Wide Diameter Bone Anchored Implant Study - Full Text View

Purpose

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	Intervention
Conductive Hearing Loss Mxed Hearing Loss Single Sided Deafness	Device: 4.5 mm bone anchored implant

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Clinical Study of the Oticon Medical Ponto 4.5mm Wide Implant

Resource links provided by NLM:

Genetics Home Reference related topics: nonsyndromic deafness Pendred syndrome

MedlinePlus related topics: Hearing Disorders and Deafness

U.S. FDA Resources

Further study details as provided by Oticon Medical:

Primary Outcome Measures:

To determine that Ponto 4.5mm Wide Diameter implant has similar or better outcomes in terms of Quality of Life (QoL) benefit when compared to the 3.75 mm implant [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
The 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.
To determine that Ponto 4.5mm Wide Diameter implant has similar or better outcomes in terms of Quality of Life (QoL) benefit when compared to the 3.75mm diameter implant [ Time Frame: 3 months ] [ Designated as safety issue: No ]
The 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.
To determine that Ponto 4.5mm Wide Diameter implant has similar or better outcomes in terms of Quality of Life (QoL) benefit when compared to the 3.75mm diameter implant [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The 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.
To determine that 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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The 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 Outcome Measures:

Determine if the 4.5 mm implant is sufificiently stable in the temporal bone to load the sound processor at 3 weeks postoperatively [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Presently, the recommendations to load the sound processor on a bone anchored implant is 3 months (for adults). Using outcome measures, i.e., OSTELL ISQ data is one method to determine implant stability at different intervals
Assess adverse skin reactions [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Assess adverse skin reactions [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Assess adverse skin reactions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Assess adverse skin reactions [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To investigate 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. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
To investigate 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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
To investigate 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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To investigate 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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Other Outcome Measures:

Glasgow Benefit Inventory [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Glasgow Benefit Inventory is a Quality of Life measurement
Glasgow Benefit Inventory [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Glasgow Benefit Inventory [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Holger's Scale [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Holger's Scale is a 5 point scale that assesses skin reactions at the implant site
Holger's Scale [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Holger's Scale is a 5 point scale that assesses skin reactions at the implant site
Holger's Scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Holger's Scale is a 5 point scale that assesses skin reactions at the implant site
Holger's Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Holger's Scale is a 5 point scale that assesses skin reactions at the implant site
Holger's Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Holger's Scale is a 5 point scale that assesses skin reactions at the implant site
Holger's Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Holger's Scale is a 5 point scale that assesses skin reactions at the implant site
Implant Stability Quotient [ Time Frame: At surgery ] [ Designated as safety issue: No ]
Implant Stability Quotient (ISQ 26) is a measurement scale used for Resonance Frequency Analysis (RFA) when evaluating implant stability. The measurement is performed by utilizing the Osstell® ISQ and Osstell Mentor stability meters provided by Osstell. The ISQ values range from 1-100. The more stable the implant, the higher the ISQ value.
Implant Stability Quotient [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Implant Stability Quotient (ISQ 26) is a measurement scale used for Resonance Frequency Analysis (RFA) when evaluating implant stability. The measurement is performed by utilizing the Osstell® ISQ and Osstell Mentor stability meters provided by Osstell. The ISQ values range from 1-100. The more stable the implant, the higher the ISQ value.
Implant Stability Quotient [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Implant Stability Quotient (ISQ 26) is a measurement scale used for Resonance Frequency Analysis (RFA) when evaluating implant stability. The measurement is performed by utilizing the Osstell® ISQ and Osstell Mentor stability meters provided by Osstell. The ISQ values range from 1-100. The more stable the implant, the higher the ISQ value.
Implant Stability Quotient [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Implant Stability Quotient (ISQ 26) is a measurement scale used for Resonance Frequency Analysis (RFA) when evaluating implant stability. The measurement is performed by utilizing the Osstell® ISQ and Osstell Mentor stability meters provided by Osstell. The ISQ values range from 1-100. The more stable the implant, the higher the ISQ value.
Implant Stability Quotient [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Implant Stability Quotient (ISQ 26) is a measurement scale used for Resonance Frequency Analysis (RFA) when evaluating implant stability. The measurement is performed by utilizing the Osstell® ISQ and Osstell Mentor stability meters provided by Osstell. The ISQ values range from 1-100. The more stable the implant, the higher the ISQ value.
Implant Stability Quotient [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Implant Stability Quotient (ISQ 26) is a measurement scale used for Resonance Frequency Analysis (RFA) when evaluating implant stability. The measurement is performed by utilizing the Osstell® ISQ and Osstell Mentor stability meters provided by Osstell. The ISQ values range from 1-100. The more stable the implant, the higher the ISQ value.
Implant Stability Quotient [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Implant Stability Quotient (ISQ 26) is a measurement scale used for Resonance Frequency Analysis (RFA) when evaluating implant stability. The measurement is performed by utilizing the Osstell® ISQ and Osstell Mentor stability meters provided by Osstell. The ISQ values range from 1-100. The more stable the implant, the higher the ISQ value.

Estimated Enrollment:	80
Study Start Date:	May 2012
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
4.5 mm diameter bone anchored implant Implantation of 4.5 mm diameter bone anchored implant	Device: 4.5 mm bone anchored implant Measure implant stability with Osstell ISQ Other Names: Ponto Pro Ponto Pro Power Osstell ISQ

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671176

Contacts

Contact: Ravi Sockalingam, PhD

908-202-3524

rxs@oticonmedicalusa.com

Locations

United States, Florida
Silverstein Institute	Recruiting
Sarasota, Florida, United States, 34239
Contact: Julie Daugherty, MS 941-400-6883 juliearnp@verizon.net
Principal Investigator: Jack Wazen, MD
United States, Michigan
Michigan Ear Institute	Recruiting
Farmington Hills, Michigan, United States, 48833
Contact: Jennifer Monitz 248-465-4828 Jennifer.Monitz@providence-stjohnhealth.org
Principal Investigator: Seilesh Babu, MD
United States, Virginia
Balance and Ear Center	Recruiting
Richmond, Virginia, United States, 23233
Contact: Wayne Shaia, MD 804-288-3277 shaiawr@gmail.com
Principal Investigator: Wayne Shaia, MD

Sponsors and Collaborators

Oticon Medical

More Information

No publications provided

Responsible Party:	Oticon Medical
ClinicalTrials.gov Identifier:	NCT01671176 History of Changes
Other Study ID Numbers:	Wide04262012
Study First Received:	August 15, 2012
Last Updated:	August 21, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Oticon Medical:

Wide diameter implant
ISQ
Ponto
Bone anchored implant

Additional relevant MeSH terms:

Deafness
Hearing Loss
Hearing Loss, Conductive
Hearing Disorders
Ear Diseases

Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013