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Original Research| Volume 8, ISSUE 3, P177-183, June 2023

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Latin American formal consensus on the appropriate indications of extra-articular lateral procedures in primary anterior cruciate ligament reconstruction

Open AccessPublished:September 06, 2022DOI:https://doi.org/10.1016/j.jisako.2022.08.007

      Abstract

      Objectives

      To create a practice guideline for the appropriate indications of an extra-articular procedure in primary anterior cruciate ligament reconstruction (ACLR).

      Methods

      The formal consensus method described by the Haute Autorité de Santé was used. The Latin American Society of Arthroscopy, Articular Replacement, and Sports Injuries (SLARD) recruited three groups of experts on ACLR. Initially, the steering group, consisting of eight surgeons, performed a systematic review of the literature and elaborated on 192 scenarios for primary ACLR. The rating group, composed of 23 surgeons, rated each scenario in two rounds, with an in-between in-person meeting for discussion. Median scores and agreement levels were estimated to classify each scenario as inappropriate, uncertain or appropriate for adding anterolateral reconstruction. Finally, the lecture group, consisting of 10 surgeons, revised each stage of the method, results and interpretation.

      Results

      Of the scenarios, 11.97% were rated as appropriate for adding an extra-articular lateral procedure, 7.81% as inappropriate and 80.21% as uncertain. The key recommendations for the addition of extra-articular lateral techniques were as follows: it is appropriate when the patient is under 25 years of age, has high-grade physical examination findings, practises a pivoting sport and has hyperlaxity; meanwhile, it is inappropriate when the patient has low-grade physical examination findings, has normal laxity and does not practise a pivoting sport.

      Conclusions

      The appropriate indications of extra-articular lateral procedures in primary ACLR were determined on the basis of the best available evidence and expert opinion following a formal consensus method.

      Level of evidence

      V.

      Keywords

      What are the new findings?

      • A Formal consensus was performed on the appropriate indications of anterolateral procedures in primary anterior cruciate ligament reconstruction.
      • Age, laxity, physical examination and pivoting sports were the four variables that most significantly impacted the ratings.
      • The appropriateness of adding an anterolateral procedure lies in the combination of factors and not in one variable alone.

      Introduction

      Anatomic arthroscopic-assisted anterior cruciate ligament reconstruction (ACLR) is currently the gold standard treatment for restoring knee stability, assisting in return to sports and avoiding meniscal or cartilage injuries [
      • Lord B.
      • Grice J.
      • Cox G.
      • Yasen S.
      • Wilson A.
      (iii) Anterior cruciate ligament reconstruction–evolution and current concepts.
      ]. Although the rates of return to sports and satisfactory functional results are high [
      • Minhas S.V.
      • Kester B.S.
      • Larkin K.E.
      • Hsu W.K.
      The effect of an orthopaedic surgical procedure in the National Basketball Association.
      ], the proportion of patients with residual instability and early failure reaches 10% at 10 years after surgery [
      • Anderson M.J.
      • Browning III, W.M.
      • Urband C.E.
      • Kluczynski M.A.
      • Bisson L.J.
      A systematic summary of systematic reviews on the topic of the anterior cruciate ligament.
      ]. A graft tear is a catastrophic event for patients and their families, sports clubs and medical teams. Moreover, functional results after ACL revision are deficient compared with those after the first surgery [
      • Kaeding C.C.
      • Pedroza A.D.
      • Reinke E.K.
      • Huston L.J.
      • Consortium M.
      • Spindler K.P.
      Risk factors and predictors of subsequent ACL injury in either knee after ACL reconstruction: prospective analysis of 2488 primary ACL reconstructions from the MOON cohort.
      ,
      • Wright R.W.
      • Gill C.S.
      • Chen L.
      • Brophy R.H.
      • Matava M.J.
      • Smith M.V.
      • et al.
      Outcome of revision anterior cruciate ligament reconstruction: a systematic review.
      ].
      Various strategies have been proposed to decrease the rates of residual laxity and early failure (graft tear). There is a constant search to improve the surgical technique, including evaluation of more details of the morphology and attachment of the ACL, discussion on the appropriate graft to use and performance of the double-bundle procedure [
      • Mo Z.
      • Li D.
      • Yang B.
      • Tang S.
      Comparative efficacy of graft options in anterior cruciate ligament reconstruction: a systematic review and network meta-analysis.
      ,
      • Schreiber V.M.
      • van Eck C.F.
      • Fu F.H.
      Anatomic double-bundle ACL reconstruction.
      ,
      • Chambat P.
      • Guier C.
      • Sonnery-Cottet B.
      • Fayard J.-M.
      • Thaunat M.
      The evolution of ACL reconstruction over the last fifty years.
      ]. Recently, alignment has been highlighted, specifically in varus and tibial slopes. Finally, in the last decade, there has been a return to the use of extra-articular anterolateral techniques, which were widely used as isolated techniques in the ’70s [
      • Bonasia D.E.
      • D'Amelio A.
      • Pellegrino P.
      • Rosso F.
      • Rossi R.
      Anterolateral ligament of the knee: back to the future in anterior cruciate ligament reconstruction.
      ]. Adding an extra-articular procedure to ACLR aims to reduce the anterolateral rotatory instability and the rate of ACL retear [
      • Kittl C.
      • El-Daou H.
      • Athwal K.K.
      • Gupte C.M.
      • Weiler A.
      • Williams A.
      • et al.
      The role of the anterolateral structures and the ACL in controlling laxity of the intact and ACL-deficient knee.
      ,
      • Sonnery-Cottet B.
      • Lutz C.
      • Daggett M.
      • Dalmay F.
      • Freychet B.
      • Niglis L.
      • et al.
      The involvement of the anterolateral ligament in rotational control of the knee.
      ]. The indication is most agreed upon in cases of ACL revision; thus, the discussion has switched to primary ACLR being the target to screen for patients at a greater risk for graft failure [
      • Rossi M.J.
      Editorial commentary: anterolateral ligament augmentation for the anterior cruciate ligament–deficient knee debate—the proof is in the pudding.
      ].
      Currently, evidence-based medicine is the most accepted practice; however, questions regarding daily medical practice still remain. Several meta-analyses have been conducted but were limited by the quality of the original studies, heterogeneity of anterolateral techniques and patient characteristics [
      • Rhatomy S.
      • Ariyanto M.W.
      • Fiolin J.
      • Dilogo I.H.
      Comparison of clinical outcomes between isolated ACL reconstruction and combined ACL with anterolateral ligament reconstruction: a systematic review and meta-analysis.
      ,
      • Cheng X.
      • Liu F.
      • Zhou D.
      • Paulus A.C.
      Surgical intra-and extraarticular anterior cruciate ligament reconstruction: a meta-analysis.
      ,
      • Devitt B.M.
      • Bell S.W.
      • Ardern C.L.
      • Hartwig T.
      • Porter T.J.
      • Feller J.A.
      • et al.
      The role of lateral extraarticular tenodesis in primary anterior cruciate ligament reconstruction: a systematic review with meta-analysis and best-evidence synthesis.
      ,
      • Xu C.
      • Chen J.
      • Cho E.
      • Zhao J.
      The effect of combined anterolateral and ACL reconstruction on reducing pivot shift rate and clinical outcomes: a meta-analysis.
      ]. Good clinical practice guidelines based on the experience of a specific group and better available evidence are essential to fill this gap [
      • Siwiec J.
      • Konieczna M.
      • Koperny M.
      Good practice for guidance development–review of consensus methods.
      ]. The formal consensus method described by the Haute Autorité de Santé (HAS) is a consensus and guideline method [
      • De Santé H.A.
      Practice guidelines "Formal Consensus" method.
      ]. As a consensus method, it aims to formalise the degree of agreement among experts using iteratively rated scenarios with feedback. As a practice guideline method, it seeks to draft a few brief and unambiguous statements regarding the matter in question.
      The appropriate indications of primary ACLR are controversial, and it is necessary to formulate guidelines that could help in the daily practice of knee surgeons. The purpose of this study was to obtain a formal consensus and create a practice guideline for the appropriate indications of an extra-articular lateral procedure in primary ACLR.

