Keywords
anterior cruciate ligament reconstruction - anterior cruciate ligament injuries -
joint instability - tenodesis
Introduction
Traditional, single-bundle anterior cruciate ligament reconstruction (ACLR) techniques
have been demonstrated to provide good subjective results; however, multiple studies
have shown that many patients continue to have complications related to the procedure.
Failure of ACLR might be caused by anterolateral rotational instability due to inadequacy
of the intra-articular graft to recreate a normal knee kinematics.[1] One of the proposed solutions is to use lateral-based soft-tissue reconstructive
techniques in addition to ACLR. The present metaanalysis will discuss lateral extraarticular
tenodesis (LET) as an augmentation technique for ACLR.
Lateral extraarticular tenodesis is not a new concept. It was originally used to treat
the ACL-deficient knee in the absence of intraarticular reconstruction techniques.
The goal is to place a lateral soft-tissue restraint a distance from the central pivot
of the knee, thereby improving the mechanical advantage to control rotation when treating
the ACL-deficient knee.[2] Along with the widespread use of intra-articular reconstruction, in particular the
introduction of arthroscopic techniques, LET became less known, especially since there
was no proven additional advantage with its application.[3]
The paradigm changed when a significant focus was placed upon the anterolateral complex
(ALC). On the lateral side of the knee, there are soft-tissue structures whose function
is to prevent anterolateral rotatory laxity. The ALC includes the superficial and
deep iliotibial band (ITB), the capsuloosseous layer of the ITB, and a thickening
of the lateral capsule referred to as the anterolateral ligament (ALL).[4] Anterolateral ligament was diversely described by many authors as either the mid-third
capsular ligament, the capsuloosseous layer of the ITB, or a combination of both.[5] Cadaveric studies have shown that in conjunction with ACLR, LET is an excellent
surgical technique to control anterolateral rotatory laxity of the knee due to injury
or deficiency of the ALC.[6] There were also previous systematic reviews and metaanalyses that reported good
mid-term results even with a limited number of patients.[7]
[8]
[9]
[10]
The purpose of this study is to gather evidence of the latest randomized controlled
trials (RCTs) on LET regarding its functional outcome and complications as an augmentation
of the ACLR procedure.
Materials and Methods
This systematic review and metaanalysis was performed in accordance with the preferred
reporting items for systematic reviews and metaanalyses (PRISMA) guideline.
Search Strategy and Selection Criteria
Search Strategy and Selection Criteria
We performed a literature search using the PubMed/MEDLINE and Google Scholar databases.
There was no limitation regarding publication date. Language was limited to English.
Search terms included, but were not limited to: lateral extraarticular ligament, tenodesis, anterolateral ligament reconstruction, and anterior cruciate ligament reconstruction.
All types of clinical trials published as full article were included in the present
study. The articles were selected based on inclusion and exclusion criteria according
to the population, intervention, comparison, outcome (PICO) model as depicted in [Table 1].
Table 1
|
Inclusion criteria
|
Exclusion criteria
|
Population
|
Patients aged ≥ 18 years or older with primary ACL rupture and planned to undergo
ACL reconstruction with arthroscopy.
|
• Animal studies.
• Revision cases of ACL reconstruction.
• Concomitant PCL or meniscus reconstruction.
• Underlying congenital condition or neoplasm.
|
Intervention
|
ACL reconstruction with lateral extraarticular tenodesis.
|
• ACLR with (ALL) reconstruction.
• Pharmacologic treatment.
• Nutrition treatment.
• Physical therapy or rehabilitation which stands alone.
|
Control
|
ACL reconstruction alone.
|
|
Outcome
|
Primary outcome measures
Clinical outcomes including the IKDC score, VAS for pain, and SF-36 for quality of
life are the primary outcomes. Mean difference will be reported with 95% confidence
intervals.
Secondary outcome measures
Additional outcomes of interest include complications. Dichotomous outcomes will be
measured using risk ratios with 95% confidence intervals.
|
• Study is ongoing, and no results have been reported
• Outcome measures not reported in completion
|
Data Extraction
The articles were screened by a research team, with each article screened independently
by two team members (HN and MFD). Disagreements between reviewers regarding whether
to include or exclude a study were resolved by consensus and, if necessary, consultation
with a third reviewer.
Data were collected from each article by two independent reviewers, with disagreements
resolved through consensus and, if required, consultation with a third reviewer. Data
were recorded in a form developed a priori.
Abstracted variables included patient age, gender, sample size, mean follow-up, ALL
augmentation technique, ALL augmentation graft, ACLR technique, ACLR graft, IKDC score,
Lysholm score, and complications (e.g., graft failure).
