Wide Diameter Bone Anchored Implant Study

Conductive Hearing Loss Clinical Trial

Official title:

A Clinical Study of the Oticon Medical Ponto 4.5mm Wide Implant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01671176
• Other study ID #: Wide04262012
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: November 2014

Study information

• Verified date: April 2018
• Source: Oticon Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• conductive, mixed or single sided deafness

• 18 years of age or older

Exclusion Criteria:

• younger than 18 years of age

Related Conditions & MeSH terms

• Conductive and Sensori-neural Hearing Loss in the Same Ear
• Conductive Hearing Loss
• Deafness
• Hearing Loss
• Hearing Loss, Conductive
• Hearing Loss, Sensorineural
• Unilateral, Profound Sensori-neural Hearing Loss

Intervention

Device:
• Wide diameter bone anchored implant
4.5 mm wide diameter bone anchored implant

Locations

Country	Name	City	State
United States	Michigan Ear Institute	Farmington Hills	Michigan
United States	Silverstein Institute	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Oticon Medical

Country where clinical trial is conducted

United States, 

References & Publications (1)

Wazen JJ, Babu S, Daugherty J, Metrailer A. Three-week loading of the 4.5mm wide titanium implant in bone anchored hearing systems. Am J Otolaryngol. 2016 Mar-Apr;37(2):132-5. doi: 10.1016/j.amjoto.2015.08.005. Epub 2015 Aug 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Holger's Scale	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	1 week, 3 weeks, 6 weeks, 3 months, 6 months and 12 months
Primary	Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane	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.	At surgery, 1 week, 3 weeks, 6 weeks, 12 weeks, 6 months and 12 months