      Methods

      The formal consensus method described by the HAS was carefully followed as previously described [
      • De Santé H.A.
      Practice guidelines "Formal Consensus" method.
      ]. The Latin American Society of Arthroscopy, Articular Replacement, and Sports Injuries (SLARD) sequentially recruited three groups of experts on ACLR. These groups were independent, and no members belonged to more than one group.
      The first group was the steering group, whose objective was to review the literature, write a systematic review and select the variables for the construction of scenarios. The scenarios represent all the possible combinations of each variable. The group consisted of eight surgeons.
      Thereafter, 25 Latin American surgeons were recruited for the rating group to rate all scenarios. Two of them declined the invitation. All members received the systematic review performed by the steering group and instructions to respond to the scenarios and learn how to perform the ratings. All members rated all the scenarios in two rounds on a scale of 1–9, in which ‘1’ indicated completely inappropriate; ‘5’, uncertain; and ‘9’, completely appropriate. Because the group had more than 15 members, two outlier values could be omitted from each scenario. A scenario was considered appropriate when the median value was 7 or higher and all ratings were 5 or higher. Meanwhile, a scenario was deemed inappropriate when the median value was 3 or lower and the ratings ranged from 1 to 5. All other results were considered uncertain.
      After the first round, a meeting was conducted for feedback; all members received the condensed results and the anonymous answers of the 23 members and were allowed to discuss each rating to reach agreements. After this meeting, all members were allowed to maintain or change the rating of all scenarios.
      After the second round, the median value and range were calculated. Ordinal regression was used to determine which variables had more weight for the raters. The median value of each scenario was the dependent variable. For this purpose, it was re-coded as ‘0’ when the median value was 3 or lower; ‘1’, between 4 and 6 and ‘2’, 7 or higher. The odds ratio (OR) and 95% confidence interval were estimated. The parallel assumption was tested using the brand test; a p-value above 0.15 considered that the null hypothesis of parallelism was valid. In addition, quantile regression was used to generate an equation to predict the median value of the ratings in the rating group that could be used to decide whether to add an extra-articular technique.
      Later, the recommendations and final text were presented to a lecture group consisting of 10 surgeons. The purpose of this group was to rate each recommendation from ‘1’ (completely disagree) to ‘9’ (completely agree). When the recommendation achieved a median rating above ‘6’ and all ratings were above ‘5’, it was retained. Other results indicate that the statement is vetoed and requires a revision by the steering and rating group. Additionally, the lecture group had to supervise that each stage was conducted appropriately according to the HAS. Comments and criticisms on the final text were welcomed.