Quality Assessment
The included clinical trials were assessed in terms of quality by two independent
reviewers based on the 13 items of the 2015 Updated Method Guideline for Systematic
Reviews in the Cochrane Back and Neck Group.[11] The following domains were assessed for each included study: randomization (selection
bias), allocation concealment (selection bias), blinding of participants and personnel
(performance bias), blinding of outcome assessment (detection bias), drop-out rate
(attrition bias), all participants analyzed in proper group (attrition bias), selective
reporting bias (reporting bias), similar baseline regarding the most important prognostic
indicators (selection bias), cointerventions (performance bias), acceptable compliance
in all groups (performance bias), other sources of bias (e.g., industry sponsorship).
Disagreements during quality assessment were resolved through discussion and consensus
and, if necessary, consultation with a third reviewer.
Data Synthesis
The mean differences in the IKDC score, Lysholm score, and graft failures were the
primary outcomes investigated. Continuous variables were reported as means and 95%
confidence intervals (CIs). Dichotomous outcomes will be measured using risk ratios
with 95% confidence intervals. Heterogeneity was determined by estimating the proportion
of between-study inconsistencies due to actual differences, rather than differences
due to random error or chance, using the I statistic, with values of 25%, 50%, and
75% indicating low, moderate, and high degrees of heterogeneity, respectively. The
statistical analysis was performed using RevMan version 5.4 (Nordic Cochrane Centre,
Copenhagen, Denmark). A p-value < 0.05 was considered significant.
Results
Literature Search and Study Characteristics
The preliminary electronic search of all databases resulted in 1,364 records, which
were screened for duplicates, publication period, study methodology (only RCTs were
included), and language. The remaining articles were subsequently studied by two independent
investigators based on the full text extracted using a form developed a priori. This
selection text yielded six final articles to be included in the metaanalysis, with
the flow of selection process depicted in [Fig. 1]. All articles had high quality of evidence except one which had moderate quality[12] ([Table 2]).
Fig. 1 Flow chart showing article selection.
Table 2
No
|
Author (year)
|
Adequate randomizationb
|
Concealed allocation
|
Patient blinded
|
Care provider blinded
|
Assessor blinded
|
Drop-out rate acceptable
|
Analyzed according to group
|
Free of selective outcome reporting
|
Similar at baseline
|
Cointerventions avoided
|
Compliance acceptable
|
Timing of outcome similar
|
No other sources of potential bias
|
Quality assessment
|
1
|
Dejour et al. (2013)
|
No
|
Unsure
|
No
|
No
|
No
|
Yes
|
Yes
|
Yes
|
Yes
|
Yes
|
No
|
Yes
|
Yes
|
Moderate
|
2
|
Trichine et al. (2014)
|
Yes
|
Unsure
|
Yes
|
No
|
Yes
|
Yes
|
Yes
|
Yes
|
Yes
|
Yes
|
Yes
|
Yes
|
Yes
|
High
|
3
|
Ferretti et al. (2016)
|
Yes
|
Unsure
|
No
|
No
|
No
|
Yes
|
Yes
|
Yes
|
Yes
|
Yes
|
Yes
|
Yes
|
Yes
|
High
|
4
|
Getgood et al. (2019)
|
Yes
|
Yes
|
No
|
No
|
No
|
No
|
Yes
|
Yes
|
Unsure
|
Yes
|
Yes
|
Yes
|
Yes
|
High
|
5
|
Castoldi et al. (2020)
|
Yes
|
Unsure
|
No
|
No
|
No
|
No
|
Yes
|
Yes
|
Unsure
|
Unsure
|
Yes
|
Yes
|
Yes
|
High
|
6
|
Getgood et al. (2020)
|
Yes
|
Unsure
|
No
|
No
|
No
|
No
|
Yes
|
Yes
|
Yes
|
Yes
|
Yes
|
Yes
|
Yes
|
High
|
Baseline Characteristics
A total of 1,049 patients were investigated in this study. The complete list of baseline
characteristics can be seen in [Table 3]. From six studies, four used the Lemaire[13] technique for the LET, while two studies used the techniques described by MacIntosh[14] and Christel, respectively.[15] The ITB was utilized for the tenodesis in four studies, and the gracilis graft was
used in two studies. The ACL reconstruction technique was varied in all studies, with
three studies using ACL graft from the hamstring tendon (gracilis and semitendinosus),
and three using bone patellar tendon bone graft. The follow-up period was similar
in most studies, that is, in average 24 months (range, 6–63 months), while 2 studies
had long-term follow-up, that is, a follow-up period longer than 10 years.
