scholarly journals Randomized Controlled Trial of the Clinical Recovery and Biodegradation of Polylactide-co-glycolide Implants Used in the Intramedullary Nailing of Children’s Forearm Shaft Fractures with at Least Four Years of Follow-Up

2021 ◽  
Vol 10 (5) ◽  
pp. 995
Author(s):  
Marja Perhomaa ◽  
Tytti Pokka ◽  
Linda Korhonen ◽  
Antti Kyrö ◽  
Jaakko Niinimäki ◽  
...  
Keyword(s):  
Intramedullary Nailing ◽  
Controlled Trial ◽  
Long Term Outcomes ◽  
Intramedullary Nails ◽  
Metal Implants ◽  
Shaft Fractures ◽  
Fractures In Children ◽  
Significant Difference

The preferred surgical fixation of forearm shaft fractures in children is Elastic Stable Intramedullary Nailing (ESIN). Due to known disadvantageous effects of metal implants, a new surgical method using biodegradable polylactide-co-glycolide (PLGA) intramedullary nails has been developed but its long-term outcomes are unclear. The aim of this study was to compare the long-term outcomes of Biodegradable Intramedullary Nailing (BIN) to ESIN and assess the biodegradation of the study implants via magnetic resonance imaging (MRI). The study population of the prospective, randomized trial consisted of paediatric patients whose forearm shaft fractures were treated with BIN (n = 19) or ESIN (n = 16). Forearm rotation at minimally four years’ follow-up was the main outcome. There was no clinically significant difference in the recovery of the patients treated with the BIN as compared to those treated with the ESIN. More than half of the implants (57.7%, n = 15/26) were completely degraded, and the rest were degraded almost completely. The PLGA intramedullary nails used in the treatment of forearm shaft fractures in this study resulted in good function and anatomy. No unexpected disadvantages were found in the degradation of the implants. However, two implant failures had occurred in three months postoperatively.

scholarly journals Casting versus flexible intramedullary nailing in displaced forearm shaft fractures in children aged 7–12 years: a study protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e048248
Author(s):  
Petra Grahn ◽  
Juha-Jaakko Sinikumpu ◽  
Yrjänä Nietosvaara ◽  
Johanna Syvänen ◽  
Anne Salonen ◽  
...  
Keyword(s):  
Range Of Motion ◽  
Intramedullary Nailing ◽  
Closed Reduction ◽  
Intramedullary Nails ◽  
Cast Immobilisation ◽  
Flexible Intramedullary Nailing ◽  
Shaft Fractures ◽  
Fractures In Children ◽  
Flexible Intramedullary Nails

IntroductionThe forearm is the most common fracture location in children, with an increasing incidence. Displaced forearm shaft fractures have traditionally been treated with closed reduction and cast immobilisation. Diaphyseal fractures in children have poor remodelling capacity. Malunion can cause permanent cosmetic and functional disability. Internal fixation with flexible intramedullary nails has gained increasing popularity, without evidence of a better outcome compared with closed reduction and cast immobilisation.Method and analysisThis is a multicentre, randomised superiority trial comparing closed reduction and cast immobilisation to flexible intramedullary nails in children aged 7–12 years with >10° of angulation and/or >10 mm of shortening in displaced both bone forearm shaft fractures (AO-paediatric classification: 22D/2.1–5.2). A total of 78 patients with minimum 2 years of expected growth left are randomised in 1:1 ratio to either treatment group. The study has a parallel non-randomised patient preference arm. Both treatments are performed under general anaesthesia. In the cast group a long arm cast is applied for 6 weeks. The flexible intramedullary nail group is immobilised in a collar and cuff sling for 4 weeks. Data are collected at baseline and at each follow-up until 1 year.Primary outcome is (1) PROMIS paediatric upper extremity and (2) forearm pronation-supination range of motion at 1-year follow-up. Secondary outcomes are Quick DASH, Paediatric Pain Questionnaire, Cosmetic Visual Analogue Scale, wrist and elbow range of motion as well as any complications and costs of treatment.We hypothesise that flexible intramedullary nailing results in a superior outcome.Ethics and disseminationWe have received ethical board approval (number: 78/1801/2020) and permissions to conduct the study from all five participating university hospitals. Informed consent is obtained from the parent(s). Results will be disseminated in peer-reviewed publications.Trial registration numberNCT04664517.

scholarly journals Hyperglycemia in the Posttransplant Period: NODAT vs Posttransplant Diabetes Mellitus

2018 ◽  
Vol 2 (11) ◽  
pp. 1314-1319 ◽  
Author(s):  
Suruchi Gupta ◽  
Teresa Pollack ◽  
Candice Fulkerson ◽  
Kathleen Schmidt ◽  
Diana Johnson Oakes ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Liver Transplant ◽  
Controlled Trial ◽  
Organ Transplant ◽  
Long Term Outcomes ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Persistent Hyperglycemia

Abstract Objective To characterize the types of hyperglycemia that occur up to 1 year following liver transplant and to clarify the nomenclature for posttransplant hyperglycemia. Design We analyzed 1-year glycemic follow-up data in 164 patients who underwent liver transplant and who had been enrolled in a randomized controlled trial comparing moderate to intensive insulin therapy to determine if patients had preexisting known diabetes, transient hyperglycemia, persistent hyperglycemia, or new-onset diabetes after transplantation (NODAT). Results Of 119 patients with posttransplant hyperglycemia following hospital discharge, 49 had preexisting diabetes, 5 had insufficient data for analysis, 48 had transient hyperglycemia (16 resolved within 30 days and 32 resolved between 30 days and 1 year), 13 remained persistently hyperglycemic out to 1 year and most likely had preexisting diabetes that had not been diagnosed or insulin resistance/insulinopenia prior to transplant, and 4 had NODAT (i.e., patients with transient hyperglycemia after transplant that resolved but then later truly developed sustained hyperglycemia, meeting criteria for diabetes). Conclusions Distinct categories of patients with hyperglycemia following organ transplant include known preexisting diabetes, persistent hyperglycemia (most likely unknown preexisting diabetes or insulin resistance/insulinopenia), transient hyperglycemia, and NODAT. Those with preexisting diabetes for many years prior to transplant may well have very different long-term outcomes compared with those with true NODAT. Therefore, it would be prudent to classify patients more carefully. Long-term outcome studies are needed to determine if patients with true NODAT have the same poor prognosis as patients with preexisting diabetes (diagnosed and undiagnosed) undergoing transplant.

scholarly journals Suprapatellar versus infrapatellar approaches in the treatment of tibia intramedullary nailing ： A retrospective cohort study

2019 ◽  
Author(s):  
Yiliang Cui ◽  
Xingyi Hua ◽  
Florian Schmidutz ◽  
Jian Zhou ◽  
Zongsheng Yin ◽  
...  
Keyword(s):  
Blood Loss ◽  
Intramedullary Nailing ◽  
Functional Outcomes ◽  
Operation Time ◽  
Tibial Shaft ◽  
Shaft Fractures ◽  
Significant Difference ◽  
Special Surgery ◽  
Tibial Shaft Fractures

Abstract Background: Tibial shaft fractures are routinely managed with intramedullary nailing (IMN). An increasingly accepted technique is the suprapatellar (SP) approach. The purpose of this study was to compare the clinical and functional outcomes of knee joint after tibia IMN through an suprapatellar (SP) or traditional infrapatellar (IP) approach. Methods: Retrospective analysis was performed in patients with tibial shaft fractures that were treated with IMN through a SP or IP approach between 01/01/2014 and 31/12/2016. The clinical and functional outcomes of the knee were assessed with the Hospital for Special Surgery (HSS) Knee Score. Secondary outcomes included the operation time and intraoperative blood loss. Results: A total of 50 patients/fractures (26 IP and 24 SP) with a minimum follow-up of 15 months were evaluated. All fractures were OTA 42. No significant differences were found between the two groups in age, gender, side of fractures, operation time, intra-operative blood loss, and follow-up time. No significant difference was seen in HSS score ( P = 0.62) between them. Sub analysis of all the HSS components scores revealed no significant differences between pain ( P = 0.57), the stand and walk ( P = 0.54), the need for walking stick ( P = 0.60) and extension lag ( P = 0.60). The other HSS components showed full scores (IP 10 vs. SP 10) in both approaches, including muscle force, flexion deformity and stability components. The range of motion (ROM) component score was superior in the IP group ( P = 0.04) suggesting a higher ROM. Conclusions: Both SP and IP approach results in equivalent overall HSS knee scores. However, for the HSS component, the IP approach was superior to SP approach regarding the ROM.

