The PreOperative Management of Patients Awaiting Anterior Cruciate Ligament Reconstruction

NCT05529511 | Completed Results

• 1 other identifier: UHDB/2020/022
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Rupture; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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.

  Interviews completed within approximately 60 minutes

• 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.

  Two online meetings completed, up to 2 hours on 2 days approximately 1-month apart.

Study Arms (2)

Phase 1 - Preoperative

Interviews to be completed with approximately 12 participants at three time points: 1. Prior to anterior cruciate ligament surgery 2. 3-month after anterior cruciate ligament surgery 3. 12-months anterior cruciate ligament surgery

Other: Phase 1 - semi-structured 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

Interventions

Phase 1 - semi-structured interviews OTHER

Semi-structured face-to-face or virtual interviews.

Phase 1 - Preoperative

Phase 2 - consensus meeting OTHER

Face-to-face or virtual meeting(s)

Phase 2 - Nominal Group Technique panel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals of Derby and Burton NHS Foundation Trust: lead
• Health Education England, Wessex: collaborator
• University of Nottingham: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Research and Development Department, Medical School, Royal Derby Hospital

Derby, DE22 3DT, United Kingdom

Location

Related Publications (2)

• Carter HM, Beard DJ, Leighton P, Moffatt F, Smith BE, Webster KE, Logan P. 'Going through the motions'; a rich account of the complexity of the anterior cruciate ligament reconstruction pathway, a UK qualitative study. BMJ Open. 2024 Sep 17;14(9):e079468. doi: 10.1136/bmjopen-2023-079468.

  PMID: 39289010 DERIVED

• Carter H, Beard D, Leighton P, Moffatt F, Smith BE, Webster KE, Logan P. Development of an intervention for patients following an anterior cruciate ligament rupture: an online nominal group technique consensus study. BMJ Open. 2024 Jul 18;14(7):e082387. doi: 10.1136/bmjopen-2023-082387.

  PMID: 39025812 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Results Point of Contact

• Title: Hayley Carter
• Organization: University Hospitals of Derby and Burton NHS Foundation Trust

hayley.carter1@nhs.net

01332254631

Study Officials

• Hayley Carter

  University Hospitals of Derby and Burton NHS Foundation Trust / University of Nottingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 7, 2022
• Study Start: August 3, 2022
• Primary Completion: August 30, 2023
• Study Completion: September 4, 2023
• Last Updated: April 15, 2025
• Results First Posted: April 15, 2025

Record last verified: 2025-04

Locations

GB (1)