Table 3
Study (year)
|
ALL augmentation technique
|
ALL augmentation graft
|
ACLR technique
|
ACLR graft
|
Age
|
Gender
|
Sample size
|
Mean follow-up
|
ACLR alone
|
ACLR + LET
|
ACLR alone
|
ACLR + LET
|
ACLR alone
|
ACLR + LET
|
ACLR alone
|
ACLR + LET
|
Dejour et al. (2013)
|
Modified Lemaire
|
Gracilis
|
Single Bundle
|
Bone patellar tendon bone graft
|
27.5 years (range: 14–42 years)
|
21.4 years (range: 14–34 years)
|
Male: 17 (68%)
|
Male: 20 (80%)
|
25
|
25
|
25.4 (range 18–30 months)
|
25.6 (range 14–33 months)
|
Trichine et al. (2014)
|
Kenneth Jones plasty
|
Iliotibial band
|
Single-incision arthroscopic technique (Kenneth Jones)
|
Patellar tendon
|
27.7 ± 4.75 years
|
28.6 ± 4.69 years
|
Comparable statistically
|
60
|
60
|
24.5 months (range 6–63 months)
|
23.4 months (range 6–45 months)
|
Ferretti et al. (2016)
|
MacIntosh modified by Cocker-Arnold
|
Iliotibial band
|
Single Bundle
|
Semitendinosus and gracilis
|
27.3 (range: 18–50 years)
|
25.7 (range: 18–46 years)
|
Male 51 (71%)
|
Male 56 (82%)
|
72
|
68
|
10 years 5 months (range 121–128 months)
|
Getgood et al. (2019)
|
Modified Lemaire
|
Iliotibial band
|
Triple bundle
|
Semitendinosus and gracilis
|
18.7 ± 3.2 years
|
19.0 ± 3.1 years
|
Male 79 (45.9%)
|
Male 75 (44.4%)
|
180
|
176
|
24 months
|
24 months
|
Castoldi et al. (2020)
|
Lemaire extra-articular tenodesis
|
Gracilis
|
NA
|
Bone patellar tendon bone graft
|
26 years (range: 15–40 years)
|
Male 43 (70%)
|
Male 47 (78%)
|
61
|
60
|
19.4 years (range, 19–20.2 years)
|
Getgood et al. (2020)
|
Modified Lemaire
|
Iliotibial band
|
Various
|
Semitendinosus and/or gracilis.
|
18.9 years (range: 14–25 years)
|
Male 151 (48%)
|
Male 151 (49%)
|
312
|
306
|
24 months
|
24 months
|
Functional Outcome
There are a wide variety of clinical parameters that can be used to assess the outcome
of procedures in the knee. The complete list of functional outcomes of LET in ACLR
can be seen in [Table 4]. The most widely used is the IKDC score, with 3 studies using this parameter[1]
[16]
[17] favoring ACLR along with LET procedure and 1 study resulting in insignificant difference
between the 2 procedures.[18] The addition of the LET procedure to ACLR resulted in significant difference of
functional outcome based on the IKDC score (p < 0.05). The mean difference was -0.71 (95% CI, -0.84–-0.58). ([Figs. 2] and [3]) Two studies confirmed better Lysholm score with addition of the LET procedure.[12]
[19]
Fig. 2 Forrest plot showing that addition of lateral extraarticular tenodesis procedure
to anterior cruciate ligament reconstruction results in significant difference of
functional outcome based on the International Knee Documentation Committee score.
Fig. 3 Forrest plot showing lower graft failure in anterior cruciate ligament reconstruction
plus lateral extraarticular tenodesis group.
Table 4
Study (year)
|
IKDC
|
Lysholm
|
Graft failure (%)
|
ACLR alone
|
ACLR + LET
|
ACLR alone
|
ACLR + LET
|
ACLR alone
|
ACLR + LET
|
Dejour et al. (2013)
|
90.1
|
86
|
NA
|
NA
|
NA
|
NA
|
Trichineet al. (2014)
|
92.1
|
88.2
|
NA
|
NA
|
NA
|
NA
|
Ferretti et al. (2016)
|
93.77 (SD 6.63)
|
96.19 (SD 3.3)
|
95.46 (SD 5.68)
|
96.24 (SD 3.5)
|
NA
|
NA
|
Getgood et al. (2019)
|
NA
|
NA
|
NA
|
NA
|
11.67%
|
13.07%
|
Castoldi et al. (2020)
|
81.1 (range, 42.5–100)
|
82.4 (range, 55.2–100)
|
86.6 (42–100)
|
90.3 (67–100)
|
47.54%
|
21.67%
|
Complication
Of all the complications reported in each study, the most often reported is graft
failure.[16]
[19] Graft failure was found to be lower in the ACLR plus LET group (16 of 342 patients)
compared with the ACLR-only group (46 of 341 patients) (p < 0.05). The risk ratio was 2.63 (95% CI, 1.53–4.52).
