The ACL Repair vs Reconstruction Study (ACL STARR)
| ISRCTN | ISRCTN24078391 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24078391 |
| IRAS number | 317530 |
| Secondary identifying numbers | CPMS 53259, NIHR157938 |
- Submission date
- 24/01/2025
- Registration date
- 30/01/2025
- Last edited
- 30/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
The knee is the most injured joint. The Anterior Cruciate Ligament (ACL) is an important band of tissue that supports the knee. It is a strong structure in the centre of the knee which attaches the femur (thigh bone) to the tibia (shin bone). It is often injured during manual work or sports. Injury to the ACL can lead to the knee becoming unstable, giving way and a loss of confidence. An unstable knee can cause damage to other parts of the knee such as the cartilage or meniscus (shock absorbers), which can lead to osteoarthritis (OA) developing in later life.
There are different surgical options for people with an ACL injury. The most common is reconstruction, which uses tissue from other parts of the body, such as the hamstrings, to act as a replacement. This is a successful operation but does involve damage to bones from drilling holes, removal of tissue from elsewhere in the body, and does not keep any of the torn ligament which has potentially useful nerve endings. An alternative approach is to reattach the original ligament back from where it has torn in a “repair” rather than reconstruction. By preserving the ligament, avoiding tissue harvest and drilling smaller holes in the bone, ACL repair could provide faster recovery, better medium to long term stability, and might reduce likelihood of OA in the future. Older versions of ACL repair techniques have not worked well enough, but newer techniques are available, and this may now make repair a viable option.
Modern ACL repair (stitching) is relatively new and, despite clear potential, has not been fully evaluated. It remains unknown whether it confers any of the theoretical benefits. We aim to conduct a comparative study to find out which is the best technique, reconstructing the ligament or repairing it. The research question is: For patients with recent proximal ACL ruptures (where the ligament has pulled directly off the bone), is ACL repair superior to ACL reconstruction at 24 months post-surgery? This will be measured by a questionnaire relating to the knee called KOOS-4.
A special type of study called a randomised controlled trial is needed to answer this question. This involves assigning participants to different treatments using a process called randomisation so the effects of each treatment can be compared fairly.
Who can participate?
People who have injured their ACL, who may be suitable for either operation, will be invited to join the study.
What does the study involve?
Participants will be randomly allocated to one of the two types of ACL surgery.
ACL REPAIR: this group will have surgery to repair the ACL, with the ligament being stitched back onto the bone.
ACL RECONSTRUCTION: this group will have surgery to reconstruct the ACL. This will involve replacing the torn ACL with other tissue from their body to act as a replacement.
Participants will be asked to complete a pain score at 3 and 6 weeks after surgery. Then they will be asked to complete questionnaires relating to their knee at 6-, 12- and 24-months post-surgery. Participants will be able to complete questionnaires electronically or on paper according to their preference.
What are the possible benefits and risks of participating?
We do not know whether one of these operations will be better for patients than the other. We hope that by comparing them, we will gather evidence to show which surgical option is better.
Both surgical procedures are designed to help reduce the symptoms people experience.
There are risks associated with both ACL repair and reconstruction surgery, such as re-rupture or graft failure.
Other risks associated with these surgeries include pain, infections, tendon, ligament or nerve damage, scars, blood clots and swelling. These are the same risks for patients who do not take part in the study and decide to have ACL surgery. The risks will be discussed in detail with participants by the clinical teams looking after them in hospital.
Where is the study run from?
Cambridge University Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
May 2024 to Dec 2029
Who is funding the study?
NIHR Health Technology Assessment Programme (UK)
Who is the main contact?
