Clinical trial NCT05529511: The PreOperative Management of Patients Awaiting Anterior Cruciate Ligament Reconstruction
Official title: The PreOperative Management of Patients Awaiting Anterior Cruciate Ligament Reconstruction: a Mixed-methods Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anterior Cruciate Ligament Injuries
Anterior Cruciate Ligament Rupture
Rehabilitation
Lead sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Health Education England, Wessex
name: University of Nottingham
name: National Institute for Health Research, United Kingdom
First posted: 2022-09-07
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Phase 1: Patients who have had or who are awaiting an anterior cruciate ligament reconstruction in the NHS

Phase 2: Healthcare professional with a special interest/expertise in treating ACL injuries, therapy manager of an NHS musculoskeletal outpatient therapy department or patient who is awaiting or has had an anterior cruciate ligament reconstruction in the NHS

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Phase 1:

1. ≥ 18-years-old
2. Patient who is awaiting or has previously had an ACLR in the NHS

Phase 2

1. ≥ 18-years-old
2. Participants will be in one of the following categories:

   1. 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)
   2. Therapy manager of an NHS musculoskeletal outpatient therapy department
   3. Patient who is awaiting or has previously had an ACLR in the NHS

Exclusion Criteria:

Phase 1:

1. Concomitant injuries requiring surgical intervention that will significantly alter the postoperative rehabilitation protocol e.g. meniscal repair requiring a non-weight bearing period
2. Previous knee surgery to the affected limb
3. Co-existing injuries requiring surgical intervention impacting on the individual's participation in pre-or post-operative rehabilitation
4. Pregnancy

Phase 2:

(1) Anyone with a recognised conflict of interest

Primary outcomes:
measure: Number of Participants Who Completed Semi-structured Interviews
timeFrame: Interviews completed within approximately 60 minutes
measure: Number of Participants in the Nominal Group Technique Panel
timeFrame: Two online meetings completed, up to 2 hours on 2 days approximately 1-month apart.
Secondary outcomes:
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: Research and Development Department, Medical School, Royal Derby Hospital
Study officials:
affiliation: University Hospitals of Derby and Burton NHS Foundation Trust / University of Nottingham
name: Hayley Carter
role: PRINCIPAL_INVESTIGATOR
References: