ABSTRACT
In this study, the effect of patient- and procedure-related parameters on organ doses (ODs), peak skin dose (PSD) and effective dose (E) during anterior cervical discectomy and fusion (ACDF) was evaluated. Patient- and procedure-related parameters, as well as fluoroscopy time, kerma-area product (KAP), cumulative air-kerma (Kair) and incident Kair, were analysed for 50 ACDF procedures performed with a mobile C-arm. These parameters were inserted in VirtualDose-IR software implementing sex-specific and body mass index (BMI)-adjustable anthropomorphic phantoms to calculate OD, PSD and E. The BMI, gender and type of implants did not significantly affect KAP, incident Kair, PSD and E. However, the type of fusion significantly affected the E. The single fusions in C5/C6 resulted in significantly higher KAP, incident Kair and E than C4/C5 levels, while those performed in C6/C7 resulted in significantly higher E and PSD than C4/C5 levels. The thyroid, oesophagus and salivary glands received the largest doses in all groups studied. The BMI did not significantly affect ODs. The salivary glands absorbed significantly higher doses in males than females, while the extrathoracic region's dose significantly increased for multi- than single-level fusions. The fusions in C6/C7 resulted in significantly higher oesophagus and thyroid doses than C3/C4 and C4/C5 levels, as well as fusions performed in C5/C6 compared with C4/C5 levels. The data presented here could be used by the neurosurgeons as a comparator for future studies in optimising radiation protection during ACDF procedures in the operating theatre by keeping the ODs, PSD and E as low as reasonably practicable.
Subject(s)
Cervical Vertebrae , Diskectomy , Male , Female , Humans , Cervical Vertebrae/surgery , Software , FluoroscopyABSTRACT
COVID-19, a contagious disease caused by the novel coronavirus SARS-CoV-2, emerged in 2019 and quickly became a pandemic, infecting more than 700 million people worldwide. The disease incidence, morbidity and mortality rates have started to decline since the development of effective vaccines against the virus and the widespread immunization of the population. SARS-CoV-2 vaccines are associated with minor local or systemic adverse reactions, while serious adverse effects are rare. Thyroid-related disorders have been reported after vaccination for COVID-19, and Graves' disease (GD) is the second most common amongst them. Thyroid eye disease (TED), an extrathyroidal manifestation of GD, is rarely observed post-COVID-19 vaccination. All TED cases followed mRNA-based vaccinations, but two new onset mild TED cases post-viral vector vaccine (ChAdox1nCoV-19) have also been reported. We report the case of a 63-year-old woman who presented with new onset hyperthyroidism and moderate-to-severe and active TED 10 days after she received the first dose of a viral vector vaccine against SARS-CoV-2. This is the first case of moderate-to-severe TED after such a vaccine. Our patient was initially treated with intravenous glucocorticoids, and subsequently with intravenous rituximab, due to no response. The disease was rendered inactive after rituximab, but constant diplopia persisted, and the patient was referred for rehabilitative surgery.
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BACKGROUND: The formation, growth, and rupture of intracranial aneurysms (IA) are due to several pathophysiological mechanisms, including focal hemodynamic injury and inflammation of the arterial wall. We investigated the differences between venous, parent artery, and intra-aneurysmal blood by measuring inflammatory factors and antibodies in patients with ruptured (rIA) or unruptured intracranial aneurysms (uIA). METHOD: A prospective study was performed in patients who presented with IA and required endovascular treatment. Blood was drawn from the lumen of the aneurysm sac, the parent artery, and the peripheral veins, to determine the serum concentrations of complement factors C3, C4, IgG, IgM, IgA antibodies, and C-reactive protein (CRP). RESULTS: Thirty-six patients (15 with uIA and 21 with rIA) were enrolled in the study. In both groups, C3, C4, IgM, IgG, and IgA showed a gradual decrease from venous to intra-aneurysmal samples, but only IgG in the parent artery and intra-aneurysmal samples reached a significant decrease in uIA compared with venous samples. Accordingly, C3 and IgG concentrations in the intra-aneurysmal samples showed a significant decrease in rIA compared with venous samples. A significant increase in CRP concentrations was observed in parent artery and intra-aneurysmal samples from patients with rIA compared with patients with uIA; a significant increase in C3 concentrations was observed in parent artery samples from patients with rIA compared with patients with uIA, and a significant decrease in IgM concentrations was observed in venous, parent artery, and intra-aneurysmal samples from patients with rIA compared with patients with uIA. CONCLUSIONS: A decrease in C3 and IgG in the aneurysm sac indicates activation of the complement system in the arterial wall. CRP in the aneurysm sac and lumen of the parent artery was significantly increased in ruptured compared with unruptured aneurysms, whereas venous, parent artery, and intra-aneurysmal IgM were decreased in ruptured compared with unruptured aneurysms. These results argue for the role of an ongoing inflammatory process in aneurysms leading to their growth and rupture.
Subject(s)
Aneurysm, Ruptured , Intracranial Aneurysm , Humans , Intracranial Aneurysm/therapy , Prospective Studies , Aneurysm, Ruptured/complications , Immunoglobulin A , Immunoglobulin G , Immunoglobulin MABSTRACT
Objective. To establish institutional diagnostic reference levels (IDRLs) based on clinical indications (CIs) for three- and four-phase computed tomography urography (CTU).Methods. Volumetric computed tomography dose index (CTDIvol), dose-length product (DLP), patients' demographics, selected CIs like lithiasis, cancer, and other diseases, and protocols' parameters were retrospectively recorded for 198 CTUs conducted on a Toshiba Aquilion Prime 80 scanner. Patients were categorised based on CIs and number of phases. These groups' 75th percentiles of CTDIvoland DLP were proposed as IDRLs. The mean, median and IDRLs were compared with previously published values.Results. For the three-phase protocol, the CTDIvol(mGy) and DLP (mGy.cm) were 22.7/992 for the whole group, 23.4/992 for lithiasis, 22.8/1037 for cancer, and 21.2/981 for other diseases. The corresponding CTDIvol(mGy) and DLP (mGy.cm) values for the four-phase protocol were 28.6/1172, 30.6/1203, 27.3/1077, and 28.7/1252, respectively. A significant difference was found in CTDIvoland DLP between the two protocols, among the phases of three-phase (except cancer) and four-phase protocols (except DLP for other diseases), and in DLP between the second and third phases (except for cancer group). The results are comparable or lower than most studies published in the last decade.Conclusions. The CT technologist must be aware of the critical dose dependence on the scan length and the applied exposure parameters for each phase, according to the patient's clinical background and the corresponding imaging anatomy, which must have been properly targeted by the competent radiologist. When clinically feasible, restricting the number of phases to three instead of four could remarkably reduce the patient's radiation dose. CI-based IDRLs will serve as a baseline for comparison with CTU practice in other hospitals and could contribute to national DRL establishment. The awareness and knowledge of dose levels during CTU will prompt optimisation strategies in CT facilities.
Subject(s)
Diagnostic Reference Levels , Lithiasis , Humans , Retrospective Studies , Urography , Tomography, X-Ray ComputedABSTRACT
The GORE EXCLUDER Conformable abdominal aortic aneurysm (AAA) Endoprosthesis (CEXC), is currently the newest stent-graft system for treating patients with AAA. CEXC is approved for patients with proximal aortic neck angles ≤90° with a ≥15 mm aortic neck length or proximal aortic neck angles ≤60° with ≥10 mm aortic neck length. The present study describes a clinical series of 5 males with AAA, one of whom had a ruptured infrarenal AAA and a 90° proximal aortic neck angle. All patients were treated with 100% technical success using the CEXC device. Dosimetric data were recorded regarding the total kerma-area product and total fluoroscopy time. During the 30-day follow-up, no device migration or failure was detected, whereas type Ib and II endoleaks were observed in two patients. The type Ib endoleak required re-intervention with limb extension placement, and the type II endoleak was treated with lumbar artery embolization. This clinical series showed that CEXC has no technical defects or AAA-related mortality. We also reviewed the current knowledge on CEXC's clinical outcomes, showing promising technical and clinical results in some studies, even outside the instructions for use. CEXC expands the vascular surgeons' armamentarium against hostile neck anatomy, as it is the only repositionable endovascular aneurysm repair device available. Multicenter, long-term outcome studies should confirm the promising preliminary results of our case series and the literature review.
