The PreOperative Management of Patients Awaiting Anterior Cruciate Ligament Reconstruction

NCT ID: NCT05529511

Last Updated: 2025-04-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-03

Study Completion Date

2023-09-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anterior Cruciate Ligament Injuries Anterior Cruciate Ligament Rupture Rehabilitation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Intervention Type OTHER

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

Intervention Type OTHER

Face-to-face or virtual meeting(s)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Phase 1 - semi-structured interviews

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

Intervention Type OTHER

Phase 2 - consensus meeting

Face-to-face or virtual meeting(s)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Health Education England, Wessex

OTHER

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

University Hospitals of Derby and Burton NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hayley Carter

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research and Development Department, Medical School, Royal Derby Hospital

Derby, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39289010 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39025812 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UHDB/2020/022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.