      Results

      The 41 knee surgeons involved in this consensus study had a mean experience performing ACLR of 19.44 years (standard deviation, ±8.07), mean number of 114 ACLRs performed in the last 12 months (standard deviation, ±78.04) and mean rate of adding an extra-articular technique to primary ACLR of 0.24 (standard deviation, ±0.16). The preferred extra-articular technique was tenodesis in 72%, while anterolateral ligament reconstruction was favoured by 28% of the surgeons (Table 1).
      Table 1Summary of the characteristics related to the expertise of the surgeons who participated in the consensus study according to each group.
      NY ACLR
      Mean (standard deviation).
      N 12 month
      Mean (standard deviation).
      Rate EA ACLR
      Mean (standard deviation).
      Preferred EA
      Steering group815.0 (±8.77)126.1 (±85.43)0.26 (±0.19)Tenodesis, 56%
      Rating group2321.1 (±7.47)113 (±79.30)0.24 (±0.15)Tenodesis, 75%
      Lecture group1020.6 (±7.79)100 (±73.71)0.25 (±0.15)Tenodesis, 86%
      Total4119.4 (±8.07)113 (±78.04)0.24 (±0.15)Tenodesis, 73%
      Abbreviations: N, Number of participants; Y ACLR, Years performing ACLR; N 12 month, Number of ACLRs performed in the last 12 month; R EA ACLR, Rate of extra-articular technique in primary ACLR; Preferred EA, Preferred extra-articular technique.
      a Mean (standard deviation).
      The steering group selected seven variables that created 192 scenarios (Table 2). After the first round of ratings, there were 55 scenarios (28.65%) with a median value of 3 or lower, 43 scenarios (22.40%) with a median value of 4–6 and 94 scenarios (48.96%) with a median value of 7 or higher (Fig. 1, Fig. 2). An agreement was reached for a total of 38 scenarios (19.79%), of which 23 (11.97%) were rated appropriate for the addition of an extra-articular lateral procedure, while 15 (7.81%) were rated inappropriate. After the second round, none of the experts changed their ratings; thus, the rate of uncertainty remained high (80.21%).
      Table 2Variables selected by the steering group.
      VariableOptionsExplanation
      Age<25 yearsAge at ACLR
      >25 yearsAge at ACLR
      Physical examination findingsLow gradeLachman test finding of <10 mm and pivot shift grade 2 or lower
      High gradeLachman test finding of >10 mm or pivot shift grade 2 or higher
      Radiological risk factorPresentSegond fracture or Ferreti grade ≥2 on MRI or subchondral sinking of the femoral condyle or tibial slope of >12°
      AbsentNo presence of a Segond fracture and Ferreti grade ≥2 on MRI and subchondral sinking of the femoral condyle and tibial slope of <12°
      Pivoting SportPresentSports requiring shifts of direction or speed, such as soccer, basketball, handball, or tennis
      AbsentSports not requiring a shift of direction or speed, such as marathon or running
      TemporalityAcuteLess than 6 months between the ACL tear and surgery
      Chronic6 or more months between the ACL tear and surgery
      LaxityNormalLess than 10° of knee recurvatum and Beighton score of <4
      HyperlaxityMore than 10° of knee recurvatum or general laxity defined as a Beighton score of ≥4
      Meniscal StatusIntactIntact menisci
      Meniscectomy >50%Lateral or medial meniscus requiring meniscectomy above 50%
      Meniscal repairLateral or medial meniscus requiring repair, including radial tears, ramp lesions, root tears, and longitudinal lesions sized >1 cm
      Abbreviations: ACLR, Anterior cruciate ligament reconstruction; ACL, anterior cruciate ligament; MRI, Magnetic resonance image; CM, centimetre.
      Fig. 1
      Fig. 1The 96 scenarios for acute lesions are presented. Red highlights the scenarios of agreement where an extra-articular lateral technique was considered inappropriate; meanwhile, blue highlights the scenarios of agreement where an extra-articular lateral technique was considered appropriate. Green presents the scenarios with a median rating between 4 and 6; thus, they were considered uncertain. Ecru highlights the scenarios with a median rating of ≤3 and ≥7, but which did not reach the criteria for agreement; thus, they were considered uncertain. Low grade: Low-grade physical examination, High grade: High-grade physical examination, Red: Inappropriate to perform an extra-articular lateral procedure, Green: Uncertain, Blue: Appropriate to perform an extra-articular lateral procedure, Ecru: Median rating of ≤3 and ≥7, but the scenario did not meet the criteria for agreement.
      Fig. 2
      Fig. 2The 96 scenarios for chronic lesions are presented. Red highlights the scenarios of agreement where an extra-articular lateral technique was considered inappropriate; meanwhile, blue highlights the scenarios of agreement where an extra-articular lateral technique was considered appropriate. Green presents the scenarios with a median rating between 4 and 6; thus, they were considered uncertain. Ecru highlights the scenarios with a median rating of ≤3 and ≥7, but which did not reach the criteria for agreement; thus, they were considered uncertain. Red: Inappropriate to perform an extra-articular lateral procedure, Green: Uncertain, Blue: Appropriate to perform an extra-articular lateral procedure, Ecru: Median rating of <3 and >7, but the scenario did not meet the criteria for agreement.
