The ACL STARR study
About the study
The ACL STARR study wants to find out if acute ACL repair provides superior clinical outcomes at 24 months, and if it is cost effective compared to ACL reconstruction in patients with recent proximal ACL ruptures.
Aim of the study
The primary aim of the study is to establish whether ACL repair provides more benefit than ACL reconstruction in patients with recent proximal ACL ruptures of the knee.
There have been research studies already undertaken which show that both surgeries are safe. However, there are no large-scale studies which directly compare the two types of surgery to help us know whether the injury is best treated with reconstruction or repair surgery. A randomised controlled trial is needed to answer this question. We will compare all the information collected to find out the best treatment to use and we hope our study will provide evidence to better inform treatment options available for patients in the NHS.
Current enrolment curve
Recruitment target: 214
Locations
Information about the Study
Study design
The ACL STARR study is a multi-centre two arm, parallel design, superiority randomised controlled trial.
Treatments
Participants will be randomised to receive ACL repair or ACL reconstruction.
Post-study care
After surgery, all participants will have physiotherapy to help with rehabilitation (as part of routine NHS care).
Outcome measures
The primary outcome measure is the aggregated and averaged score of four of the five sub-scales of KOOS (KOOS-4): pain, symptoms, quality of life, and sport and recreation function, at 24 months post randomisation.
Participant data
The study sample size is 214 patients (107 in each of the two study arms) with acute proximal tears of the ACL. Patients will be identified and recruited following a routine pre-intervention MRI scan which identifies the proximal tear pattern.
Study funders
The study is funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) Programme. The sponsors are Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge.
Chief Investigator, Professor Stephen McDonnell
The Chief Investigator is the overall lead researcher for a clinical trial and is responsible for the overall conduct of the trial. Their responsibilities are set out in more detail in the UK Policy Framework for Health and Social Care Research.
Professor McDonnell is also the Principal Investigator (PI) for the lead research site in Cambridge (Addenbrookes). The PI is responsible for the conduct of the research at a research site. There is usually one PI for each research site.
Professor McDonnell is an academic orthopaedic surgeon within the Department of Surgery at the University of Cambridge and an Honorary Consultant Knee Surgeon at Addenbrookes. His research focuses on knee injuries, early knee osteoarthritis, and the development of personalised treatments and patient stratification using novel imaging techniques, including the Cambridge Knee Injury Toolkit (CamKIT). He has conducted key trials such as the EU ADIPOA2 Study on stem cell therapy for early osteoarthritis and is leading the ACL STARR trial comparing ACL repair with reconstruction.
Clinical Trial Managers
Clinical Trial Managers are responsible for the overall management of clinical trials, from planning and protocol development to execution and reporting. They ensure that trials are conducted in compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines. They also oversee the recruitment and selection of trial participants, ensuring that eligible subjects are enrolled and that their rights and safety are protected throughout the trial.
Nicholas Beale
Clinical Trial Manager
Nicholas is a clinical trial manager within the Nuffield Department of Orthopeadics, Rheumatology and Musculoskeletal Sciences (NDORMS) at the University of Oxford. He is an experienced trial manager and has worked on several multicentre randomised controlled trials whilst at NDORMS, and whilst working previously within the Nuffield Department of Primary Care Health Sciences (University of Oxford), and the Centre for Movement, Occupational and Rehabilitation Sciences (MOReS -Oxford Brookes University).
Jenny O’Callaghan
Clinical Trial Manager
Jenny is a clinical trial manager based in Cambridge with an honorary contract to work within the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS) at the University of Oxford, on the ACL STARR study. Jenny is an experienced clinical research professional, and divides her time between trial management for ACL STARR and clinical research nurse activities for the Department of Trauma and Orthopaedic Surgery at Addenbrooke’s Hospital in Cambridge.