N/A
Completed N=103
Clinical and Health Economic Evaluation With a New Baha® Abutment Combined With a Minimally Invasive Surgical Technique
Deafness · Hearing Loss · Hearing Loss, Conductive · Hearing Loss, Mixed Conductive-Sensorineural
Source: ClinicalTrials.gov NCT01796236 ↗
Enrolled (actual)
103
Serious AEs
16.4%
Results posted
Dec 2015
Primary outcomePrimary: Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability — 15; 7; 14; 13 participants — p=0.12
Summary
To demonstrate that the minimally invasive surgical procedure in combination with the use of the Cochlear Baha BA400 abutment is associated with a reduction of inflammation/infection, overgrowth, pain and numbness at the site of implantation compared to the traditional surgical procedure in combination with the use of the standard Baha abutment (Cochlear Baha BA300 Abutment).
To demonstrate that the minimally invasive surgical procedure in combination with the use of the Cochlear Baha BA400 abutment is associated with a reduction in direct medical costs, due to shorter surgical procedures, faster wound healing and less complications compared to the traditional surgical procedure in combination with the use of the standard Baha abutment (Cochlear Baha BA300 Abutment).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability |
12; 5; 12; 15; 16; 23 | 0.45 |
| PRIMARY Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability |
12; 5; 12; 15; 16; 23 | 0.45 |
| SECONDARY Surgery Time |
15.3; 24.7 | <0.0001 sig |
| SECONDARY Wound Healing |
4; 14; 47; 38; 4; 8 | 0.020 sig |
| SECONDARY Inflammation - Max of Holgers Index |
10; 8; 26; 32; 7; 10 | 0.40 |
| SECONDARY Inflammation - Holgers Index by Visit |
32; 35; 15; 15; 2; 2 | 0.38 |
| SECONDARY Max Numbness |
27; 9; 17; 12; 7; 31 | <0.0001 sig |
| SECONDARY Pain in the Scar and Neuropathic Pain |
1.45; 1.65; 1.90; 2.08; 1.38; 1.75 | 0.74 |
| SECONDARY Pain - Maximum of Neuropathic and Scar Pain |
34; 27; 7; 8; 7; 9 | 0.076 |
| SECONDARY Pain - Maximum of Neuropathic and Scar Pain |
34; 27; 7; 8; 7; 9 | 0.076 |
| SECONDARY Pain by Visit - Categorical |
43; 43; 5; 4; 2; 2 | 0.52 |
| SECONDARY Soft Tissue Thickening/Overgrowth |
48; 52; 2; 0; 1; 0 | 0.12 |
| SECONDARY Visible Abutment Length by Visit for Patients With no Change of Abutment |
3.30; 4.17; 3.34; 3.91; 4.00; 3.85 | 0.0009 sig |
| SECONDARY The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. |
2.11; 2.81; 1.98; 2.28; 1.69; 2.13 | 0.026 sig |
Eligibility Criteria
Inclusion Criteria
- Eligible for the Baha system
- Signed informed consent
Exclusion Criteria
- Patient scheduled for simultaneously bilateral implant surgery
- Uncontrolled diabetes as judged by the investigator
- Condition that could jeopardize osseointegration and/or wound healing, e.g. osteoporosis, psoriasis and use of corticosteroids
- Unable to follow the cleaning instruction
- Unable to follow investigational procedures, e.g. to complete quality of life scales
- Participation in another investigation with pharmaceuticals and/or device
- Condition that may have an impact on the outcome of the investigation as judged by the investigator
- Suitable implant position for the 4 mm implant not found during surgery due to insufficient bone quality and/or bone thickness
Data sourced from ClinicalTrials.gov (NCT01796236). 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.