Prospective Controlled Trial Research Articles

Telescopic dissection versus balloon dissection during laparoscopic totally extraperitoneal inguinal hernia repair: A prospective randomised control trial.

Totally extraperitoneal (TEP) repair involves creating a preperitoneal space. The preperitoneal space can be created by balloon or telescopic dissection (TD). Nevertheless, these techniques may have some complications. However, there are very few studies that compare these two techniques. This study aims to assess the impact and comprehensively compare the TD and balloon dissection (BD) methods in patients undergoing laparoscopic TEP inguinal hernia repair. This was a single-centre, double-blinded, prospective, randomised, controlled trial comparing BD and TD for the creation of the preperitoneal space. The primary end point was to compare the post-operative pain score, intraoperative complications and surgical site occurrence between the two groups. The secondary end point was to assess the impact of the dissection technique on operative time for the creation of extraperitoneal space during laparoscopic TEP inguinal hernia repair. A total of 46 patients were included in the study (23 in each group). Baseline parameters were comparable between the groups. The total operative time between the groups (120 min vs. 160 min; P < 0.005) was statistically significant. The incidence of the peritoneal breach was statistically less in the BD group (43% vs. 13%; P < 0.005). Other short-term and long-term complications were less in the BD group but not statistically significant. BD in TEP inguinal hernia repair reduces the operative time and peritoneal breach. When compared to TD in terms of operative time, routine use of BD can be proposed. It will be beneficial in the early part of the learning curve.

Efficacy of Dexamethasone Injection at Different Sites on Postoperative Sequelae After Extracting Mandibular Impacted Third Molars: A Randomized Controlled Trial

BackgroundDexamethasone, an efficacious anti-inflammatory agent, is widely used after tooth extraction. However, its optimal injection site has yet to be investigated. PurposeWe compare the efficacy of dexamethasone injection at different sites on postoperative sequelae after extracting mandibular impacted third molars (MITMs). Study design, setting, and sampleA prospective randomized controlled trial was conducted. Healthy adults with fully MITMs scheduled for extraction were included. Exclusion criteria were 1) Patients with the systemic alteration that prevented the surgical procedure; 2) pregnancy, breastfeeding, premenstrual period; 3) hypersensitivity to the drug under test; and 4) those who did not return for postoperative follow-up at one, three, and seven days. Exposure variableThe subjects were randomized to three groups. An online randomization plan generator assigned each subject to a single treatment by randomly permuting blocks. Different sites for postoperative dexamethasone injections included the buccal side of the adjacent second molar and extraction sockets. Dexamethasone injection (4 mg) on the buccal side of the adjacent second molar (group 1), an injection on the buccal side of extraction sockets (group 2), an injection of physiological saline (0.8 mL) on the buccal side of the adjacent second molar (control). Outcome variablesThe outcome variables were postoperative facial swelling, limitation of the mouth opening, postoperative pain, and postoperative quality of life evaluation. The pain was assessed using a visual analog scale (VAS) at one, three and seven days, postoperatively. The quality of life was recorded throughout the Posse scale at seven days. CovariatesThe covariates are age, sex, length of operation, and type of impacted teeth and surgery. AnalysesThe statistical analysis was performed using ANOVA, repeated measures ANOVA, Chi-square, or Fisher’s exact tests with P-values < 0.05 considered statistically significant. ResultsOur study included 58 participants with a mean age of 19.48 ± 3.31 years; group 1 (n = 24), group 2 (n = 20), and control group (n = 14). On day three postoperative, the swelling and trismus were significantly less in group one than in the other two groups (P < 0.05), and group one had an overall postoperative quality of life compared to other groups (P < 0.05). Unaffected speech function was present in 73.7% of patients in group 1, while 50% of patients in group 2 had affected speech function three days after the operation (p < 0.05). The "unable to open mouth" of the “Eating subscale” and “felt tingling” had statistical significance (p < 0.05). ConclusionsDexamethasone injections on the buccal side of the adjacent second molar can be a viable option for treating facial swelling and limitation of mouth opening after total MITMs extraction.

Abstract PO5-18-03: A Randomized Controlled Trial to Evaluate the Safety and Efficacy of 1 cm versus 2 cm resection margins in Phyllodes Tumours of the Breast - An Exploratory Study