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Abdominal aortic aneurysm in a patient with myasthenia gravis (MG) is extremely rare. We present a 64-year-old male with MG and an asymptomatic abdominal aortic aneurysm treated endovascularly. After extubation, he suffered a cardiac arrest due to an acute myocardial infarction. Cardiopulmonary resuscitation and a primary coronary angioplasty led to a satisfactory outcome. Special care is needed due to higher rates of postoperative complications in these patients.
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In this study, the effect of patient- and procedure-related parameters on organs' dose (OD), peak skin dose (PSD) and effective dose (ED) during lumbar discectomy and fusion (LDF) was assessed. Intra-operative parameters obtained from 102 LDFs were inserted into VirtualDose-IR software implementing sex-specific and BMI-adjustable anthropomorphic phantoms for dosimetric calculations. Fluoroscopy time (FT), kerma-area product (KAP), cumulative and incident air-kerma (Kair) were also recorded from the dosimetric report of the mobile C-arm. An increase in KAP, Kair, PSD and ED was found for male or higher BMI patients, multi-level or fusion or L5/S1 procedures. However, a significant difference was found only for PSD and incident Kair between normal and obese patients and for FT between discectomy and discectomy and fusion procedures. The spleen, kidneys and colon received the highest doses. The BMI have a significant impact only for kidneys, pancreas, and spleen doses when comparing obese to overweight and for urinary bladder when comparing overweight to normal patients. Multi-level and fusion procedures resulted in significantly higher doses for lungs, heart, stomach, adrenals, gallbladder and kidneys, while pancreas and spleen doses significantly increased only for multi-level procedures. Additionally, a significant increase was found only for urinary bladder, adrenals, kidneys, and spleen ODs when comparing L5/S1 and L3/L4 levels. The mean ODs were lower compared to the literature. These data may aid neurosurgeons in optimising exposure techniques during LDF to keep patients' dose as low as is practicably possible.
Subject(s)
Obesity , Overweight , Female , Humans , Male , Radiation Dosage , Monte Carlo Method , DiskectomyABSTRACT
Recent advances in diagnostic neuroradiological imaging, allowed the detection of unruptured intracranial aneurysms (IAs). The shape - irregular or multilobular - of the aneurysmal dome, is considered as a possible rupture risk factor, independently of the size, the location and patient medical background. Disturbed blood flow fields in particular is thought to play a key role in IAs progression. However, there is an absence of widely-used hemodynamic indices to quantify the extent of a multi-directional disturbed flow. We simulated blood flow in twelve patient-specific anterior circulation unruptured intracranial aneurysms with daughter blebs utilizing the spectral/hp element framework Nektar++. We simulated three cardiac cycles using a volumetric flow rate waveform while we considered blood as a Newtonian fluid. To investigate the multidirectionality of the blood flow fields, besides the time-averaged wall shear stress (TAWSS), we calculated the oscillatory shear index (OSI), the relative residence time (RRT) and the time-averaged cross flow index (TACFI). Our CFD simulations suggest that in the majority of our vascular models there is a formation of complex intrasaccular flow patterns, resulting to low and highly oscillating WSS, especially in the area of the daughter blebs. The existence of disturbed multi-directional blood flow fields is also evident by the distributions of the RRT and the TACFI. These findings further support the theory that IAs with daughter blebs are linked to a potentially increased rupture risk.
Subject(s)
Aneurysm, Ruptured , Intracranial Aneurysm , Humans , Aneurysm, Ruptured/diagnostic imaging , Hemodynamics/physiology , Hydrodynamics , Intracranial Aneurysm/diagnostic imaging , Nuclear Family , Risk Factors , Stress, MechanicalABSTRACT
INTRODUCTION: Our purpose was to review the scientific literature and collect information regarding clinical and technical parameters of different single- or multiphase CT protocols, their diagnostic performance and patient dose during parathyroid imaging. EVIDENCE ACQUISITION: PubMed and Scopus databases were searched for studies investigating the diagnostic performance of CT in detecting parathyroid lesions and the corresponding patients' dose. The following information was retrieved for each article: CT system, number, combination and time interval between phases, scanning length, sensitivity, specificity, accuracy, positive and negative predictive values, contrast enhancement in Hounsfield Units (HUs), technical and exposure parameters, and dose indices. Fifty studies published during the last sixteen years (2005-2021) were reviewed. EVIDENCE SYNTHESIS: A large discrepancy in the number and combination of phases, as well as clinical and technical parameters of the CT protocols was indicated. The variations in patients' doses are mainly due to scanners' technology, number and combination of phases, the extent of scanning length, technical parameters (tube voltage, tube current modulation, pitch, reconstruction algorithms), and patient-related parameters. Technical parameters are not always adjusted appropriately to the clinical question or patient size. These variations indicate a large potential to optimize dose during parathyroid imaging without compromising diagnostic performance. The potential is to decrease the number of phases or use low tube voltage protocols, tube current modulation, iterative reconstruction, and reduce the scanning length during some phases. CONCLUSIONS: The reporting results could inform researchers about the current status of CT parathyroid imaging and guide their future efforts to optimize both patients' dose and corresponding image quality.
