Ligament Augmentation Reconstruction System Research Articles

Ligament Augmentation Reconstruction System (LARS) for Ankle Lateral Ligament Reconstruction in Higher-Risk Patients: A 5-Year Prospective Cohort Study.

Background:The modified Broström-Gould (MBG) procedure is the gold standard for patients with chronic ankle instability (CAI), but it is relatively contraindicated for patients with higher body weight or generalized ligamentous laxity (GLL). The use of the ligament augmentation reconstruction system (LARS) is an alternative.Hypothesis:It was hypothesized that clinical outcomes would be similar in patients with increased body weight (>90 kg) or GLL, relative to controls.Study Design:Cohort study; Level of evidence, 2.Methods:A total of 66 patients satisfying the inclusion criteria were invited to participate and were divided into 3 groups: controls (no risk factors for inferior clinical outcome), patients with body weight >90 kg, and patients with GLL (Beighton score, ≥5 of 9). All patients underwent imbrication of the lateral collateral ligament complex augmented with the LARS. Primary outcomes of interest were Tegner activity scale (TAS) and Foot and Ankle Outcome Score (FAOS) subscale scores. Secondary outcomes were recurrence of ankle instability, the need for further surgery, and/or complications. Patients were reviewed at 2 and 5 years postoperatively, and outcomes between groups were compared using repeated-measures analysis of variance.Results:Complete data were available for 63 patients (21 patients in each group). TAS improved in all groups from preoperatively to 2 years and 5 years postoperatively (P < .001 for all). Relative to the controls, the TAS scores were lower in the >90-kg group at 2 years and 5 years (P < .001 for both periods), while the GLL group had similar scores to controls at both postoperative periods. Both the >90-kg and the GLL groups showed no significant difference in improvement on any FAOS subscale scores relative to the controls, at both 2 and 5 years postoperatively. There were no recurrences, repeat surgeries, or major complications.Conclusion:Relative to controls, patients with body weight >90 kg or GLL had similar FAOSs, and TAS scores were lower in the >90-kg group, at 2 and 5 years, after the use of the LARS to augment lateral collateral ligament imbrication for CAI. Use of the LARS in this manner is a viable option in patients for whom the MBG procedure is relatively contraindicated.

Medium- to long-term results of acromioclavicular joint stabilisation using the Ligament Augmentation Reconstruction System (LARS) ligament.

Opinion is divided as to optimum management of grade III acromioclavicular joint injuries that have failed conservative management. We objectively investigated the radiological and functional outcome of acromioclavicular joint reconstruction using the Ligament Augmentation Reconstruction System (LARS®). Retrospective review of patients with LARS reconstruction of acromioclavicular joint dislocations with minimum six-year follow-up. Functional assessment was performed using the constant score, Disability of Arm Shoulder and Hand score and simple satisfaction score. Radiological assessment was undertaken using plain radiographs. Results were compared with the uninjured limb. Twenty-four of 25 patients were included. Mean constant score for the injured shoulder was 87.0, Disability of Arm Shoulder and Hand score was 11.6. All patients indicated that they would have the operation again. There were five complications including two patients that suffered small cracks in the clavicle. Coracoid erosion was frequently seen but was most often minor. In two cases, this resulted in a complete dissociation of the coracoid tip but without functional detriment. LARS is a safe and effective method of acromioclavicular joint reconstruction producing good results, and we recommend its use for these injuries. We also caution clinicians who use cerclage methods to be aware of coracoid erosion when following up their patients.

