NCT02438618已完成不适用
Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Incidence of inflammation (Holgers index ≥ 2)
研究概览
简要总结
The objective of this study is to make a comparison between two surgical techniques used when implanting a Ponto bone anchored hearing system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Adult patient, i.e. ≥ 18 years of age
- •Eligible for the Ponto system
排除标准
- •Known history of immunosuppressive disease
- •Use of systemic immunosuppressive medication
- •Receiving bilateral bone anchored hearing system
- •Relevant dermatological diseases as judged by the investigator
- •Not being able to finish the study, for example because of failure to complete the questionnaires
- •Participating in another study with medical aids or medication
- •When there is no suitable implantation-site for the 4 mm implant during surgery because of insufficient bone quality.
研究组 & 干预措施
Minimally invasive punch technique
Experimental
New surgical technique for Ponto bone anchored hearing implants
干预措施: Surgery for Ponto bone anchored hearing aids (Procedure)
Hultcrantz technique
Other
Standard surgical technique for bone anchored hearing implants
干预措施: Surgery for Ponto bone anchored hearing aids (Procedure)
结局指标
主要结局
Incidence of inflammation (Holgers index ≥ 2)
时间窗: 3 months post surgery
次要结局
- Visual Analogue Scale (VAS) pain scale > 6 (Noted on a scale from 0 - 10)(24 months post surgery)
- Soft tissue overgrowth (mm)(24 months post surgery)
- Presence of dehiscence after surgery (Noted in a binary fashion (present/not present))(3 months post surgery)
- Presence of dehiscence after surgery (present/not present)(24 months post surgery)
- Cosmetic result (10 point scale)(24 months post surgery)
- Loss of sensibility (Measured in mm outwards from the abutment)(24 months post surgery)
- Implant stability quotient (ISQ) measurements (ISQ units 1-100)(24 months post surgery)
- Holgers index ≥ 2 at any time point(24 months post surgery)
- Extrusion rate (number of implants lost)(24 months post surgery)
- Surgical time (minutes)(3 months post surgery)
- Wound healing time (time to reach healed)(3 months post surgery)
研究者
研究点 (1)
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