Final Follow-up Visit Research Articles

Arthroscopic capsular release for frozen shoulder: when etiology matters.

No therapeutic intervention is universally accepted for frozen shoulder, and the most effective management to restore motion and diminish pain has yet to be defined. The aim of this study was to investigate functional and psychological outcomes in patients who underwent arthroscopic capsular release for a frozen shoulder. A retrospective study with prospective data collection was conducted with 78 patients suffering from frozen shoulder resistance to conservative treatment. Considering the etiology, there were 36 (46.2%) idiopathic, 31 (39.7%) postoperative, and 11 (14.1%) posttraumatic cases. Preoperatively, each patient was evaluated with the range of motion (ROM) assessment and the Constant-Murley score (CMS). At follow-up, the 4-point subjective satisfaction scale (SSS), the ROM assessment, the SF-12 questionnaire, the numerical rating scale (NRS) for the subjective assessment of pain, the CMS and the Hospital Anxiety and Depression Scale (HADS) were assessed. After a mean follow-up of 54.2 ± 22.3months, ROM and CMS showed a statistically significant improvement between pre- and postoperative values (all p < 0.001). Before surgery, the mean CMS was 36.9% that of sex- and age-matched healthy individuals, and all patients showed a CMS lower than the normative data. At the final follow-up visit, the mean CMS was 99.9% that of sex- and age-matched healthy individuals, and 49 (62.8%) patients showed a CMS equal to or higher than the normative data. The mean increase in the CMS was 56.1 ± 8.3 points. The mean SSS, HADS-A, HADS-D, and NRS were 3.7 ± 0.5, 2.5 ± 1.6, 2.2 ± 1.3, and 2.2 ± 1.0, respectively. All patients returned to their previous level of work and sports activity after 2 and 2.5months, respectively. The multivariate analysis showed the association between a higher postoperative CMS and the idiopathic etiology of a frozen shoulder (p = 0.004, β = 3.971). No intraoperative complications occurred. Postoperatively, four patients (5.1%) were treated with intra-articular steroid injections to manage residual symptoms. One patient (1.3%) with a postoperative frozen shoulder showed persistent symptoms and underwent a new successful arthroscopic capsular release. High patient satisfaction and statistically significant ROM and CMS recovery can be achieved after arthroscopic capsular release to manage frozen shoulder. Better functional outcomes are expected when the etiology is idiopathic. Results can help surgeons identify the patients who will most benefit from surgery and should be discussed with the patient. III.

Relaxing radial retinal incisions for the treatment of persistent macular holes.

Various surgical techniques have been described for managing persistent macular holes after an unsuccessful vitrectomy with internal limiting membrane (ILM) peeling. However, the closure and functional improvement rates after these procedures are limited. Therefore, the aim of this study was to evaluate the usefulness of radial retinal incisions (retinotomies) in eyes with persistent large macula holes despite previous vitrectomy with ILM peeling. In a retrospective case series, closure rate and best-corrected visual acuity (BCVA) were evaluated in eyes with persistent macular holes after an unsuccessful vitrectomy that included posterior vitreous detachment and ILM peeling. 22 eyes of 22 patients (10 men and 12 women) underwent re-vitrectomy with radial retinal incisions. All the patients had undergone an unsuccessful surgery before. Small-incision re-vitrectomy with radial retinal incisions (retinotomies) and air tamponade was performed. For all eyes, high-definition SD-OCT scans (SD-OCT Spectralis, Heidelberg Engineering GmbH, Germany) of the macula were routinely performed before surgery; 1 week and 1 month after surgery; and at final follow-up. Additionally, age, gender, axial length, macular hole diameter, biomicroscopic fundus evaluation and best-corrected visual acuity (BCVA) in logMAR and Snellen at baseline, 1 and 4 months after operation, and at the final follow-up visit were analyzed. The mean baseline macular hole diameter was 668.5 ± 226.8 μm. At the final examination, 16 (72.72%) of the 22 macula holes were closed. Visual acuity increased in 17 eyes, was stable in 3 eyes, and decreased in 2 eyes owing to central retinal atrophy in both. The mean BCVA increased from logMAR 1.04 ± 0.29 at baseline to 0.57 ± 0.31 (Snellen 0.11 ± 0.05 to 0.33 ± 0.18). In all successful cases, macula hole closure was attained after 3 days, and none of the eyes showed macula hole recurrence. The results of this limited case series suggest that radial retinal incisions of the rim in persistent macula holes after initial surgery with ILM peeling increase the success rate of macula hole closure and results in a relevant increase in BCVA. However, as the number of eyes included in this series is limited, the results must be confirmed in a study with a larger sample size.

High tibial lateral closing wedge and opening wedge valgus osteotomy produce different effects on posterior tibial slope and patellar height.

