scholarly journals Comparison of Clinical Outcomes between Hyaluronic and Polylactic Acid Filler Injections for Penile Augmentation in Men Reporting a Small Penis: A Multicenter, Patient-Blinded/Evaluator-Blinded, Non-Inferiority, Randomized Comparative Trial with 18 Months of Follow-up

2020 ◽  
Vol 9 (4) ◽  
pp. 1024
Author(s):  
Dae Yul Yang ◽  
Hyun Cheol Jeong ◽  
Kyungtae Ko ◽  
Seong Ho Lee ◽  
Young Goo Lee ◽  
...  

Although several types of penile augmentation (PA) fillers have been recently introduced, no long-term follow-up studies have compared them. This study aimed to compare the long-term clinical outcomes of hyaluronic acid (HA) and polylactic acid (PLA) filler injections for PA. Our multicenter, patient-blinded/evaluator-blinded, randomized comparative trial was performed for 18 months after the single injection of fillers. Sixty-seven healthy men reporting a small penis were administered an injection between November 2016 and May 2017. Subjects were divided into the HA group (n = 33) and PLA group (n = 34). At 18 months, the mean penile girths had significantly increased in both groups (each p < 0.001). Changes in the mean penile girth of both groups were not significantly different during the study period. Satisfaction levels at 18 months were significantly higher than those at baseline in both groups (each p < 0.01). Changes in satisfaction levels did not differ significantly during the study period. Injection-associated adverse events (AEs) occurred in three (9.1%) patients in the HA group and in two (5.9%) patients in the PLA group; no serious AEs occurred. In conclusion, HA and PLA filler injections for PA led to significant augmentation and increased satisfaction. Clinical efficacy and safety were comparable between groups.

2021 ◽  
Vol 10 (7) ◽  
pp. 1499
Author(s):  
Damian Hudziak ◽  
Adrianna Hajder ◽  
Radoslaw Gocol ◽  
Marcin Malinowski ◽  
Maciej Kazmierski ◽  
...  

This study aimed to prospectively evaluate the safety and long-term clinical outcomes of cerebral-oximetry-guided transcarotid transcatheter aortic valve implantation (TC-TAVI) with systematic follow-up with carotid ultrasound. Thirty-three TCTAVI procedures were performed in our center from 2017 to 2019. Our analysis includes in-hospital outcomes and long-term follow-up data on mortality, echocardiographic parameters, carotid Doppler ultrasound, and VARC-2 defined clinical events. Intraoperatively, one patient died, and one had a transient ischemic attack (TIA). The following events occurred in-hospital postoperatively: myocardial infarction (3.0%), cardiac tamponade (3.0%), new-onset atrial fibrillation (6.3%), need for temporary pacing (27.3%) and need for pacemaker implantation (15%). The mean follow-up was 19.5 ± 9.52 months. In the long-term follow-up, the two-year survival rate was 83% ± 14. The echocardiographic parameters did not differ significantly from the postprocedural values, and the ultrasound did not show any cases of significant vessel narrowing. The mean peak systolic velocity (PSV) was 71.6 cm/s in the left common carotid artery and 70.6 cm/s in the right common carotid artery. In conclusion, cerebral oximetry-guided TC access is safe, has a favorable long-term outcome, and does not increase the risk of plaque formation in the carotid artery. In a carefully selected group of patients, it might be considered as a first-choice alternative to TF access.


Author(s):  
Quinten G. H. Rikken ◽  
Jari Dahmen ◽  
Sjoerd A. S. Stufkens ◽  
Gino M. M. J. Kerkhoffs

Abstract Purpose The purpose of the present study was to evaluate the clinical and radiological outcomes of arthroscopic bone marrow stimulation (BMS) for the treatment of osteochondral lesions of the talus (OLTs) at long-term follow-up. Methods A literature search was conducted from the earliest record until March 2021 to identify studies published using the PubMed, EMBASE (Ovid), and Cochrane Library databases. Clinical studies reporting on arthroscopic BMS for OLTs at a minimum of 8-year follow-up were included. The review was performed according to the PRISMA guidelines. Two authors independently conducted the article selection and conducted the quality assessment using the Methodological index for Non-randomized Studies (MINORS). The primary outcome was defined as clinical outcomes consisting of pain scores and patient-reported outcome measures. Secondary outcomes concerned the return to sport rate, reoperation rate, complication rate, and the rate of progression of degenerative changes within the tibiotalar joint as a measure of ankle osteoarthritis. Associated 95% confidence intervals (95% CI) were calculated based on the primary and secondary outcome measures. Results Six studies with a total of 323 ankles (310 patients) were included at a mean pooled follow-up of 13.0 (9.5–13.9) years. The mean MINORS score of the included studies was 7.7 out of 16 points (range 6–9), indicating a low to moderate quality. The mean postoperative pooled American Orthopaedic Foot and Ankle Society (AOFAS) score was 83.8 (95% CI 83.6–84.1). 78% (95% CI 69.5–86.8) participated in sports (at any level) at final follow-up. Return to preinjury level of sports was not reported. Reoperations were performed in 6.9% (95% CI 4.1–9.7) of ankles and complications related to the BMS procedure were observed in 2% (95% CI 0.4–3.0) of ankles. Progression of degenerative changes was observed in 28% (95% CI 22.3–33.2) of ankles. Conclusion Long-term clinical outcomes following arthroscopic BMS can be considered satisfactory even though one in three patients show progression of degenerative changes from a radiological perspective. These findings indicate that OLTs treated with BMS may be at risk of progressing towards end-stage ankle osteoarthritis over time in light of the incremental cartilage damage cascade. The findings of this study can aid clinicians and patients with the shared decision-making process when considering the long-term outcomes of BMS. Level of evidence Level IV.


2021 ◽  
pp. 036354652110182
Author(s):  
Craig R. Bottoni ◽  
John D. Johnson ◽  
Liang Zhou ◽  
Sarah G. Raybin ◽  
James S. Shaha ◽  
...  

Background: Recent studies have demonstrated equivalent short-term results when comparing arthroscopic versus open anterior shoulder stabilization. However, none have evaluated the long-term clinical outcomes of patients after arthroscopic or open anterior shoulder stabilization, with inclusion of an assessment of preoperative glenoid tracking. Purpose: To compare long-term clinical outcomes of patients with recurrent anterior shoulder instability randomized to open and arthroscopic stabilization groups. Additionally, preoperative magnetic resonance imaging (MRI) studies were used to assess whether the shoulders were “on-track” or “off-track” to ascertain a prediction of increased failure risk. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A consecutive series of 64 patients with recurrent anterior shoulder instability were randomized to receive either arthroscopic or open stabilization by a single surgeon. Follow-up assessments were performed at minimum 15-year follow-up using established postoperative evaluations. Clinical failure was defined as any recurrent dislocation postoperatively or subjective instability. Preoperative MRI scans were obtained to calculate the glenoid track and designate shoulders as on-track or off-track. These results were then correlated with the patients’ clinical results at their latest follow-up. Results: Of 64 patients, 60 (28 arthroscopic and 32 open) were contacted or examined for follow-up (range, 15-17 years). The mean age at the time of surgery was 25 years (range, 19-42 years), while the mean age at the time of this assessment was 40 years (range, 34-57 years). The rates of arthroscopic and open long-term failure were 14.3% (4/28) and 12.5% (4/32), respectively. There were no differences in subjective shoulder outcome scores between the treatment groups. Of the 56 shoulders, with available MRI studies, 8 (14.3%) were determined to be off-track. Of these 8 shoulders, there were 2 surgical failures (25.0%; 1 treated arthroscopically, 1 treated open). In the on-track group, 6 of 48 had failed surgery (12.5%; 3 open, 3 arthroscopic [ P = .280]). Conclusion: Long-term clinical outcomes were comparable at 15 years postoperatively between the arthroscopic and open stabilization groups. The presence of an off-track lesion may be associated with a higher rate of recurrent instability in both cohorts at long-term follow-up; however, this study was underpowered to verify this situation.


