Wide Diameter Bone Anchored Implant Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Oticon Medical
Sponsor:
Information provided by (Responsible Party):
Oticon Medical
ClinicalTrials.gov Identifier:
NCT01671176
First received: August 15, 2012
Last updated: July 1, 2014
Last verified: August 2012
  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:


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: November 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 1, 2014
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
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014