To compare the clinical outcomes of performing a closed tibial high osteotomy with an open osteotomy and the changes in posterior tibia slope and patellar height. Methods were collected from three hundred and forty patients (440 knees) with high tibial osteotomy performed from January 2019 to January 2020. Forty patients (50 knees) had a lateral closed wedge tibial osteotomy (LCWHTO), and 300 patients (390 knees) had a medial open wedge tibial osteotomy (MOWHTO). The follow-up periods were 20.5 months and 19.9 months, respectively. At the final follow-up visit, both groups evaluated the Lysholm score and joint range of motion (ROM). Changes in preoperative and postoperative mechanical axis deviation (MAD), proximal medial tibial angle (MPTA), posterior tibial slope (PTS), and M-K index were compared between the two groups of patients. Lysholm scores were 79.6 ± 15.6 preoperatively and 96.0 ± 5.0 postoperatively in the LCWHTO group (p < 0.01); 83.7 ± 16.0 preoperatively and 94.3 ± 9.1 postoperatively in the MOWHTO group (p < 0.01). ROM was 136.0° ± 8.4° preoperatively and 133.2° ± 10.1° postoperatively in the LCWHTO group (p > 0.05); 136.5° ± 8.4° preoperatively and 135.7° ± 9.3° postoperatively in the MOWHTO group (p > 0.05). the MAD was (26.5 ± 4.1) mm preoperatively and 0.3 ± 2.9 mm postoperatively in the LCWHTO group (p < 0.01); 21.8 ± 6.5 mm preoperatively and -0.3 ± 2.6 mm postoperatively in the MOWHTO group (p < 0.01). The MPTA in the LCWHTO group was 75.3° ± 3.2° preoperatively and 89.5° ± 2.4° postoperatively (p < 0.01). 77.1° ± 3.0° preoperatively and 90.6° ± 2.7° postoperatively in the MOWHTO group (p < 0.01). M-K index was 0.78 ± 0.08 preoperatively and 0.79 ± 0.07 postoperatively in the LCWHTO group (p > 0.05). 0.78 ± 0.05 before and 0.75 ± 0.05 after surgery in the MOWHTO. 10.8° ± 3.0° PTS before and 8.1° ± 3.4° after surgery in the LCWHTO group (p < 0.05); 10.2° ± 3.1° preoperatively and 10.9° ± 4.0° postoperatively (p > 0.05). LCWHTO decreases the PTS and has no effect on patellar height; MOWHTO does not affect the PTS but decreases patellar height. The patient should individualize the choice of the osteotomy.

Central posterior hyaloid fibrosis: evolution and outcomes

PurposeTo report contributory factors and clinical outcomes of central posterior hyaloid fibrosis (CPHF) associated with neovascular age-related macular degeneration (nAMD).MethodsIn this retrospective, single-center study, patients with CPHF and nAMD were included. Demographic and imaging characteristics, as well as the anatomical and functional outcomes, of these patients were analysed.ResultsWe identified 530 eyes in 273 patients with chronic predominantly scarred macular neovascularisation (MNV), and 32 eyes in 29 patients revealed CPHF, representing a prevalence of 6%. Patients had a mean age of 72.76 years. Before and during the development of CPHF, Type 2 MNV was observed in all eyes. At the time of MNV diagnosis, mean logMAR visual acuity was 1.308 ± 0.559 (20/407). The average time to develop CPHF was 27.3 months since the diagnosis of MNV. At the time of CPHF identification, the mean logMAR visual acuity was 1.498 ± 0.374 (20/630). RPE tear was observed in 6% (n = 2) of CPHF eyes. The average number of intravitreal anti-VEGF injections administered prior to the diagnosis of CPHF was 2.4 and after the onset of CPHF was 0.9. The final visual acuity was not significantly different at the final follow-up visit [1.304 ± 0.42 (20/402); p = 0.646].ConclusionRarely observed in eyes with predominantly scarred subfoveal type 2 MNVs and extensive subretinal fibrosis, CPHF is associated with poor visual outcomes. Its presence could possibly suggest a profibrotic effect of MNV on the posterior hyaloid. Trial Registration Number: Not applicable.