2020 ◽  
pp. 112067212097604
Author(s):  
Reem R Al Huthail ◽  
Yasser H Al-Faky

Objective: To evaluate the effect of chronicity on the size of the ostium after external dacryocystorhinostomy (DCR) with intubation. Methods: Design: A retrospective chart review of patients who underwent external DCR with intubation over 10 years from January 2003 at a tertiary hospital. All patients were recruited and examined with rigid nasal endoscope. Results: A total number of 66 (85 eyes) patients were included. The mean age at the time of evaluation was 53.1 years with gender distribution of 54 females (81.8 %). The mean duration ±SD between the date of surgery and the date of evaluation was 33.2 ± 33.6 (6–118 months). Our study showed an overall anatomical and functional success of 98.8% and 95.3%, respectively. The mean size of the ostium (±SD) was 23.0 (±15.7) mm2 (ranging from 1 to 80.4 mm2). The size of the ostium was not a significant factor for failure ( p = 0.907). No statistically significant correlation was found between the long-term duration after surgery and the size of the ostium ( R: 0.025, p = 0.157). Conclusions: Nasal endoscopy after DCR is valuable in evaluating the ostium with no observed potential correlation between the long-term follow-up after surgery and the size of the ostium.


2013 ◽  
Vol 118 (1) ◽  
pp. 58-62 ◽  
Author(s):  
William J. Kemp ◽  
Daniel H. Fulkerson ◽  
Troy D. Payner ◽  
Thomas J. Leipzig ◽  
Terry G. Horner ◽  
...  

Object A small percentage of patients will develop a completely new or de novo aneurysm after discovery of an initial aneurysm. The natural history of these lesions is unknown. The authors undertook this statistical evaluation a large cohort of patients with both ruptured and unruptured de novo aneurysms with the aim of analyzing risk factors for rupture and estimating a risk of subarachnoid hemorrhage (SAH). Methods A review of a prospectively maintained database of all aneurysm patients treated by the vascular neurosurgery service of Goodman Campbell Brain and Spine from 1976–2010 was performed. Of the 4718 patients, 611 (13%) had long-term follow-up imaging. The authors identified 27 patients (4.4%) with a total of 32 unruptured de novo aneurysms from routine surveillance imaging. They identified another 10 patients who presented with a new SAH from a de novo aneurysm after treatment of their original aneurysm. The total study group was thus 37 patients with a total of 42 de novo aneurysms. The authors then compared the 27 patients with incidentally discovered aneurysms with the 10 patients with SAH. A statistical analysis was performed, comparing the 2 groups with respect to patient and aneurysm characteristics and risk factors. Results Thirty-seven patients were identified as having true de novo aneurysms. This group had a female predominance and a high percentage of smokers. These 37 patients had a total of 42 de novo aneurysms. Ten of these 42 aneurysms hemorrhaged. De novo aneurysms in both the SAH and non-SAH group were anatomically small (< 10 mm). The estimated risk of hemorrhage over 5 years was 14.5%, higher than the expected SAH risk of small, unruptured aneurysms reported in the ISUIA (International Study of Unruptured Intracranial Aneurysms) trial. There was no statistically significant correlation between hemorrhage and any of the following risk factors: hypertension, diabetes, tobacco and alcohol use, polycystic kidney disease, or previous SAH. There was a statistically significant between-groups difference with respect to patient age, with the mean patient age being significantly older in the SAH aneurysm group than in the non-SAH group (p = 0.047). This is likely reflective of longer follow-up and discovery time, as the mean length of time between initial treatment and discovery of the de novo aneurysm was longer in the SAH group (p = 0.011). Conclusions While rare, de novo aneurysms may have a risk for SAH that is comparatively higher than the risk associated with similarly sized, small, initially discovered unruptured saccular aneurysms. The authors therefore recommend long-term follow-up for all patients with aneurysms, and they consider a more aggressive treatment strategy for de novo aneurysms than for incidentally discovered initial aneurysms.


