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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 12
- 主要终点
- Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for the Baha system
- •Signed informed consent
排除标准
- •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
研究组 & 干预措施
Minimally invasive surgery and BA400
This arm involves no soft tissue reduction around the BA400 implant.
干预措施: Minimally invasive surgery and BA400 (Device)
Traditional surgery and BA300
This arm involves traditional soft tissue reduction around the BA300 implant
干预措施: Traditional surgery and BA300 (Device)
结局指标
主要结局
Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability
时间窗: 36 months
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.
次要结局
- Pain by Visit - Categorical(Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36)
- Inflammation - Max of Holgers Index(From Day 10 to 12 Months, and to 36 Months)
- Inflammation - Holgers Index by Visit(Day 10, Weeks 3, 6, 12, 24, months 12, 24 and 36)
- Pain - Maximum of Neuropathic and Scar Pain(36 months)
- Surgery Time(Day 0)
- Wound Healing(Day 10, Weeks 3, 6, 12 and 24)
- Visible Abutment Length by Visit for Patients With no Change of Abutment(Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36)
- Pain in the Scar and Neuropathic Pain(Day 10, Weeks 3, 6, 12, 24, Months 12 and 36)
- Max Numbness(12 & 36 months)
- Soft Tissue Thickening/Overgrowth(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.(Week 12, Months 12 and 36)