VITAMIN D STATUS AND ITS EFFECT ON FUNCTIONAL OUTCOME IN PATIENTS WITH HIP FRACTURE: AN OBSERVATIONAL STUDY

Aims and Objectives: The study aimed to study the Vitamin D status of adult patients presenting with hip fractures and analyze potential impact of Vitamin D status on outcome of these patients. Methods: This was an observational study of Vitamin D status of patients presenting with hip fractures. It was conducted in the department of orthopedics of a tertiary care medical college. One hundred and twenty adult patients presenting with hip fractures were included in this study on the foundation of a predefined inclusion and exclusion criteria. Demographic details of all the patients such as age, gender, and socioeconomic status were noted. Vitamin D status of patients was determined and correlated with functional outcome at the time of final follow-up visit at 6 months. Results: Among the 120 studied with hip fractures, 64 cases (53.33%) involved females, while 56 cases (46.67%) involved males having a M: F ratio of 1:1.14. The mean age of male and female patients was found to be 45.85±10.12 and 46.74±9.86 years. Overall, 65 (54.17%) patients were Vitamin D sufficient and remaining 55 (45.83%) were either inefficient (26.67%) or deficient (19.17%). Seventy-three (60.83%) patients had excellent to good outcome whereas 31 (25.83%) patients had fair outcome. Out of remaining 16 patients, 11 (9.17%) patients had poor outcome and 5 (4.17%) patients had very poor outcome. The patients with sufficient Vitamin D status were found to have a better outcome as compared to those patients with inefficient or deficient Vitamin D status and the difference was found to be statistically significant (p=0.01). Conclusion: It is significant to treat Vitamin D deficiency in patients presenting with hip fractures as Vitamin D deficiency is associated with suboptimal functional outcome in cases with hip fractures.

Can the reduction quality of distal humeral transphyseal fractures be determined using reference measurements on conventional radiography?

Our objective was to compare the radiological outcomes of transphyseal fractures treated using closed reduction and percutaneous fixation, without arthrography, with those of supracondylar humerus fractures treated using the same method within a similar age group. Additionally, we aimed to assess the efficacy of the reference points in the lateral and anteroposterior radiographs utilized for the evaluation of reduction. The study included patients aged 0-3 years who underwent surgery for supracondylar and transphyseal fractures between 2013 and 2022. All the patients were diagnosed using anteroposterior (AP) and lateral elbow X-rays. No arthrographic intervention was used either in the diagnosis or treatment phase. On the AP X-rays, we assessed the alignment between the humeral shaft line and the ulnar long axis line to determine the positioning of the distal humeral physis segment in relation to the humerus. Additionally, we evaluated the relationship between the anterior cortex line of the humerus and the coronoid process on lateral radiographs. At the final follow-up visit, Flynn criteria were used for functional assessment. The study comprised 24 patients with supracondylar humerus fractures and 24 patients with transphyseal fractures. In the early post-operative radiographs, the humero-ulnar angle measured 6.43° (-7° - 16.6°) in the supracondylar group and 9.8° (-4.3° - 25.3°) in the transphyseal group (p = 0.087). The distance between the coronoid and the anterior humeral line was 9.19 mm (4.27 - 16.08) for the supracondylar fracture group and 8.05 mm (3.29 - 14.85) for the transphyseal fracture group (p = 0.513). The current study's findings suggest that both the humero-ulnar angle and the distance between the coronoid and the anterior humeral line are valuable indicators for assessing the quality of reduction in transphyseal distal humerus fractures.

Seizure outcome in medically treated patients with adult-onset epilepsy and cerebral cavernous malformation

PurposeWe evaluated long-term seizure outcomes of antiseizure medications (ASMs) and risk factors for drug resistance in patients with adult-onset epilepsy associated with cerebral cavernous malformation (CCM). Materials and methodsThis retrospective observational study included patients newly diagnosed with adult-onset focal epilepsy associated with CCM. Patients received individualized treatments with ASMs. All patients were followed-up for at least 2 years. The main outcome measure was terminal 2 year seizure freedom (2-YSF). ResultsForty eight subjects (28 men and 20 women) were included. Thirty-one (64.6%) subjects achieved a terminal 2-YSF (range 2.0–17.0 years). After treatment with the first drug regimen, 31 (64.6%) subjects achieved 2-YSF, with 23 remaining seizure-free until final follow-up visit. Of the 23 subjects treated with the second drug regimen and the six treated with the third drug regimen, ten (43.5%) and one (16.7%), respectively, achieved a terminal 2-YSF. Stepwise logistic regression analyses showed that terminal 2-YSF was negatively associated with epileptiform discharge on EEG at the time of diagnosis (odds ratio = 0.214, p = 0.047) and tended to be associated with age ≥ 45 years at seizure onset (odds ratio = 4.260, p = 0.056). ConclusionThe present study found that 64.6% of CCM patients with adult-onset epilepsy achieved terminal 2-YSF after ASM initiation. Interictal epileptiform discharge on EEG at the time of diagnosis was associated with poor prognosis. Failure to achieve sustained seizure freedom after two ASMs may indicate the need for surgical treatment.