2021 ◽  
Vol 10 (2) ◽  
pp. 189
Author(s):  
Joanna Konopińska ◽  
Łukasz Lisowski ◽  
Zofia Mariak ◽  
Iwona Obuchowska

This study evaluated the characteristics and clinical course of patients with iris cysts in the long-term follow-up (24–48 months). We retrospectively analyzed the medical records of 39 patients with iris cysts (27 women and 12 men). Age, visual acuity, intraocular pressure (IOP), slit-lamp evaluation, and ultrasound biomicroscopy images were assessed. The mean age at diagnosis was 40.6 ± 17.48 years. Thirty (76.9%) cysts were peripheral, five (12.8%) were located at the pupillary margin, two (5.1%) were midzonal, and two (5.1%) were multichamber cysts extending from the periphery to the pupillary margin. A total of 23 (59%) cysts were in the lower temporal quadrant, 11 (28.2%) were in the lower nasal quadrant, and 5 (12.8%) were in the upper nasal quadrant. Cyst size was positively correlated with patient age (rs = 0.38, p = 0.003) and negatively correlated with visual acuity (rs = −0.42, p = 0.014). Cyst growth was not observed. The only complication was an increase in IOP in three (7.7%) patients with multiple cysts. The anatomical location of the cysts cannot differentiate them from solid tumors. The vast majority of cysts are asymptomatic, do not increase in size, and do not require treatment during long-term follow-up.


2021 ◽  
Vol 103-B (12) ◽  
pp. 1815-1820
Author(s):  
Stefan Huhnstock ◽  
Ola Wiig ◽  
Else Merckoll ◽  
Svein Svenningsen ◽  
Terje Terjesen

Aims The aim of this study was to assess the prognostic value of the modified three-group Stulberg classification, which is based on the sphericity of the femoral head, in patients with Perthes’ disease. Methods A total of 88 patients were followed from the time of diagnosis until a mean follow-up of 21 years. Anteroposterior pelvic and frog-leg lateral radiographs were obtained at diagnosis and at follow-up of one, five, and 21 years. At the five- and 21-year follow-up, the femoral heads were classified using a modified three-group Stulberg classification (round, ovoid, or flat femoral head). Further radiological endpoints at long-term follow-up were osteoarthritis (OA) of the hip and the requirement for total hip arthroplasty (THA). Results There were 71 males (81%) and 17 females. A total of 13 patients had bilateral Perthes’ disease; thus 101 hips were analyzed. At five-year follow-up, 37 hips were round, 38 ovoid, and 26 flat. At that time, 66 hips (65%) were healed and 91 (90%) were skeletally immature. At long-term follow-up, when the mean age of the patients was 28 years (24 to 34), 20 hips had an unsatisfactory outcome (seven had OA and 13 had required THA). There was a strongly significant association between the modified Stulberg classification applied atfive-year follow-up and an unsatisfactory outcome at long-term follow-up (p < 0.001). Between the five- and 21-year follow-up, 67 hips (76%) stayed in their respective modified Stulberg group, indicating a strongly significant association between the Stulberg classifications at these follow-ups (p < 0.001). Conclusion The modified Stulberg classification is a strong predictor of long-term radiological outcome in patients with Perthes’ disease. It can be applied at the healing stage, which is usually reached five years after the diagnosis is made and before skeletal maturity. Cite this article: Bone Joint J 2021;103-B(12):1815–1820.


2018 ◽  
Vol 08 (01) ◽  
pp. 037-042
Author(s):  
William Aibinder ◽  
Ali Izadpanah ◽  
Bassem Elhassan

Background Management of scapholunate (SL) ligament disruption is a challenging problem. The reduction and association of the scaphoid and lunate (RASL) procedure has been described with varying results. This study assessed the outcomes of the RASL procedure. Purpose The objective of this study was to assess the outcomes of patients undergoing the RASL procedure at our institution in regard to pain relief, range of motion, radiographic and functional outcomes, complications, and reoperations. Materials and Methods Twelve patients with symptomatic chronic SL instability underwent the RASL procedure. The mean age was 35 years. The mean time from injury to surgery was 40 weeks. The mean follow-up was 89 months. Outcomes included visual analog score for pain, wrist range of motion, grip strength, and Mayo Wrist Scores. Preoperative and postoperative radiographs were reviewed. Results Pain scores improved in 10 wrists. Range of motion and grip strength worsened. The average Mayo Wrist Score was 63.3. The mean SL diastasis and angle improved, but seven wrists developed progressive degenerative changes, with two requiring a salvage procedure. Symptomatic progressive screw lucency occurred in eight wrists requiring screw removal. Conclusion The RASL procedure can improve SL widening but has a high rate of early failure and reoperation. Following reoperation, long-term follow-up demonstrates reasonable long-term durability in some cases. Level of Evidence This is a Level IV, therapeutic case study.


