Wide Diameter Bone Anchored Implant Study
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01671176 |
|
Recruitment Status :
Completed
First Posted : August 23, 2012
Results First Posted : May 7, 2018
Last Update Posted : May 7, 2018
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| 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 | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| 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 2012 |
| Actual Primary Completion Date : | November 2014 |
| Actual Study Completion Date : | November 2014 |
| Arm | Intervention/treatment |
|---|---|
|
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:
|
- Holger's Scale [ Time Frame: 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
- Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane [ Time Frame: 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.
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01671176
| United States, Florida | |
| Silverstein Institute | |
| Sarasota, Florida, United States, 34239 | |
| United States, Michigan | |
| Michigan Ear Institute | |
| Farmington Hills, Michigan, United States, 48833 | |
| Principal Investigator: | Jack Wazen, MD | Sarasota Ear Institute |
| Responsible Party: | Oticon Medical |
| ClinicalTrials.gov Identifier: | NCT01671176 |
| Other Study ID Numbers: |
Wide04262012 |
| First Posted: | August 23, 2012 Key Record Dates |
| Results First Posted: | May 7, 2018 |
| Last Update Posted: | May 7, 2018 |
| Last Verified: | April 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
|
Wide diameter implant ISQ Ponto Bone anchored implant |
|
Hearing Loss Deafness Hearing Loss, Conductive Retrocochlear Diseases Hearing Loss, Sensorineural Hearing Disorders |
Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases |