The POP-ACLR Study

Rehabilitation Clinical Trial

— POP-ACLR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05529511
• Other study ID #: UHDB/2020/022
• Status: Completed
• Start date: August 3, 2022
• Est. completion date: September 4, 2023

Study information

• Verified date: October 2023
• Source: University Hospitals of Derby and Burton NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 4, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Rupture
• Rehabilitation
• Rupture

Intervention

Other:
• Phase 1 - semi-structured interviews
Semi-structured face-to-face or virtual interviews.
• Phase 2 - consensus meeting
Face-to-face or virtual meeting(s)

Locations

Country	Name	City	State
United Kingdom	Research and Development Department, Medical School, Royal Derby Hospital	Derby

Sponsors (4)

Lead Sponsor	Collaborator
University Hospitals of Derby and Burton NHS Foundation Trust	Health Education England, National Institute for Health Research, United Kingdom, University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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