      The agreements for inappropriate indications were as follows:
      • (i)
        Combination of normal laxity, low-grade physical examination findings, absence of radiological findings and non-participation in pivoting sports, regardless of the age, temporality or meniscal status: The median rating by the lecture group was 9 (range, 8–9).
      • (ii)
        High-grade physical examination findings, >25 years of age, normal laxity and acute lesions without meniscal injury or radiological risk factors: The median rating by the lecture group was 8 (range, 7–9).
      • (iii)
        Desire to return to pivoting sports, ≥25 years of age, low-grade physical examination findings, normal laxity and no meniscal injury or radiological risk factors: The median rating by the lecture group was 8 (range, 6–9).
      The agreements for appropriate indications were as follows:
      • (i)
        Combination of <25 years of age, high-grade physical examination findings, desire to practise a pivoting sport and hyperlaxity, along with the meniscal status, temporality and presence of radiological risk factors: The median rating by the lecture group was 9 (range, 7–9).
      • (ii)
        Combination of high-grade physical examination findings, practice of a pivoting sport, presence of radiological risk factors and hyperlaxity, along with the meniscal status, temporality and age: The median rating by the lecture group was 9 (range, 7–9).
      • (iii)
        Non-practice of a pivoting sport, <25 years of age, chronic lesions, hyperlaxity, high-grade physical examination findings, presence of radiological risk factors and need for meniscectomy or meniscal repair: The median rating by the lecture group was 9 (range, 7–9).
      • (iv)
        Low-grade physical examination findings, chronic lesions, need for meniscectomy or meniscal repair, <25 years of age, hyperlaxity, desire to practise a pivoting sport and presence of radiological risk factors: The median rating by the lecture group was 8 (range, 6–9).
      The lecture group approved all the statements. Also, it was found that when radiological risk factors and hyperlaxity were combined, no scenario reached inappropriate agreement. Meanwhile, appropriateness was not achieved in any scenario that combined >25 years of age with normal laxity or low-grade physical examination findings with normal laxity.
      Ordinal regression showed that age, laxity, physical examination findings and pivoting sports were the four variables that significantly impacted the ratings (Table 3). The radiological risk factors had a significant OR; nevertheless, the brand test violated the parallel assumption of the ordinal model, making it difficult to interpret the importance of this variable.
      Table 3Odds ratio estimated in the ordinal regression.
      OR (95% CI)Brant test (p)
      Age of 25 years0.42 (0.25–0.74)
      Significant.
      0.20
      Hyperlaxity4.75 (2.69–8.38)
      Significant.
      0.97
      High-grade physical examination5.23 (2.95–9.27)
      Significant.
      0.42
      Radiological risk factor6.08 (3.40–10.88)
      Significant.
      0.06
      Parallel assumption of the ordinal regression was not achieved.
      Pivoting sport5.42 (3.05–9.64)
      Significant.
      0.60
      Meniscal status1.24 (0.90–1.73)0.61
      Chronic lesion1.18 (0.69–2.00)0.24
      The parallel assumption was tested using the brand test; a p-value above 0.15 considered the null hypothesis of parallelism as valid.
      a Significant.
      b Parallel assumption of the ordinal regression was not achieved.
      The semiparametric model estimated a pseudo-R2 value of 0.56. The equation for calculating the median rating by the rating group was as follows Median=1+(0.91Age<25)+(1.91Hiperlaxity)+(2.27highgradephysicalexam)+(2.36Radiologicalriskfactor)+(2.36Pivotsport)+(0.36Meniscalinjury)+(0.45Chroniclesion) (Table 4).
      Table 4Coefficients and factors to use in the equation for estimating the median rating in the rating group.
      Coefficientp valueFactor = 1Factor = 0
      Age0.91<0.000<25 years≥25 years
      Hyperlaxity1.91<0.000PresentAbsent
      Physical examination2.27<0.000High-gradeLow-grade
      Radiological risk factor2.36<0.000PresentAbsent
      Pivoting sport2.36<0.000PracticeNot practice
      Meniscal status0.360.003Meniscectomy or repair neededNormal
      Temporality0.450.022ChronicAcute
      Constant10.001N/AN/A
      For example, for a patient aged 35 years with hyperlaxity, low-grade physical examination findings, and no radiological risk factor and who has not practised a pivoting sport, an intact meniscus, and an acute ACL tear, the median rating is calculated as follows: Median=1+(0.910)+(1.911)+(2.270)+(2.360)+(2.360)+(0.360)+(0.450). A median rating of 2.91 indicates that the addition of an extra-articular procedure is inappropriate according to this consensus.