Abstract Introduction Phyllodes tumors are rare fibroepithelial tumors constituting 0.3-1% of breast tumors. It presents as a rapidly growing breast lump, with a bosselated surface and overlying shiny stretched skin with dilated prominent veins. Diagnosis is made by mammography and ultrasonography and tissue diagnosis is made by core needle biopsy. The tumor is known for its propensity to grow rapidly within the mesenchymal elements of breast tissue, and to locally recur. Surgery with adequate margins of excision has been known to prevent local recurrence. Phyllodes tumors have inspired much debate among surgeons, regarding the extent of margins during resection. These margins have been defined clearly for carcinoma of the breast (no ink on tumor) but the same consensus has not been reached for Phyllodes tumor. We carried out the world’s first randomized trial to settle the debate to compare the effects of a 1cm margin with that of a 2 cm margin, aiming to arrive at a consensus on the appropriate surgical margin to prevent re-excision and recurrences. We also aimed to compare cosmetic outcomes both subjectively and objectively between the 2 arms. Materials and Methods We carried out a prospective exploratory randomized control trial on patients with suspected phyllodes tumors of the breast from July 2020 to January 2022. After establishing diagnosis, and obtaining informed consent, patients were randomized to either of the 2 arms, to undergo resection with a lcm vs a 2 cm margin. Intraoperatively, the margin of the tumor was delineated by ultrasound for maximum accuracy. The incision made was deepened through the breast and pectoralis major muscle at a distance of exactly 1 cm or 2 cm from the tumor edge. The entire mass was excised en bloc with a 3 dimensional clearance from all sides. If the tumor was found infiltrating the underlying muscle (e.g Pectoralis major muscle, Serratus anterior), a full thickness section of the muscle was also excised with the specimen. The patients were followed up every 3 months with clinical examination and ultrasonography (followed by core needle biopsy for any suspicious mass), for a period of 12-18 months, to evaluate for recurrence.Cosmesis was evaluated by a 5-point Likert scale evaluated by the patient and the surgeon, and objectively using Breast Retraction Assessment and Nipple Deviation. Results We analysed the results of 41 patients who underwent surgery for Phyllodes tumor of the breast. All patients had negative margins after surgery. The mean margin distance (SD) in the 1 cm arm was 0.69 (0.20) cm and 1.83 (0.67) cm in the 2 cm arm. which was statistically significant between the groups. On the follow up ultrasound examination at 12 months, 1 patient (5.3%) was found to have a locoregional recurrence, but this was not statistically significant. There was no statistically significant difference in cosmesis between the arms. Conclusions We achieved our primary objective of histologically negative margins in all patients within both the groups. However, due to the limited number of patients recruited in the study, and due to the short duration of follow-up, we are not able to report significance in terms of recurrences between the 2 groups, to advocate for one over the other. The practice in our unit has been the 2 cm margin, as it offers good oncological outcomes and is definitely safe. Given that cosmetic outcomes were comparable in both arms, one can be assured that a 2 cm margin does not offer worse cosmesis compared to a 1 cm margin. However, our study at this point in time, establishes non inferiority of a 1 cm margin. There have been no randomized control trials conducted in world literature to influence guidelines and clinical practice regarding the ideal margin resection for phyllodes tumor. Our study would be the first of its kind, and is a novel concept not yet conducted for phyllodes tumor. We will continue this trial for years to come, and hope to generate level I data, with increased patient enrolment and a longer duration of follow up. Citation Format: Vandhana Rajgopal, Anita Dhar, Kamal Kataria, Piyush Ranjan, Anurag Srivastava. A Randomized Controlled Trial to Evaluate the Safety and Efficacy of 1 cm versus 2 cm resection margins in Phyllodes Tumours of the Breast - An Exploratory Study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-18-03.

A RANDOMIZED CONTROLLED TRIAL ASSESSING TRADITIONAL VERSUS DYNAMIC REHABILITATION REGIMES FOLLOWING SURGICAL REPAIR OF A PROXIMAL HAMSTRING TENDON AVULSION

Proximal hamstring tendon avulsion from the ischial tuberosity is a significant injury, with surgical repair shown to have superior functional outcomes compared to non-surgical treatment. However, limited data exists regarding the optimal rehabilitation regime following surgical repair. The aim of this study was to investigate patient outcomes following repair of proximal hamstring tendon avulsions between a conservative (CR) versus an accelerated rehabilitation (AR) regimen.This prospective randomized controlled trial (RCT) randomised 50 patients undergoing proximal hamstring tendon repair to either a braced, partial weight-bearing rehabilitation regime (CR=25) or an accelerated, unbraced regime, that permitted full weight-bearing as tolerated (AR=25).Patients were evaluated pre-operatively and at 3 and 6 months post-surgery, via patient-reported outcome measures (PROMs) including the Lower Extremity Functional Scale (LEFS), Perth Hamstring Assessment Tool (PHAT) and 12-item Short Form Health Survey (SF-12). Primary analysis was per protocol and based on linear mixed models.Both groups were matched at baseline with respect to patient characteristics. All PROMs improved (p&gt;0.05) and, while the AR group reported a significantly better Physical Component Score for the SF-12 at 3 months (p=0.022), there were no other group differences. Peak isometric hamstrings strength and peak isokinetic quadriceps and hamstrings torque symmetry were all comparable between groups (p&gt;0.05). Three re-injuries have been observed (CR=2, AR=1).After proximal hamstring repair surgery, post-operative outcomes following an accelerated rehabilitation regimen demonstrate comparable outcomes to a traditionally conservative rehabilitation pathway, albeit demonstrating better early physical health-related quality of life scores, without an increased incidence of early re-injury.

Comparison of the therapeutic effects of febuxostat combined with a low-purine diet and allopurinol combined with a low-purine diet on the improvement of gout patients.