Subject(s)
Parathyroid Glands , Tomography, X-Ray Computed , Humans , Algorithms , Parathyroid Glands/diagnostic imaging , Predictive Value of Tests , Radiation Dosage , Tomography, X-Ray Computed/adverse effects , Tomography, X-Ray Computed/methodsABSTRACT
The coexistence of an abdominal aortic aneurysm and a congenital pelvic kidney is extremely rare. We present a 66-year-old male with an inflammatory aneurysm and an aberrant origin of the superior mesenteric artery. The inflammatory infrarenal abdominal aortic aneurysm with a congenital left pelvic kidney was successfully treated with endovascular repair. Coverage of one out of the two renal ectopic arteries was performed, without clinical evidence of renal function impairment.
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The aneurysm coiling process presents a risk of thromboembolic complications, mostly in patients with ruptured aneurysms, given the fact that they cannot receive antiplatelet therapy. Management strategies include medical anticoagulation or antiplatelet therapy, intra-arterial thrombolysis, and mechanical thrombectomy using direct aspiration first-pass technique or stent retrievers. We report our own experience of using an Excelsior SL-10 Microcatheter (Stryker, Fremont, California, USA) with an internal diameter of 0.0165", originally designed for coil delivery, for contact aspiration of a thrombotic occlusion of a distal anterior cerebral artery during coiling of a broad-based trilobar anterior communicating artery aneurysm. The clot was removed under continuous manual aspiration, and complete recanalization has been accomplished. Mechanical thrombectomy through microcatheter aspiration may be a safe and feasible treatment option for acute distal artery occlusions, especially in the case of tortuous distal vessels during embolization of cerebral aneurysms.
ABSTRACT
OBJECTIVE: To estimate organs' absorbed dose from the two-phase CT of parathyroid glands, effective dose (ED) based on three different methods, and compare the dose values with those reported by other published protocols. METHODS: Volumetric-computed-tomography-dose-index (CTDIvol), dose-length-product (DLP), and the corresponding scan length during each phase of a parathyroid protocol were recorded, for seventy-six patients. One k-factor, and two different k-factors for the neck and chest area were used to estimate the ED from DLP. A Monte Carlo software, VirtualDoseCT, was also used for the estimation of organs' absorbed dose and ED. RESULTS: Two-phase parathyroid CT resulted in a mean ED of 3.93 mSv, 4.29 mSv and 4.21 mSv according to the one k-factor, two k-factors, and VirtualDoseCT methods, respectively. The two k-factors method resulted in a slight overestimation of 1.9% in total ED compared to VirtualDoseCT. No statistically significant difference was found in ED values between these methods (Wilcoxon test, p > 0.05), except for female patients in the pre-contrast phase. The organs inside the scanning field of view (SFOV) received the following doses: thymus 23.3 mGy, lungs 11.5 mGy, oesophagus 9.2 mGy, thyroid 6.9 mGy, and breast 6.3 mGy. The ED and organs' dose (OD) values were significantly lower in the pre-contrast than in the arterial phase (Wilcoxon test, p < 0.001). A statistically significant difference was observed between male and female patients for the pre-contrast phase (Mann-Whitney test, p < 0.05), regarding the ED values obtained with the two k-factors method and VirtualDoseCT software. CONCLUSIONS: The two k-factors method could be applied for the ED estimation in clinical practice, if appropriate software is not available. An extensive range of ED values derived from the literature, mainly depending on the acquisition protocol parameters and the estimation method.
Subject(s)
Parathyroid Glands , Tomography, X-Ray Computed , Female , Humans , Male , Monte Carlo Method , Parathyroid Glands/diagnostic imaging , Radiation Dosage , Thorax , Tomography, X-Ray Computed/methodsABSTRACT
BACKGROUND: Thoracic endovascular aortic repair (TEVAR) is a widely used procedure that has drastically changed the management of thoracic aortic diseases. We assess the effectiveness of supra-aortic debranching during antegrade TEVAR procedures with a retrospective analysis of our clinical experience. METHODS: Between December 2005 and April 2017, 55 patients underwent 64 TEVAR procedures. Among them, there were 8 male patients, mean age 72, who underwent hybrid antegrade stent-graft deployment. Particularly, for degenerative aneurysms of the aortic arch, 3 patients for aneurysm of descending thoracic aorta 3, for post-traumatic pseudoaneurysm 1, and for penetrating aortic ulcer 1 which had resulted in an aortoesophageal fistula. Proximal landing zones were Z0:1, Z1:3 and Z2:4. Type I hybrid aortic arch repair was performed in 1 case, carotid-carotid bypass in 2, carotid-subclavian in 5 and aorto-carotid in 1. RESULTS: The 30-day postoperative mortality was 12.5%. One patient suffered a temporary right hemiplegia which resolved after left aorto-carotid bypass. No endoleaks were observed postoperatively and in follow-up period. In the long term and a mean follow-up of 4.9 years, there were no deaths related to the stent-graft implantation or to revascularization procedures. Regarding the aortic arch rerouting procedure, there were no pseudoaneurysm or other anastomotic events. CONCLUSIONS: Antegrade delivery of the endograft, combined with hybrid and revascularization procedures of the supra-aortic vessels is a safe treatment modality, in complex hostile anatomies. However, further improvements are recommended due to the presence of neurologic complications and reinterventions.
Subject(s)
Aortic Aneurysm, Thoracic , Aortic Diseases , Aortic Dissection , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Aged , Aortic Dissection/surgery , Aorta, Thoracic/diagnostic imaging , Aorta, Thoracic/surgery , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/surgery , Aortic Diseases/diagnostic imaging , Aortic Diseases/surgery , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Endovascular Procedures/adverse effects , Humans , Male , Retrospective Studies , Stents , Treatment OutcomeABSTRACT
ABSTRACT: A patient with concurrent occurrence of polyradiculopathy and myelopathy is presented. Diagnostic investigation and clinical outcome supported the diagnosis of chronic inflammatory demyelinating polyradiculoneuropathy variant.
Subject(s)
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating , Polyradiculopathy , Humans , Magnetic Resonance Imaging , Polyradiculoneuropathy, Chronic Inflammatory Demyelinating/diagnosis , Spinal Cord , Spinal Nerve Roots/diagnostic imagingABSTRACT
Tentorium is a rare location of the brain dural arteriovenous fistulae (DAVF) consisting <4% of cases. Hemorrhagic clinical presentation is common, as cortical venous reflux consists a usual characteristic of tentorial DAVF's angioarchitecture. We present a case of transvenous, transjugular embolization of a ruptured huge venous ectasia of a Cognard IV tentorial middle-line DAVF, as a first step life-saving procedure. Initially, a transarterial antegrade embolization attempt was performed but failed due to the tortuous course of arterial feeders. Subsequently, the internal jugular vein (IJV) was directly catheterized under ultrasound (U/S) guidance and a 6F guiding catheter was placed at the ipsilateral transverse sinus. A microcatheter was navigated inside the venous ectasia and eventually, coils were deployed inside causing complete occlusion of the huge venous ectatic aneurysm. In this way, initial occlusion of the venous ectatic ruptured point has been achieved as a first-stage lifesaving treatment. Subsequently, the patient underwent stereotactic radiosurgery for the DAVF 4 months after embolization. Angiographic control with digital subtraction angiography 2 years after embolization and additional stereotactic radiosurgery revealed complete occlusion of the tentorial DAVF. The patient experienced complete neurological recovery. Direct puncture of the IJV under U/S guidance may assist transvenous embolization of ruptured venous ectasia in case of complex tentorial middle-line DAVFs type IV when the ecstatic venous aneurysm is recognized as the bleeding source.
