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骨导式种植体 4 周时早期负载的证据。

Evidence for early loading of osseointegrated implants for bone conduction at 4 weeks.

机构信息

Newcastle BAHA Programme, ENT Department, Freeman Hospital, Freeman Road, High Heaton, Newcastle upon Tyne, UK.

出版信息

Otol Neurotol. 2012 Dec;33(9):1578-82. doi: 10.1097/MAO.0b013e31826dba5f.

Abstract

INTRODUCTION

The purpose of our study was to directly measure the stability of the abutment using resonance frequency analysis (RFA) and to report on the change in stability over time for implants loaded 4 weeks postoperatively.

MATERIALS AND METHODS

The principle behind RFA is to obtain a numerical value relating to stability. The Osstell RFA recording device measures the resonance in a magnetic field of a 1 cm commercially manufactured attachment (SmartPeg) that is screwed onto the bone conduction device abutment. RFA measurements were obtained at surgery, 1, 4, and 16 weeks after implant surgery. The degree of movement (vibration) is inversely proportional to the stability of the abutment, and a numerical figure, the implant stability quotient (ISQ), is derived. Patients were fitted with the new Cochlear Bone-Anchored Hearing Aid (BAHA) BI300 series implant using a 1-stage procedure and loaded 4 weeks postoperatively.

RESULTS

Prospectively 68 consecutive patients were recruited with a male to female ratio of 23:45. Nineteen patients had bilateral BAHA devices fitted, giving a total of 88 implants. The average ISQ change (delta) for the cohort gives a value of 0 at time of surgery. The change in ISQ at 1 week was -0.10 (95% confidence interval [CI], 0.74), at 4 weeks was 1.21 (95% CI, 0.59), and at 16 weeks was 1.60 (95% CI, 0.77).

DISCUSSION

Successful early loading of the BAHA sound processor has been achieved. RFA provides a reliable means of assessing stability for loading and measuring implant stability in the longer term. These data support the evidence for early loading at 4 weeks with good clinical safety.

摘要

简介

本研究的目的是通过共振频率分析(RFA)直接测量基台的稳定性,并报告术后 4 周负载时稳定性随时间的变化。

材料与方法

RFA 的原理是获得与稳定性相关的数值。Osstell RFA 记录设备测量磁场中 1cm 商用制造附件(SmartPeg)的共振,该附件拧在骨传导设备基台上。RFA 测量在手术时、植入手术后 1、4 和 16 周进行。运动(振动)程度与基台的稳定性成反比,得出一个数值,即种植体稳定性指数(ISQ)。患者采用 1 期手术植入新的 Cochlear 骨锚式听力植入物(BAHA)BI300 系列,并在术后 4 周负载。

结果

前瞻性地招募了 68 名连续患者,男女比例为 23:45。19 名患者植入双侧 BAHA 设备,共植入 88 个种植体。该队列的平均 ISQ 变化(Delta)值在手术时为 0。第 1 周时 ISQ 的变化为-0.10(95%置信区间[CI],0.74),第 4 周时为 1.21(95%CI,0.59),第 16 周时为 1.60(95%CI,0.77)。

讨论

已成功实现 BAHA 声音处理器的早期加载。RFA 提供了一种可靠的方法来评估加载时的稳定性,并在更长时间内测量种植体的稳定性。这些数据支持在第 4 周进行早期加载并具有良好临床安全性的证据。

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