The POP-ACLR Study

Study Overview
=================
Brief Summary
-----------------
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. Secondly, the prehabilitation treatment package will be designed with healthcare professionals, therapy managers and patients.

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

Conditions
-----------------
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Rehabilitation

Intervention / Treatment
-----------------
* Other: Phase 1 - semi-structured interviews
* Other: Phase 2 - consensus meeting


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Phase 1 - Preoperative<br>Interviews to be completed with approximately 12 participants at three time points: Prior to anterior cruciate ligament surgery 3-month after anterior cruciate ligament surgery 12-months anterior cruciate ligament surgery | Other: Phase 1 - semi-structured interviews<br>* Semi-structured face-to-face or virtual interviews.<br>|
| Phase 2 - Nominal Group Technique panel<br>Consensus meeting with up to 12 participants (clinicians, patients and stakeholders) to develop the prehabilitation intervention | Other: Phase 2 - consensus meeting<br>* Face-to-face or virtual meeting(s)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1 - understanding of patients' lived experiences | understanding of patients' lived experiences of the treatment pathway following a diagnosis of an ACL rupture and agreed surgical management. | Interviews completed within approximately 60 minutes | 
| Phase 2 - prehabilitation intervention developed | Prehabilitation intervention developed with clinicians, patients and stakeholders for use with patients awaiting anterior cruciate ligament reconstruction in the National Health Service (NHS) | A single face-to-face meeting lasting up to a full day of 7.5 hours) or in a series of shorter online meetings |