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OpenTrials
Completed

NCT Number: NCT05529511

The PreOperative Management of Patients Awaiting Anterior Cruciate Ligament Reconstruction

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research and Development Department, Medical School, Royal Derby Hospital

Derby, DE22 3DT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Phase 1:

  • ≥ 18-years-old
  • Patient who is awaiting or has previously had an ACLR in the NHS

Phase 2

  • ≥ 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

Exclusion criteria

Phase 1:

  • 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
  • Pregnancy

Phase 2:

(1) Anyone with a recognised conflict of interest

Treatment and study plan

Phase 1 - semi-structured interviews

Other

Semi-structured face-to-face or virtual interviews.

Phase 2 - consensus meeting

Other

Face-to-face or virtual meeting(s)

Primary outcomes

  1. Number of Participants Who Completed Semi-structured Interviews

    Time frame: 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.

  2. Number of Participants in the Nominal Group Technique Panel

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospitals of Derby and Burton NHS Foundation Trust

Other

Collaborators

  • Health Education England, Wessex
  • National Institute for Health Research, United Kingdom
  • University of Nottingham

Registry information

Official study title

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

Acronym: POP-ACLR

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 7, 2022
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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