Long Term Stability, Survival and Tolerability of a (Novel) Baha® Implant System

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Brief Title

Long Term Stability, Survival and Tolerability of a (Novel) Baha® Implant System

Official Title

Long Term Stability, Survival and Tolerability of a (Novel) Baha® Implant System

Brief Summary

      An international multicentre, open, comparative, parallel group, prospective clinical
      investigation with a single 5 year follow up visit.
    

Detailed Description

      Two implant products, the standard implant and abutment and the novel implant and abutment,
      both developed by Cochlear Bone Anchored Solutions AB were tested in the CAG5173 clinical
      investigation that was completed in December 2012. The primary objective was to show
      superiority of the novel implant compared to standard implant in terms of implant stability
      quotient (ISQ) as as measured by resonance frequency analysis1. Results after 6 and 36 months
      after implantation showed that the new design, the novel implant and abutment, provided
      statistically significantly higher stability at the time of insertion and over time compared
      to the standard Baha implant2,3,4. In the investigation, sound processor fitting was
      performed from 6 weeks post-implantation. No reduction in implant stability following sound
      processor fitting was recorded, suggesting that it is safe to load the implant 6 weeks after
      implantation. The investigation also showed improved soft tissue outcomes, in terms of lower
      Holgers index5 scores for the novel implant and abutment compared to the standard implant and
      abutment.

      After initiation of the 3-year CAG5173 investigation, Cochlear Bone Anchored Solutions AB
      launched the Cochlear Baha BIA300 Implant and Abutment, which in all critical aspects are
      identical to the novel implant used in the investigation.

      The 36-month visit was the last visit of the investigation. Hence, no further visits were
      planned or scheduled for the subjects participating in that investigation.participating
      subjects. It is of clinical and scientific interest to evaluate the clinical performance and
      safety data of the implants in these subjects after an additional two-year period, in order
      to gain additional understanding of how implant stability and soft tissue status evolves over
      time with the two implant and abutment designs, and in order to evaluate long-term implant
      survival. No randomised controlled investigation of Baha implants with a 5-year follow-up has
      been conducted to date.

      The rationale behind this clinical investigation is to collect long term stability, survival
      and tolerability data of a novel Baha implant system 5 years after implantation in a
      population that previously have been followed in a completed controlled investigation during
      a 3 year period. The collected data will enable comparison with the data gathered in the
      previous completed CAG5173 clinical investigation.
    


Study Type

Interventional


Primary Outcome

Implant Stability

Secondary Outcome

 Longterm Survival of Implant

Condition

Conductive Hearing Loss

Intervention

Novel Implant BI300

Study Arms / Comparison Groups

 Standard Implant BI300
Description:  The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long

Publications

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

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

77

Start Date

May 2014

Completion Date

March 2015

Primary Completion Date

March 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Participated in the CAG5173 investigation

          -  Signed informed consent

        Exclusion Criteria:

          -  Unable to follow investigational procedure

          -  Any factor, at the discretion of the investigator, that is considered to
             contraindicate participation
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Johan Blechert, M.Sc, , 

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations


NCT ID

NCT02092610

Organization ID

CBAS5562


Responsible Party

Sponsor

Study Sponsor

Cochlear Bone Anchored Solutions


Study Sponsor

Johan Blechert, M.Sc, Study Director, Cochlear Bone Anchored Solutions AB


Verification Date

January 2016