Anterior Cruciate Ligament RuptureNCT03229369
Association of ALL and ACL Reconstruction Versus Isolated ACL Reconstruction in High-risk Population: a RCT.
A study testing Isolated anatomic ACL reconstruction and Combined Anterior Cruciate Ligament and Anterolateral Ligament reconstruction in people with Anterior Cruciate Ligament Rupture and Ligament Knee Injury, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Rupture, Ligament Knee Injury
- What is being tested?
- Isolated anatomic ACL reconstruction and Combined Anterior Cruciate Ligament and Anterolateral Ligament reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2018to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Grade 2 or 3 pivot shift test
- Chronic ACL lesions (>or= 1 year after lesion)
Who cannot join
- Previous knee surgeries
- Chondral grade IV knee lesions
- Concomitant knee ligament injuries, other than ACL and ALL ligaments
- Knee osteoarthritis
- Semitendinosus graft length shorter than 24mm.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Sao Paulo, Orthopedics and Traumatology Department (UNIFESP-EPM)
São Paulo, 04038-031
Fernando C Rezende, MD, (55)1155764848, fernandocuryrezende@gmail.com
Carlos Eduardo Franziozi, PhD, (55)1155762887, cacarlos66@hotmail.com
About this study
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.
Read the detailed description
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.
- Being tested
- Isolated anatomic ACL reconstruction, Combined Anterior Cruciate Ligament and Anterolateral Ligament reconstruction
- Keywords
- ACL, ALL, Ligament injury, Reconstruction
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolated anatomic ACL reconstructionProcedure or surgery
Hamstrings free grafts using a two-incision intra-articular Anterior Cruciate ligament (ACL) reconstruction technique. Both ST and gracilis will be prepared with doubled strands, a standard quadrupled graft. The femoral tunnel will be performed in outside-in manner. The tibial tunnel will be drilled in the center of the ACL tibial footprint, sparing the ACL tibial stump, when possible. ACL graft will be first fixed in the femur and then in the tibia, both with an interference screw at 30 degrees of knee flexion.
Combined Anterior Cruciate Ligament and Anterolateral Ligament reconstructionProcedure or surgery
Hamstrings free grafts using a two-incision ACL reconstruction with the addition of a gracilis prolongation for ALL reconstruction. ACL graft will exhibit a quadruple strand (tripled ST + single gracilis) and the ALL graft, a single strand with the gracilis prolongation. ALL tibial tunnel will be performed with a 5mm drill, 1cm distal to the articular level, midway from the fibular head and Gerdy Tubercle, crossing the tibia toward its anteromedial cortex, 1cm distal to the ACL tunnel. Femoral ACL and ALL tunnels are coincident and located posterior and proximal to the lateral epicondyle. Intra-articular surgery will be performed in the same manner as comparative group. Gracilis prolongation is routed through the tibial ALL tunnel and then retrieved in the anteromedial aspect of the tibia, 1cm distal to the ACL tunnel entrance. ALL is fixed in full extension and neutral rotation, tying both graft extremities with 3 knots.
| Study group | Role | What they receive |
|---|---|---|
| Isolated ACL | Active comparator | Standard Anterior Cruciate Ligament Reconstruction only Receives: Procedure: Isolated anatomic ACL reconstruction |
| Combined ACL and ALL | Experimental | Anterior Cruciate Ligament Reconstruction associated with Anterolateral Ligament Reconstruction Receives: Procedure: Combined Anterior Cruciate Ligament and Anterolateral Ligament reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
IKDC subjective part for functional outcome
International Knee Documentation Committee
Measured: 24 months
Lysholm for functional outcome
Lysholm
Measured: 24 months
KOOS for functional outcome
Knee injury and Osteoarthritis Outcome Score
Measured: 24 months
Knee stability (subjective measures)
Lachman and pivot shift tests
Measured: 24 months
Knee stability (objective measure)
Differential laxity (Rolimeter)
Measured: 24 months
Secondary outcomes (3)
Re-rupture
Presence of instability and pathological laxity postoperatively needing ACL revision (Middleton KK 2014).
Measured: 24 months
Pain
Visual Analogue Scale (VAS)
Measured: 24 months
Activity Level
Tegner
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study startOct 2018 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Cury Rezende, Federal University of São Paulo
- Investigators
- Fernando C Rezende, MD, Principal investigator, research assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229369
- Sponsor's protocol ID
- Anterolateral ligament trial
- Status last verified
- Aug 2018
- First submitted
- 14 Jul 2017
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No IPD plan established yet.
