Neither operative nor nonoperative approach is superior for treating displaced midshaft clavicle fractures: a partially blinded randomized controlled clinical trial

2021 ◽  
Vol 103-B (4) ◽  
pp. 762-768
Author(s):  
Ilija Ban ◽  
Morten Tange Kristensen ◽  
Kristoffer Weisskirchner Barfod ◽  
Jacob Eschen ◽  
Thomas Kallemose ◽  
...  
Keyword(s):  
Relative Risk ◽  
Operative Treatment ◽  
Initial Treatment ◽  
Controlled Clinical Trial ◽  
Number Needed To Treat ◽  
Dash Score ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Nonoperative Group

Aims To compare the functionality of adults with displaced mid-shaft clavicular fractures treated either operatively or nonoperatively and to compare the relative risk of nonunion and reoperation between the two groups. Methods Based on specific eligibility criteria, 120 adults (median age 37.5 years (interquartile range (18 to 61)) and 84% males (n = 101)) diagnosed with an acute displaced mid-shaft fracture were recruited, and randomized to either the operative (n = 60) or nonoperative (n = 60) treatment group. This randomized controlled, partially blinded trial followed patients for 12 months following initial treatment. Functionality was assessed by the Constant score (CS) (assessor blinded to treatment) and Disability of the Arm, Shoulder and Hand (DASH) score. Clinical and radiological evaluation, and review of patient files for complications and reoperations, were added as secondary outcomes. Results At 12 months, 87.5% of patients (n = 105) were available for analysis. The two groups were well balanced based on demographic and fracture-related characteristics. At six weeks of follow-up a significant difference in DASH score (p < 0.001) was found in favour of operative treatment. The functionality at 12 months of follow-up based on CS and DASH was excellent in both groups (CS > 90 points and DASH < 10 points) with no significant difference (p = 0.277 for DASH and p = 0.184 for CS) between the two groups. The risk of symptomatic nonunion was significantly higher in the nonoperative group (p = 0.014), with a relative risk of 9.47 (95% confidence interval (CI) 1.26 to 71.53) in this group compared to the operative group. The number-needed-to-treat to avoid one symptomatic nonunion was 6.2. Initial treatment and age were factors significantly associated with nonunion in a logistic analysis. There were 26% in both groups (n = 14 in operative group and n = 15 in nonoperative group) who required secondary surgery, with most indications in the nonoperative group mandatory due to nonunion compared to most relative indications in the operative group requiring intervention due to implant irritation. Conclusion Superiority was not identified with either an all-operative or all-nonoperative approach. The functionality at short term (within six weeks) seems igreater following operative treatment but was not found at one year. The risk of nonunion is significantly higher with nonoperative treatment. However, an all-operative approach to lower the nonunion risk may result in unnecessary surgery and is not recommended. Cite this article: Bone Joint J 2021;103-B(4):762–768.

scholarly journals Peri-Implant Bone Loss of External Hexagon and Morse Taper in Patients Wearing Immediately Loaded Overdentures

2017 ◽  
Vol 28 (6) ◽  
pp. 694-698 ◽  
Author(s):  
Laércio Almeida de Melo ◽  
Mariana Barbosa Câmara de Souza ◽  
Gustavo Augusto Seabra Barbosa ◽  
Adriana da Fonte Porto Carreiro
Keyword(s):  
Clinical Trial ◽  
Bone Loss ◽  
Success Rate ◽  
High Success Rate ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Significant Difference

Abstract The aim of this study was to evaluate the peri-implant bone loss of External Hexagon (EH) and Morse Taper (MT) implants in patients wearing immediately loaded mandibular overdentures during a 1-year follow-up. This is a non-randomized controlled clinical trial including 18 MT and 22 EH implants. Periapical radiographs were taken after overdentures insertion and following 1 year. The peri-implant bone loss was assessed through digitalization and analysis of the radiographs in the software Corel DRAW X7. For this, measurement from implant platform to residual ridge at mesial and distal surfaces of each implant was conducted. The results showed high success rate in the groups EH (100%) and MT (94.4%). For peri-implant bone levels, it was found significant difference between the groups (p=0.032) and greater bone loss was observed in the group EH. In general, bone loss was 0.85mm (±0.82) for EH and 0.10mm (±1.0) for MT. It was concluded that greater bone loss occurred in the group EH in comparison to the group MT after a 1-year follow-up.

scholarly journals Randomized controlled clinical trial comparing the efficacy and tolerability of aripiprazole and sodium valproate in the treatment of Tourette syndrome

2019 ◽  
Vol 18 (1) ◽  
Author(s):  
Deshuang Tao ◽  
Tangwu Zhong ◽  
Shuxia Ma ◽  
Jialin Li ◽  
Xiaojie Li
Keyword(s):  
Tourette Syndrome ◽  
Sodium Valproate ◽  
Adverse Reactions ◽  
Onset Time ◽  
Controlled Clinical Trial ◽  
Symptom Scale ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Tic Severity

Abstract Objective This study compared the efficacy and tolerability of sodium valproate and aripiprazole in the treatment of Tourette syndrome (TS). Method 24 children and adolescents with a diagnosis of TS from the Jiamusi Central Hospital between January 2014 and August 2017 were randomly divided into sodium valproate group and aripiprazole group according to the order of clinic visits and treated for 10 days. Tic severity was rated using the Yale Global Tic Severity Scale (YGTSS) and the Clinical Global Impressions Scale for tics (CGI-Tics) and the adverse reactions were valued using the Treatment Emergent Symptom Scale (TESS) at baseline and at each follow-up visit. Results The TTS score in the YGTSS scale decreased over time in both groups while the aripiprazole group was significantly higher on the 5th day (p < 0.05) and 10th day (p < 0.05) than the sodium valproate group. There was no significant difference in TESS score between the two groups. Conclusions The study indicates that the patients treated with sodium valproate injection have a faster onset time than the patients treated with oral aripiprazole in controlling tics.