Discussion
This metaanalysis investigated the recent high-quality evidence of LET procedure in
addition to ACLR. Despite the current enormous interest in this procedure, there is
not enough quantitative evidence about how the addition of LET might affect the functional
outcome. Therefore, this procedure is not common, and it is mainly indicated for revision
and grade III pivot shift.[20] Previous systematic reviews reported good mid-term result even with a limited number
of patients.[7]
[8]
[9]
[10] The current study is the first to present quantitative analysis of recent studies
which concluded that LET procedure in addition to ACLR yielded a satisfactory functional
outcome.
Failure to reconstruct anterolateral structure, especially ALL, was considered to
be one of the factors producing unsatisfactory result in anatomical ACLR.[21] Anterolateral ligament was diversely described by many authors as a component of
ALC, which was thought to be either the mid-third capsular ligament, the capsuloosseous
layer of the ITB, or a combination of both. It has a significant role in rotatory
instability, along with the ITB.[5] The quantitative analysis of previous clinical trials showed that graft failure
is lower in combined ACLR and LET procedure. The additional procedure is beneficial
in reducing complication probably due to its effect in reducing residual rotational
laxity.
The anterolateral augmentation procedure improves rotatory instability significantly
and eliminates pivot shift in high-risk patients.[22]
[23] It can be performed with two techniques: LET procedure and modern ALL reconstruction.
The main difference between the two methods is that ALL reconstruction allows more
anatomical reconstruction than LET.[24] Another difference is that in the LET procedure, the proximal fixation point is
near the femoral epicondyle, and the distal fixation point is around the Gerdy tubercle,
while in ALL, it is integrated with the fibular collateral ligament (FCL).[4]
A previous metaanalysis found that even when patients reported generally satisfactory
outcome measures, combined LET procedure and ACL reconstruction provided worse anterior
stability.[8] On the other hand, one metaanalysis provided good mid-term follow-up results with
low rates of residual rotatory laxity, re-ruptures, or complications. In terms of
functional outcome, there was a trend that the IKDC subjective outcome was more similar
between the two groups in primary reconstruction procedure than the one in revision
procedure.[7] However, the studies included in both metaanalysis were all retrospective studies
dating back to 1986[8] and 2006.[7]
The present study focused on recent literature, with the latest clinical trial dating
back to 2013[12] since the technique of arthroscopy and surgeon's familiarity with the technique
has progressed well in recent years. Even though there are several clinical trials
comparing ACLR procedure alone with ACLR combined with LET, these studies found no
significant difference between the two groups in terms of pain and functional outcome,
using tools such as the limb symmetry index (LSI).[25]
[26]
[27] These studies used different techniques and graft, making it difficult to derive
a conclusion.
In recent years, more uniform techniques were utilized in LET procedure in addition
to ACLR with a more standardized method to assess the functional outcome, thus making
the methodology more rigorous. Most studies included in our analysis used the IKDC
scoring system as the functional outcome. Even though Getgood et al.[16] reported a greater amount of pain in the first 3 months after surgery and a delay
to quadriceps strength recovery and reduction in the lower extremity functional scale
(LEFS), these differences were small and transient.
Another interesting topic is how LET procedure provides additional benefit, especially
in delayed ACLR procedures (after 12 months of injury).[10] The additional benefit was shown in terms of pivot shift test, which was not described
regarding its grading and might influence the statistical analysis. To provide better
recommendation for delayed ACLR procedures, future studies should consider utilizing
functional outcome, that is, using the IKDC score as outcome measurement. It is patient-oriented
and should be more considered in future studies.
There are several limitations of the present study that should be mentioned. First,
the data available in the studies are limited. For example, the mean and standard
deviation was not always provided in the studies; thus, a quantitative analysis could
not be performed. Secondly, only four out of six studies were RCTs, while two of them
were retrospective studies.[12]
[17] Therefore some data presented in the systematic review is not of high quality. Third,
all studies included were published in English, which might lead to publication bias.
Fourth, we only investigated functional outcome and complications since those two
were the most associated factors with the development of the ACLR technique. Finally,
the variability in the follow-up period might have also influenced our data analysis.
Conclusion
There is high-level evidence that LET procedure in addition to ACLR is preferable
to ACLR alone in terms of functional outcome and rate of graft failure.