Anterior Cruciate Ligament Rupture Clinical Trial
Official title:
Association of Anterolateral Ligament and Anterior Cruciate Ligament Reconstruction Lead to Superior Outcomes and Lower Failure Rates in High-risk Population?: a Randomized Controlled Trial.
Persistent rotational instability after standard ACL reconstruction have been extensively
described, and it has been shown to keep straight correlation with worse outcomes
post-operatively (Chouliaras 2007, Kocher 2004). Anterolateral ligament (ALL) injury have
been shown to play a relevant role in the genesis of rotational instability of the knee
(Claes 2013, Helito 2013). Many anatomical publications have defined the ALL as a distinct
ligament (Claes 2013). Meanwhile, some authors have proposed the association of ACL and ALL
reconstruction in selected ACL-deficient individuals to further enhance knee stability
postoperatively (Sonnery-Cottet 2015, Dodds 2014). Lack of consensus still predominates among
ACL experts regarding the reliability of the combined ACL and ALL considering the controversy
that involves both ALL anatomy and biomechanics (Guenther D 2016, Kittl C 2016). Clinical
trials with high level of evidence and long term follow-up may be useful in order to
determine the reliability of the combined procedure in the clinical setting.
So, the present study aims to compare the effectiveness of the combined ACL and ALL
reconstruction with isolated ACL reconstruction in individuals with high-risk of ACL
re-rupture, through a randomized controlled trial.
Rotational knee stability is a topic with great interest among Anterior Cruciate Ligament
(ACL) Reconstruction experts. Previous papers have questioned whether current ACL
reconstruction techniques may provide adequate rotational stability in all ACL-deficient
individuals, considering their broad spectrum of clinical presentations (Logan 2004, Ristanis
2005). Persistent rotational instability after standard ACL reconstruction have been
extensively described, and it has been shown to keep straight correlation with worse outcomes
post-operatively (Chouliaras 2007, Kocher 2004). Besides, lack of knee stability could lead
to further chondral and meniscal lesions, which could enhance development of knee
osteoarthritis (Stergiou 2007).
This discussion has gained increased attention after recent publications regarding the
Anterolateral ligament (ALL), described as a structure whose lesion seems to worsen
rotational instability when associated to ACL ruptures. (Claes 2013, Helito 2013, etc).
Segond first described this ligament in 1897 as a "resistant fibrous band" located in the
anterolateral knee compartment with a singular characteristic of tensioning in forced
internal rotation (Segond 1879). Afterwards, some authors referred to this structure as a
capsular thickening (Hughston 1976). More recently, various anatomical publications brought
up this controversy, defining the ALL as a distinct ligament (Claes 2013, Dodds 2014, Helito
2015). Biomechanical data have shown straight correlation between its rupture and worsening
of rotational stability, defined with a presence of an obvious positive pivot shift test
(Claes 2013, Monaco 2012). Lack of consensus still exists regarding the validity of these
findings, but many authors proposed the association of ACL and ALL reconstruction in selected
ACL-deficient individuals, considering the theoretical biomechanical advantage of this
procedure in promoting combined anteroposterior and rotational stability (Sonnery-Cottet
2015, Sonnery-Cottet 2017, Dodds 2014, Marcacci 2009). In a recent meta-analysis of
randomized controlled trials, isolated ACL reconstruction techniques were compared to
combined ACL and extra-articular reconstruction techniques and, although Lachman and pivot
shift tests were superior in the combined ACL reconstruction group, functional scores were
similar (Rezende 2015). Knee stiffness and infection, were also similar between groups,
despite previous publications suggesting increased rates in the combined procedure (Anderson
2001, Sonnery-Cottet 2011). However, considering the lack of improvement of knee scores
tests, the authors concluded it is still uncertain whether this increased stability surpasses
the morbidity of adding an extra-articular procedure (Rezende 2015). In contrast to the
obsolete extra-articular techniques included in the latter meta-analyses, anatomical ALL
reconstruction techniques have been proposed to better replicate the anatomy of the
anterolateral compartment (Sonnery-Cottet 2015). Promising results have been published in a
recent prospective cohort study comparing combined ALL and ACL reconstruction with isolated
ACL reconstruction techniques, using either hamstrings and bone-patellar-tendon bone grafts.
Re-rupture rates were 3.1 times fold less in combined ACL and ALL procedure compared to
isolated ACL with hamstrings and 2.3 times fold less compared to isolated ACL with
bone-patellar-bone graft . The percutaneous ALL reconstruction technique described in this
study not just reproduces more reliably the anatomy of the anterolateral compartment, but it
is also less invasive diminishing the morbidity associated with the non-anatomic
extra-articular reconstruction techniques, such as the iliotibial band tenodesis
(Sonnery-Cottet 2017).
Many controversy still predominates among ACL experts not just regarding ALL in vitro
studies, but also the debate about the reliability of the combined ACL and ALL procedure when
bringing it to the clinical setting (Guenther D 2016, Kittl C 2016). Concerns have been
raised about some aspects of the combined ACL and ALL procedure, in particular its
theoretical potential in leading to an excessive knee constriction, as demonstrated in some
biomechanical papers (Schon JM 2016). Experts opinions diverge about the potential long-term
consequences of the combined ACL and ALL procedure; while defenders state that improved
rotational instability should minimize degenerative consequences of a "sub-optimal" knee
joint stability supposedly provided by an isolated intra-articular reconstruction, many other
surgeons argue that knee osteoarthritis might the evolution of the abnormal kinematics of an
overconstrained knee (Inderhaug E 2017, Schon JM 2016, Sonnery-Cottet B 2017). In order to
resolve such lack of consensus, clinical trials with high level of evidence should be the
priority in this field, with a long term follow-up, aiming to compare functional scores, knee
stability tests and complications rates between isolated ACL and combined ACL and ALL
reconstruction techniques.
So, the present study aims to compare the effectiveness of the combined ACL and ALL
reconstruction with isolated ACL reconstruction in individuals with high risk of ACL
re-rupture, through a randomized controlled trial.
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