Anterior Cruciate Ligament InjuriesPOP-ACLRNCT05529511
The PreOperative Management of Patients Awaiting Anterior Cruciate Ligament Reconstruction
An observational study of Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Rehabilitation
- What is being tested?
- Phase 1 - semi-structured interviews and Phase 2 - consensus meeting
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Aug 2022to 4 Sep 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- 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:
- Anyone with a recognised conflict of interest
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Research and Development Department, Medical School, Royal Derby Hospital
Derby, DE22 3DT
About this study
Official title: The PreOperative Management of Patients Awaiting Anterior Cruciate Ligament Reconstruction: a Mixed-methods Study
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.
Read the 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.
- Being tested
- Phase 1 - semi-structured interviews, Phase 2 - consensus meeting
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase 1 - semi-structured interviewsOther
Semi-structured face-to-face or virtual interviews.
Phase 2 - consensus meetingOther
Face-to-face or virtual meeting(s)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Phase 2 - consensus meeting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Two online meetings completed, up to 2 hours on 2 days approximately 1-month apart.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start3 Aug 2022
- Primary completion30 Aug 2023
- Study completion4 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Health Education England, Wessex, University of Nottingham, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Hayley Carter, Principal investigator, University Hospitals of Derby and Burton NHS Foundation Trust / University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529511
- Sponsor's protocol ID
- UHDB/2020/022
- Acronym
- POP-ACLR
- Status last verified
- Apr 2025
- First submitted
- 2 Sep 2022
- Last updated
- 15 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39289010Carter 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.
PubMed 39025812
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PreOperative Management of Patients Awaiting Anterior Cruciate Ligament Reconstruction: a Mixed-methods Study
- ClinicalTrials.gov ID
- NCT05529511
- Acronym / sponsor ID
- POP-ACLR / UHDB/2020/022
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Health Education England, Wessex, University of Nottingham, National Institute for Health Research, United Kingdom
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 4 Sep 2023 (actual)
- First posted
- 7 Sep 2022 (actual)
- Results
- Posted 15 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 - Preoperative | – | Other: Phase 1 - semi-structured interviewsInterviews 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 2 - Nominal Group Technique panel | – | Other: Phase 2 - consensus meetingConsensus meeting with up to 12 participants (clinicians, patients and stakeholders) to develop the prehabilitation intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (9 listed)
- ≥ 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:
Key exclusion criteria (7 listed)
- 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
- Anyone with a recognised conflict of interest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phase 1 - semi-structured interviewsSemi-structured face-to-face or virtual interviews. | Other | Phase 1 - Preoperative |
| Phase 2 - consensus meetingFace-to-face or virtual meeting(s) | Other | Phase 2 - Nominal Group Technique panel |
Primary outcome
Number of Participants Who Completed Semi-structured Interviews
Time frame: 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.
Number of Participants in the Nominal Group Technique Panel
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39289010Carter 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.
- Derived from this study: PubMed 39025812Carter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hayley Carter principal investigator
University Hospitals of Derby and Burton NHS Foundation Trust / University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Completed Semi-structured Interviews (time frame: Interviews completed within approximately 60 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05529511, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.