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CONSORT flow diagram.  

CONSORT flow diagram.  

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Purpose: This prospective case series is designed to determine the 2-year clinical and radiological outcomes of patients undergoing an ACL reconstruction using the ligament augmentation reconstruction system (LARS) 133 prosthesis as an augmentation device for a 4-tunnel autologous hamstrings graft, in the context of accelerated rehabilitation. Meth...

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... In order to improve patient's outcome and decrease the risk of reinjury, especially for patients with high activity levels, extra-articular procedure, such as anterolateral ligament (ALL) reconstruction, as well as ACL reconstruction with autograft or allograft augmented with a synthetic device method have been proposed [17][18][19][20][21][22]. Early generations of synthetic intra-articular devices raised concerns about non-infectious knee joint synovitis with effusion, but a new generation, such as the ligament augmentation and reconstruction system (LARS; surgical implants and devices), have shown low rates of 0.2% [23]. ...
... This outcome contrasts with the high failure rate and synovitis rate and carries an increased risk of developing early-onset knee osteoarthritis [24,25]. Falconer et al. concluded that the combined intra-articular autograft/LARS device can provide a graft construct that can accelerate rehabilitation without increasing the risk of knee laxity or graft failure [18]. ...
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PurposeTo compare the clinical, radiological, and second-look arthroscopic outcomes in patients who underwent anterior cruciate ligament (ACL) reconstruction using a four-strand hamstring tendon graft (hamstring group) either without augmentation or with ligament augmentation and reconstruction system (LARS) augmentation (LARS augmentation group).Methods From January 2018 to December 2019, patients who underwent ACL reconstruction were included. Patient-reported outcome measures (PROMs) were undertaken pre-operatively and at three, six, 12, and 24 months post-operatively. Arthroscopic evaluation was performed focusing on the morphology of the graft based on graft tension, graft tear, and synovial coverage.ResultsA total of 178 consecutive patients received single-bundle ACL reconstruction, 89 patients in each group, and 20 patients were lost to follow-up in the first two years. At the three month follow-up, the LARS augmentation group had significantly higher Lysholm scores, IKDC scores, and KOS-ADLS scores than the hamstring group (P < 0.001). At the three, six and 12-month follow-ups, there were significantly higher Tegner scores and ACL-RSI scores in the LARS augmentation group than in the hamstring group (P < 0.05). At the three and six month follow-ups, the LARS augmentation group had significantly higher rates of return to sports and return to sports at their preinjury level (P < 0.05). There were no between-group differences in other outcomes, including arthroscopic outcomes, graft signal intensity, post-operative complications or rerupture rates.Conclusions Autologous hamstring augmented with the LARS augmentation technique provides good and realistic clinical and functional results during the early post-operative period with high levels of satisfaction of patients, including participation in sports and physical activity, and high rates of return to sports at the preinjury level, without any apparent complications compared with hamstring ACL reconstruction alone. No increases in complication, reinjury rates, or increased lateral laxity were observed at the 12-month or 24-month follow-up.
... There is a diminished level of graft strength and stiffness observed during the early tissue revascularization process [11], with an associated requirement to control patient activity and associated graft stress with early accelerated rehabilitation potentially risking excessive graft laxity which can be associated with subsequent instability and/or re-injury [27]. Therefore, ACLR surgical techniques augmenting (or reinforcing) an auto or allograft with a synthetic device have been reported [2,4,8,10,13,32], though high rates of synovitis, early osteoarthritic change and failure rates limited the early use and subsequent adoption of synthetics for ACLR [16,18,19,21,22,29,30]. ...