Ankle Lateral Ligament Augmentation Versus the Modified Broström-Gould Procedure: A 5-Year Randomized Controlled Trial

Background: “Ankle sprain” is a common injury, and >20% of patients may develop chronic instability for which surgery is indicated. The modified Broström-Gould (MBG) procedure remains the gold standard; however, there are a number of relative contraindications to this procedure, and the longer-term outcomes after the MBG have been questioned. An alternative procedure is augmentation of a primary repair with a ligament augmentation reconstruction system (LARS). Purpose: To conduct a randomized controlled trial testing the null-hypothesis that there is no difference in patient scored outcomes and activity levels, between patients undergoing a MBG procedure compared with those undergoing a primary repair with LARS augmentation, for lateral ligament instability of the ankle. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients who satisfied the inclusion criteria were invited to take part in the study. Patients were randomly allocated to undergo the LARS or MBG procedure. Both groups followed similar postoperative rehabilitation. Patients completed the Foot and Ankle Outcome Score (FAOS) before surgery and then at 1, 2, and 5 years after surgery. Tegner activity scores were recorded at 5years. The scores in the 2 groups were compared via statistical analysis (P < .05). Results: Of the 50 patients satisfying the inclusion criteria, 47 agreed to take part in the study. Twenty-two were randomized to the LARS group and 25 to the MBG group. At 5 years, follow-up data were complete for 20 patients in the LARS group and 21 in the MBG. There were 2 failures in the MBG group and 0 in the LARS group. The LARS group had significantly better improvement in total FAOS at 1 year (mean ± SD, 92.4 ± 2.5 vs 78.2 ± 3.4, P = .005), 2 years (94.0 ± 3.0 vs 78.0 ± 5.2, P = .003), and 5 years (93.7 ± 6.0 vs 75.1 ± 5.5, P = .002) after surgery. The 5-year Tegner activity scores were higher in the LARS group (8.25 ± 1.1 vs 7.2 ± 0.9, P = .03). Conclusion: Among physically active patients with chronic lateral ligament instability, primary repair combined with LARS results in better total FAOS at 5-year follow-up and higher Tegner activity scores as compared with the MBG procedure. Registration: ACTRN12618000906257 (Australia New Zealand Clinical Trial Registry).

Utilisation du ligament artificiel LARS dans le traitement de la luxation acromio-claviculaire. Résultats à long terme au recul moyen de 7,4 ans

BackgroundThe acromioclavicular (AC) joint is of great importance for shoulder stability and one of the most frequently injured regions of the shoulder. HypothesisAC joint reconstruction with the ligament augmentation & reconstruction system (LARS™) leads to a good-to-excellent outcome at long-term follow-up. Patients and methodsThis study was performed as a retrospective single-centre data analysis of a level-I trauma centre. All patients treated operatively for an acute AC dislocation with the LARS™ between 2003 and 2013 were included. ResultsThe study group consisted of three female (6%) and 44 male patients (94%) with an average age of 37 years and a minimum follow-up of two years. The overall mean clinical outcomes at latest follow-up were: Constant 93, DASH 2.64, ASES 96, SST 97, UCLA 34 and VAS 0.4 – representing a good-to-excellent outcome in all patients. Overall, 45 patients (96%) reported to be very satisfied with the achieved result at latest follow-up. In five patients (11%) complications occurred during the follow-up period, requiring surgical revision in four of the five patients (80%). ConclusionAC joint reconstruction with the LARS™ achieves good-to-excellent clinical and functional outcomes at long-term follow-up with a surgical revision rate of 8.5%. Level of evidenceRetrospective follow-up study, case series, level IV.

The use of the LARS system in the treatment of AC joint instability -Long-term results after a mean of 7.4 years.

The acromioclavicular (AC) joint is of great importance for shoulder stability and one of the most frequently injured regions of the shoulder. AC joint reconstruction with the ligament augmentation & reconstruction system (LARS™) leads to a good-to-excellent outcome at long-term follow-up. This study was performed as a retrospective single-centre data analysis of a level-I trauma centre. All patients treated operatively for an acute AC dislocation with the LARS™ between 2003 and 2013 were included. The study group consisted of three female (6%) and 44 male patients (94%) with an average age of 37 years and a minimum follow-up of two years. The overall mean clinical outcomes at latest follow-up were: Constant 93, DASH 2.64, ASES 96, SST 97, UCLA 34 and VAS 0.4-representing a good-to-excellent outcome in all patients. Overall, 45 patients (96%) reported to be very satisfied with the achieved result at latest follow-up. In five patients, (11%) complications occurred during the follow-up period, requiring surgical revision in four of the five patients (80%). AC joint reconstruction with the LARS™ achieves good-to-excellent clinical and functional outcomes at long-term follow-up with a surgical revision rate of 8.5%. Retrospective follow-up study, case series, level IV.

