The PreOperative Management of Patients Awaiting Anterior Cruciate Ligament Reconstruction
NCT ID: NCT05529511
Last Updated: 2025-04-15
Study Results
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View full resultsBasic Information
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COMPLETED
26 participants
OBSERVATIONAL
2022-08-03
2023-09-04
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
OTHER
Study Groups
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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
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
Phase 2 - consensus meeting
Face-to-face or virtual meeting(s)
Interventions
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Phase 1 - semi-structured interviews
Semi-structured face-to-face or virtual interviews.
Phase 2 - consensus meeting
Face-to-face or virtual meeting(s)
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Health Education England, Wessex
OTHER
University of Nottingham
OTHER
National Institute for Health Research, United Kingdom
OTHER_GOV
University Hospitals of Derby and Burton NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Hayley Carter
Role: PRINCIPAL_INVESTIGATOR
University Hospitals of Derby and Burton NHS Foundation Trust / University of Nottingham
Locations
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Research and Development Department, Medical School, Royal Derby Hospital
Derby, , United Kingdom
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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UHDB/2020/022
Identifier Type: -
Identifier Source: org_study_id
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