      Discussion

      This study combined the best available scientific evidence with expert opinions to create a guideline for the appropriate indications of an extra-articular procedure in primary ACLR. The main finding of this study was that the appropriateness of adding an anterolateral procedure lies in a combination of factors and not in one variable alone. However, this study also showed that there is still a significant area of uncertainty regarding this topic, which is why it is imperative to promote the conduct of clinical trials.
      Two randomised controlled trials showed no advantage in the addition of anterolateral surgery to primary ACL. In both studies, the inclusion criteria were broad, not selecting any specific characteristics of patients; this indicates that not every patient required anterolateral reconstruction [
      • Anderson A.F.
      • Snyder R.B.
      • Lipscomb Jr., A.B.
      Anterior cruciate ligament reconstruction: a prospective randomized study of three surgical methods.
      ,
      • Castoldi M.
      • Magnussen R.A.
      • Gunst S.
      • Batailler C.
      • Neyret P.
      • Lustig S.
      • et al.
      A randomized controlled trial of bone–patellar tendon–bone anterior cruciate ligament reconstruction with and without lateral extra-articular tenodesis: 19-year clinical and radiological follow-up.
      ]. Nevertheless, recent randomised controlled studies reported significantly better outcomes in a specific population: Getgood et al. [
      • Getgood A.M.
      • Bryant D.M.
      • Litchfield R.
      • Heard M.
      • McCormack R.G.
      • Rezansoff A.
      • et al.
      Lateral extraarticular tenodesis reduces failure of hamstring tendon autograft anterior cruciate ligament reconstruction: 2-year outcomes from the STABILITY study randomized clinical trial.
      ] included patients under 25 years old with two of the following: high pivot shift, desire to practise pivot sport, hyperlaxity and genu recurvatum. They reported in this specific population that the number needed to treat to avoid one ACL revision was 14 anterolateral tenodesis. Efforts to identify subpopulations with a higher risk for ACL retear are necessary to reach adequate indications of anterolateral procedures.
      Age, pivoting sports, laxity and physical examination findings were the four variables that had more weight on the ratings. These variables were repeatedly found in the reviewed literature and in the randomised controlled trial by Getgood et al. [
      • Getgood A.M.
      • Bryant D.M.
      • Litchfield R.
      • Heard M.
      • McCormack R.G.
      • Rezansoff A.
      • et al.
      Lateral extraarticular tenodesis reduces failure of hamstring tendon autograft anterior cruciate ligament reconstruction: 2-year outcomes from the STABILITY study randomized clinical trial.
      ,
      • Getgood A.
      • Hewsion C.
      • Bryant D.
      • Litchfield R.
      • Heard M.
      • Buchko G.
      • et al.
      No difference in functional outcomes when lateral extraarticular tenodesis is added to anterior cruciate ligament reconstruction in young active patients: the Stability Study.
      ]. Youth has been consistently associated with a higher risk for ACL retear, and the MOON group reported that the risk for retear increased by 9% each year in younger patients [
      • Kaeding C.C.
      • Pedroza A.D.
      • Reinke E.K.
      • Huston L.J.
      • Consortium M.
      • Spindler K.P.
      Risk factors and predictors of subsequent ACL injury in either knee after ACL reconstruction: prospective analysis of 2488 primary ACL reconstructions from the MOON cohort.
      ]. Moreover, Schulemberg et al. [
      • Schlumberger M.
      • Schuster P.
      • Schulz M.
      • Immendörfer M.
      • Mayer P.
      • Bartholomä J.
      • et al.
      Traumatic graft rupture after primary and revision anterior cruciate ligament reconstruction: retrospective analysis of incidence and risk factors in 2915 cases.
      ] demonstrated that patients aged <25 years had a six-fold higher risk for ACL re-injury than patients aged >25 years.
      The type of sports practised also plays an essential role in the risk for ACL retear. A study conducted with National Collegiate Athletic Association data showed different risks among the types of sports practised [
      • Gans I.
      • Retzky J.S.
      • Jones L.C.
      • Tanaka M.J.
      Epidemiology of recurrent anterior cruciate ligament injuries in national collegiate athletic association sports: the injury surveillance program, 2004-2014.
      ]. In addition, using the Marx scale, the MOON group identified an association between ACLR and the volume and intensity of the sports [
      • Kaeding C.C.
      • Pedroza A.D.
      • Reinke E.K.
      • Huston L.J.
      • Consortium M.
      • Spindler K.P.
      Risk factors and predictors of subsequent ACL injury in either knee after ACL reconstruction: prospective analysis of 2488 primary ACL reconstructions from the MOON cohort.
      ].
      Hyperlaxity and genu recurvatum have a high prevalence among patients aged between 18 and 25 years, reaching 26.8% and 18.6%, respectively [
      • Antonio D.H.
      • Magalhaes C.S.
      Survey on joint hypermobility in university students aged 18–25 years old.
      ]. In a level III study, Helito et al. [
      • Helito C.P.
      • Sobrado M.F.
      • Giglio P.N.
      • Bonadio M.B.
      • Pécora J.R.
      • Camanho G.L.
      • et al.
      Combined reconstruction of the anterolateral ligament in patients with anterior cruciate ligament injury and ligamentous hyperlaxity leads to better clinical stability and a lower failure rate than isolated anterior cruciate ligament reconstruction.
      ] demonstrated that adding anterolateral reconstruction in patients with hyperlaxity reduced the risk of revision. A recent study showed a strong correlation between knee hyperlaxity and high pivot grade [
      • Batty L.M.
      • Firth A.
      • Moatshe G.
      • Bryant D.M.
      • Heard M.
      • McCormack R.G.
      • et al.
      Association of ligamentous laxity, male sex, chronicity, meniscal injury, and posterior tibial slope with a high-grade preoperative pivot shift: a post hoc analysis of the stability study.
      ].
      Regarding pivot shift, it has been well documented that it takes more than just an ACL tear to have a high-grade pivot shift. Injury to the anterolateral knee corner is strongly associated with anterolateral rotatory instability. Other factors have been linked to a high pivot shift, such as an increased tibial slope, a smaller tibial plateau volume and a lateral meniscus tear [
      • Tanaka M.
      • Vyas D.
      • Moloney G.
      • Bedi A.
      • Pearle A.
      • Musahl V.
      What does it take to have a high-grade pivot shift?.
      ].
      Unlike the four previous variables, the imaging risk factor did not reach the necessary probability to validate the parallel assumption of the ordinal regression model despite obtaining a significant OR. This variable included the presence of a Segond fracture or Ferreti grade ≥2 on magnetic resonance imaging (MRI), subchondral sinking of the femoral condyle or tibial slope of above 12°. Controversial evidence on this topic has been reported in literature. Some studies have shown a direct correlation between the severity of anterolateral injuries on MRI and the grade of the pivot shift [