1. Associate Professor Stephen McDonnell: sm2089@cam.ac.uk
2. Jenny O’Callaghan/ Nick Beale: acl_starr@ndorms.ox.ac.uk
Contact information
Public
Department of Trauma and Orthopaedics, Box 180, Cambridge University Hospitals, Hills Road
Cambridge
CB2 0QQ
United Kingdom
| Phone | +44 1223 768010 |
|---|---|
| jennifer.ocallaghan@nihr.ac.uk |
Public
Botnar Research Centre Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Nuffield Orthopaedic Centre, Windmill Road, Headington
Oxford
OX3 7HE
United Kingdom
| Phone | +44 1865 613756 |
|---|---|
| Nicholas.beale@ndorms.ox.ac.uk |
Scientific, Principal Investigator
Department of Trauma and Orthopaedics, Box 180, Cambridge University Hospitals, Hills Road
Cambridge
CB2 0QQ
United Kingdom
 ORCID ID |
0000-0002-3181-4192 |
|---|---|
| Phone | +44 1223 767977 |
| sm2089@cam.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | To follow |
| Scientific title | Anterior Cruciate Ligament Stratified Accelerated Repair or Reconstruction Single blind randomised controlled trial for patients with proximal ACL injuries treatment with ACL repair v ACL reconstruction (ACL STARR) |
| Study acronym | ACLSTARR-UK |
| Study hypothesis | In patients with recent proximal ACL ruptures, ACL repair is superior to ACL reconstruction at 24 months post intervention |
| Ethics approval(s) |
Approved 28/01/2025, East of England- Cambridge South Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8084; cambridgesouth.rec@hra.nhs.uk), ref: 25/EE/0016 |
| Condition | Anterior cruciate ligament injuries |
| Intervention | The ACL STARR study is a randomised controlled trial. Participants will be allocated to either repair or reconstruction surgery at random using a computer. This will enable us to find out which treatment is best by making a fair comparison. A two-way superiority design has been chosen, which means that we can show if one treatment method is better than the other for this patient group. If ACL repair is better than ACL reconstruction, it provides evidence to enable its wider use in clinical practice. If reconstruction is better than ACL repair, then ACL repair should not be used except in specific circumstances. This will improve treatment for patients for whom there is currently uncertainty and variable practice. The study sample size is 214 participants (107 in each group) with acute proximal tears of the ACL (a complete tear of the ACL where the ligament has pulled off the bone). Participants will be identified and recruited following a routine MRI scan which identifies the tear pattern. Potential participants must have undergone shared treatment decision-making discussions with their clinical team and have decided on having surgery over non-surgical treatment (physiotherapy) for their ACL injury. BASK has categorised ACL repair as a ‘priority 2 procedure’, meaning that ideally, surgery should be performed within 4 weeks. This trial specifies that surgery (for both repair and reconstruction) is undertaken no more than 50 days post-injury. This timeframe means that repair surgery is more likely to be successful, while keeping in mind the current pressures on NHS waiting lists. For those participants who consent to take part, we will collect baseline information including demographic data and baseline questionnaires relating to their knee and mental wellbeing. Randomisation will be performed during surgery after the surgeon has assessed the ligament. Participants will be randomised to have either ACL repair or ACL reconstruction. We anticipate 25% of those who consent will be deemed unsuitable for repair during surgery. These participants will have reconstruction surgery and will not continue in the trial. Participants will be recruited from approximately 20 sites in the UK. Both our adult and young people PPI groups felt that as long as both surgeries were safe, randomisation in theatre would be acceptable. Following surgery, all participants will be referred and undergo physiotherapy with a senior physiotherapist with experience of ACL injuries, which follows the routine care treatment pathway. Post-operative pain scores will be collected at 3 and 6 weeks, and questionnaires relating to the knee and participant wellbeing will be collected at 6, 12, and 24 months post-surgery with the primary outcome of KOOS-4 (knee function questionnaire) at 24 months. Our PPI groups helped us choose our questionnaires, based on the outcomes which are most important to them (post-operative pain, mental wellbeing, and return to work and sport). They feel that our outcomes are reasonable and would be happy to complete the series