)	# Events
Total	1/30 (3.3%)
Skin and subcutaneous tissue disorders
Skin revision	1/30 (3.3%)
Other (Not Including Serious) Adverse Events
	Wide Diameter Bone Anchored Implant
	Affected / at Risk (%)	# Events
Total	0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.