Gene Therapy in Patients with the Crigler–Najjar Syndrome

BackgroundPatients with the Crigler–Najjar syndrome lack the enzyme uridine diphosphoglucuronate glucuronosyltransferase 1A1 (UGT1A1), the absence of which leads to severe unconjugated hyperbilirubinemia that can cause irreversible neurologic injury and death. Prolonged, daily phototherapy partially controls the jaundice, but the only definitive cure is liver transplantation.MethodsWe report the results of the dose-escalation portion of a phase 1–2 study evaluating the safety and efficacy of a single intravenous infusion of an adeno-associated virus serotype 8 vector encoding UGT1A1 in patients with the Crigler–Najjar syndrome that was being treated with phototherapy. Five patients received a single infusion of the gene construct (GNT0003): two received 2×1012 vector genomes (vg) per kilogram of body weight, and three received 5×1012 vg per kilogram. The primary end points were measures of safety and efficacy; efficacy was defined as a serum bilirubin level of 300 μmol per liter or lower measured at 17 weeks, 1 week after discontinuation of phototherapy.ResultsNo serious adverse events were reported. The most common adverse events were headache and alterations in liver-enzyme levels. Alanine aminotransferase increased to levels above the upper limit of the normal range in four patients, a finding potentially related to an immune response against the infused vector; these patients were treated with a course of glucocorticoids. By week 16, serum bilirubin levels in patients who received the lower dose of GNT0003 exceeded 300 μmol per liter. The patients who received the higher dose had bilirubin levels below 300 μmol per liter in the absence of phototherapy at the end of follow-up (mean [±SD] baseline bilirubin level, 351±56 μmol per liter; mean level at the final follow-up visit [week 78 in two patients and week 80 in the other], 149±33 μmol per liter).ConclusionsNo serious adverse events were reported in patients treated with the gene-therapy vector GNT0003 in this small study. Patients who received the higher dose had a decrease in bilirubin levels and were not receiving phototherapy at least 78 weeks after vector administration. (Funded by Genethon and others; ClinicalTrials.gov number, NCT03466463.)

Clinical and Radiographic Outcomes of Adjunctive Photodynamic Therapy for Treating Peri-Implant Mucositis Among Cigarette Smokers and Diabetics: A Systematic Review and Meta-Analysis.

Objective: This systematic review aimed to assess the influence of antimicrobial photodynamic therapy (aPDT) as an adjunct to mechanical debridement (MD) on peri-implant clinical and radiographic outcomes among cigarette smokers and diabetics with peri-implant mucositis (piM). Methods: Randomized controlled trials, assessing the clinical and radiographic parameters of aPDT versus MD alone among smokers and diabetics with piM, were included in the study. Meta-analyses were conducted to calculate the standard mean difference with a 95% confidence interval. The methodological quality of the included studies was assessed utilizing the modified Jadad quality scale. Results: The meta-analyses found statistically significant differences between the impact of adjunct aPDT and MD alone on the peri-implant plaque index (PI), probing depth (PD), and bleeding on probing among smokers and diabetics with piM at the final follow-up visit. However, no significant differences were found between the impact of adjunct aPDT and MD alone on the peri-implant crestal bone loss among smokers and diabetics with piM at the final follow-up. Conclusions: The application of aPDT as an adjunctive to MD demonstrated improved scores of the peri-implant clinical parameters among smokers and diabetics with piM in comparison with MD alone.

The efficacy of different anti-vascular endothelial growth factor agents, and dexamethasone implant therapy in patients with serous retinal detachment caused by Irvine-Gass syndrome.

The aim of this study is to compare the efficacy of intravitreal aflibercept (IVA), bevacizumab (IVB), ranibizumab (IVR), and dexamethasone implant (IVDI) in the treatment of serous retinal detachment (SRD) caused by Irvine-Gass syndrome (IGS). Retrospective cohort, comparative study. The medical records of 128 eyes with no previous history of intravitreal agents in 128 IGS patients with SRD that received IVA, IVB, IVR, and IVDI monotherapy were retrospectively reviewed. The patients were divided into 4 groups, according to treatment. Patients with recurrence and/or were unresponsive following a course of topical steroids and non-steroidal anti-inflammatory drugs (NSAIDs) were included in the study. Best corrected visual acuity (BCVA), central macular thickness (CMT), subfoveal choroidal thickness (SFCT), and SRD were compared between the 4 treatment groups at baseline, at follow-up months 1, 3, 6, and 12, and at the final follow-up visit. Serous retinal detachment completely resolved in 74%, 45.7%, 66.4%, and 40.8% of the eyes at month 1 (P = 0.042), 87%, 50.9%, 75.8%, and 80.9% at month 3 (p = 0.031), 88.9%, 50.4%, 75.7%, 80.2% at month 6 (p = 0.028), 81.7%, 72.8%, 68.7%, 80.1% at month 12 (p = 0.580), and 100%, 66.4%, 87.9%, 93.2% (p = 0.478) at final follow-up visit in the IVA, IVB, IVR, and IVDI groups, respectively. BCVA was significantly better in the IVA group at all follow-up time points (month 1: p < 0.001; month 3: p < 0.001; month 6: p = 0.002; month 12: p = 0.009, final follow-up visit: p < 0.001). CMT was significantly lower in the IVA group at months 3 (p = 0.008), 6 (p = 0.011), and 12 (p = 0.010), and at the final follow-up visit (p < 0.001). Recurrence was observed after a longer period of time and fewer injections were needed in the IVDI and IVA groups (p < 0.05). Resolution of CME was most rapid in the IVA group (p = 0.032). All intravitreal agents were effective in terms of visual results in the SRD patients; however, eyes treated with IVA and IVDI required fewer injections, as compared to the eyes treated with IVB and IVR. Furthermore, SRD entirely resolved in all eyes in the IVA group at the final follow-up visit.

