Anterior Cruciate Ligament Accelerated Repair or Reconstruction
Looking at whether ACL repair provides more benefit than ACL reconstruction in patients with recent proximal ACL ruptures of the knee
Eligibility
Local study conflicts
Cannot be co-enrolled to any other study which is looking at lower limb outcomes
Inclusion Criteria:
Patients aged 14 years and above
Willing & able to provide informed consent and comply with study procedures
Proximal ACL tear pattern diagnosed by MRI suitable for both repair or reconstruction*
Willing to accept either study arm allocation
*A proximal tear will be diagnosed on review of the MRI scan, and eligibility will be confirmed intra-operatively on arthroscopic inspection, to confirm a Sherman Type 1 or Type 2 tear and acceptable tissue quality for repair (i.e. an intact synovial sheath surrounding the torn ACL as a single unit).
Exclusion Criteria:
History of major knee surgery
Has had previous knee surgery (other than diagnostic arthroscopy or partial meniscectomy) to the index knee
Concomitant severe injury to the contra-lateral knee
High grade multi ligament injury
High grade injuries to other ligaments (i.e. medial collateral, lateral collateral,
posterior cruciate) in the knee (Grade >2)
Other considerations
Surgery for both repair or reconstruction must take place within 50 days of injury
If the patient is eligible:
Inform the patient that they may be eligible for a research study
Gain verbal agreement in principle before proceeding. Explain:
Taking part in research is likely to improve the quality of their care
Risks are carefully controlled - research is safe
Explain the uncertainty that exists with respect to treatment of their condition
If they change their mind they can withdraw their participation at any point
Step-by-Step Guide to Recruitment:
In standard working hours
The research nurse team aims to be available Monday to Friday 08.00 - 16.00.
Contact them via Secure Chat: Research Delivery Team
Eligibility confirmation
Eligibility can only be confirmed by delegated personnel (including research nurses).
Mr Stephen McDonnell, consultant orthopaedic / trauma surgeon, is the PI and will know which members of staff are delegated on this study.
Gaining formal consent
Patients identified via Virtual Fracture Clinic or trauma list
Research Nurse team will check if MRI has been requested as standard of care and will follow up with clinical teams if necessary to facilitate
If eligible on MRI, clinical team to have initial conversation with the patient during their routine initial OPA and ask if they would like to hear more details about the study. Research Nurse will see the patient at the same appointment and give PIS.
If patient is willing to participate at this appointment, then research nurse team will complete consent and baseline assessments. If the patient would like more time to consider, consent and baseline can be completed remotely at a later date.
Clinical team will book surgery for ACL Starr.
Randomisation procedure
Research Nurse team will attend theatre and randomise intra-operatively when instructed by the operating surgeon.
Carrying out the intervention:
Operating surgeon must be on the delegation log for the study.
Operation note should not reveal allocated treatment.
Disposition and follow-up:
Follow up questionnaires will be completed with the patient by the central team.
Physiotherapy and any follow up clinic appointments to be arranged as standard care but patient and physio are blinded to treatment allocation