      • Song G-y
      • Zhang H.
      • Wu G.
      • Zhang J.
      • Liu X.
      • Xue Z.
      • et al.
      Patients with high-grade pivot-shift phenomenon are associated with higher prevalence of anterolateral ligament injury after acute anterior cruciate ligament injuries.
      ]; however, other studies have not found the same results [
      • Lee D.W.
      • Lee J.H.
      • Kim J.N.
      • Moon S.G.
      • Kim N.R.
      • Kim J.G.
      Evaluation of anterolateral ligament injuries and concomitant lesions on magnetic resonance imaging after acute anterior cruciate ligament rupture.
      ]. Two reasons can explain these findings. First, a low interobserver agreement for evaluating anterolateral injuries on MRI has been reported [
      • Monaco E.
      • Helito C.P.
      • Redler A.
      • Argento G.
      • De Carli A.
      • Saithna A.
      • et al.
      Correlation between magnetic resonance imaging and surgical exploration of the anterolateral structures of the acute anterior cruciate ligament–injured knee.
      ]. Second, the time elapsed between the injury and the date of MRI has been shown to change the incidence of complex anterolateral injuries [
      • Muramatsu K.
      • Saithna A.
      • Watanabe H.
      • Sasaki K.
      • Yokosawa K.
      • Hachiya Y.
      • et al.
      Three-dimensional magnetic resonance imaging of the anterolateral ligament of the knee: an evaluation of intact and anterior cruciate ligament–deficient knees from the Scientific Anterior Cruciate Ligament Network International (SANTI) Study Group.
      ]. Segond fractures have been identified as avulsion lesions of the anterolateral capsule [
      • Bonasia D.E.
      • D'Amelio A.
      • Pellegrino P.
      • Rosso F.
      • Rossi R.
      Anterolateral ligament of the knee: back to the future in anterior cruciate ligament reconstruction.
      ]. However, to our knowledge, no study has evaluated knee instability in patients with this fracture after ACLR by comparing it alone or with anterolateral reconstruction. Finally, it has been established that a tibial slope greater than 12° increases the risk of ACL retear [
      • Nazzal E.M.
      • Zsidai B.
      • Pujol O.
      • Kaarre J.
      • Curley A.J.
      • Musahl V.
      Considerations of the posterior tibial slope in anterior cruciate ligament reconstruction: a scoping review.
      ]. The use of osteotomy to correct the tibial slope in primary ACLR has shown good outcomes [
      • Song G-y
      • Ni Q-k
      • Zheng T.
      • Zhang Z-j
      • Feng H.
      • Zhang H.
      Slope-reducing tibial osteotomy combined with primary anterior cruciate ligament reconstruction produces improved knee stability in patients with steep posterior tibial slope, excessive anterior tibial subluxation in extension, and chronic meniscal posterior horn tears.
      ]; nevertheless, it is a challenging surgery with a rate of complications higher than that of extra-articular techniques [
      • Dejour D.
      • Saffarini M.
      • Demey G.
      • Baverel L.
      Tibial slope correction combined with second revision ACL produces good knee stability and prevents graft rupture.
      ]. The use of extra-articular lateral tenodesis in the study performed by the Stability group showed that it maintained a protective effect on ACL retear in the multivariate logistic model that included the tibial slope [
      • Firth A.D.
      • Bryant D.M.
      • Litchfield R.
      • McCormack R.G.
      • Heard M.
      • MacDonald P.B.
      • et al.
      Predictors of graft failure in young active patients undergoing hamstring autograft anterior cruciate ligament reconstruction with or without a lateral extraarticular tenodesis: the stability experience.
      ]; however, more evidence is needed to determine the role of extra-articular techniques in patients with an increased slope.
      Another critical issue is that most trials comparing the addition of anterolateral reconstruction in a primary ACL tear have less than 2 years of follow-up [
      • Anderson A.F.
      • Snyder R.B.
      • Lipscomb Jr., A.B.
      Anterior cruciate ligament reconstruction: a prospective randomized study of three surgical methods.
      ,
      • Getgood A.M.
      • Bryant D.M.
      • Litchfield R.
      • Heard M.
      • McCormack R.G.
      • Rezansoff A.
      • et al.
      Lateral extraarticular tenodesis reduces failure of hamstring tendon autograft anterior cruciate ligament reconstruction: 2-year outcomes from the STABILITY study randomized clinical trial.
      ,
      • Abdelrazek B.H.
      • Gad A.M.
      • Abdel-Aziz A.
      Rotational stability after ACL reconstruction using anatomic double bundle technique versus anatomic single bundle technique plus anterolateral ligament augmentation.
      ,
      • Goncharov E.N.
      • Koval O.A.
      • Dubrov V.E.
      • Bezuglov E.N.
      • Filimonova A.M.
      • Goncharov N.G.
      Clinical experience with combined reconstruction of the anterior cruciate and anterolateral ligaments of the knee in sportsmen.
      ,
      • Ibrahim S.A.
      • Shohdy E.M.
      • Marwan Y.
      • Ramadan S.A.
      • Almisfer A.K.
      • Mohammad M.W.
      • et al.
      Anatomic reconstruction of the anterior cruciate ligament of the knee with or without reconstruction of the anterolateral ligament: a randomized clinical trial.
      ,
      • Porter M.
      • Shadbolt B.
      Modified iliotibial band tenodesis is indicated to correct intraoperative residual pivot shift after anterior cruciate ligament reconstruction using an autologous hamstring tendon graft: a prospective randomized controlled trial.
      ,
      • Vadalà A.P.
      • Iorio R.
      • De Carli A.
      • Bonifazi A.
      • Iorio C.
      • Gatti A.
      • et al.
      An extraarticular procedure improves the clinical outcome in anterior cruciate ligament reconstruction with hamstrings in female athletes.
      ,
      • Zhang H.
      • Qiu M.
      • Zhou A.
      • Zhang J.
      • Jiang D.
      Anatomic anterolateral ligament reconstruction improves postoperative clinical outcomes combined with anatomic anterior cruciate ligament reconstruction.
      ,
      • Sonnery-Cottet B.
      • Pioger C.
      • Vieira T.D.
      • Franck F.
      • Kajetanek C.
      • Fayard J.-M.
      • et al.
      Combined ACL and anterolateral reconstruction is not associated with a higher risk of adverse outcomes: preliminary results from the SANTI randomized controlled trial.
      ]. Zaffagnini et al. [
      • Zaffagnini S.
      • Marcacci M.
      • Presti M.L.
      • Giordano G.
      • Iacono F.
      • Neri M.P.
      Prospective and randomized evaluation of ACL reconstruction with three techniques: a clinical and radiographic evaluation at 5 years follow-up.
      ] published a study with 5 years of follow-up, in which they found no difference in the ACLR rate. The same finding was reported by Castaldi et al. [
      • Castoldi M.