Publications
Anderson AF, Snyder RB, Lipscomb AB Jr. Anterior cruciate ligament reconstruction. A prospective randomized study of three surgical methods. Am J Sports Med. 2001 May-Jun;29(3):272-9. doi: 10.1177/03635465010290030201.
PubMed 11394593Chouliaras V, Ristanis S, Moraiti C, Stergiou N, Georgoulis AD. Effectiveness of reconstruction of the anterior cruciate ligament with quadrupled hamstrings and bone-patellar tendon-bone autografts: an in vivo study comparing tibial internal-external rotation. Am J Sports Med. 2007 Feb;35(2):189-96. doi: 10.1177/0363546506296040. Epub 2007 Jan 23.
PubMed 17251174Claes S, Vereecke E, Maes M, Victor J, Verdonk P, Bellemans J. Anatomy of the anterolateral ligament of the knee. J Anat. 2013 Oct;223(4):321-8. doi: 10.1111/joa.12087. Epub 2013 Aug 1.
PubMed 23906341Dodds AL, Halewood C, Gupte CM, Williams A, Amis AA. The anterolateral ligament: Anatomy, length changes and association with the Segond fracture. Bone Joint J. 2014 Mar;96-B(3):325-31. doi: 10.1302/0301-620X.96B3.33033.
PubMed 24589786Guenther D, Rahnemai-Azar AA, Bell KM, Irarrazaval S, Fu FH, Musahl V, Debski RE. The Anterolateral Capsule of the Knee Behaves Like a Sheet of Fibrous Tissue. Am J Sports Med. 2017 Mar;45(4):849-855. doi: 10.1177/0363546516674477. Epub 2016 Dec 8.
PubMed 27932332Helito CP, Demange MK, Bonadio MB, Tirico LE, Gobbi RG, Pecora JR, Camanho GL. Anatomy and Histology of the Knee Anterolateral Ligament. Orthop J Sports Med. 2013 Dec 9;1(7):2325967113513546. doi: 10.1177/2325967113513546. eCollection 2013 Dec.
PubMed 26535259Hughston JC, Andrews JR, Cross MJ, Moschi A. Classification of knee ligament instabilities. Part II. The lateral compartment. J Bone Joint Surg Am. 1976 Mar;58(2):173-9.
PubMed 1254620Inderhaug E, Stephen JM, Williams A, Amis AA. Biomechanical Comparison of Anterolateral Procedures Combined With Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2017 Feb;45(2):347-354. doi: 10.1177/0363546516681555. Epub 2016 Dec 27.
PubMed 28027653Kittl C, El-Daou H, Athwal KK, Gupte CM, Weiler A, Williams A, Amis AA. The Role of the Anterolateral Structures and the ACL in Controlling Laxity of the Intact and ACL-Deficient Knee. Am J Sports Med. 2016 Feb;44(2):345-54. doi: 10.1177/0363546515614312. Epub 2015 Dec 10.
PubMed 26657572Kocher MS, Steadman JR, Briggs KK, Sterett WI, Hawkins RJ. Relationships between objective assessment of ligament stability and subjective assessment of symptoms and function after anterior cruciate ligament reconstruction. Am J Sports Med. 2004 Apr-May;32(3):629-34. doi: 10.1177/0363546503261722.
PubMed 15090377Logan MC, Williams A, Lavelle J, Gedroyc W, Freeman M. Tibiofemoral kinematics following successful anterior cruciate ligament reconstruction using dynamic multiple resonance imaging. Am J Sports Med. 2004 Jun;32(4):984-92. doi: 10.1177/0363546503261702.
PubMed 15150047Marcacci M, Zaffagnini S, Giordano G, Iacono F, Presti ML. Anterior cruciate ligament reconstruction associated with extra-articular tenodesis: A prospective clinical and radiographic evaluation with 10- to 13-year follow-up. Am J Sports Med. 2009 Apr;37(4):707-14. doi: 10.1177/0363546508328114. Epub 2009 Feb 3.