Article
PurposeTo compare the clinical and radiological outcomes in patients undergoing anterior cruciate ligament reconstruction (ACLR) with, or without, LARS augmentation.Methods One-hundred and thirty-six patients that underwent double-bundle ACLR with (DB Hams/LARS, n = 67), or without (DB Hams, n = 69), LARS augmentation, were assessed clinically and with Magnetic Resonance Imaging (MRI) at a minimum of 7-years post-surgery. Patients were assessed via patient-reported outcome measures (PROMs), KT-1000 (laxity), isokinetic knee extensor and flexor strength and a 4-hop test battery. Limb symmetry indices (LSIs) were calculated. The Whole-Organ Magnetic Resonance Imaging Score (WORMS) evaluated knee status via MRI. Sport participation, secondary operations, ACL re-tears and contralateral ACL tears were reported.ResultsNo differences (n.s.) were observed in demographics, PROMs, KT-1000 scores or strength and hop LSIs. Normal (< 3 mm side-to-side differences) KT-1000 scores were observed in 64 (92.8%) and 59 (88.1%) of DB Hams and DB Hams/LARS patients, respectively. Comparative rates of satisfaction were reported. Knee flexor strength and hop test LSIs were all ˃95% in both groups, which was 94.2% and 96.7% for knee extensor strength in the DB Hams and DB Hams/LARS cohorts, respectively. While 53 (76.8%) and 52 (77.6%) of the DB Hams and DB Hams/LARS patients had returned to pivoting sports, 42 (60.9%) and 41 (61.2%) were participating in pivoting sports at the minimum 7-year review. No difference (n.s.) was observed in the WORMS (12.3 DB Hams, 16.7 DB Hams/LARS). Of the cohort assessed, 8 (11%) DB Hams and 11 (16%) DB Hams/LARS patients had undergone secondary surgery. In addition to one patient in each group that demonstrated ACL rupture on MRI, an additional cohort of patients were excluded from the current analysis due to prior re-tear (DB Hams n = 6, DB Hams/LARS n = 8) or contralateral ACL tear (DB Hams n = 4, DB Hams/LARS n = 4).Conclusions Comparable outcomes were observed after double-bundle ACLR using autologous hamstrings with, or without, LARS augmentation. Therefore, while these outcomes do not justify the additional use of synthetic augmentation given the lack of further benefit and additional cost, higher rates of graft failure, synovitis and early osteoarthritic change previously reported were not observed.Level of EvidenceIII.
... Augmentation of ACLR autografts with synthetic material is a recognized technique proposed to facilitate and accelerate rehabilitation. 18,19,20,32 Fears regarding noninfective synovitis with effusion were noted with earlier generations of intra-articular synthetic devices, but new generations, such as the Ligament Augmentation and Reconstruction System (LARS; Surgical Implants and Devices), have shown low rates of 0.2%. 35 This is in contrast to earlier devices that had high failure and synovitis rates and an increased risk of early-onset osteoarthritis. ...
... The reported failure (retear) rate of 2.0% in the current study is comparable with the rates in other similar studies. 2,12,20 First-generation synthetic augmentations used intra-articularly did cause concerns regarding noninfective synovitis, persistent effusion, early failure, and potentially early degeneration of chondral surfaces. 10,33 We found none of these issues within the study population. ...
... The overall result led to only 7% of patients having a side-to-side difference >3 mm at 2 years. 20 Bodendorfer et al 12 conducted a similar comparative cohort study to the current study, assessing the differences between single-bundle 4-strand hamstring ACLR with or without suture augmentation using the InternalBrace (Arthrex). They reported outcomes in 30 augmented ACLRs and a matched cohort of 30 hamstring-only ACLRs at 2 years and demonstrated that having a suture-augmented construct predicted a greater improvement in IKDC scores and KOOS Sport and Recreation and Quality of Life subscores, among other outcomes. ...