Current practice in the management of Rockwood type III acromioclavicular joint dislocations-National survey.

Our aim was to conduct this survey among consultant shoulder surgeons in the United Kingdom to document the current management of Rockwood type III acromioclavicular joint (ACJ) injuries. British Elbow and Shoulder Society Research Committee-approved online survey was used and 137 responses were collected within 3 months. One hundred percent of responders would treat type III injuries conservatively initially. Routine physiotherapy would be offered by 86% of surgeons. The patient's factors that influence the decision to consider surgery are pre-injury functional demand, current functional deficit, pain and patient request for surgery. Across all groups the mean time to surgical intervention from injury was 3.8 months. About 45% of all consultants would use the same technique for all cases and there were differences between the varieties of techniques used by surgeons, depending on their degree of experience. LockDown was the most widely used technique in all groups of patients. This was followed by Ligament Augmentation & Reconstruction System (LARS), hook plate and Arthroscopic TightRope/DogBone technique for acute injuries. LARS, modified Weaver-Dunn and ACJ resection were used most commonly after LockDown for delayed cases. Our survey revealed the current trends in clinical practice to treat symptomatic Rockwood type III ACJ injuries, but it also confirmed the controversial and complex management differences, which vary among shoulder surgeons in the United Kingdom.

THE LARS AUGMENTED 4-TUNNEL HAMSTRING “HYBRID” ACLR GRAFT CONSTRUCTION ALLOWS ACCELERATED REHABILITATION WITHOUT KNEE LAXITY — CASE SERIES OF 111 PATIENTS AFTER 2 YEARS

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. Methods: A total of 91 patients were assessed at 2 years post-operatively after undergoing an anterior cruciate ligament reconstruction (ACLR) with a doubled semitendinosis and LARS 133 prosthesis for the anteromedial bundle (AMB) and gracilis for the posterolateral bundle. Assessment included clinical review, KT-1000 arthrometry, IKDC, Tegner, Lysholm, Cincinnati and ACL QOL knee scoring, graft failure and re-operation rates. Tunnel positions and synovitis were assessed using gadolinium magnetic resonance imaging (MRI) scans and X-rays. Results: This technique in the context of accelerated rehabilitation is not associated with increased knee laxity and failure. There was no increase in knee laxity, with a mean side-to-side difference in KT-1000 arthrometer testing of 0.5[Formula: see text]mm ([Formula: see text]/[Formula: see text] 1.7). Two-year outcomes were satisfactory with 98% of all patients having an IKDC rating of A or B, and mean values of IKDC subjective 86.5 ([Formula: see text]/[Formula: see text] 11.6), Tegner 6.5 ([Formula: see text]/[Formula: see text] 2.0), Lysholm 87.1 ([Formula: see text]/[Formula: see text] 8.9), Cincinnati 378.8 ([Formula: see text]/[Formula: see text] 41.5) and ACL Quality of Life 81.5 ([Formula: see text]/[Formula: see text] 19.3). There was no evidence of synovitis and all tunnels were positioned satisfactorily. The graft failure rate was 1.1% and there was a re-operation rate of 15.4%. Conclusion: We conclude that LARS 133 augmentation of autologous hamstrings ACLR provides a graft construct allowing accelerated rehabilitation without increased knee laxity. It is not associated with significant synovitis within the first two years. Re-operation rates however are higher. The rates at which patients recover and return to life and sports activity following different ACLR graft types appears as a topic of future research interest.

