None listed
Conditions
Brief summary
The anterior cruciate ligament (ACL) is an important stabilizing ligament of the knee. It is also the most common knee ligament injury requiring surgery, with an annual incidence of approximately 1 in 3500 in the general population. Numerous technological advances have been made in recent times in the surgical techniques for ACL reconstruction but, in spite of this, the failure rate remains approximately 7-15% and many people do not return to full function in their knee after ACL reconstruction. The anterolateral ligament (ALL), a structure located in the anterolateral part of the knee, has recently been identified as an important contributor to rotational stability of the knee in addition to the ACL. Loss of ALL integrity may be responsible for some cases of failure post-operatively. Although intra-articular ACL reconstruction remains the current gold standard for operative management, it does not address the extra-articular ALL deficiency and therefore does not restore normal knee kinematics. The aim of this study is to compare the return to function and re-rupture rates following combined ACL reconstruction with lateral extra-articular tenodesis versus an isolated intra-articular ACL reconstruction. Participants will be randomly allocated to one of two treatment arms by opening a sealed envelope. They will then undergo either i) ACL reconstruction using a 4-strand hamstring ACL graft and iliotibial band (ITB) lateral extra-articular tenodesis, or ii) isolated intra-articular ACL reconstruction with a 4-strand hamstring graft. Following surgery, clinical reviews will be conducted at 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively during which the physiotherapist will make an assessment using a variety of objective knee scoring systems and a patient satisfaction survey. Any post-operative complications will also be recorded. Comparison will then be made to determine which technique has better functional outcome and lower re-rupture rate.
Interventions
Participants will be randomly allocated to one of two treatment arms by opening a sealed envelope. They will then undergo either i) ACL reconstruction using a 4-strand hamstring ACL graft and iliotibial band (ITB) lateral extra-articular tenodesis, or ii) isolated intra-articular ACL reconstruction with a 4-strand hamstring graft. The duration of each procedure is approximately 45-60 minutes and will be performed by the consultant orthopaedic surgeon and his team. Post-operatively, participants
Participants will be randomly allocated to one of two treatment arms by opening a sealed envelope. They will then undergo either i) ACL reconstruction using a 4-strand hamstring ACL graft and iliotibial band (ITB) lateral extra-articular tenodesis, or ii) isolated intra-articular ACL reconstruction with a 4-strand hamstring graft. The duration of each procedure is approximately 45-60 minutes and will be performed by the consultant orthopaedic surgeon and his team. Post-operatively, participants will undertake a standard rehabilitation protocol for ACL reconstruction. Following surgery, clinical reviews will be conducted at 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively. Participants will no longer receive the yearly questionnaire, as stated previously.
Sponsors
Toby Leys
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
For inclusion in the study patients must be aged between 18 and 40 years, have Grade 2 or 3 knee instability on pivot shift test and have a confirmed ACL tear on MRI scan. They must also be medically able to undergo a general or regional anaesthetic.
Exclusion criteria
Patients with multi-ligament knee injury or any other ligaments requiring surgery will be excluded, along with people from non-English speaking backgrounds, those residing interstate or overseas and those who are unable to provide their own consent for any reason.
Outcome results
None listed