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).
Despite extensive soft tissue reduction, the most common complications associated with Baha implants are related to adverse skin reactions around the abutment. The reduction of the skin also adds complexity to the surgical procedure that is otherwise a routine type of skin incision. A less invasive surgical technique avoiding reducing the thickness of the skin would render a simpler and shorter procedure and would be aesthetically appealing to the patients, as permanent hair removal in the area around the abutment would not be required. Faster healing and less numbness (sensory loss/ paraesthesia) at the implant site may also be expected if the soft tissue thickness is left intact. The Cochlea Baha BA300 Abutment together with a surgical procedure that includes soft tissue reduction was CE marked in April 2010. The test abutment, Cochlear Baha BA400, together with a surgical procedure that does not require soft tissue reduction was CE marked in June 2012. The rationale behind this investigation was to make a 'head-to-head' comparison between the BA300 and BA400 Abutment and the associated surgical techniques in order to collect information regarding complications (inflammation/infection, numbness and pain), aesthetic outcome and utilisation of direct medical cost associated with surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).
The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
Service ORL
Toulouse, France
KNO arts, Amphia Ziekenhuis
Breda, Netherlands
Deventer Ziekenhuis
Deventer, Netherlands
Dept. ENT/KNO
Eindhoven, Netherlands
NT department
Maastricht, Netherlands
Otorhinolaryngology, Hospital Clinico Universitario De Valencia
Valencia, Spain
ENT Clinic
Gothenburg, Sweden
Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability
Combined endpoint of infection/inflammation, overgrowth, pain and numbness will be evaluated, as the sum of the following four events: 1. Holgers Index \>=2 any time between 3 weeks to 1 year 2. Any overgrowth any time between 3 weeks to 1 year 3. Pain (scar/neuropathic) according to POSAS \>=3 any time between 3 weeks to 1 year 4. Any numbness any time between 3 weeks to 1 year Each medical event is counted only once per subject resulting in a score of 0 to 4 for every subject.
Time frame: 12 months
Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability
Combined endpoint of infection/inflammation, overgrowth, pain and numbness will be evaluated, as the sum of the following four events: 1. Holgers Index \>=2 any time between 3 weeks to 1 year 2. Any overgrowth any time between 3 weeks to 1 year 3. Pain (scar/neuropathic) according to POSAS \>=3 any time between 3 weeks to 1 year 4. Any numbness any time between 3 weeks to 1 year Each medical event is counted only once per subject resulting in a score of 0 to 4 for every subject.
Time frame: 36 months
Surgery Time
Surgery time (minutes) was recorded
Time frame: Day 0
Wound Healing
A surgeon or a surgical nurse determined if the wound was healed or not healed.
Time frame: Day 10, Weeks 3, 6, 12 and 24
Inflammation - Max of Holgers Index
Max of Holgers index from day 10 to month 12, and to month 36 was recorded, using the Holgers scale from 0 - 4, where 0 = no inflammation and 4 = removal of abutment/implant necessary due to infection. 0\. No irritation 1. Slight redness. Local temporary treatment, if needed 2. Red and slightly moist tissue. No granulation formation, local treatment and extra controls as indicated\* 3. Reddish and moist; sometimes granulations tissue, revision surgery is indicated\* R. Removal of the abutment / implant necessary due to infection\* R Removal of implant for reasons not related to skin problems\*
Time frame: From Day 10 to 12 Months, and to 36 Months
Inflammation - Holgers Index by Visit
Infection and inflammation were evaluated by the holgers index at visits 3-10 (Day 10, Weeks 3, 6, 12, 24, months 12, 24 and 36) and the following scale was used: 0\. No irritation. Epidermal debris removed, if present 1. Slight redness. Local temporary treatment, if needed 2. Red and slightly moist tissue. No granulation formation, local treatment and extra controls as indicated\* 3. Reddish and moist; sometimes granulations tissue, revision surgery is indicated\* 4. Removal of the abutment / implant necessary due to infection\* R. Removal of implant for reasons not related to skin problems\*
Time frame: Day 10, Weeks 3, 6, 12, 24, months 12, 24 and 36
Max Numbness
Subjects were asked if they experience any numbness around the abutment at each visit. The maximum numbness each subject experienced is summarized in this analysis. The following scale will be used: 1. No numbness 2. Numbness within 2 cm from the abutment 3. Numbness within and beyond 2 cm from the abutment
Time frame: 12 & 36 months
Pain in the Scar and Neuropathic Pain
The subject rated the following questions 'has the scar been painful the past few weeks' and 'have you had any neuropathic pain during the past weeks' on the 1-10 scale were 1 = no, not at all and 10 = yes, very much.
Time frame: Day 10, Weeks 3, 6, 12, 24, Months 12 and 36
Pain - Maximum of Neuropathic and Scar Pain
The maximum neuropathic pain and the maximum scar pain experienced at any time throughout the study up until and including 12 months.
Time frame: 12 months
Pain - Maximum of Neuropathic and Scar Pain
The maximum neuropathic pain and the maximum scar pain experienced at any time throughout the study up until and including 36 months.
Time frame: 36 months
Pain by Visit - Categorical
The subject rated the following questions 'has the scar been painful the past few weeks' and 'have you had any neuropathic pain during the past weeks' on the 1-10 scale were 1 = no, not at all and 10 = yes, very much. Pain scale was categorised as 1='no pain', 2-3='mild pain', 4-6='moderate pain', 7-10='severe pain'.
Time frame: Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36
Soft Tissue Thickening/Overgrowth
The investigator rated the implant site in regards to soft tissue thickening/overgrowth at visits 3-10 according to the following scale: 0\. No soft tissue thickening or overgrowth 1. Slight soft tissue thickening or overgrowth 2. Moderate soft tissue thickening or overgrowth. Local treatment and extra controls as indicated\* 3. Marked/distinct soft tissue thickening or overgrowth. Revision surgery is indicated.\* * Should also be reported on the AE page in the CRF
Time frame: Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36
Visible Abutment Length by Visit for Patients With no Change of Abutment
The investigator measured the visible abutment length at each visit. The length of BA400 test abutments initially placed were longer than BA300 control abutments places. A direct comparison between the groups is not relevant. In some cases of increased soft tissue thickening or overgrowth, the abutment was exchanged for a longer abutment. The results presented here are only for patients with no change of abutment
Time frame: Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36
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.
The patient scale contains six items (pain, itching, color, stiffness, thickness and irregularity) scored 1-10. The observer scale contains six items (vascularity, pigmentation, thickness, relief, pliability and surface area) scored 1-10. Besides the 10-step scale, category boxes are available to score nominal parameters (e.g. type of color). Both patient and observer should also score the overall opinion of the scar on the 1-10 scale. For all above scales 1=normal skin, 10 worst scar imaginable. Total score is the sum of the variables pain, itching, color, stiffness, thickness and irregularity (patient) and vascularity, pigmentation, thickness, relief, pliability and surface area (observer). The scale ranges from 6 to 60 (6 normal, 60 worst scar imaginable). The "pain not with in the scar" variable ranges from 1 to 10. 1 being no pain at all and 10 being very much pain
Time frame: Week 12, Months 12 and 36
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