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临床试验/NCT03054753
NCT03054753已完成不适用

Prospective Sensor Controlled Compliance Analysis of Shoulder Abduction Splint After Rotator Cuff Repair

Balgrist University Hospital2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2017年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
2
主要终点
Objective abduction brace wearing time

研究概览

简要总结

The postoperative shoulder rehabilitation in an abduction brace after rotator cuff reconstruction of the shoulder is crucial for a successful healing of the reconstruction.

In this study the investigators want to analyse the abduction brace-wearing time using a electronic sensor, which is implanted in the abduction brace. The participants will be informed about the sensor after completion of the abduction brace rehabilitation 6 weeks postoperatively.

详细描述

After arthroscopic reconstruction of a rotator cuff tear the healing depends on a tension free positioning of the reconstructed tendon. Therefore a abduction brace is administered routinely for 6 weeks. The re-rupture rate of rotator cuff reconstruction is about 30%. One of the reason may be mechanical overuse caused by non wearing of the abduction brace. From experience the investigators suggest that the abduction brace wearing behaviour differs among patients. The participant´s wearing compliance has been evaluated by Silverio et al. with a questionary but never with a sensor. In this study the investigators want to analyse the participant´s abduction brace wearing compliance by using an sensor, which is implanted in the abduction brace and monitors the wearing time, which reveals the objective wearing time.

The sensor is a certificated sensor, which measures temperature in °C every 15 min. If the abduction brace is worn by the participants the body temperature can be captured by the sensor. If the measured temperature is over 33°C the sensor capture the time period as a "worn" time. With this measurements the abduction brace wear time should be captured objectively. A similar kind of sensors were used to evaluate the wearing time of scoliosis-braces in patients with adolescent idiopathic scoliosis (Miller DJ eta al., Morton A et al., Takemitsu et al.) With a questionary the participants are asked of the wearing time before they will be informed about the implanted sensor. This answer represents the subjective wearing time.

The first endpoint of the study is the evaluation of the objective and subjective abduction wearing time. The second endpoint is the evaluation of the correlation between compliance and subjective outcome.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with rotator cuff repair and postoperative abduction for 6 weeks

排除标准

  • Revision surgery

结局指标

主要结局

Objective abduction brace wearing time

时间窗: 6 weeks postoperative

A sensor is implanted in the abduction brace, which captures every 15min. the temperature. If the abduction brace is worn the sensor can measure the body temperature. The objective wearing time can be evaluated.

次要结局

  • Correlation of compliance and patient satisfaction(3 months postoperative)
  • Correlation of compliance and subjective outcome(3 months postoperative)
  • Correlation of compliance and functional outcome(1 year postoperative)

研究者

发起方
Balgrist University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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