2018 ◽  
Vol 24 (6) ◽  
pp. 666-673 ◽  
Author(s):  
Sung Hyun Baik ◽  
Hyo Sung Kwak ◽  
Gyung Ho Chung ◽  
Seung Bae Hwang

Background Insertion of a balloon-expandable stent (BES) in patients with symptomatic intracranial atherosclerosis is a treatment option for reperfusion therapy. In this study, we retrospectively reviewed clinical outcomes during long-term follow-up after insertion of balloon-expandable stents in patients with symptomatic middle cerebral artery (MCA) stenosis. Methods Institutional review board approval was obtained for retrospective review of patient data. Thirty-four patients (15 men, 19 women; median age, 67.5 years) with symptomatic MCA stenosis underwent balloon-expandable stent insertion between June 2008 and December 2010. Patient records were reviewed for angiographic findings and clinical outcomes during long-term follow-up. Results Of these patients, 22 presented with acute ischemic stroke with underlying MCA atherosclerosis and had good clinical outcomes (modified Rankin Scale score (mRS): 0–2) after reperfusion therapy. Indications for stenting for the remaining 12 patients were recurrent transient ischemic attacks (TIAs) refractory to medical therapy and MCA stenosis greater than 70%. During the poststenting follow-up period, which ranged from 61 to 108 months (median, 67.5 months), a TIA occurred in five patients. Of these five patients, one experienced a complete reocclusion of the MCA stent, and three had symptomatic restenosis. The remaining 29 patients did not experience any further ischemic events or restenosis during the follow-up period. Conclusions In our study, treatment with balloon-expandable stents in patients with symptomatic MCA stenosis resulted in low recurrence rates for both ischemic events and restenosis during long-term follow-up.


2021 ◽  
Vol 8 ◽  
Author(s):  
Belén Alfonso-Bartolozzi ◽  
Carlos Lisa ◽  
Luis Fernández-Vega-Cueto ◽  
David Madrid-Costa ◽  
José F. Alfonso

Purpose: To assess the outcomes of implanting a new polymethylmethacrylate (PMMA) ring (Neoring; AJL Ophthalmic) in pre-descemet deep anterior lamellar keratoplasty (PD-DALK) procedure for moderate-advanced keratoconus.Methods: This prospective study included 10 eyes of 10 patients with moderate-advanced keratoconus who underwent PD-DALK with Neoring implantation. Neoring was implanted in a pre-descemetic pocket. The post-operative examination included refraction, corrected distance visual acuity (CDVA), corneal tomography, and endothelial cell density (ECD). The root mean squares (RMSs) for coma-like aberrations and spherical aberration were evaluated for a pupil size of 4.5 mm. The junctional graft (Tg) and host (Th) thicknesses were measured. The post-operative follow-up was 24 months.Results: Post-operative CDVA was 0.82 ± 0.14 (decimal scale), 100% of the eyes achieved a CDVA of 0.7 (decimal scale). The refractive cylinder was −2.86 ± 1.65 2-years after surgery. No eyes had a post-operative refractive cylinder ≥5.00 D and in five eyes (50%), it was ≤2.50 D. At the last visit, the mean keratometry was 45.64 ± 1.96 D, the RMS for coma-like aberrations was 0.30 ± 0.15 μm and spherical aberration was 0.22 ± 0.09. The mean ECD remains without changes over the follow-up (P = 0.07). At the last visit, Tg and Th were 679.9 ± 39.0 and 634.8 ± 41.2 μm, respectively. The thickness of the complex (host-Neoring) was 740.6 ± 35.6 μm. In all cases, this thickness was thicker than Tg.Conclusion: The results of this study suggest that PD-DALK along Neoring implantation is a viable, effective, and safe option to optimize the post-operative results for moderate-severe keratoconus.


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