PubMed 19193599Monaco E, Ferretti A, Labianca L, Maestri B, Speranza A, Kelly MJ, D'Arrigo C. Navigated knee kinematics after cutting of the ACL and its secondary restraint. Knee Surg Sports Traumatol Arthrosc. 2012 May;20(5):870-7. doi: 10.1007/s00167-011-1640-8. Epub 2011 Aug 30.
PubMed 21877296Rezende FC, de Moraes VY, Martimbianco AL, Luzo MV, da Silveira Franciozi CE, Belloti JC. Does Combined Intra- and Extraarticular ACL Reconstruction Improve Function and Stability? A Meta-analysis. Clin Orthop Relat Res. 2015 Aug;473(8):2609-18. doi: 10.1007/s11999-015-4285-y. Epub 2015 Apr 7.
PubMed 25845949Ristanis S, Stergiou N, Patras K, Vasiliadis HS, Giakas G, Georgoulis AD. Excessive tibial rotation during high-demand activities is not restored by anterior cruciate ligament reconstruction. Arthroscopy. 2005 Nov;21(11):1323-9. doi: 10.1016/j.arthro.2005.08.032.
PubMed 16325082
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03229369
- Acronym / sponsor ID
- Anterolateral ligament trial
- Keywords
- ACL, ALL, Ligament injury, Reconstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 25 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isolated ACL | Active comparator | Procedure: Isolated anatomic ACL reconstructionStandard Anterior Cruciate Ligament Reconstruction only |
| Combined ACL and ALL | Experimental | Procedure: Combined Anterior Cruciate Ligament and Anterolateral Ligament reconstructionAnterior Cruciate Ligament Reconstruction associated with Anterolateral Ligament Reconstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Grade 2 or 3 pivot shift test
- Chronic ACL lesions (>or= 1 year after lesion)
Key exclusion criteria (5 listed)
- Previous knee surgeries
- Chondral grade IV knee lesions
- Concomitant knee ligament injuries, other than ACL and ALL ligaments
- Knee osteoarthritis
- Semitendinosus graft length shorter than 24mm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isolated anatomic ACL reconstructionHamstrings free grafts using a two-incision intra-articular Anterior Cruciate ligament (ACL) reconstruction technique. Both ST and gracilis will be prepared with doubled strands, a standard quadrupled graft. The femoral tunnel will be performed in outside-in manner. The tibial tunnel will be drilled in the center of the ACL tibial footprint, sparing the ACL tibial stump, when possible. ACL graft will be first fixed in the femur and then in the tibia, both with an interference screw at 30 degrees of knee flexion. | Procedure or surgery | Isolated ACL |
| Combined Anterior Cruciate Ligament and Anterolateral Ligament reconstructionHamstrings free grafts using a two-incision ACL reconstruction with the addition of a gracilis prolongation for ALL reconstruction. ACL graft will exhibit a quadruple strand (tripled ST + single gracilis) and the ALL graft, a single strand with the gracilis prolongation. ALL tibial tunnel will be performed with a 5mm drill, 1cm distal to the articular level, midway from the fibular head and Gerdy Tubercle, crossing the tibia toward its anteromedial cortex, 1cm distal to the ACL tunnel. Femoral ACL and ALL tunnels are coincident and located posterior and proximal to the lateral epicondyle. Intra-articular surgery will be performed in the same manner as comparative group. Gracilis prolongation is routed through the tibial ALL tunnel and then retrieved in the anteromedial aspect of the tibia, 1cm distal to the ACL tunnel entrance. ALL is fixed in full extension and neutral rotation, tying both graft extremities with 3 knots. | Procedure or surgery | Combined ACL and ALL |
Primary outcome
IKDC subjective part for functional outcome
Time frame: 24 months
International Knee Documentation Committee
Lysholm for functional outcome
Time frame: 24 months
Lysholm
KOOS for functional outcome
Time frame: 24 months
Knee injury and Osteoarthritis Outcome Score
Knee stability (subjective measures)
Time frame: 24 months
Lachman and pivot shift tests
Knee stability (objective measure)
Time frame: 24 months
Differential laxity (Rolimeter)
3 secondary outcomes
Re-rupture
Time frame: 24 months
Pain
Time frame: 24 months
Activity Level
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Background: PubMed 11394593Anderson AF, Snyder RB, Lipscomb AB Jr. Anterior cruciate ligament reconstruction. A prospective randomized study of three surgical methods. Am J Sports Med. 2001 May-Jun;29(3):272-9. doi: 10.1177/03635465010290030201.
