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临床试验/NCT05529511
NCT05529511已完成不适用

The PreOperative Management of Patients Awaiting Anterior Cruciate Ligament Reconstruction: a Mixed-methods Study

University Hospitals of Derby and Burton NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2022年8月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
Number of Participants Who Completed Semi-structured Interviews

研究概览

简要总结

Patient experiences of the NHS ACL treatment pathway are unknown.

This study aims to explore patient experiences of anterior cruciate ligament ruptures at three different time points on the patient pathway: (1) 12 participants up to 2 weeks before surgery, (2) 12 participants 3 months after surgery, (3) 12 participants 12 months after surgery.

详细描述

The anterior cruciate ligament is one of four key ligaments in the knee. It is the most commonly injured knee ligament with an estimated 200,000 injuries occurring each year in the US (UK data unavailable). Surgery is currently standard treatment for this injury and helps patients return to work and their preinjury activity levels (such as running, playing football or netball). Patients expect surgery to be successful. However, the number of patients who are able to return to their normal activities is low, with only 24% returning at 1 year after surgery. Research has shown that after surgery, patients lack confidence, feel fearful about reinjuring their knee and need to continue to seek advice from healthcare professionals.

Receiving physiotherapy before surgery (called 'prehabilitation') is recommended by researchers and physiotherapists to help patients prepare for surgery and postoperative rehabilitation. Although physiotherapy is recommended, some patients don't receive any treatment before their operation, but it is not known why this might be. There are also no guidelines for the treatment patients receive and current treatment varies.

If an intervention to be delivered to patients prior to anterior cruciate ligament surgery (prehabilitation treatment package) is developed, patient care may be improved. Patient outcomes could also be improved resulting in more patients returning to physical activity after surgery.

This study will firstly, interview participants at three different time points along the patient pathway (1) 12 participants up to 2 weeks before surgery, (2) 12 participants 3 months after surgery, (3) 12 participants 12 months after surgery.

The interviews will allow participants to tell the story of their experiences from the point of receiving their injury diagnosis to returning to physical activity and what they expect from their surgery.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

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-old
  • Patient who is awaiting or has previously had an ACLR in the NHS
  • ≥ 18-years-old
  • Participants will be in one of the following categories:
  • Healthcare professional in the NHS with a special interest/expertise in treating ACL injuries (must have treated a patient prior to or post ACLR within the last 2 years)
  • Therapy manager of an NHS musculoskeletal outpatient therapy department
  • Patient who is awaiting or has previously had an ACLR in the NHS

排除标准

  • Concomitant injuries requiring surgical intervention that will significantly alter the postoperative rehabilitation protocol e.g. meniscal repair requiring a non-weight bearing period
  • Previous knee surgery to the affected limb
  • Co-existing injuries requiring surgical intervention impacting on the individual's participation in pre-or post-operative rehabilitation
  • (1) Anyone with a recognised conflict of interest

结局指标

主要结局

Number of Participants Who Completed Semi-structured Interviews

时间窗: Interviews completed within approximately 60 minutes

Understanding of patients' lived experiences of the treatment pathway following a diagnosis of an ACL rupture and agreed surgical management. Qualitative data collected from individual semi-structured interviews.

Number of Participants in the Nominal Group Technique Panel

时间窗: Two online meetings completed, up to 2 hours on 2 days approximately 1-month apart.

Intervention developed with clinicians, patients and stakeholders for use with patients awaiting anterior cruciate ligament reconstruction in the National Health Service (NHS). Consensus was determined through voting set at an 70% threshold.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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