The Safety and Effectiveness of Decapeptide in Patients With Vitiligo: A Real-World Study.

Background Vitiligo, a chronic autoimmune depigmenting skin disease, affects a significant portion of the global population. One of the topical treatment options for vitiligo is basic fibroblast growth factor (bFGF)-related decapeptide (bFGFrP) 0.1% solution. This study aimed to assess the real-world effectiveness and safety of decapeptide in treating vitiligo. Methods This retrospective analysis utilized data collected from routine clinical practice in the management of vitiligo, focusing on patients treated with topical decapeptide lotion (Melgain™, manufactured by Zydus Healthcare Ltd., Ahmedabad, India). The primary outcome measures included the extent of re-pigmentation (EOR) and the grade of re-pigmentation (GOR) assessed at each follow-up visit. Results The analysis included data from 65 patients (24 males and 41 females) with an average age of 30.83 years. Segmental vitiligo was present in 52.31% of cases, with the face being the most commonly affected site. Among the patients, 33 received decapeptide as monotherapy, while 32 received decapeptide alongside adjuvant drug/phototherapy. The mean duration of treatment was five months. The first, second, and final follow-ups were observed to be at a mean of 45 days, two months, and five months, respectively. During the second and final follow-up, a significant response (>75% re-pigmentation) was observed in 12% (eight) and 71% (46) of the patients. A mild response (<50% re-pigmentation) was noted in 45% (29) of the patients during the first follow-up visit, 15% (10) during the second follow-up visit, and 6% (four) during the final follow-up visit. Grade 6 and 7 re-pigmentation occurred in a higher number of patients at the final visit, indicating treatment effectiveness. Overall, nearly all patients (96.92%) reported excellent tolerability of the decapeptide lotion based on the global assessment of tolerability. Conclusion This real-world study demonstrates that decapeptide promotes re-pigmentation and improves patient outcomes in vitiligo. Both decapeptide regimens, as monotherapy or in combination with other therapies, were effective and well tolerated by most patients. Thus, decapeptide represents a safe and effective therapeutic option for vitiligo treatment.

Sagittal plane assessment of manual concave rod bending for posterior correction in adolescents with idiopathic thoracic scoliosis (Lenke 1 and 3)

ObjectivesThe objectives of this study were to evaluate the repeatability and reproducibility of a method for measuring freehand rod bending and to analyze the relationship between the rod's bend and the resulting sagittal correction. Materials and methodsAll the children who underwent correction by posterior translation using pedicle screws at all levels were included prospectively in 2018 and 2019. The rod's sagittal parameters were measured retrospectively by three independent surgeons on two separate occasions using the same protocol. After the rods were bent but before they were inserted, the surgeon traced the contours of the rods on a sheet of paper that was later scanned and analyzed semiautomatically. The spinal parameters were calculated based on biplanar radiographs taken preoperatively, postoperatively and at the final follow-up visit. Patients who had less than 10° thoracic kyphosis (T5–T12) made up the “Lenke N−” subgroup. ResultsThirty patients were included (14 of whom were Lenke N−) who had a Cobb angle of 59.2±11.3° preoperatively and 13.3±8.4° postoperatively (p<0.00001). The inter- and intrarater ICC for the rod measurements were>0.9 (excellent). The mean kyphosis of the concave rod was 48.4±5.7° (38.3–60.9°). The mean change in T5–T12 kyphosis was 9.7±10.8° (−14.3–30.8°) (p<0.0001) in the entire population, while it was 17.7±7.1° (5.5–30.8°) (p<0.0001) in the Lenke N− subgroup. The change in thoracic kyphosis was positively correlated with the kyphosis of the concave rod (rho=0.52; p=0.003). ConclusionThis study found excellent reproducibility and repeatability of measuring freehand rod bending. The kyphosis applied to the concave rod is positively correlated to the change in the resulting kyphosis and made it possible to restore satisfactory thoracic kyphosis. Level of evidenceIII.

Evaluation of the clinical efficacy of the bilateral pedicle cement anchoring technique in percutaneous vertebroplasty for Kümmell disease.

The present study aimed to evaluate the clinical efficacy of the bilateral pedicle cement anchoring technique combined with the postural reduction in percutaneous vertebroplasty (PVP) for Kümmell disease. For this purpose, a retrospective study was performed on 18 patients with Kümmell disease who between January 2018 and June 2021 underwent bilateral pedicle cement anchoring combined with postural reduction in PVP. Pre- and post-operative bone mineral density, injected cement volume, visual analogue scale (VAS) values, Oswestry disability index (ODI) scores, Cobb angle measurements and anterior vertebral height (AVH) were recorded and assessed. The mean follow-up duration was 8.4±1.2 months. The average VAS score decreased from 8.17±0.71 pre-operatively to 1.56±0.62 post-operatively and remained at 2.00±0.91 at the final follow-up visit (P<0.05). The average ODI improved from 86.44±5.5 pre-operatively to 24.33±7.82 post-operatively. Until the last follow-up, the ODI remained at 27.11±8.76 (P<0.05). Similarly, the changes in the Cobb angle and AVH before and after surgery were also statistically significant in the radiological evaluation (P<0.05). During the follow-up, two patients experienced adjacent vertebral fractures. The loosening of cement was not found. Overall, the present study demonstrated that during the treatment of Kümmell disease with PVP, the bilateral pedicle cement anchoring technique combined with postural reduction can achieve good clinical outcomes.

PN HPT™ and Striae Albae-Exploratory Interim Analysis of a Randomised Prospective Study

Introduction: The outcomes of striae albae remodelling are currently disappointing. Replenishing the fibroblast pool of nucleotide precursors through passive exposure to Polynucleotides Highly Purified Technology (PN HPT™) facilitates the dermal production of new fibres. The manuscript reports on the outcomes of a prospective study with an intradermal PN HPT™-based medical device. Methods: Intra-subject-controlled randomised real-world study to evaluate the efficacy and safety of a medical device containing 20 mg/mL of PN HPT™ (functional ingredient) intradermal gel as therapy for moderate-to-severe striae albae. Based on a preliminary sample size assessment, the study estimated the need to enrol at least 65 mature albae from 18-to-55-year-old male and female subjects seeking ambulatory treatment (mean age: 34.1 ± 10.65). Up to eight symmetrical striae albae in the target areas (breast, abdomen, buttocks, thighs) per enrolled subject underwent randomisation into the two parallel “PN HPT™ intradermal infiltration” active group and “no-treatment striae albae” intra-subject control group. Actively treated striae albae underwent a four-session intradermal therapy cycle with the PN HPT™ device. Comparative efficacy assessments, performed at the two final evaluation visits by independent evaluators: Width of actively treated and untreated control striae albae (digital calliper). Global Aesthetic Improvement Scale (GAIS) outcomes (by investigators and subjects, respectively; assessments on digital photographic documentation). Width and wrinkling of actively treated and control striae albae (quantitative Antera 3D CS skin imaging technology). Results: The digital-calliper-assessed width for the exploratory sample of the 44 actively treated striae albae (29 control striae) decreased, on average, from 4.6 ± 2.31 at the V1 baseline visit to 2.7 ± 1.42 at V5 (first follow-up visit) one month after the last PN HPT™ intradermal infiltration at V4 (–40.8% vs. baseline, p &lt;0.01). In a subset of 17 striae (7 subjects), the mean digital-calliper-assessed width was still a significant 2.0 ± 0.94 at the final V6 follow-up visit, six months after V1 and three months after V4 (–54.5% vs control striae albae at V6, p &lt;0.05). At the V5 assessment, three months after V1 and one month and a half after V4, investigators and treated subjects reported average GAIS scores of 3.8 ± 0.51 (median, 4.0) and 4.0 ± 0.66 (median, 4.0) out of 5.0 as GAIS maximum score for both. The occasional mild local pain and irritation at the injection site, expected and known in the previous PN HPT™ literature, were of no clinical significance and rapidly transitory. Discussion: PN HPT™ are an innovative option with a solid rationale for treating mature striae albae. The efficacy outcomes of PN HPT™ dermal infiltrations appear noteworthy, with excellent safety and ease of use, confirming the previous results. However, waiting for complete results and confirmation by other controlled studies is prudent.

No Association of Preablation Thyroglobulin Antibody Positivity and Outcome in Pediatric Patients With Papillary Thyroid Carcinoma.

This multicenter study was designed to evaluate the relationship between preablation thyroglobulin antibody (TgAb) positivity and clinical outcomes in pediatric patients with papillary thyroid carcinoma (PTC). In the period 2005-2020, all consecutive PTC patients 18 years or younger who underwent total thyroidectomy and radioiodine ablation at 3 tertiary hospitals in southwestern China were retrospectively included. Thyroglobulin antibody was measured before remnant ablation. Tumor characteristics and long-term outcomes were compared between TgAb-positive and TgAb-negative patients. One hundred thirty-two patients were analyzed. Preablation TgAb positivity was presented in 37.1% of patients. Tumor characteristics, lymph node metastases, and median duration of follow-up were similar between TgAb-positive and -negative patients. During follow-up, the percentage of patients with either surgical reintervention for lymph node metastases (4.1% vs 4.8%, P = 1.000) or repeated 131 I therapy (14.3% vs 20.5%, P = 0.373) was similar between TgAb-positive and -negative patients. At the final follow-up visit, the rates of structural disease did not differ between the 2 groups (6.1% vs 4.8%, P = 0.710). This multicentric study highlights no association of preablation TgAb positivity and clinical outcome in pediatric patients with PTC.

Efficacy of combined treatment with human adipose tissue stem cell-derived exosome-containing solution and microneedling for facial skin aging: A 12-week prospective, randomized, split-face study.

Studies have reported promising results of mesenchymal stem cell therapies for skin aging. However, in the use of mesenchymal stem cells, some drawbacks including rarely possible tumorigenicity and low engraftment rates have limited their widespread clinical use. Adipose tissue stem cell-derived exosomes (ASCEs) are emerging as effective cell-free therapeutic agents. It was evaluated the clinical efficacy of combining the application of human ASCE-containing solution (HACS) with microneedling to treat facial skin aging. A 12-week, prospective, randomized, split-face, comparative study was conducted. Twenty-eight individuals underwent three treatment sessions separated by 3-week intervals and were followed up for 6 weeks after the last session. At each treatment session, HACS and microneedling were administered to one side of the face, and normal saline solution and microneedling were administered to the other side as a control. The Global Aesthetic Improvement Scale score was significantly higher on the HACS-treated side than on the control side at the final follow-up visit (p = 0.005). Objective measurements obtained by different devices including PRIMOS Premium, Cutometer MPA 580, Corneometer CM 825, and Mark-Vu confirmed greater clinical improvements in skin wrinkles, elasticity, hydration, and pigmentation on the HACS-treated side than on the control side. The results of the histopathological evaluation were consistent with the clinical findings. No serious adverse events were observed. These findings demonstrate that combined treatment using HACS and microneedling is effective and safe for treating facial skin aging.

Progression of Pentosan Polysulfate Sodium Maculopathy in a Prospective Cohort

To describe the progression of pentosan polysulfate sodium (PPS) maculopathy after drug discontinuation qualitatively and quantitatively using multimodal imaging assessmen. Prospective case series. Patients with PPS maculopathy were evaluated after discontinuation of PPS. Near-infrared reflectance (NIR), fundus autofluorescence (FAF), and optical coherence tomography (OCT) were evaluated in all patients at baseline and at the final follow-up visit at least 12 months later. A qualitative and quantitative analysis of the retinal imaging findings was performed. Patterns of disease progression were evaluated. Area of disease involvement on FAF, retinal pigment epithelium (RPE) atrophy on FAF and NIR, and retinal layer thicknesses on OCT were measured at baseline and at the follow-up visit. A total of 26 eyes were included, with a follow-up period ranging from 13 to 30 months. The diseased area measured on FAF showed significant expansion in all eyes from baseline to follow-up despite drug cessation (P=.03) with a median linearized rate of change of 0.42 mm/y. There was significant reduction in the central macular thickness (P=.04), inner nuclear layer thickness (P=.003), outer nuclear layer thickness (P=.02), and subfoveal choroidal thickness (P=.003) at follow-up vs baseline. New areas of RPE atrophy on FAF in the macula developed in 4 eyes while preexisting atrophic lesions increased in size in 5 eyes. Eyes with baseline PPS maculopathy all exhibited remarkable progression with qualitative and quantitative multimodal imaging analysis despite drug discontinuation. Disease progression may be attributed to underlying inner choroidal ischemia or RPE impairment.

Association between early nonpharmacological management and follow-up for low back pain in the veterans health administration

BackgroundLow back pain (LBP) is a common reason individuals seek healthcare. Nonpharmacologic management (NPM) is often recommended as a primary intervention, and earlier use of NPM for LBP shows positive clinical outcomes. Our purpose was to evaluate how timing of engagement in NPM for LBP affects downstream LBP visits during the first year. MethodsThis study was a secondary analysis of an observational cohort study of national electronic health record data. Patients entering the Musculoskeletal Diagnosis/Complementary and Integrative Health Cohort with LBP from October 1, 2016 to September 30, 2017 were included. Exclusive patient groups were defined by engagement in NPM within 30 days of entry (“very early NPM”), between 31 and 90 days (“early NPM”), or not within the first 90 days (“no NPM”). The outcome was time, in days, to the final LBP follow-up after 90 days and within the first year. Cox proportional hazards regression was used to model time to final follow up, controlling for additional demographic and clinical covariables. ResultsThe study population included 44,175 patients, with 16.7% engaging in very early NPM and 13.1% in early NPM. Patients with very early NPM (5.2 visits, SD=4.5) or early NPM (5.7 visits, SD=4.6) had a higher mean number of LBP visits within the first year than those not receiving NPM in the first 90 days (3.2 visits, SD = 2.5). The very early NPM (HR=1.50, 95% CI: 1.46–1.54; median=48 days, IQR=97) and early NPM (HR=1.27, 95% CI: 1.23–1.30; median=88 days, IQR=92) had a significantly shorter time to final follow-up than the no NPM group (median=109 days, IQR=150). ConclusionsVeterans Health Administration patients receiving NPM for LBP within the first 90 days after initially seeking care demonstrate a significantly faster time to final follow-up visit within the first year compared to those who do not.

Clinical Outcomes of Closed Reduction and External Fixation for Isolated Second Metacarpal Base Fracture-Dislocations.

The isolated second metacarpal base fracture-dislocations in adults are rare, and the traditional main treatments include closed reduction with the plaster or splint and open reduction with internal fixation (ORIF). However, closed reduction with the plaster or splint is not solid enough and ORIF can damage the surrounding important tissues. The purpose of this study was to explore the clinical outcomes of closed reduction and external fixation (CREF) for the treatment of isolated second metacarpal base fracture-dislocations. Ten patients who suffered isolated second metacarpal base fracture-dislocations between January 1, 2010, and February 1, 2020, were reviewed. All of the patients were treated by CREF. Radiographs and computed tomography scans were performed regularly after the operation. The grip and pinch strength, visual analog scale (VAS) pain score, American Society for Surgery of the Hand total active movement (TAM) and total active flexion (TAF) scores, Cooney score, Sollerman hand function test (SHFT) score, QuickDASH score, and range of motion of the index finger were recorded at the last follow-up visit to evaluate functional recovery; the injured and healthy hands were compared and we also recorded postoperative complications. The paired samples t-test was used to compare the healthy and injured sides. The patients were followed up for a median of 29.50 ± 4.2 months. There were no significant differences in the grip strength, pinch strength, angle of proximal interphalangeal joint (PIPJ) flexion, or angle of distal interphalangeal joint (DIPJ) flexion between the injured and healthy sides at the final follow-up visit (all p > 0.05). The mean TAM (268.20 ± 4.21) and TAF scores (270.60 ± 4.17) on injured side were significantly lower than those on healthy side (all p < 0.05). The mean Cooney score (93.50 ± 7.47) and SHFT score (78.50 ± 1.08) on injured side were lower, while the mean QuickDASH score (7.05 ± 3.11) on injured side was higher than those on healthy side (all p < 0.05). The mean VAS pain score was 0.50 ± 0.53 on injured side. There were no significant postoperative complications except for traumatic arthritis in one patient without obvious clinical symptoms. CREF achieves the satisfactory curative effect, and the patients obtain the good functional recovery without significant postoperative complications. CREF is a safe and effective treatment for isolated second metacarpal base fracture-dislocations with satisfactory clinical outcomes.

Effectiveness of locking compression plate for proximal humeral fracture in elderly patients without structural bone grafting: age group of 65-79 compared to 80 and above.

This study shows the effectiveness of locking compression plate for proximal humeral fractures in elderly patients over 80years old without structural bone grafting compared age group of 65-79 (Group 1) with 80 and above (Group 2). This study included sixty-one patients who underwent using locking compression plate for proximal humeral fractures between April 2016 and November 2021. The patients were divided into two groups. The neck shaft angle (NSA) was checked at immediately after surgery, at 1month and the final follow-up visit. The NSA changes in the two groups were compared using the independent t-test. In addition, multiple regression analysis was used to find out which factors affect NSA changes. In group 1, the mean difference between NSA immediately after surgery and 1month after surgery was 2.74°, and group 2 was 2.89°. In group 1, the mean difference in NSA for 1month after surgery and at the last follow-up was 1.43°, and group 2 was 1.75°. No significant difference was observed in the NSA changes between two groups (p = 0.59, 0.173). Bone marrow density and four-part fracture type were significant difference in NSA changes (p = 0.003, 0.035). The disabilities of the arm, shoulder and hand scale (DASH scale), age, medical support, diabetes and three-part fracture type were no significant in NSA changes. Using locking compression plate without structural bone grafting is a good option in elderly patients over 80years old and can help achieve radiological results similar to patients which age group of 67-79.