Abstract 12022: Long-Term Clinical Outcomes of Everolimus-Eluting Stents versus Sirolimus-Eluting Stents: Systematic Review and a Meta-Analysis of 14 Randomized Control Trials, Focused on Stent Thrombosis

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
TOSHIAKI TOYOTA ◽  
Hiroki Shiomi ◽  
Takeshi Morimoto ◽  
Takeshi Kimura
Keyword(s):  
Clinical Outcomes ◽  
Stent Thrombosis ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Target Lesion ◽  
Pooled Analysis ◽  
Significant Difference ◽  
Artery Disease

Background: We sought to compare the long-term clinical outcomes between everolimus-eluting stent (EES) and sirolimus-eluting stents (SES) with a meta-analysis method. The long-term clinical outcomes, especially stent thrombosis (ST), after EES versus SES implantation has not been clearly defined among trials directly comparing the 2 types of stents. Methods: We searched PubMed, Cochrane database, and ClinicalTrials.gov. for trials comparing outcomes between EES (Xience V/Promus) and SES (Cypher select/Cypher select plus) in patients with native coronary artery disease using randomized controlled trial (RCT) design. We selected the article reporting the longest follow-up outcomes from each RCT. The outcome measure was all-cause death, myocardial infarction (MI), definite ST, and target-lesion revascularization (TLR). ST was further classified as those occurring early (<=30 days), late (30-365 days), or very late (<365 days). Results: We identified 14 RCT comparing EES and SES including 2 trials reporting the longest follow-up outcomes as a pooled analysis. We analyzed 13,434 randomly assigned patients with the weighted follow-up period of 2.1 years (Follow-up <=1-year: 7 trials, and 3191 patients; >1-year: 7 trials, and 10243 patients). EES as compared to SES was associated with significantly lower risks for overall ST, and early ST (pooled odds ratio (OR) 0.49, 95% confidence interval (CI) 0.30-0.81, P=0.01, and OR 0.42, 95% CI 0.18-0.99, P=0.046, respectively), while there was no significant difference in the risk for late ST and very late ST (OR 0.49, 95% CI 0.17-1.43, P=0.19, and OR 0.66, 95% CI 0.23-1.85, P=0.43, respectively). EES as compared to SES was also associated with significantly lower risks for TLR (OR 0.84, 95% CI 0.71-0.99, P=0.04). There was no significant difference in the risk for all-cause death, and MI between EES and SES. (OR 0.91, 95% CI 0.78-1.07, P=0.11, and OR 0.92, 95% CI 0.75-1.13, P=0.44, respectively). Conclusions: In the current meta-analysis of 14 RCT directly comparing EES with SES, implantation of EES as compared to SES implantation was associated with significantly lower risk for definite ST and TLR.

scholarly journals Liver Transplantation from Voluntary Organ Donor System in China: A Comparison between DBD and DCD Liver Transplants

2019 ◽  
Vol 2019 ◽  
pp. 1-7
Author(s):  
Wei Chen ◽  
Dipesh Kumar Yadav ◽  
Xueli Bai ◽  
Jianying Lou ◽  
Risheng Que ◽  
...  
Keyword(s):  
Liver Transplantation ◽  
Organ Donation ◽  
Survival Rates ◽  
Organ Donor ◽  
Long Term Outcomes ◽  
Significant Difference ◽  
Short And Long Term ◽  
Donor System

Background. In China, the cases of liver transplantation (LT) from donation after citizens’ death have rose year by year since the citizen-based voluntary organ donor system was initiated in 2010. The objective of our research was to investigate the early postoperative and late long-term outcomes of LT from donation after brain death (DBD) and donation after circulatory death (DCD) according to the current organ donation system in China. Methods. Sixty-two consecutive cases of LT from donation after citizens’ death performed in our hospital between February 2012 and June 2017 were examined retrospectively for short- and long-term outcomes. These included 35 DCD LT and 27 DBD LT. Result. Subsequent median follow-up time of 19 months and 1- and 3-year graft survival rates were comparative between the DBD group and the DCD group (81.5% and 66.7% versus 67.1% and 59.7%; P=0.550), as were patient survival rates (85.2% and 68.7% versus 72.2% and 63.9%; P=0.358). The duration of ICU stay of recipients was significantly shorter in the DBD group, in comparison with that of the DCD group (1 versus 3 days, P=0.001). Severe complication incidence (≥grade III) after transplantation was identical among the DBD and DCD groups (48.1% versus 60%, P=0.352). There was no significant difference in postoperative mortality between the DBD and DCD groups (3 of 27 cases versus 5 of 35 cases). Twenty-one grafts (33.8%) were lost and 18 recipients (29.0%) were dead till the time of follow-up. Malignancy recurrence was the most prevalent reason for patient death (38.8%). There was no significant difference in incidence of biliary stenosis between the DBD and DCD groups (5 of 27 cases versus 6 of 35 cases, P=0.846). Conclusion. Although the sample size was small to some extent, this single-center study first reported that LT from DCD donors showed similar short- and long-term outcomes with DBD donors and justified the widespread implementation of voluntary citizen-based deceased organ donation in China. However, the results should be verified with a multicenter larger study.

