None listed
Conditions
Brief summary
Augmentation of anterior cruciate ligament reconstruction using autologous hamstring graft, with a modified iliotibial band tenodesis or lateral extracapsular tenodesis, for patients with a residual pivot shift: A 2 year prospective randomised controlled trial comparing recurrence rate and clinical outcome. Background: Approximately 10% of ACLs injuries are associated with damage to the anterolateral complex (ALC) of the knee, manifest as greater anterolateral rotatory instability (ALRI). The pivot shift test is the best available clinical test for ALRI. Addition of an ALC reconstructive procedure can improve stability of the knee and clinical outcome in these patients following ACL reconstruction. There is little data comparing the efficacy of the various ALC procedures. Hypothesis: We hypothesized that the clinical outcome would be similar when either a modified ilio-tibial band tenodesis (MITBT) or lateral extracapsular tenodesis (LET) was added to ACL reconstruction. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: The inclusion criteria were a residual pivot shift following ACL reconstruction, in a skeletally mature patient, pre-injury Tegner Activity Score of at least 7, desirous to return to a similar level of activity, an intact contra-lateral ACL ligament and consenting to be randomly allocated to either treatment group. Patients in group A underwent MITBT, those in group B, LET, in addition to their ACL reconstruction. The primary outcome was recurrent ACL rupture and / or meniscal tears. Secondary outcomes were the Knee injury Osteoarthritis and Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score, ACL Quality of Life Questionnaire (QOL) and Tegner activity scores (TAS). Patients were reviewed at 12, and 24 months postoperatively. Statistical comparison of the groups was performed, P<0.05 denoting significance. A power analysis determined that 140 patients were required to achieve a power of 80% and 5% risk of a type 1 error.
Interventions
The LET procedure involves taking a 1cm strip of the ITB, 15cm long, left attached distally, and then re-routed deep to the proximal lateral collateral ligament (LCL) of the knee and attached to the periosteum posterior and superior to the LCL where it is secured under hand tension using a titanium bone staple.
The surgery is performed by a consultant orthopaedic surgeon and takes approximately 30 mins to perform. The surgeon is one of the researchers so adherence to the interventio
The LET procedure involves taking a 1cm strip of the ITB, 15cm long, left attached distally, and then re-routed deep to the proximal lateral collateral ligament (LCL) of the knee and attached to the periosteum posterior and superior to the LCL where it is secured under hand tension using a titanium bone staple. The surgery is performed by a consultant orthopaedic surgeon and takes approximately 30 mins to perform. The surgeon is one of the researchers so adherence to the intervention is not indicated and the operative notes document the procedure performed. The study is on-going and may last for 20 years.
Sponsors
Mark Porter
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 confirmed on MRI and at time of surgery, the presence of clinical signs of instability immediate following the performance of the ACL reconstruction when the patients re-assessed after the ACL reconstruction (the presence of a pivot shift test despite the ACL reconstruction) involved in sports that require twisting / pivoting, desirous to return to this sport, patient willing to be randomly allocated to either treatment group, Tegner activity score of at least 7
Exclusion criteria
Unwilling to take part, presence of other ligament damage in the injured knee, previous contra-lateral ACL rupture, injury associated with an unstable fracture, not fit for a general anaesthetic,
Outcome results
None listed