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临床试验/NCT05614908
NCT05614908Enrolling By Invitation不适用

Patient-reported Outcomes After Non-operative Treatment of Acute Achilles Tendon Rupture: a Prospective Cohort Study.

Aarhus University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
100
试验地点
1
主要终点
Self-reported ATRS score at 12 months after injury

研究概览

简要总结

The main purpose of the study is to investigate self-reported functional ability of patients undergoing conservatively treated achilles tendon rupture at 6, 12 and 24 months from the date of injury.

详细描述

Background:

The achilles tendon is the most injured tendon in the lower extremity. An achilles tendon rupture (ATR) is treated either surgically or non-surgically. Previous studies have investigated early controlled motion and weight-bearing for non-surgically treated ATR. Early motion may cause tendon elongation, which leads to decrease in push off strength, and thus potentially a poorer functional outcome. Conversely, delayed initiation of mobilisation and weight-bearing may similarly hinder or delay optimal recovery of function and return to work and sports. The correct treatment and rehabilitation, including the timing of rehabilitation initiation, may therefore be crucial to ensure the patients' functional ability.

Most hospitals in Denmark treating patients with ATR, provide a regime of 8 weeks immobilization for conservatively treated patients with ATR. At Aarhus University Hospital (AUH), however, a more restrictive regime is provided for these patients, requiring immobilization for 11 weeks after injury. Typically, a late initiation of mobilization is defined as mobilization beginning in week 8, i.e. 3 weeks sooner than the standard regime at AUH. Furthermore, many "late" mobilization regimes allows for some non-weightbearing exercises prior to week 8, but at AUH patients are recommended to limit any movement during the first 11 weeks after injury. This is primarily to reduce the risk of a re-rupture, the rate of which is lower at AUH than on a national level (i.e. <5% versus 7-8% re-rupture rate). However, this delayed onset of mobilization and weight-bearing may have a negative effect on return to normal function, sports and work.

Since 2012, a number of Danish hospitals, treating patients with ATR, have reported re-rupture rates, and self-reported functional ability and working status, etc. is reported at 6, 12 and 24 months. This data are published in a report, enabling comparison with other populations. At present, AUH does not report these data into to the database, and the data published in the early report may therefore serve as comparison group in this quality assurance study.

Purpose: The aim of this quality assurance study is therefore to investigate to what extent the stricter regime at AUH following conservatively treated ATR affects the patients' functional ability after 6, 12 and 24 months after injury, compared to patients treated at other Danish hospitals with less strict regimes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patients with an acute achilles tendon rupture treated conservatively at AUH
  • 18 years or older

排除标准

  • Patients who have not followed the regime at AUH (e.g. terminated use of the ROM- walker prematurely or similar).

结局指标

主要结局

Self-reported ATRS score at 12 months after injury

时间窗: 12 months post-injury

Achilles tendon Total Rupture Score (ATRS) is a self-reported questionnaire with 10 items, summing up to a score of 0-100 points, with 100 points reflecting no disability. The primary outcome will be ATRS score at 12 months, but data will also be collected at 6 and 24 months to describe any changes over time.

次要结局

  • Percentage of participants with re-rupture at 12 months(12 months post-injury)
  • Percentage of participants who have returned to previous working status at 12 months(12 months post-injury)
  • Extend of participants who have returned to sports activities at 24 months(24 months post-injury)

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mette Frank Fenger

Principal Investigator

Aarhus University Hospital

研究点 (1)

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