scholarly journals Suprapatellar versus infrapatellar approaches in the treatment of tibia intramedullary nailing: a retrospective cohort study

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Yiliang Cui ◽  
Xingyi Hua ◽  
Florian Schmidutz ◽  
Jian Zhou ◽  
Zongsheng Yin ◽  
...  
Keyword(s):  
Blood Loss ◽  
Intramedullary Nailing ◽  
Functional Outcomes ◽  
Operation Time ◽  
Tibial Shaft ◽  
Shaft Fractures ◽  
Significant Difference ◽  
Special Surgery ◽  
Tibial Shaft Fractures

Abstract Background Tibial shaft fractures are routinely managed with intramedullary nailing (IMN). An increasingly accepted technique is the suprapatellar (SP) approach. The purpose of this study was to compare the clinical and functional outcomes of knee joint after tibia IMN through an suprapatellar (SP) or traditional infrapatellar (IP) approach. Methods Retrospective analysis was performed in patients with tibial shaft fractures that were treated with IMN through a SP or IP approach between 01/01/2014 and 31/12/2016. The clinical and functional outcomes of the knee were assessed with the Hospital for Special Surgery (HSS) Knee Score. Secondary outcomes included the operation time and intraoperative blood loss. Results A total of 50 patients/fractures (26 IP and 24 SP) with a minimum follow-up of 15 months were evaluated. All fractures were OTA 42. No significant differences were found between the two groups in age, gender, side of fractures, operation time, intra-operative blood loss, and follow-up time. No significant difference was seen in HSS score (P = 0.62) between them. Sub analysis of all the HSS components scores revealed no significant differences between pain (P = 0.57), the stand and walk (P = 0.54), the need for walking stick (P = 0.60) and extension lag (P = 0.60). The other HSS components showed full scores (IP 10 vs. SP 10) in both approaches, including muscle force, flexion deformity and stability components. The range of motion (ROM) component score was superior in the IP group (P = 0.04) suggesting a higher ROM. Conclusions Both SP and IP approach results in equivalent overall HSS knee scores. However, for the HSS component, the IP approach was superior to SP approach regarding the ROM.

scholarly journals Prospective Evaluation of Transpancreatic Sphincterotomy Comparing to Needle-knife Precut in Difficult Biliary Cannulation: Short-and Long-term Outcomes

2020 ◽  
Author(s):  
Fatema Tabak ◽  
Guo-Zhong Ji ◽  
Lin Miao
Keyword(s):  
Long Term Outcomes ◽  
Significant Difference ◽  
Difficult Biliary Cannulation ◽  
Short And Long Term ◽  
Needle Knife ◽  
Transpancreatic Sphincterotomy ◽  
Cannulation Success ◽  
Selective Cannulation

AbstractBackground/AimsTranspancreatic sphincterotomy (TPS) can be an alternative approach of biliary access in difficult cannulation cases. We aimed to prospectively evaluate the efficacy and safety of TPS compared to needle-knife precut (NKP), considering the late consequences of both techniques.MethodsA total of 122 enrolled patients have been divided into three groups based on the applied secondary cannulation techniques. Selective cannulation success, ERCP procedure findings, and immediate adverse events were compared between groups. We investigated the long-term outcomes during six-month after the procedure.ResultsSuccessful selective cannulation was achieved in 92.9% with TPS similarly to other groups. The mean procedure time was shorter in the TPS group without significant difference. Using TPS did not affect the rate of post-ERCP pancreatitis (PEP) with less frequent post-ERCP bleeding and perforation after TPS compared to NKP, without significant difference. Patients who received TPS, NKP, or both had no symptoms related to papillary stenosis or chronic pancreatitis during the follow-up period.ConclusionsUsing TPS was useful to achieve success cannulation in difficult cases with an acceptable PEP rate. Furthermore, it was associated with reducing bleeding and perforation rates comparing with NKP and no differences related to the long term consequences within the follow-up period.

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