To compare the clinical efficacy of febuxostat combined with a low-purine diet versus allopurinol combined with a low-purine diet in the treatment of gout. In this prospective controlled trial, 98 gout patients admitted to our hospital from February 2021 to December 2022 were enrolled as study subjects. Patients were randomly assigned to the study group (febuxostat combined with a low-purine diet) and the control group (allopurinol combined with a low-purine diet), with 49 patients in each group. The therapeutic effect was evaluated based on joint function and serum uric acid levels after treatment, and classified into three levels: markedly effective, effective, and ineffective. The levels of inflammatory factors, including tumor necrosis factor-a (TNF-a), cytokine interleukin-1beta (IL-1β), and interleukin (IL)-18 (IL-18), were collected. The Numeric Rating Scale (NRS) was used to assess the degree of pain in patients. Clinical indicators before and 6 months after treatment were compared between the two groups. There was no statistically significant difference in age and gender between the two groups. After 6 months of treatment, the effective rate in the study group (48 cases, 97.96%) was higher than that in the control group (42 cases, 85.71%), with a statistically significant difference (p = .027). At the same time, the study group had significantly lower levels of serum uric acid (162.39 μmol/L ± 17.23 μmol/L vs. S198.32 μmol/L ± 18.34 μmol/L, p < .001), creatinine (87.39 mmol/L ± 9.76 mmol/L vs. 92.18 mmol/L ± 9.27 mmol/L, p = .014), total cholesterol (3.65 mmol/L ± 0.65 mmol/L vs. 4.76 mmol/L ± 0.73 mmol/L, p < .001), and triglycerides (1.76 mmol/L ± 0.32 mmol/L vs. 2.28 mmol/L ± 0.41 mmol/L, p < .001) compared to the control group, with statistically significant differences (p < .05). After treatment, the levels of inflammatory factors and degree of pain in the study group were significantly lower than those in the control group (all p < .05). During the treatment process, the incidence of adverse reactions in the study group (2 cases, 4.08%) was lower than that in the control group (9 cases, 18.37%), with a statistically significant difference (p = .025). Febuxostat combined with a low-purine diet can reduce inflammatory factors and alleviate the degree of pain in gout patients, significantly improving their clinical symptoms.

Platelet-rich Plasma versus Corticosteroid Injection for the Treatment of Lateral Epicondylitis – A Prospective Randomised Controlled Study

Abstract Introduction: Lateral epicondylitis, commonly known as tennis elbow, is one of the most common chronic disabling painful conditions that affect the forearm’s common extensor tendons. This study aimed to compare the effectiveness of platelet-rich plasma (PRP) versus corticosteroid injection in the treatment of lateral epicondylitis. Aims: The purpose of this study is to compare the efficacy of PRP versus corticosteroid injection in the treatment of lateral epicondylitis, focusing on the early response. Settings and Design: This was a prospective randomised controlled study. Materials and Methods: This study was a prospective randomised control trial of 100 patients, clinically diagnosed with lateral epicondylitis in Karnataka Institute of Medical Sciences Hospital, Hubli. Patients were randomly allocated (1:1) using computer-generated random numbers to two groups. Group A received corticosteroid injection. Group B received PRP injection. Outcome assessment was done using the Oxford Elbow Score (OES), Visual Analogue Scale (VAS), Patient-rated Tennis Elbow Evaluation (PRTEE) and Disabilities of Arm, Shoulder and Hand Score (DASH). All patients were followed up at regular intervals of 2 weeks, 4 weeks, 3 months and 6 months post-injection. Statistical Analysis Used: Using SPSS Statistics version 25 software, statistical analysis was done. Results: Pre–injection, the mean OES, VAS, PRTEE and DASH scores were similar in both the groups with insignificant P value. The mean pre-injection OES, VAS, PRTEE and DASH scores in the corticosteroid group were 11.22, 7.88, 75.950 and 69.364, whereas in the PRP group, it was 10.66, 7.96, 76.170 and 69.466, with P = 0.165, 0.322, 0.834 and 0.869, respectively. At the end of 6 months in the corticosteroid group, the mean score of OES increased from 11.22 ± 1.71 to 38.94 ± 5.17, VAS decreased from 7.88 ± 0.385 to 1.74 ± 1.24, PRTEE decreased from 75.95 ± 4.86 to 24.3 ± 12 and DASH decreased from 69.36 ± 2.90 to 23.31 ± 11.5, with a significant P &lt; 0.005. At the end of 6 months in the PRP group, the mean scores of OES increased from 10.66 ± 2.07 to 45.38 ± 1.41, VAS decreased from 7.96 ± 0.45 to 0.06 ± 0.31, PRTEE decreased from 76.1 ± 5.04 to 7.47 ± 3.16 and DASH decreased from 69.47 ± 3.44 to 7.78 ± 2.65, with a significant P &lt; 0.005. Conclusion: We concluded that patients treated with PRP had significantly reduced pain, increased functional activity, less recurrence and without requirement of any further intervention, outperforming corticosteroid injection effect at the end of 6 months follow up.

A RANDOMIZED CONTROLLED TRIAL EVALUATING AN ACCELERATED WEIGHT-BEARING REHABILITATION PATHWAY AFTER MATRIX-INDUCED AUTOLOGOUS CHONDROCYTE IMPLANTATION FOR SYMPTOMATIC KNEE CARTILAGE DEFECTS

INTRODUCTION &amp; AIMS Matrix-induced autologous chondrocyte implantation (MACI) has demonstrated encouraging outcomes in treating symptomatic knee cartilage lesions which, if untreated, can progress toward early osteoarthritis. Rehabilitation is imperative to optimize outcome, though has been traditionally conservative. This study investigated the long-term outcomes of an accelerated return to full weight bearing (WB) after MACI. METHODS This prospective randomized controlled trial (RCT) allocated 35 patients (37 knees) to a 6-week (n=18) or 8-week (n=19) return to full WB after MACI. Patients were evaluated pre-operatively and at 1, 2, 5 and ≥10 years, via patient-reported outcome measures (PROMs) including the Knee Osteoarthritis Outcome Score (KOOS). Single limb hop capacity and peak knee extensor and flexor torque were assessed, with limb symmetry indices (LSIs) calculated. Magnetic resonance imaging (MRI) evaluated repair tissue, while a validated MRI composite graft score was calculated. RESULTS While the 6-week WB group reported significantly better 1-year KOOS Quality of Life scores, no other differences (p&amp;gt;0.05) in PROMs existed. The peak knee extensor torque LSI significantly improved (p&amp;lt;0.0001) over time, with mean LSIs of 100.8 (6-week) and 99.1 (8-week) at ≥10 years. No group differences (p&amp;gt;0.05) were observed in hop LSIs. A non-significant decline (p&amp;gt;0.05) was observed for the MRI composite score from 1-year to final ≥10-year review and, apart from a significant group effect (p=0.028) for graft tissue intensity in favor of the 6-week group suggesting repair tissue more reflective of native cartilage, no other MRI-based differences (p&amp;gt;0.05) existed. At ≥10-years, no grafts on MRI had failed, though 3 patients (6-week n=1, 8-week n=2) had progressed toward knee arthroplasty. CONCLUSION The 6-week accelerated rehabilitation program provided comparable clinical and MRI-based outcomes beyond 10 years post-surgery, without jeopardizing the graft.

A RANDOMIZED CONTROLLED TRIAL ASSESSING A BRACE-FREE AND ACCELERATED WEIGHT-BEARING PROTOCOL AFTER SURGICAL REPAIR OF ACUTE PROXIMAL HAMSTRING TENDON AVULSIONS

INTRODUCTION &amp; AIMS Proximal hamstring tendon avulsion from the ischial tuberosity is a significant injury, with surgical repair advocated. After surgery, limited data exists regarding the optimal rehabilitation regime with extensive variation in published protocols. This study investigated patient outcomes following a traditionally conservative (CR) versus accelerated (AR) rehabilitation regimen after proximal hamstring tendon repair. METHODS This prospective randomized controlled trial (RCT) allocated 50 patients undergoing proximal hamstring tendon repair to either a braced, partial weight-bearing rehabilitation regime (CR=25) or an accelerated, unbraced regime, that permitted full weight-bearing as tolerated (AR=25). Patients were evaluated pre-operatively and at 3, 6 and 12 months post-surgery, via patient-reported outcome measures (PROMs) including the Lower Extremity Functional Scale (LEFS), Perth Hamstring Assessment Tool (PHAT) and 12-item Short Form Health Survey (SF-12). The single (SHD), triple (THD) and triple crossover (TCHD) hop tests were assessed at 6 and 12 months, as was peak isometric hamstring strength and peak isokinetic knee extensor and flexor torque. RESULTS All PROMs improved (p&amp;gt;0.05) and, while the AR group reported a significantly better Physical Component Score for the SF-12 at 3 months (p=0.022), as well as a lower severity of hamstring pain at 12 months (p=0.032), there were no other group differences. Peak isometric hamstrings strength and peak isokinetic quadriceps and hamstrings torque symmetry were all comparable between groups (p&amp;gt;0.05). While the AR group demonstrated significantly better (p=0.009) limb symmetry for the THD at 6 months, no other hop test differences were seen between groups. Three re-injuries have been observed (CR=2, AR=1). CONCLUSION After proximal hamstring repair surgery, post-operative outcomes following an accelerated rehabilitation regimen were largely comparable to a traditionally conservative

A RANDOMIZED CONTROLLED TRIAL INVESTIGATING FUNCTIONAL RECOVERY AFTER ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING A SINGLE VERSUS DOUBLE TENDON HARVEST

INTRODUCTION &amp; AIMS Anterior cruciate ligament (ACL) tears are common. While surgical reconstruction (ACLR) is commonly advocated and a hamstring autograft is the popular choice, hamstring tendon harvest has been linked to reduced hamstring strength and ongoing donor site pain. While traditional surgical techniques required a harvest of both semitendinosus/gracilis tendons, modern harvesting and fixation methods permit a shorter, broader harvest of semitendinosus only. This study investigated donor site pain, strength and functional recovery in patients undergoing ACLR via a single (ST) versus dual (DT) tendon hamstring harvest. METHODS This prospective randomized controlled trial (RCT) allocated 138 patients to ACLR with one of the two hamstring tendon graft options (ST=71, DT=67) followed by a structured rehabilitation program. Patients were assessed pre-surgery and at 3, 6, and 12 months, with a range of patient-reported outcome measures (PROMs) including a validated donor-site morbidity score. Graft laxity, peak isokinetic knee extensor and flexor strength and a 6-hop performance battery were assessed. Limb Symmetry Indices (LSIs) were calculated. RESULTS All PROMs significantly improved (p&amp;lt;0.0001) and were largely similar between groups (p&amp;gt;0.05), apart from significantly less graft morbidity reported in the ST group (p=0.001). No group differences were observed for knee laxity or LSIs for hop measures (p&amp;gt;0.05), nor the LSIs for peak knee flexor (p=0.113) or extensor (p=0.286) torque. CONCLUSION While the ST ACLR group reported significantly less harvest site morbidity, no other subjective or functional differences were observed in patients undergoing ACLR with either a single or dual hamstring tendon autograft harvest.

Intravitreal Aflibercept vs Laser Therapy for Retinopathy of Prematurity

Prospective long-term data after retinopathy of prematurity (ROP) treatment with anti-vascular endothelial growth factor injections vs laser therapy are scarce. The FIREFLEYE (Aflibercept for ROP IVT Injection vs Laser Therapy) next trial is prospectively evaluating the long-term efficacy and safety outcomes following ROP treatment with intravitreal aflibercept vs laser therapy. To evaluate 2-year ophthalmic and safety outcomes after 0.4-mg aflibercept injection or laser therapy in the 24-week randomized (2:1) FIREFLEYE trial (FIREFLEYE outcomes previously reported). This prospective nonrandomized controlled trial performed in 24 countries in Asia, Europe, and South America (2020-2025) follows up participants treated in the FIREFLEYE randomized clinical trial (2019-2021) through 5 years of age. Participants included children born very or extremely preterm (gestational age ≤32 weeks) or with very or extremely low birth weight (≤1500 g) who were previously treated with a 0.4-mg injection of aflibercept compared with laser therapy for severe acute-phase ROP. Data for the present interim analysis were acquired from March 18, 2020, to July 25, 2022. Complications of ROP treated at investigator discretion (no study treatment). Efficacy end points included ROP status, unfavorable structural outcomes, ROP recurrence, treatment for ROP complications, completion of vascularization, and visual function. Safety end points included adverse events and growth and neurodevelopmental outcomes. Overall, 100 children were enrolled (median gestational age, 26 [range, 23-31] weeks; 53 boys and 47 girls). Of these, 21 were Asian, 2 were Black, 75 were White, and 2 were of more than 1 race. At 2 years of age, 61 of 63 children (96.8%) in the aflibercept group vs 30 of 32 (93.8%) in the laser group had no ROP. Through 2 years of age, 62 of 66 (93.9%) in the aflibercept group and 32 of 34 (94.1%) in the laser group had no unfavorable structural outcomes. No new retinal detachment occurred during the study. Four children in the aflibercept group (6.1%) were treated for ROP complications before 1 year of age (2 had preexisting end-stage disease and total retinal detachment; 1 had reactivated plus disease; and 1 had recurrent retinal neovascularization not further specified). Most children were able to fix and follow a 5-cm toy (aflibercept group, 118 of 122 eyes [96.7%] among 63 children; laser group, 62 of 63 eyes [98.4%] among 33 children). High myopia was present in 9 of 115 eyes (7.8%) among 5 children in the aflibercept group and 13 of 60 eyes (21.7%) among 9 children in the laser group. No relevant differences in growth and neurodevelopmental outcomes by Bayley Scales of Infant and Toddler Development, Third Edition and Vineland Adaptive Behavior Scales, Second Edition were identified. In this nonrandomized follow-up of a randomized clinical trial comparing treatment of severe acute-phase ROP with 0.4-mg injection of aflibercept and laser, disease control was stable and visual function was appropriate in children through 2 years of age. No adverse effects on safety, including growth and neurodevelopment, were identified. These findings provide clinically relevant long-term information on intravitreal aflibercept injection therapy for ROP. ClinicalTrials.gov Identifier: NCT04015180.

Chronic non-bacterial osteomyelitis (CNO) and chronic recurrent multifocal osteomyelitis (CRMO) with a focus on pamidronate therapy.

Chronic recurrent multifocal osteomyelitis (CRMO), also called chronic nonbacterial osteomyelitis (CNO) or nonbacterial osteomyelitis (NBO), is a rare autoinflammatory bone disease of unknown etiology. However, the number of patients properly diagnosed would increase with better knowledge of the disease. In this regard, whole-body magnetic resonance imaging (WB MRI) has been found to be a better predictor of active lesions than clinical examination. Importantly, the RINBO index (radiologic index for NBO) quantifies the involvement based on the WB MRI. Further, a chronic nonbacterial osteomyelitis MRI scoring (CROMRIS) has been developed as an online tool for assessing WB MRI. The therapy consists of non-steroidal anti-inflammatory drugs (NSAIDs), bisphosphonates (pamidronate, zoledronate, etc.) and other drugs, including biologics. Pamidronate is an appropriate and safe therapy. The first pilot prospective randomised controlled trial (RCT) on pamidronate vs. placebo was carried out in adults. No RCT has been done in children yet. Besides RCTs, there are a number of issues to be explored in future, i.e. predictors of therapy effect, optimal therapy duration, predictors of therapy discontinuation and evaluation of optimal therapy protocol. Recently, the CNO clinical disease activity score (CDAS) was constructed and validated but the classification criteria are still being developed. As collaboration on this rare disease is essential, a prospective Chronic Nonbacterial Osteomyelitis International Registry (CHOIR) was established to generate future comparative effectiveness research data.

A prospective randomized control trial comparing outcomes of casting, pinning, and plating for distal end of radius fractures (AO type A2, A3, C1, or C2) in the elderly population.

With this prospective randomized control trial (RCT), we aim to provide the outcome analyses of the three most used treatment modalities for distal end of radius (DER) fracture management in the elderly. A prospective randomized control trial was performed. Fifty-two patients with DER fractures (AO A2, A3, C1, or C2) were randomized to the casting (n = 17), percutaneous pinning (n = 18), and the volar plating group (n = 17). Radiological measurements measured were radial inclination (RI), radial height (RH), volar tilt (VT), and ulnar variance (UV). The outcome was measured based on range-of-motion, grip strength, Patient-Related-Wrist-Evaluation (PRWE) score, and the Quick-Disabilities-of-the-Arm-Shoulder-Hand (QDASH) score. Immediate post-operative and 1-year-follow-up X-rays showed a significant difference measurement between the groups (p < 0.05). Pairwise comparisons of the casting and pinning groups (p < 0.05) and the casting and plating groups (p < 0.05) revealed significant differences at the 1-year follow-up, but not the pinning and plating groups (p > 0.05). The analysis found significant differences in clinical outcomes after 1 month of follow-up, with the plating group outperforming the other two (p > 0.05). However, after a year of follow-up, all groups had comparable outcomes; however, the plating group showed improved palmar flexion (p < 0.001), radial deviation (p < 0.001), and a lower PRWE score (p < 0.05), indicating better wrist function. Complications were more in casting group. The study found a radiologically significant difference between groups throughout the follow-up, but it did not affect functional results. Clinical outcomes were similar across the groups, with plating showing better palmar flexion and radial deviation. Grip strength was also better in the plating group, but statistically insignificant. The study suggests plating should be chosen over other treatments for high-demand patients.

Efficacy and Safety of Tirzepatide in Overweight and Obese Adult Patients with Type 1 Diabetes.

Introduction and Objective: Most patients with type 1 diabetes (T1D) in the United States are overweight (OW) or obese (OB), contributing to insulin resistance and suboptimal glucose control. The primary Food and Drug Administration-approved treatment for T1D is insulin, which may adversely affect weight. Tirzepatide is approved for managing type 2 diabetes, improves glucose control, facilitates weight loss, and improves cardiovascular disease outcomes. We assessed the use of tirzepatide in OW/OB subjects with T1D. Methods: This was a retrospective single-center real-world study in 62 OW/OB adult patients with T1D who were prescribed tirzepatide (treated group) and followed for 1 year. At least 3 months of use of tirzepatide was one of the inclusion criteria. Based on the inclusion criteria, this study represents 62 patients out of 184 prescribed tirzepatide. The control group included 37 OW/OB patients with T1D (computer frequency matched by age, duration of diabetes, gender, body mass index (BMI), and glucose control) who were not using any other weight-loss medications during the same period. The mean (±standard deviation [SD]) dose of weekly tirzepatide at 3 months was 5.6 ± 1.9 mg that increased to 9.7 ± 3.3 mg at 1 year. Results: The gender, mean baseline age, duration of diabetes, and glycosylated hemoglobin (HbA1c) were similar in the two groups, whereas BMI and weight were higher in the treated group. There were significantly larger declines in BMI and weight in the treated group than in controls across all time points among those in whom data were available. HbA1c decreased in the treated group as early as 3 months and was sustained through a 1-year follow-up (-0.67% at 1 year). As expected, insulin dose decreased at 3 months and throughout the study period. There were no reported hospitalizations from severe hypoglycemia or diabetic ketoacidosis. The mean glucose, time-in-range, time-above-range, SD, and coefficient of variation (continuous glucose monitoring metrics) significantly improved in the treated group. Conclusions: In this pilot (off label) study, we conclude that tirzepatide facilitated an average 18.5% weight loss (>46 pounds) and improved glucose control in OW/OB patients with T1D at 1 year. For safe use of tirzepatide in patients with T1D, we strongly recommend a large prospective randomized control trial in OW/OB patients with T1D.

Simulator-Based Versus Traditional Training of Fundus Biomicroscopy for Medical Students: A Prospective Randomized Trial.

Simulation training is an important component of medical education. In former studies, diagnostic simulation training for direct and indirect funduscopy was already proven to be an effective training method. In this prospective controlled trial, we investigated the effect of simulator-based fundus biomicroscopy training. After completing a 1-week ophthalmology clerkship, medical students at Saarland University Medical Center (n = 30) were block-randomized into two groups: The traditional group received supervised training examining the fundus of classmates using a slit lamp; the simulator group was trained using the Slit Lamp Simulator. All participants had to pass an Objective Structured Clinical Examination (OSCE); two masked ophthalmological faculty trainers graded the students' skills when examining patient's fundus using a slit lamp. A subjective assessment form and post-assessment surveys were obtained. Data were described using median (interquartile range [IQR]). Twenty-five students (n = 14 in the simulator group, n = 11 in the traditional group) (n = 11) were eligible for statistical analysis. Interrater reliability was verified as significant for the overall score as well as for all subtasks (≤ 0.002) except subtask 1 (p = 0.12). The overall performance of medical students in the fundus biomicroscopy OSCE was statistically ranked significantly higher in the simulator group (27.0 [5.25]/28.0 [3.0] vs. 20.0 [7.5]/16.0 [10.0]) by both observers with an interrater reliability of IRR < 0.001 and a significance level of p = 0.003 for observer 1 and p < 0.001 for observer 2. For all subtasks, the scores given to students trained using the simulator were consistently higher than those given to students trained traditionally. The students' post-assessment forms confirmed these results. Students could learn the practical backgrounds of fundus biomicroscopy (p = 0.04), the identification (p < 0.001), and localization (p < 0.001) of pathologies significantly better with the simulator. Traditional supervised methods are well complemented by simulation training. Our data indicate that the simulator helps with first patient contacts and enhances students' capacity to examine the fundus biomicroscopically.

Paradoxical effect of anti-inflammatory drugs on IL-6 mRNA expression in patients with PTSD during treatment

The pathophysiology of posttraumatic stress disorder (PTSD) is associated with the activation of the innate immune system, including cytokines like interleukin 6 (IL-6). However, the role of IL-6 in the etiology and treatment of PTSD still remains elusive. We conducted a prospective controlled trial to investigate the development of IL-6 during psychosomatic treatment in individuals with PTSD in comparison with individuals without PTSD. We assessed IL-6 mRNA expression before and after 2 months of psychosomatic treatment in individuals with and without PTSD. Severities of PTSD and depressive symptoms were assessed in parallel. Linear mixed regression was applied for statistical analysis, including the factors diagnosis PTSD and pre–post treatment after subgrouping for intake of anti-inflammatory drugs. The development of IL-6 mRNA expression during treatment was affected by the use of anti-inflammatory drugs. In the subgroup without intake of anti-inflammatory drugs, no significant statistical treatment effect in individuals with and without PTSD emerged. In the subgroup of individuals taking anti-inflammatory drugs, a significant interaction effect of the factors pre–post treatment and diagnosis PTSD was observed. Whereas IL-6 mRNA expression in individuals without PTSD decreased according to amelioration of symptoms, IL-6 mRNA expression in individuals with PTSD increased significantly during treatment, in opposite direction to symptom severity. Anti-inflammatory drugs might affect IL-6 mRNA expression in individuals with PTSD in a paradoxical way. This study offers a further piece of evidence that IL-6 could be involved in the pathophysiology of PTSD and PTSD-specific immunologic molecular mechanisms.

Comparison of the effect of intraoperative dexmedetomidine versus ketamine on postoperative analgesia in fracture femur patients operated under subarachnoid block – A prospective randomized double-blind controlled trial

Abstract Background and Aims: Intravenous sedation during spinal anesthesia has the advantages of increased duration of spinal anesthesia and better postoperative pain control. The aim of this study was to compare the effect of intravenous bolus and infusion of dexmedetomidine versus ketamine given intraoperative on the postoperative analgesia in fracture femur patients operated under subarachnoid block. Material and Methods: In this prospective randomized double-blind controlled study, 75 patients aged 18–65 years posted for elective surgery were selected and randomly divided into three groups to receive ketamine (group K), dexmedetomidine (group D), and saline (control group C). Postoperative pain was evaluated using the numerical rating scale (NRS). The duration of analgesia and the amount of analgesic consumption were also recorded. Student’s t-test and Chi-square test were used to compare the two groups, and one-way ANOVA with posthoc analysis was performed for comparison of the three groups. Results: Patients in the ketamine group had better postoperative analgesia as assessed by decreased pain (on the NRS scale) and decreased need for postoperative rescue analgesics (P &lt; 0.001). The duration of sensory block and motor block was prolonged in group K as compared to the other two groups (P &lt; 0.001). Conclusion: Intraoperative use of intravenous ketamine was superior to dexmedetomidine for postoperative analgesia in fracture femur patients operated under subarachnoid block.

Efficacy of Intrawound Vancomycin in Prevention of Periprosthetic Joint Infection After Primary Total Knee Arthroplasty: A Prospective Double-Blinded Randomized Control Trial

