Clinical Survey of Oticon Medical Ponto Implants and a Surgical Technique With Tissue Preservation

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Brief Title

Clinical Survey of Oticon Medical Ponto Implants and a Surgical Technique With Tissue Preservation

Official Title

Clinical Survey of Oticon Medical Ponto Implants and a Surgical Technique With Tissue Preservation

Brief Summary

      A bone anchored hearing system is used to improve hearing for patients with e.g.
      conductive/mixed hearing loss or single sided deafness.

      With this type of system, a titanium implant is installed in the temporal bone, where it
      osseointegrates, i.e. integrates with the bone. An abutment (also in titanium) is attached to
      the implants and penetrates the skin. The sound processor (hearing aid) is then connected to
      the abutment, and can be attached and removed by the patient via a snap-coupling. This type
      of system has been successfully implanted in more than 100.000 patients. Recently, a
      simplified surgical procedure, where no skin thinning around the abutment is made, was
      approved. The results after using this installation technique, here called soft tissue
      preservation, are the focus of this study.

      The objective of the study is to compare the outcomes after a surgical procedure with soft
      tissue preservation (test) and a surgery with soft tissue reduction (control) for placing
      Oticon Medical Ponto implants and abutments. The main hypothesis is that patient numbness
      around the implant is less in the test group compared to the control group.
    



Study Type

Observational


Primary Outcome

Numbness around implant, specifically mean Total sensibility

Secondary Outcome

 Length of surgery

Condition

Conductive Hearing Loss


Study Arms / Comparison Groups

 Tissue preservation
Description:  Ponto implant installed using a tissue preservation surgical technique

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

25

Start Date

February 2014

Completion Date

September 2017

Primary Completion Date

April 2015

Eligibility Criteria

        Inclusion Criteria:

          -  18 years or older

          -  Patient indicated for an ear level bone anchored sound processor

          -  Bone thickness at the implant site of at least 4 mm

        Exclusion Criteria:

          -  Inability to participate in follow-up

          -  Psychiatric disease in the medical history

          -  Mental disability

          -  Presumed doubt, for any reason, that the patient will be able to show up on all follow
             ups

          -  Diseases or treatments known to compromise the bone quality at the implant site, e.g.
             radiotherapy, osteoporosis, diabetes mellitus.

          -  Patients with natural skin height of >10 mm
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Myrthe KS Hol, MD, PhD, , 

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations


NCT ID

NCT02064478

Organization ID

C47


Responsible Party

Sponsor

Study Sponsor

Oticon Medical

Collaborators

 Statistiska konsultgruppen

Study Sponsor

Myrthe KS Hol, MD, PhD, Principal Investigator, Radboud University


Verification Date

February 2018