None listed
Conditions
Brief summary
A functioning intact anterior cruciate ligament (ACL) is important as it stabilizes movement of the tibia in relation to the femur, providing the stability required to participate in sporting activities. It is often injured leading to rupture resulting in knee instability and primary repair of the ligament is usually unsuccessful. Surgeons have be reconstructing the ACL since 1930 and technique has been continuously refined. Even after surgical reconstruction, a small percentage of patients continue to experience knee instability, especially rotatory instability. Recently a scientific paper identified an additional ligament called the anterolateral ligament (ALL). The ALL has been bio-mechanically examined and plays an important role in stabilizing the knee in the rotational axis. Patients will be invited to participate in the study if they are undergoing ACL reconstruction surgery. Prior to the surgery commencing, after they have had a general anesthetic, they will have their pivot shift assessed on the operating table. If the pivot shift is grade 3 (as described by Macintosh - tibia persistently subluxing anteriorly on the femur even with external rotation) then they will be randomised to ACL only or ACL and ALL reconstruction. In this study patients will undergo standard arthroscopic ACL reconstruction using a hamstring graft and be randomized to have their ALL reconstructed using a hamstring graft. The group that the patients are allocated to will be concealed from them, the additional ALL reconstruction requires only one, very small additional incision. Those not undergoing ALL reconstruction will not undergo any form of sham ALL reconstruction. The patients knee function will be assessed pre-operatively and post-operatively, using subjective patient reported scores and objectively assessed using range of motion. They will be followed up at two weeks, six weeks, three months, six months and 12 months. A secondary objective of the study will be correlating the findings of the Antero-lateral ligament on MRI with the pivot shift findings under anesthetic.
Interventions
Patients undergoing anterior cruciate ligament reconstruction will be examined on the operating table by an under anaesthetic by a orthopaedic surgeon, if they have a grade 3 pivot shift, they will be recruited and randomized to Anterior Cruciate Ligament (ACL) reconstruction or ACL reconstruction with anterolateral ligament reconstruction (ALL).
The ACL reconstruction will be performed using a 4 strand anatomically placed semitendinosis graft, with proximal and distal suspensory fixation. The
Patients undergoing anterior cruciate ligament reconstruction will be examined on the operating table by an under anaesthetic by a orthopaedic surgeon, if they have a grade 3 pivot shift, they will be recruited and randomized to Anterior Cruciate Ligament (ACL) reconstruction or ACL reconstruction with anterolateral ligament reconstruction (ALL). The ACL reconstruction will be performed using a 4 strand anatomically placed semitendinosis graft, with proximal and distal suspensory fixation. The ALL will be reconstructed using a gracilis tendon harvested from the ipsilateral side and secured with anchors. The Patients will complete subjective knee function scores post operatively. Orthopaedic Surgeons will assess the patients post op range of motion and pivot shift.
Sponsors
Orthopaedic Research Institute of Queensland (ORIQL)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
ACL rupture. Consented for ACL reconstruction Grade 3 pivot shift.
Exclusion criteria
Previous ACL recontruction Age less than 18yrs Unable to consent, high dependency, cognitive impairment
Outcome results
None listed