BackgroundPeriprosthetic joint infection (PJI) after total knee arthroplasty (TKA) is a devastating complication. Intrawound vancomycin powder has been shown to reduce infection rates in spine surgery, but its role in arthroplasty remains controversial. This prospective randomized control trial aimed to evaluate the efficacy of intrawound vancomycin in preventing PJI after primary TKA. MethodsA total of 1,022 patients were randomized to the study group (n = 507, who received 2 grams intrawound vancomycin powder before arthrotomy closure) or to the control group (n = 515, no local vancomycin) with a minimum follow-up of 12-months. The primary outcome was the incidence of PJI or surgical site infection (SSI). Secondary outcomes included associated minor complications such as stitch abscess, persistent wound drainage, and delayed stitch removal. Other parameters evaluated include reoperation rates and incidences of nephrotoxicity. ResultsThe overall infection rate in 1,022 patients was 0.66%. There was no significant difference in PJI rate in the study group (N = 1; 0.2%) versus the control group (N = 3; 0.58%), P = .264. Reoperation rates in the study group (N = 4; 0.78%) and control (N = 5; 0.97%), and SSI rates in the study (N = 1; 0.2%) and control groups (N = 2; 0.38%) were comparable. The Vancomycin cohort, however, demonstrated a significantly higher number of minor wound complications (n = 67; 13.2%) compared to the control group (n = 39; 7.56%, P < .05). Subgroup analysis showed diabetics in the study group to also have a higher incidence of minor wound complications (24 [14.1%] versus 10 [6.2%]; P < 05]. Multivariate analyses found that vancomycin use (odds ratio = 1.64) and smoking (odds ratio = 1.85) were associated with an increased risk of developing minor wound complications. No cases of nephrotoxicity were reported. ConclusionsIntrawound vancomycin powder does not appear to reduce PJI/SSI rate in primary total knee arthroplasties, including high-risk groups. Although safe from a renal perspective, intrawound vancomycin was associated with an increase in postoperative aseptic wound complications. Intrawound vancomycin may not be effective in reducing the rate of PJI in primary TKA.

Weight gain in infants with congenital heart disease; breastfeeding alone versus supplemental spoon-feeding of expressed breast milk: an open-label, pilot, randomised control trial.

Infants with congenital heart disease and increased pulmonary blood flow frequently suffer from feeding difficulties and growth failure. Providing expressed breast milk by spoon has been hypothesised to decrease energy expenditure in these infants as compared to breastfeeding. This study assessed the effect of supplemental feeding of expressed breast milk on weight gain in infants with unoperated congenital heart disease. This was a prospective open-label randomised control trial. In total, 50 infants with post tricuspid left to right shunt were enrolled in the study. In the intervention group, apart from breastfeeding, a minimum predetermined volume of expressed breast milk was targeted to be given by spoon. 30-50 kcal/kg/day was given by expressed breast milk by spoon-feeding. In the control group, the infants were given at least 8 feeds per 24 hours by direct breastfeeding. Both groups were followed up for 1 month and assessed for weight gain. Despite a high rate of protocol breach in both groups (30% overall), infants in the intervention group had better weight gain at one-month follow-up compared to those in the control group, 780 ± 300 versus 530 ± 250 gm (p = 0.01). In infants with left to right shunts, supplemental feeding of expressed breast milk by spoon along with breastfeeding resulted in significantly higher average weight gain at 30 days compared to the control group who received breastfeeding alone. Future studies with larger sample sizes and longer follow-ups need to be done to confirm the findings of this study.

Reducing hip and non-vertebral fractures in institutionalised older adults by restoring inadequate intakes of protein and calcium is cost-saving

Older adults in aged care homes account for 30% of the population burden of hip fractures(1). Nutritional interventions to correct protein and calcium inadequacies reduce these and other debilitating fractures, perhaps partly by reducing falls and slowing deterioration in bone morphology. We aimed to determine whether a nutritional approach to fracture risk reduction in aged care homes is cost-effective. Costing was estimated based on results of a prospective two-year cluster-randomised controlled trial involving 3313 residents in 27 aged care homes (intervention using high dairy menus), 3911 residents in 29 aged care homes (controls consuming from normal menus) and cost of ambulance, hospital, rehabilitation, and residential care incurred after fracture. The incremental cost-effectiveness ratios per fracture averted within a 2-year time horizon were estimated from the Australian healthcare perspective applying a 5% discount rate on costs after the first year. Intervention resulted in a total of 3.5 servings of milk, yoghurt and/or cheese daily, achieving 1,142mg calcium and 69g protein versus usual daily intakes of 700mg calcium and 58g protein consumed by controls. This intervention reduced all fractures by 33% at a daily cost of AU$0.66 per resident. The base-case results showed that intervention was cost-saving per fracture averted, with robust results in a variety of sensitivity and scenario analyses. Scaling the benefits of intervention to the Australian community equated to a saving of AU$66,780,000 annually in Australia and remained cost saving up to a daily food expenditure of AU$1.07 per aged care resident. Averting hip and other non-vertebral fractures in older adults in aged care homes by restoring nutritional inadequacies of protein and calcium is cost saving and supports the wide-spread implementation of this type of nutritional intervention in similar settings.

Comparing two photodynamic therapy protocols for high-grade cervical intraepithelial neoplasia

SignificancePhotodynamic therapy (PDT) is a therapeutical modality which offers a minimally invasive alternative for high-grade cervical intraepithelial neoplasia (CIN) treatment. Approachthis prospective randomized controlled clinical trial aims to compare two PDT protocols for histopathologically similar high-grade CIN treatment. In protocol 1, only ectocervix is treated; in protocol 2, the patients had both the ectocervix and endocervix illuminated simultaneously with LED plus LASER (a cylindrical diffuser fiber was coupled inside the squamocolumnar junction). In both groups was applied 20% MAL overnight and the irradiance delivered was 120 mW/cm2, for 21 minutes, in a fluency rate of 150 J/cm2. Resultsafter two years of follow-up, group 1 showed 96% cure and group 2, 87%. Conclusionsno significant difference was observed between the two protocols. However, the number of patients who completed the two-year follow-up is still low and we expect better conclusions with more patients followed.