Clinical trial NCT01796236: Clinical and Health Economic Evaluation With a New Baha® Abutment Combined With a Minimally Invasive Surgical Technique
Official title: Clinical and Health Economic Evaluation of a New Baha® Abutment, With a Minimally Invasive Surgical Technique. An International Multicentre, Open, Randomised, Comparative, Parallel Group, Investigation. 1y Investigation, 2y Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deafness
Hearing Loss
Hearing Loss, Conductive
Hearing Loss, Mixed Conductive-Sensorineural
Keywords: Bone anchored hearing aid
Bone anchored implant
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Health Utility Index (HUI)
Holgers Index
Implant stability
Lead sponsor: Cochlear Bone Anchored Solutions
Sponsor class: INDUSTRY
First posted: 2013-02-21
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

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

Primary outcomes:
measure: Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability
timeFrame: 12 months
measure: Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability
timeFrame: 36 months
Secondary outcomes:
measure: Surgery Time
timeFrame: Day 0
measure: Wound Healing
timeFrame: Day 10, Weeks 3, 6, 12 and 24
measure: Inflammation - Max of Holgers Index
timeFrame: From Day 10 to 12 Months, and to 36 Months
measure: Inflammation - Holgers Index by Visit
timeFrame: Day 10, Weeks 3, 6, 12, 24, months 12, 24 and 36
measure: Max Numbness
timeFrame: 12 & 36 months
measure: Pain in the Scar and Neuropathic Pain
timeFrame: Day 10, Weeks 3, 6, 12, 24, Months 12 and 36
measure: Pain - Maximum of Neuropathic and Scar Pain
timeFrame: 12 months
measure: Pain - Maximum of Neuropathic and Scar Pain
timeFrame: 36 months
measure: Pain by Visit - Categorical
timeFrame: Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36
measure: Soft Tissue Thickening/Overgrowth
timeFrame: Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36
measure: Visible Abutment Length by Visit for Patients With no Change of Abutment
timeFrame: Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36
measure: 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.
timeFrame: Week 12, Months 12 and 36
Other outcomes:
measure: Health Utilies Index (HUI-III & HUI-II)
timeFrame: baseline (pre-surgery), week 24, months 12 and 36
measure: Abbreviated Profile of Hearing Aid Benefit (APHAB)
timeFrame: Pre-surgery (baseline) to 24 weeks, 12 and 36 months
measure: Use of Sound Processor
timeFrame: Weeks 6, 12, 24, Months 12, 24, 36
measure: Implant Stability (ISQ)
timeFrame: Surgery, Day 10, Weeks 3, 6, 12, 24, Months 12, 24, 36
measure: Smoking Habits by Visit
timeFrame: baseline, Weeks 3, 12, Months 12, 24 and 36
measure: Loss of Implant
timeFrame: from surgery through to 36 months
measure: Removal of Abutment
timeFrame: from surgery through to 36 months
Locations:
city: Toulouse
country: France
facility: Service ORL
city: Breda
country: Netherlands
facility: KNO arts, Amphia Ziekenhuis
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Dept. ENT/KNO
city: Maastricht
country: Netherlands
facility: NT department
city: Valencia
country: Spain
facility: Otorhinolaryngology, Hospital Clinico Universitario De Valencia
city: Gothenburg
country: Sweden
facility: ENT Clinic
Study officials:
affiliation: NT department, Oxford Building , Peter Debyelaan 25, 6202 AZ Maastricht, The Netherlands
name: Robert Stokroos, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Hoof M, Wigren S, Ivarsson Blechert J, Molin M, Andersson H, Mateijsen DJM, Bom SJH, Calmels MN, van der Rijt AJM, Flynn MC, van Tongeren J, Hof JR, Brunings JW, Anteunis LJC, Marco Algarra J, Stokroos RJ, Joore MA. A Multinational Cost-Consequence Analysis of a Bone Conduction Hearing Implant System-A Randomized Trial of a Conventional vs. a Less Invasive Treatment With New Abutment Technology. Front Neurol. 2020 Mar 13;11:106. doi: 10.3389/fneur.2020.00106. eCollection 2020.