ABSTRACT
This study evaluates the patient radiation dose from the two-phase protocols of two different computed tomography (CT) systems and compares this with that delivered by the other similar protocols previously published. Two hundred and fourteen patients with primary hyperparathyroidism were included in the study with a two-phase CT scan between 2008 and 2020 by using a Toshiba Aquilion Prime 80 and a GE Light Speed 16. The standard 'neck' or a modified 'parathyroid' protocol was used. The patient dose was evaluated in terms of volumetric computed tomography dose index (CTDIvol), dose length product (DLP) and effective dose (ED) per acquisition protocol and CT system. CTDIvol and DLP were recorded retrospectively, while the ED was calculated based on DLP and an appropriate conversion coefficient. Comparisons of patient dose between the two protocols and two CT systems and the corresponding published values were established. A significantly lower patient dose (40.2-43.2%) than the GE system (p < 0.0001) resulted from the Toshiba system. The 'parathyroid' protocol resulted in a 6.5-9.6% lower patient dose than the standard 'neck' protocol. Compared with the literature, the lowest ED value (3.6 mSv) was observed since this protocol consists of a lowered tube voltage of 100 kVp, a reduced scan length for the pre-contrast phase and implementation of an iterative reconstruction algorithm.
Subject(s)
Parathyroid Glands , Tomography, X-Ray Computed , Humans , Parathyroid Glands/diagnostic imaging , Prospective Studies , Radiation Dosage , Retrospective StudiesABSTRACT
A patient was referred for aortic valve replacement and aneurysm resection; however, the aneurysm was deemed to be non-resectable due to severe calcification, thus posing a high operative risk. The patient eventually underwent transcatheter aortic valve implantation. Eleven years later, coronary angiography depicted a giant coronary artery aneurysm measuring 63 mm in diameter and containing intraluminal thrombus. To our knowledge, this is the largest giant coronary artery aneurysm reported in the literature.
Subject(s)
Coronary Aneurysm , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Coronary Aneurysm/diagnosis , Coronary Aneurysm/surgery , Coronary Angiography , Coronary Vessels/diagnostic imaging , Coronary Vessels/surgery , HumansABSTRACT
PURPOSE: To compare anterior cruciate ligament (ACL) autograft reconstruction using fixed-looped suspensory versus expandable femoral fixation through the anteromedial portal. METHODS: After we performed prospective power analysis and obtained institutional review board, 70 patients with ACL rupture were block randomized to the expandable or suspensory femoral fixation group (35 in each group). All patients received autologous hamstring autograft through the anteromedial portal and fixed with a sheath-screw system in the tibia. The primary outcome measures were anteroposterior knee stability at 2 years' follow-up measured using the KT-1000 arthrometer and the degree of femoral and tibial tunnels' widening measured by the use of computed tomography imaging performed immediately postoperative and 12 months postsurgery. Secondary outcome measures included pain score on a visual analog scale, the subjective International Knee Documentation Committee 2000 assessment form, the Lysholm score, and the Tegner activity scale at 3, 6, 12, and 24 months. RESULTS: Twenty-four patients were excluded from further analysis, leaving a total of 48 patients (24 in each group) for the final evaluation. The anteroposterior knee stability (KT-1000) showed no difference between groups at 24 months' follow-up (P = .31). The percentile widening (%) of femoral and tibial tunnel at 1-year follow-up showed no difference also, except for greater values at the tibial coronal point T2 (P = .065) and tibial sagittal point T1 (P = .033) in the group of cortical buttons. Secondary clinical outcomes showed no statistical differences between groups at 3, 6, 12, and 24 months' postoperatively. Numerical pain scale (visual analog scale) was similar in both groups except for postoperative day 7, where the AperFix group showed better results (P = .014). There were no major intraoperative and late postoperative complications in any of the groups. CONCLUSIONS: Our results showed no significant differences in knee anteroposterior stability, tunnel enlargement or other clinical outcomes comparing expandable versus cortical button fixation in anteromedial hamstrings ACL reconstruction. LEVEL OF EVIDENCE: Level II, randomized controlled trial.