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Background Few studies have reported the return-to-sports (RTS) rate in patients after augmentation of autologous anterior cruciate ligament reconstruction (ACLR) with the Ligament Augmentation and Reconstruction System (LARS). Purpose/Hypothesis The purpose of this study was to compare postoperative outcomes in patients who underwent ACLR with single-bundle 4-strand hamstring autograft either without augmentation (HA-ACLR group) or with LARS augmentation (AUG-ACLR group). It was hypothesized that clinical outcomes and RTS rates would be better in the AUG-ACLR group at the 1-year follow-up, with similar outcomes in both cohorts by 2 years. Study Design Cohort study; Level of evidence, 3. Methods Patients who underwent ACLR between April 2014 and December 2017 were included in the current comparative study if they were skeletally mature and had 1- and 2-year follow-up outcomes; patients with concomitant meniscal surgery were also included. Included were 66 patients with AUG-ACLR (mean age, 26.8 years; 67% male) and 130 patients with HA-ACLR (mean age, 27.5 years; 61% male). Subjective outcome measures included the International Knee Documentation Committee Subjective Knee Evaluation Form, Knee injury and Osteoarthritis Outcome Score, Lysholm scale, Tegner activity scale, and the Noyes sports activity rating scale. Objective measures included knee laxity, maximal isokinetic knee flexion and extension strength, and the results of 4 functional hop tests. Results There were no significant differences between the study groups in age, sex distribution, body mass index, time to surgery, or number of concurrent meniscal surgeries. At the 1-year follow-up, the AUG-ACLR group had a significantly higher Tegner score ( P = .001) and rates of RTS ( P = .029) and return to preinjury level of sport ( P = .003) compared with the HA-ACLR group. At the 2-year follow-up, there were no differences in these measures between groups. There were no between-group differences in other subjective outcomes, knee laxity, or strength and hop test results at either postoperative time point. There were also no differences in rerupture rates or other complications between the groups. Conclusion Patients with AUG-ACLR had higher 1-year postoperative Tegner scores and rates of RTS and preoperative sport level compared with the HA-ACLR group. The 2-year rerupture rate for the AUG-ACLR group was low, and no intra-articular inflammatory complications were noted.
... This observational study was designed to investigate patients returning for testing as part of a larger cohort study to evaluate the clinical outcomes of the Hybrid graft configuration [13]. It was a retrospective analysis of prospectively collected data. ...
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Introduction: Understanding factors that cause loss of extension post Anterior Cruciate Ligament (ACL) reconstruction may assist surgeons in preventing this problem. The aim of this clinical trial is to determine the effect of reconstructed ACL graft size on postoperative range of motion in ACL reconstruction in human subjects. Methods: This therapeutic comparative cohort study consisted of a retrospective analysis of prospectively collected data. Participants either received an autologous double bundle ACL graft (Control) or a combined autologous/synthetic graft (Hybrid), which increased graft cross-sectional area. Femoral notch width was measured preoperatively by Magnetic Resonance Imaging. Range of motion was determined using goniometry at two years post reconstruction. Stepwise logistic regression and bivariate correlation was used to analyse data. Results: 54 participants were included in analysis, 22 Control and 32 Hybrid. Hybrid group had a significantly larger reconstructed graft cross-sectional area (× (Hybrid)=71 ± 9.30 mm2; × (Control)=59 ± 12.26 mm2, t=4.76, p<0.05). Mean notch size was smaller in Control group (1.83 ± 0.18 cm) compared to Hybrid group (1.91 ± 0.27 cm). Hybrid group had significantly fewer cases of postoperative knee extension loss (χ2=3.90, p<0.05), defined as loss of passive range ≥ 3° at 2 years post-surgery. Increased graft cross-sectional area was not a significant predictor of loss of extension. There was also no relationship between notch width and extension range of movement. (r=0.01, p=0.80). Conclusion: A 20% increase in ACL graft cross-sectional area was not a significant predictor of postoperative extension loss. graft options [9]. Upsizing
... While a recent 10-year longitudinal study 9 demonstrated satisfactory clinical outcomes and failure rates in patients undergoing primary ACLR employing a synthetic ligament and remnant preservation, excessive synovitis and high failure rates have limited their ongoing use in earlier studies. 26,27,29,36,43,45,63,64 In an attempt to improve clinical outcomes and reduce reinjury rates, particularly in patients with higher activity levels and those seeking an earlier RTS, concomitant extra-articular procedures such as anterolateral ligament reconstruction, 10 as well as methods of ACLR employing an autograft or allograft augmented (or reinforced) with a synthetic device, 14,19,20,49,51 have been proposed. As previously reported by Falconer et al, 14 the proposed advantage of the combined intra-articular autograft/Ligament Augmentation and Reconstruction System (LARS; Corin Group) construct is to permit early ACL reinforcement and accelerated rehabilitation without the increased risk of graft stretching and/or failure. ...
