The POP-ACLR Study (POP-ACLR)

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

Secondly, the prehabilitation treatment package will be designed with healthcare professionals, therapy managers and patients.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Rupture; Rehabilitation
• Intervention / Treatment: Other: Phase 1 - semi-structured interviews; Other: Phase 2 - consensus meeting

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

• Study Contact: Name: Research and Development Department, Medical School Royal Derby Hospital; Phone Number: 01332724639; Email: uhdb.sponsor@nhs.net

Study Locations

• United Kingdom
  • Derby, United Kingdom, DE22 3DT
    • Research and Development Department, Medical School, Royal Derby Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Phase 1 - Preoperative; 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; Semi-structured face-to-face or virtual interviews.
Phase 2 - Nominal Group Technique panel; Consensus meeting with up to 12 participants (clinicians, patients and stakeholders) to develop the prehabilitation intervention	Other: Phase 2 - consensus meeting; Face-to-face or virtual meeting(s)

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

Collaborators and Investigators

• Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
• Collaborators: University of Nottingham; National Institute for Health Research, United Kingdom; Health Education England

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2022
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): September 4, 2023

Study Registration Dates

• First Submitted: September 2, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Rupture; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: UHDB/2020/022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No