of questionnaires at home, particularly as they wouldn’t want extra clinic visits following discharge from physiotherapy. We have embedded an internal pilot into the study, which will take place in 9 UK sites over a period of 10 months. The overall patient recruitment target for this internal pilot phase will be 28 randomised patients. Stop-go criteria will be reviewed after 10 months of recruitment. We also plan longer-term follow-up at 5 years post-randomisation, from registry data, if additional funding is obtained. A mirror study funded by the NHMRC (conducted to the same core protocol) will be undertaken in Australia coordinated within the NHMRC Clinical Trials Centre (CTC), Sydney. This will be conducted and reported separately from ACL STARR, with a view to combining de-identified data for a meta-analysis, subject to additional funding. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Knee Injury and Osteoarthritis Outcome Score (KOOS-4) questionnaire at baseline and 24 months post surgery |
| Secondary outcome measures | 1. KOOS score is measured using KOOS 5 Questionnaire at 6, 12, and 24 months after randomisation 2. Resource use data is measured using Health Economics Questionnaire and EQ-5DL & -VAS Questionnaire at 6, 12, and 24 months after randomisation 3. Emotional functioning is measured using Emotional Functioning Questionnaire at baseline, 6, 12, and 24 months after randomisation 4. Surgeon confidence is measured using Surgery Case Report Form on the day of surgery 5. Post-operative pain score is measured using Pain NRS at 3 and 6 weeks after randomisation 6. Time to return to sport is measured using Modified Tegner Questionnaire and Tegner Questionnaire at baseline, 6, 12, and 24 months after randomisation 7. Patient satisfaction is measured using Patient Satisfaction Questionnaire at 12 and 24 months after randomisation 8. Intervention-related complications are measured using Health Economics Questionnaire and Case Report Form at 6, 12, and 24 months after randomisation 9. Objective evidence of graft/repair failure is measured using Case Report Form up to 24 months after randomisation |
| Overall study start date | 01/05/2024 |
| Overall study end date | 31/12/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 14 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 286; UK Sample Size: 286 |
| Participant inclusion criteria | 1. Patients aged 14 years and above 2. Willing & able to provide informed consent and comply with study procedures 3. Proximal ACL tear pattern suitable for both repair or reconstruction 4. Willing to accept either study arm allocation |
| Participant exclusion criteria | 1. History of major knee surgery: Have had previous knee surgery (other than diagnostic arthroscopy or partial meniscectomy) to the index knee 2. Concomitant severe injury to the contra-lateral knee 3. High grade multi ligament injury: High grade injuries to other ligaments (i.e. medial collateral, lateral collateral, posterior cruciate) in the knee (Grade > 2) |
| Recruitment start date | 01/03/2025 |
| Recruitment end date | 30/06/2027 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Sheffield
S10 2TH
United Kingdom
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Headington
Oxford
OX3 7LD
United Kingdom
Fallside Road
Bothwell
Glasgow
G71 8BB
United Kingdom
80 Newark Street
London
E1 2ES
United Kingdom
Rake Lane
North Shields
NE29 8NH
United Kingdom
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Dudley Road
Birmingham
B18 7QH
United Kingdom
Wrexham
LL13 7TD
United Kingdom
Shrewsbury
SY3 8XQ
United Kingdom
London
SE5 9RS
United Kingdom
Charles Hastings Way
Worcester
WR5 1DD
United Kingdom
Dalmellington Road
Ayr
KA6 6AB
United Kingdom
Herries Road
Sheffield
S5 7AU
United Kingdom
Sponsor information
Hospital/treatment centre
Cambridge Biomedical Campus, Hills Road
CambrIdge
CB2 0QQ
England
United Kingdom
| Phone | +44 1223 217418 |
|---|---|
| cuh.research@nhs.net | |
| Website | http://www.cuh.org.uk/ |
"ROR" |
https://ror.org/04v54gj93 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2030 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The findings will be published in a high impact peer-reviewed journal and will be disseminated across the surgical community, the wider medical community and NICE. Study papers will be published in high impact factor journals and will be made available under open access so that high visibility of the work will be maintained as per the NIHR policy. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Editorial Notes
24/01/2025: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