... 26,27,29,36,43,45,63,64 In an attempt to improve clinical outcomes and reduce reinjury rates, particularly in patients with higher activity levels and those seeking an earlier RTS, concomitant extra-articular procedures such as anterolateral ligament reconstruction, 10 as well as methods of ACLR employing an autograft or allograft augmented (or reinforced) with a synthetic device, 14,19,20,49,51 have been proposed. As previously reported by Falconer et al, 14 the proposed advantage of the combined intra-articular autograft/Ligament Augmentation and Reconstruction System (LARS; Corin Group) construct is to permit early ACL reinforcement and accelerated rehabilitation without the increased risk of graft stretching and/or failure. This study presents a remnant-sparing surgical technique for ACLR employing autologous hamstrings augmented with the LARS, together with clinical outcomes for 50 patients who underwent the technique. ...
Article
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Background There are a number of surgical methods for undertaking anterior cruciate ligament (ACL) reconstruction (ACLR), although relatively high rates of ipsilateral retears and contralateral tears exist, with only 65% of patients returning to their preinjury level of sport. ACLR techniques adopting synthetic augmentation have been proposed in an attempt to improve clinical outcomes and reduce reinjury rates. Purpose To determine the efficacy of ACLR using autologous hamstrings augmented with the Ligament Augmentation and Reconstruction System (LARS). Study Design Case series; Level of evidence, 4. Methods A total of 65 patients were prospectively treated with arthroscopically assisted single-bundle ACLR using hamstrings augmented with the LARS, of whom 50 were available for 1- and 2-year reviews. Patient-reported outcome measures (PROMs), KT-1000 arthrometer testing, knee range of motion, peak isokinetic knee strength testing, and a battery of 4 hop tests were employed. Limb symmetry indices (LSIs) were calculated. Analysis of variance was used to evaluate differences over time and between limbs. Data on return to the preinjury level of sport, retears, and reoperations were collected. Results High PROM scores were demonstrated at 1 and 2 years. Before the injury, 47 patients (94%) were actively participating in level 1 or 2 sports, with 38 (76%) and 43 (86%) patients having returned at 1 and 2 years, respectively. Normal (<3 mm; 90%) or nearly normal (3-5 mm; 10%) KT-1000 arthrometer side-to-side differences were observed at 2 years. Apart from knee flexion ( P < .0001), extension ( P = .001), and the 6-m timed hop ( P = .039), there were no between-limb differences at 1 year, and there were no differences on any objective measures at 2 years (all P > .05). Mean LSIs across all measures were ≥90%. At 2 years, 84% to 90% of patients were ≥90% on the hop tests, with 72% and 76% of patients having ≥90% for extension and flexion strength, respectively. Two reoperations were undertaken for meniscal tears (7 and 8.5 months), 1 patient (2%) suffered a retear at 7 months, and 2 patients (3%) suffered a contralateral tear (8 and 12 months). Conclusion This augmented ACLR technique demonstrated good clinical scores, a high rate of return to sport, and low rates of secondary ruptures and contralateral ACL tears at 2 years. Some caution should be noted in interpreting these results, as 15 of 65 patients (23%) were not included in the 2-year follow-up.
Article
Background: Meniscal strain patterns are not well understood during dynamic activities. Furthermore, the impact of ACL reconstruction on meniscal strain has not been thoroughly investigated. The purpose of this study was to characterize ACL and meniscal strain during dynamic activities and investigate the strain difference between ACL-intact and ACL-reconstructed ligament conditions. Methods: ACL and medial meniscal strain were measured in-vitro during gait, a double leg squat, and a single leg squat. For each activity kinematics and muscle forces were applied to seven cadaveric specimens using a dynamic knee simulator. Testing was performed in the ACL-intact and ACL-reconstructed ligament conditions. Results: Both the ACL and meniscus had distinct strain patterns that were found to have a significant interaction with knee angle during gait and double leg squat ([Formula: see text]). During gait, both tissues experienced lower strain during swing than stance (ACL: 3.0% swing, 9.1% stance; meniscus: 0.2% swing, 1.3% stance). Meniscal strain was not found to be different between ACL-intact and ACL-reconstructed conditions ([Formula: see text]). Conclusions: During dynamic activities, the strain in the meniscus was not altered between ACL ligament conditions. This indicates that meniscal mechanics after ACL reconstruction are similar to a healthy knee. These results help further the understanding of osteoarthritis risk after ACL reconstruction.