Clinical Trial: Long Term Stability, Survival and Tolerability of a (Novel) Baha® Implant System
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Summary:
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 ord
Sponsor: Cochlear Bone Anchored Solutions
Current Primary Outcome: Implant Stability [ Time Frame: At the single 60 months visit ]
Original Primary Outcome: Implant Stability [ Time Frame: At the single 60 months visit ]
Current Secondary Outcome:
- Longterm Survival of Implant [ Time Frame: At the single 60 months visit ]
To compare the long term survival of the novel implant and abutment and the standard implant and abutment in the Baha system.
All patients will be asked if they have experienced any implant osseointegration problems which would have made the implant to get loose. The time from implant implantation until implant loss or removal will be collected. In case of implant removal, reason for removal shall be recorded.
- Soft Tissue Status [ Time Frame: At the single 60 months visit ]
To evaluate the status of the soft tissue at the implant site.
The scale Holgers Index 4 is designed to capture signs and symptoms of inflammation or infection at the site of implantation. The scale should be completed at the visit.
The scale consists of the following steps:
0. No irritation. Epidermal debris removed, if present
- Slight redness. Local temporary treatment, if needed
- Red and slightly moist tissue. No granulation formation, local treatment and extra controls as indicated
- Reddish and moist; sometimes granulations tissue, revision surgery is indicated
- Removal of the abutment/implant necessary due to infection R. Removal of abutment/implant for reasons not related to skin problems
- Implant Survival [ Time Frame: 60 months ]
Original Secondary Outcome:
- Compare longterm survival of implant [ Time Frame: At the single 60 months visit ]
To compare the long term survival of the novel implant and abutment and the standard implant and abutment in the Baha system.
All patients will be asked if they have experienced any implant osseointegration problems which would have made the implant to get loose. The time from implant implantation until implant loss or removal will be collected. In case of implant removal, reason for removal shall be recorded.
- Soft Tissue Status [ Time Frame: At the single 60 months visit ]
To evaluate the status of the soft tissue at the implant site.
The scale Holgers Index 4 is designed to capture signs and symptoms of inflammation or infection at the site of implantation. The scale should be completed at the visit.
The scale consists of the following steps:
0. No irritation. Epidermal debris removed, if present
- Slight redness. Local temporary treatment, if needed
- Red and slightly moist tissue. No granulation formation, local treatment and extra controls as indicated
- Reddish and moist; sometimes granulations tissue, revision surgery is indicated
- Removal of the abutment/implant necessary due to infection R. Removal of abutment/implant for reasons not related to skin problems
- Evaluate implant survival [ Time Frame: At one single 60 months visit ]To evaluate implant survival. At the actual visit perform a visual and physical examination of the implant to determine that it is fully osseointegrated.
Information By: Cochlear Bone Anchored Solutions
Dates:
Date Received: March 14, 2014
Date Started: May 2014
Date Completion:
Last Updated: January 12, 2016
Last Verified: January 2016
