N/A
Completed N=77
Long Term Stability, Survival and Tolerability of a (Novel) Baha® Implant System
Source: ClinicalTrials.gov NCT02092610 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcomePrimary: Implant Stability — 66.7; 71.6; 67.4; 72.1 ISQ scores
Summary
An international multicentre, open, comparative, parallel group, prospective clinical investigation with a single 5 year follow up visit.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Implant Stability |
66.7; 71.6; 67.4; 72.1 | — |
| SECONDARY Longterm Survival of Implant |
90.0; 93.92; 95.0; 95.8 | — |
| SECONDARY Soft Tissue Status |
52.9; 90.0; 23.5; 7.5; 23.5; 2.5 | — |
| SECONDARY Implant Survival |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT02092610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.