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临床试验/NCT01738490
NCT01738490已完成不适用

Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant

Oticon Medical2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2012年6月最近更新:
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
59
试验地点
2
主要终点
ISQ (Implant Stability Quotient)

研究概览

简要总结

The overall aim of the study is to investigate the Ponto wide implant considering; initial implant stability, stability over time, skin reaction and long term success when loaded at 3 weeks post surgery. Patients' quality of life improvements following implantation will also be surveyed.

More specifically the primary objective of this clinical study is to test the hypothesis

  • The new Ponto wide diameter implant offers increased implant stability measured as ISQ (implant stability quotient) compared to the previous generation Ponto implant.

And the secondary objective is to

  • Investigate when in time implant stability is the lowest as the initial mechanical stability is gradually replaced by biological stability

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

入选标准

  • 18 years or older
  • Patient indicated for an ear level bone anchored sound processor
  • Bone thickness at the implant site of at least 4 mm

排除标准

  • Longer abutment (>6mm) required
  • Inability to participate in follow-up
  • Psychiatric disease in the medical history
  • Mental disability
  • Presumed doubt, for any reason, that the patient will be able to show up on all follow ups
  • Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.

研究组 & 干预措施

Wide diameter implant

Other

Bone anchored hearing implant For the wide diameter arm (test group), the Ponto wide implant (diameter 4,5mm, length 4mm) and abutment 6mm developed by Oticon Medical AB (Gothenburg, Sweden) will be installed.

干预措施: Bone anchored hearing implant (Device)

Control group

Other

Bone anchored hearing implant For the control group, the previous generation Ponto implant (diameter 3,75mm, length 4mm) and 6mm abutment (Oticon Medical AB, Gothenburg, Sweden) will be installed.

干预措施: Bone anchored hearing implant (Device)

结局指标

主要结局

ISQ (Implant Stability Quotient)

时间窗: 36 months after surgery

次要结局

  • Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire(36 months after surgery)
  • Glasgow Health Status Inventory (GHSI) questionnaire(36 months after surgery)
  • ISQ (Implant stability quotient) gradient(0, 7, 14, 21 and 28 days, 6 weeks, 12weeks, 6 months after surgery)
  • Skin condition according to Holgers score(36 months after surgery)
  • Glasgow Benefit Inventory Questionnaire(12 months after surgery)
  • Time of minimum ISQ (Implant stability quotient)(0, 7, 14, 21 and 28 days after surgery)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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