      • Magnussen R.A.
      • Gunst S.
      • Batailler C.
      • Neyret P.
      • Lustig S.
      • et al.
      A randomized controlled trial of bone–patellar tendon–bone anterior cruciate ligament reconstruction with and without lateral extra-articular tenodesis: 19-year clinical and radiological follow-up.
      ] in their study with 19 years of follow-up. The revision rate reported for primary ACLR is 10% at 10 years, and that for patellar tendon reconstruction in the primary ACL is up to 9% at 25 years [
      • Anderson M.J.
      • Browning III, W.M.
      • Urband C.E.
      • Kluczynski M.A.
      • Bisson L.J.
      A systematic summary of systematic reviews on the topic of the anterior cruciate ligament.
      ,
      • Lindanger L.
      • Strand T.
      • Mølster A.O.
      • Solheim E.
      • Inderhaug E.
      Effect of early residual laxity after anterior cruciate ligament reconstruction on long-term laxity, graft failure, return to sports, and subjective outcome at 25 years.
      ]. Studies with 10 or more years of follow-up will show whether concomitant anterolateral reconstruction could lower the revision rate.
      Two other consensus studies on anterolateral procedures have been published. The first study included 13 knee experts and was conducted in Lyon in 2015 [
      • Sonnery-Cottet B.
      • Daggett M.
      • Fayard J.-M.
      • Ferretti A.
      • Helito C.P.
      • Lind M.
      • et al.
      Anterolateral Ligament Expert Group consensus paper on the management of internal rotation and instability of the anterior cruciate ligament-deficient knee.
      ]. The discussion included anatomy, biomechanics, image diagnosis and indications using an informal method. Formal methods have been shown to lead to a less biased and more evidence-based consensus mechanism than informal methods [
      • Thompson J.C.
      • Pinter Z.W.
      • Honig R.
      • Tomov M.N.
      • Currier B.L.
      • Elder B.D.
      • et al.
      Methods used to generate consensus statements for clinical practice guidelines: a primer for the spine surgeon.
      ]. The second study included 36 knee experts and was performed in London in 2017 using the modified Delphi method, a formal method [
      • Getgood A.
      • Brown C.
      • Lording T.
      • Amis A.
      • Claes S.
      • Geeslin A.
      • et al.
      The anterolateral complex of the knee: results from the International ALC Consensus Group Meeting.
      ]. As in the first consensus study, the debate included anatomy and indications. Our consensus study has several strengths. First, it used a formal method in which the group that elaborated the scenarios was independent of the group that made the ratings; the aim was to ensure that all participants could express their ideas, as well as to ensure the transparency of the process [
      • Thompson J.C.
      • Pinter Z.W.
      • Honig R.
      • Tomov M.N.
      • Currier B.L.
      • Elder B.D.
      • et al.
      Methods used to generate consensus statements for clinical practice guidelines: a primer for the spine surgeon.
      ]. Second, it is the first consensus study that focused on primary ACLR. In addition, the method allowed the creation of different realistic scenarios that combined each of the variables included, which allowed the objective determination of variables of more weight instead of simply subjectively selecting the major or minor criteria. Furthermore, the method allowed the estimation of a formula to help in daily decision-making of knee surgeons. Also, our consensus study findings could be used to promote the conduct of trials, as they identify areas of uncertainty. Moreover, they could be used to evaluate over/underuse in a retrospective cohort of patients and determine whether they correlate with the functional outcome and revision rate.
      One limitation of this consensus study is that the number of variables included was limited. The scenarios combined all of them; therefore, if too many variables are selected, the number of scenarios increases exponentially. The steering group identified 21 potential candidate variables to include, indicating that 2,097,152 scenarios would have had to be rated. After the review of the literature and meetings, options, such as high-grade physical examination findings (Lachman test and pivot shift) and imagological risk factors, were grouped. Further, only one cut-point point was used for chronic ACL injuries, based on the findings by Abdelrazek et al. [
      • Abdelrazek B.H.
      • Gad A.M.
      • Abdel-Aziz A.
      Rotational stability after ACL reconstruction using anatomic double bundle technique versus anatomic single bundle technique plus anterolateral ligament augmentation.
      ], Ibrahim et al. [
      • Ibrahim S.A.
      • Shohdy E.M.
      • Marwan Y.
      • Ramadan S.A.
      • Almisfer A.K.
      • Mohammad M.W.
      • et al.
      Anatomic reconstruction of the anterior cruciate ligament of the knee with or without reconstruction of the anterolateral ligament: a randomized clinical trial.
      ] and Batty et al. [
      • Batty L.M.
      • Firth A.
      • Moatshe G.
      • Bryant D.M.
      • Heard M.
      • McCormack R.G.
      • et al.
      Association of ligamentous laxity, male sex, chronicity, meniscal injury, and posterior tibial slope with a high-grade preoperative pivot shift: a post hoc analysis of the stability study.
      ].
      On the other hand, sex and contralateral ACL injury were variables excluded. The MOON group and Norwegian and Swedish registries showed that women do not have an increased risk for ACL tears compared with men [
      • Kaeding C.C.
      • Pedroza A.D.
      • Reinke E.K.
      • Huston L.J.
      • Consortium M.
      • Spindler K.P.
      Risk factors and predictors of subsequent ACL injury in either knee after ACL reconstruction: prospective analysis of 2488 primary ACL reconstructions from the MOON cohort.
      ,
      • Spindler K.P.
      • Huston L.J.
      • Chagin K.M.
      • Kattan M.W.
      • Reinke E.K.
      • Amendola A.
      • et al.
      MOON Knee Group
      Ten-year outcomes and risk factors after anterior cruciate ligament reconstruction: a MOON longitudinal prospective cohort study.
      ]. The reports that found differences may be related to confounding factors, such as age and level of sports activity [
      • Kaeding C.C.
      • Pedroza A.D.
      • Reinke E.K.
      • Huston L.J.
      • Consortium M.
      • Spindler K.P.
      Risk factors and predictors of subsequent ACL injury in either knee after ACL reconstruction: prospective analysis of 2488 primary ACL reconstructions from the MOON cohort.
      ,
      • Swärd P.
      • Kostogiannis I.
      • Roos H.
      Risk factors for a contralateral anterior cruciate ligament injury.
      ], which are variables included in our consensus study. Regarding contralateral ACL lesions, the risk for contralateral lesions is 15 times greater than that in patients without a history of a knee injury. However, this consensus study focused on primary ACL tears [
      • Swärd P.
      • Kostogiannis I.
      • Roos H.
      Risk factors for a contralateral anterior cruciate ligament injury.
      ].