Clinical and functional outcome after anterior cruciate ligament reconstruction using the LARS™ system at a minimum follow-up of 10 years

BackgroundSince the 1980's several artificial ligaments were used for reconstruction of the anterior cruciate ligament (ACL) serving different complications. The aim of this study was to assess the clinical and functional outcomes of primary ACL reconstruction using the Ligament Augmentation Reconstruction System (LARS™) with a minimum follow-up of 10-years. The LARS™ presents a synthetic material consisting of non-absorbing polyethylene terephthalate fibres used for ligament reconstruction. MethodsOutcomes of 18 patients who underwent arthroscopic ACL reconstruction using the LARS™ system between 2000 and 2004 with a minimum follow-up of 10years were observed. The International Knee Documentation Committee score (IKDC), Visual Analog Scale (VAS), Lysholm score, and Tegner Activity Scale were assessed. Clinical assessment was performed by Lachman testing, assessment of side-to-side difference on KT-2000 testing and plain radiography evaluation of osteoarthritis. ResultsThere were seven males and 11 females, mean age 29years (range, 18 to 44years) and a mean follow-up of 151.5 months. Five patients (27.8%) sustained a re-rupture of the LARS™ system and underwent revision surgery after a mean time of 23months and four patients (22.2%) presented with a re-rupture. The average IKDC score was 76.60±18.18, the average Lysholm score was 88.00±10.07 and the average Tegner activity score was five at final follow-up. ConclusionOur results indicate that the LARS™ system should currently not be suggested as a potential graft for primary reconstruction of the ACL. In special cases, however, the LARS™ system can serve as an alternative graft.Level of evidence: Level IV, retrospective study.

Primary ankle ligament augmentation versus modified Brostrom-Gould procedure: a 2-year randomized controlled trial

More than 20% of patients develop chronic instability following appropriate management of an 'ankle sprain'. There is little research comparing surgical techniques. 'Anatomical' procedures, such as the modified Brostrom-Gould (MBG), are generally preferred. However, not all patients are suitable for this procedure. Augmentation of a primary repair using a synthetic ligament, such as the ligament augmentation reconstruction system (LARS), is another 'anatomic' option. Our objective was to compare the clinical outcome following the MBG with that following the LARS technique using a prospective randomized clinical trial. Patients who satisfied the study criteria were randomly allocated to undergo the LARS procedure or the MBG procedure. All patients followed a similar rehabilitation programme. Patients completed the foot and ankle outcome score (FAOS) before surgery, and then at 1 year and 2 years following surgery. Statistical analysis was used to compare the groups (P < 0.05). Forty-one patients took part in the study, 21 were randomized to the LARS group and 20 to the MBG group. The LARS group had a significantly better improvement in the total FAOS at both 1 year (25.5 standard error (SE) 3.8 versus 16.0 SE 3.3) and 2 years (27.1 SE 4.5 versus 15.8 SE 4.9) post-surgery. Primary repair combined with LARS results in better patient-scored clinical outcome, at 2 years post-surgery, than the MBG procedure. Although longer follow-up is required, the LARS procedure may be considered as an alternative, especially in those patients for whom the MBG is relatively contra-indicated.

Revision ACL reconstruction after use of the LARS ligament: A case series

Introduction: The Ligament Augmentation Reconstruction System (LARS. Surgical Implants and Devices, Arc-sur-Tille, France) is a synthetic non-absorbable augmentation device made of polyethelyne terephtalate (PET). It has rapidly gained popularity in Australia with 982 used in 2009 and 1050 in 8 months in 2010 according to the manufacturers website. Whilst autograft use in Anterior cruciate ligament (ACL) reconstruction has demonstrated excellent clinical results, little has been published to support the use of artificial ligaments. Poor patient outcomes associated with graft failure, tunnel osteolysis, foreign body synovitis and premature arthritis are among the reasons that artificial ligaments were abandoned over two decades ago.