Title: The PreOperative Management of Patients Awaiting Anterior Cruciate Ligament Reconstruction (The POP-ACLR Study).
Funder: Health Education England

Abstract: BackgroundAnterior cruciate ligament (ACL) ruptures are common, annual incidence rates are estimated at 68.6 per 100,000 person-years in the general population. Surgery is considered standard treatment for this problem. Physiotherapy is recommended before surgery (prehabilitation), but currently isn't offered to all patients and when it is, it varies and is sub-optimal. Developing an intervention for use prior to surgery could improve patient outcomes. AimTo develop a prehabilitation intervention for use with patients awaiting ACL surgery and understand its acceptability and tolerability among patients and clinicians. The evidence of effect in clinical practice will also be explored.Objectives To understand patients' lived experiences of the treatment pathway following a diagnosis of an ACL rupture and agreed surgical management (phase 1) To work with patients and stakeholders to develop a novel prehabilitation intervention (phase 2) To understand feasibility, acceptability and tolerability of the prehabilitation intervention with respect to participants and clinicians in an NHS setting (phase 3)Methods/TimelineThe project will involve three phases. Phase 1: Individual qualitative interviews will be completed with approximately 36 participants (purposively sampled for variation in personal characteristics, physical activity and prehabilitation completion) at three time points (1) 12 participants up to 2 weeks before surgery, (2) 12 participants 3 months after surgery, (3) 12 participants 12 months after surgery. Interview transcripts will be analysed thematically.Phase 2a: A consensus exercise will take place involving 6-12 physiotherapists, occupational therapists, surgeons, physiotherapy managers and patient representatives to discuss and agree the key components of the prehabilitation intervention. This exercise will use the Nominal Group Technique, a method involving idea generation, idea ranking, discussions regarding the rankings then re-ranking to form a consensus. The components of the intervention will then be developed.Phase 2b: The intervention will be refined, drawing upon the normalisation process theory, and programme theory, with logic models being developed.Phase 3: The intervention will be introduced to surgeons, physiotherapists and patients and trialled in clinical practice with 20 participants. Individual interviews will be carried out with a subsample of participants and clinicians at the end of the trial period. The finalised outcome measures to be used will be determined following phase 2 but will include sociodemographic and clinical data in addition to a mechanism of impact outcome(s) such as a quality-of-life measure (e.g. ACL quality of life questionnaire). Descriptive and statistical analysis will be used to analyse clinical data. Individual interviews will be analysed thematically.Anticipated ImpactThe outputs of this research will contribute to improving the quality, accessibility and consistency of the preoperative care provided to patients awaiting ACL surgery. The findings will contribute to the development of a protocol for a randomised controlled trial which has the potential to improve the efficiency and cost-effectiveness of ACL rehabilitation.DisseminationThe study outputs will be shared through: Publication in peer-reviewed journals Presentations at orthopaedic/physiotherapy conferences A newsletter for participants/public contributors Social media (Twitter: @h_carter43 and trial account) and trial website

Lay abstract: BackgroundThe 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). Anterior cruciate ligament injuries often cause patients pain and difficulties with walking and knee movement, strength and stability. Surgery is currently standard treatment for this injury and helps patients return to 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. AimThe aim of this research is to develop a prehabilitation treatment package for patients waiting for anterior cruciate ligament surgery. The prehabilitation treatment package will also be tested with patients and healthcare professionals. MethodsThis project will be completed in three phases. Phase 1: I will interview 36 participants (who will be chosen to ensure variation in age, sex and physical activity participation) 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. Phase 2a: I will design the prehabilitation treatment package with physiotherapists, occupational therapists, surgeons, physiotherapy managers and patients.Phase 2b: I will refine the prehabilitation treatment package using results from phase 1 and phase 2a. This will be described, using diagrams, to help show how it will work in clinical practice and affect patient outcomes (e.g. quality of life). Phase 3: The prehabilitation treatment package will be trialled in practice for 3 months on 20 patients. At the end of the 3 months patients, physiotherapists and surgeons who have used the prehabilitation treatment package will be interviewed. This will help me to understand how patients and healthcare professionals found using the prehabilitation treatment package and how it could be improved. Patient and Public Involvement A group of patients who are awaiting or who have had anterior cruciate ligament surgery have helped design this project. They consider the research question to be relevant and important. They will be involved throughout the research to help design the prehabilitation treatment package, manage the study, look at, make sense of and share the results. Sharing the FindingsI will share this research through: Publication in medical journals Presentation at medical and physiotherapy conferences Summaries for participants and public contributors in the form of a newsletter every 6 months Social media (Twitter: @h_carter43 and trial account) and trial websiteThe findings will also contribute to future research which will have a national impact on patient care.

Research activity codes: 6.4 SURGERY;6.7 PHYSICAL
Health categories: MUSCULOSKELETAL;INJURIES AND ACCIDENTS