      Conclusions

      The appropriateness of the indication of extra-articular lateral procedures in primary ACLR was determined on the basis of the best available evidence and expert opinion. This Latin American consensus study on the proper indication of an anterolateral procedure in primary ACLR can help in better informed clinical decision-making. An anterolateral procedure is not required for every patient with a primary ACL injury. The appropriateness of adding an anterolateral procedure lies in the combination of factors and not in one variable alone.

      Declarations

      All authors had approved the final form.

      Conflict of interest

      The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:Maximiliano Barahona reports administrative support and article publishing charges were provided by Latin-American Society of Arthroscopy, Articular replacement, and Sports Injuries.

      Funding

      Administrative support and article publishing charges were provided by the Latin-American Society of Arthroscopy, Articular replacement, and Sports Injuries (SLARD).

      Ethical approval

      N/A.

      Informed consent

      N/A.

      Authors contribution

      MB: Project leader. MM: Contributed the original idea and supervised the study. VDP: coordinated literature review and member of the steering group, HG: supervised the draft of literature review and member of the steering group. JDC: Supervised the final draft of the consensus and member of the steering group. SM: Perform critical review of the manuscript and member of the steering group. FBB: coordinator of the steering group. OA: Perform critical review of the manuscript and member of the steering group. AK: Chair of the steering group.

      Availability of data

      The datasets used or analysed during the current study are available from the corresponding author on reasonable request.

      Acknowledgements

      The authors acknowledge the collaborating authors of this study: Alex Vaisman, Ariel Graieb, Arturo Almazan, Camilo Helito, Christian Fuentes, Cristian Collado, Diego Esquivel, Facundo Gigante, Fernando Motta, German Ochoa, Gonzalo Arteaga, Gonzalo Ferrer, Guillermo Zvietcovich, Jesús Cardona, Jorge Hurtado, Lucio Erlund, Matías Costa-Paz, Matías Roby, Nelson Ponzo, Paula Sarmiento, Roberto Yáñez, Santiago Urbieta, Víctor Marques, Alvaro Zamorano, Fernando Radice, Lisardo Nardin, Andres Gelink, Rodrigo Hernandez, Ariel de la Rosa, Sebastian Irarrazaval, Franco Cordivani, Sergio Canuto, Giovani Gravini.

      Appendix A. Supplementary data

      The following are the Supplementary data to this article:

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