- Background: PubMed 17251174Chouliaras V, Ristanis S, Moraiti C, Stergiou N, Georgoulis AD. Effectiveness of reconstruction of the anterior cruciate ligament with quadrupled hamstrings and bone-patellar tendon-bone autografts: an in vivo study comparing tibial internal-external rotation. Am J Sports Med. 2007 Feb;35(2):189-96. doi: 10.1177/0363546506296040. Epub 2007 Jan 23.
- Background: PubMed 23906341Claes S, Vereecke E, Maes M, Victor J, Verdonk P, Bellemans J. Anatomy of the anterolateral ligament of the knee. J Anat. 2013 Oct;223(4):321-8. doi: 10.1111/joa.12087. Epub 2013 Aug 1.
- Background: PubMed 24589786Dodds AL, Halewood C, Gupte CM, Williams A, Amis AA. The anterolateral ligament: Anatomy, length changes and association with the Segond fracture. Bone Joint J. 2014 Mar;96-B(3):325-31. doi: 10.1302/0301-620X.96B3.33033.
- Background: PubMed 27932332Guenther D, Rahnemai-Azar AA, Bell KM, Irarrazaval S, Fu FH, Musahl V, Debski RE. The Anterolateral Capsule of the Knee Behaves Like a Sheet of Fibrous Tissue. Am J Sports Med. 2017 Mar;45(4):849-855. doi: 10.1177/0363546516674477. Epub 2016 Dec 8.
- Background: PubMed 26535259Helito CP, Demange MK, Bonadio MB, Tirico LE, Gobbi RG, Pecora JR, Camanho GL. Anatomy and Histology of the Knee Anterolateral Ligament. Orthop J Sports Med. 2013 Dec 9;1(7):2325967113513546. doi: 10.1177/2325967113513546. eCollection 2013 Dec.
- Background: PubMed 1254620Hughston JC, Andrews JR, Cross MJ, Moschi A. Classification of knee ligament instabilities. Part II. The lateral compartment. J Bone Joint Surg Am. 1976 Mar;58(2):173-9.
- Background: PubMed 28027653Inderhaug E, Stephen JM, Williams A, Amis AA. Biomechanical Comparison of Anterolateral Procedures Combined With Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2017 Feb;45(2):347-354. doi: 10.1177/0363546516681555. Epub 2016 Dec 27.
- Background: PubMed 26657572Kittl C, El-Daou H, Athwal KK, Gupte CM, Weiler A, Williams A, Amis AA. The Role of the Anterolateral Structures and the ACL in Controlling Laxity of the Intact and ACL-Deficient Knee. Am J Sports Med. 2016 Feb;44(2):345-54. doi: 10.1177/0363546515614312. Epub 2015 Dec 10.
- Background: PubMed 15090377Kocher MS, Steadman JR, Briggs KK, Sterett WI, Hawkins RJ. Relationships between objective assessment of ligament stability and subjective assessment of symptoms and function after anterior cruciate ligament reconstruction. Am J Sports Med. 2004 Apr-May;32(3):629-34. doi: 10.1177/0363546503261722.
- Background: PubMed 15150047Logan MC, Williams A, Lavelle J, Gedroyc W, Freeman M. Tibiofemoral kinematics following successful anterior cruciate ligament reconstruction using dynamic multiple resonance imaging. Am J Sports Med. 2004 Jun;32(4):984-92. doi: 10.1177/0363546503261702.
- Background: PubMed 19193599Marcacci M, Zaffagnini S, Giordano G, Iacono F, Presti ML. Anterior cruciate ligament reconstruction associated with extra-articular tenodesis: A prospective clinical and radiographic evaluation with 10- to 13-year follow-up. Am J Sports Med. 2009 Apr;37(4):707-14. doi: 10.1177/0363546508328114. Epub 2009 Feb 3.
- Individual participant dataSharing planned: Undecided. No IPD plan established yet.
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Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando C Rezende, MD principal investigator
research assistant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isolated anatomic ACL reconstruction and Combined Anterior Cruciate Ligament and Anterolateral Ligament reconstruction in people with Anterior Cruciate Ligament Rupture and Ligament Knee Injury, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando C Rezende, MD ((55)1155764848, fernandocuryrezende@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IKDC subjective part for functional outcome (time frame: 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03229369, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.