Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Rehabilitation
Conditions
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.
Interventions
OTHERPhase 1 - semi-structured interviews
Semi-structured face-to-face or virtual interviews.
OTHERPhase 2 - consensus meeting
Face-to-face or virtual meeting(s)
Sponsors
Health Education England, Wessex
University of Nottingham
National Institute for Health Research, United Kingdom
University Hospitals of Derby and Burton NHS Foundation Trust
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants in the Nominal Group Technique Panel | 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. |
| Number of Participants Who Completed Semi-structured Interviews | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Phase 1 - Preoperative Interviews were completed with 18 participants who were at one of three time points on the patient pathway:
1. Pre-anterior cruciate ligament surgery
2. 3-month after anterior cruciate ligament surgery
3. 12-months anterior cruciate ligament surgery
Phase 1 - semi-structured interviews: Semi-structured face-to-face or virtual interviews. | 18 |
| Phase 2 - Nominal Group Technique Panel Consensus meetings were completed with 8 participants (clinicians, patients and stakeholders) to develop the intervention.
Phase 2 - 2 online consensus meeting | 8 |
| Total | 26 |
Baseline characteristics
| Characteristic | Phase 1 - Preoperative | Phase 2 - Nominal Group Technique Panel | Total |
|---|---|---|---|
| Age, Continuous | 29 years | NA years | NA years |
| Race/Ethnicity, Customized British Asian | 1 Participants | NA Participants | NA Participants |
| Race/Ethnicity, Customized Indian | 2 Participants | NA Participants | NA Participants |
| Race/Ethnicity, Customized Pakistani | 1 Participants | NA Participants | NA Participants |
| Race/Ethnicity, Customized White | 14 Participants | NA Participants | NA Participants |
| Sex: Female, Male Female | 3 Participants | NA Participants | NA Participants |
| Sex: Female, Male Male | 15 Participants | NA Participants | NA Participants |
| Time-point on the pathway 12-months postoperative | 2 Participants | NA Participants | NA Participants |
| Time-point on the pathway 3-months post-operative | 6 Participants | NA Participants | NA Participants |
| Time-point on the pathway Preoperative | 10 Participants | NA Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 0 |
| other Total, other adverse events | 0 / 18 | 0 / 0 |
| serious Total, serious adverse events | 0 / 18 | 0 / 0 |
Outcome results
Primary
Number of Participants in the Nominal Group Technique Panel
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.
Time frame: Two online meetings completed, up to 2 hours on 2 days approximately 1-month apart.
Population: All participant data analysed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1 - Preoperative | Number of Participants in the Nominal Group Technique Panel | Patient participants | 0 Participants |
| Phase 1 - Preoperative | Number of Participants in the Nominal Group Technique Panel | Clinician participants | 0 Participants |
| Phase 1 - Preoperative | Number of Participants in the Nominal Group Technique Panel | Therapy manager participant | 0 Participants |
| Phase 2 - Nominal Group Technique Panel | Number of Participants in the Nominal Group Technique Panel | Patient participants | 2 Participants |
| Phase 2 - Nominal Group Technique Panel | Number of Participants in the Nominal Group Technique Panel | Clinician participants | 5 Participants |
| Phase 2 - Nominal Group Technique Panel | Number of Participants in the Nominal Group Technique Panel | Therapy manager participant | 1 Participants |
Primary
Number of Participants Who Completed Semi-structured Interviews
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.
Time frame: Interviews completed within approximately 60 minutes
Population: All participants remained in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1 - Preoperative | Number of Participants Who Completed Semi-structured Interviews | Explore patient experiences of preoperative treatment | 18 Participants |
| Phase 1 - Preoperative | Number of Participants Who Completed Semi-structured Interviews | Explore patient experiences of postoperative treatment | 8 Participants |
| Phase 1 - Preoperative | Number of Participants Who Completed Semi-structured Interviews | Explore views and involvement in prehabilitation | 12 Participants |
| Phase 1 - Preoperative | Number of Participants Who Completed Semi-structured Interviews | Explore sources and consistency of healthcare advice | 18 Participants |
| Phase 2 - Nominal Group Technique Panel | Number of Participants Who Completed Semi-structured Interviews | Explore patient experiences of preoperative treatment | 0 Participants |