Efficacy Comparison of Hyaluronic Acid and Corticosteroid Injection in Treatment of Trigger Digits: A Randomized Controlled Trial

2020 ◽  
Vol 25 (01) ◽  
pp. 76-81 ◽  
Author(s):  
Thepparat Kanchanathepsak ◽  
Picharn Pichyangkul ◽  
Sorasak Suppaphol ◽  
Ittirat Watcharananan ◽  
Panithan Tuntiyatorn ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hyaluronic Acid ◽  
Controlled Trial ◽  
P Value ◽  
Dash Score ◽  
Ultrasound Guided ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Group 1

Background: Although the current nonsurgical treatment for trigger digits is corticosteroid (CS) injection, it often comes with adverse effects that may cause some limitations. Currently, Hyaluronic acid (HA) has been successfully used in tendinopathy and may be used in stenosing tenosynovitis. The aim of this study is to compare the efficacy of ultrasound-guided injection between the HA and CS in trigger digits treatment. Methods: Double-blind randomized controlled trial was conducted. Fifty patients with 66 trigger digits were randomly assigned into an intervention group (1 ml of low-molecular weight HA) and a control group (1 ml of 10mg/ml triamcinolone acetate). The ultrasound-guided injection and local anesthesia (0.5 ml of 1% lidocaine without adrenaline) were used. The Quinnell grading, Visual Analog Scale (VAS) score of pain, Disabilities of the Arm, Shoulder and Hand (DASH) score and complications were collected at 1-, 3-and 6-month follow-up. Results: The mean age of HA group (33 digits) and CS group (33 digits) were 58.3 years and 54.7 years respectively. Nine patients were loss of follow-up (7 in HA group and 2 in CS group). The Quinnell grades have shown an improvement in both group. The CS group had a significant better improvement at 1-month (p-value < 0.001) and there was no significant difference at 3-and 6-month follow-up between the two groups. The median of VAS and DASH score were significantly improved by time in both groups (p-value < 0.01). The CS group showed a better significant improvement in early period of follow-up (p-value < 0.05). However, there was no significant difference between the two groups in the last follow-up. Conclusions: HA and CS injection has a comparable therapeutic effect in treatment of trigger digits. However, CS injection has higher efficacy of pain and inflammation reduction in the early phase of the disease.

scholarly journals Sofosbuvir and daclatasvir for the treatment of COVID-19 outpatients: a double-blind, randomized controlled trial

2020 ◽  
Author(s):  
Fatemeh Roozbeh ◽  
Majid Saeedi ◽  
Reza Alizadeh-Navaei ◽  
Akbar Hedayatizadeh-Omran ◽  
Shahin Merat ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Significant Difference ◽  
The Difference ◽  
Novel Coronavirus ◽  
Loss Of Appetite

Abstract Introduction Effective treatments are urgently needed to tackle the novel coronavirus disease 2019 (COVID-19). This trial aims to evaluate sofosbuvir and daclatasvir versus standard care for outpatients with mild COVID-19 infection. Methods This was a randomized controlled clinical trial in outpatients with mild COVID-19. Patients were randomized into a treatment arm receiving sofosbuvir/daclatasvir plus hydroxychloroquine or a control arm receiving hydroxychloroquine alone. The primary endpoint of the trial was symptom alleviation after 7 days of follow-up. The secondary endpoint of the trial was hospital admission. Fatigue, dyspnoea and loss of appetite were investigated after 1 month of follow-up. This study is registered with the IRCT.ir under registration number IRCT20200403046926N1. Results Between 8 April 2020 and 19 May 2020, 55 patients were recruited and allocated to either the sofosbuvir/daclatasvir treatment arm (n = 27) or the control arm (n = 28). Baseline characteristics were similar across treatment arms. There was no significant difference in symptoms at Day 7. One patient was admitted to hospital in the sofosbuvir/daclatasvir arm and four in the control arm, but the difference was not significant. After 1 month of follow-up, two patients reported fatigue in the sofosbuvir/daclatasvir arm and 16 in the control arm; P &lt; 0.001. Conclusions In this study, sofosbuvir/daclatasvir did not significantly alleviate symptoms after 7 days of treatment compared with control. Although fewer hospitalizations were observed in the sofosbuvir/daclatasvir arm, this was not statistically significant. Sofosbuvir/daclatasvir significantly reduced the number of patients with fatigue and dyspnoea after 1 month. Larger, well-designed trials are warranted.

scholarly journals Effectiveness of Text Messaging as an Incentive to Maintain Physical Activity after Cardiac Rehabilitation: A Randomized Controlled Pilot Study

2021 ◽  
Vol 18 (12) ◽  
pp. 6645
Author(s):  
Giulia Foccardi ◽  
Marco Vecchiato ◽  
Daniel Neunhaeuserer ◽  
Michele Mezzaro ◽  
Giulia Quinto ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cardiac Rehabilitation ◽  
Exercise Testing ◽  
Text Messages ◽  
Control Group ◽  
Stand Test ◽  
Randomized Controlled ◽  
Sit To Stand ◽  
Significant Difference

Although the efficacy of cardiac rehabilitation (CR) is proven, the need to improve patients’ adherence has emerged. There are only a few studies that have investigated the effect of sending text messages after a CR period to stimulate subjects’ ongoing engagement in regular physical activity (PA). A randomized controlled pilot trial was conducted after CR, sending a daily PA text message reminder to an intervention group (IG), which was compared with a usual care control group (CG) during three months of follow-up. Thirty-two subjects were assessed pre- and post-study intervention with GPAQ, submaximal iso-watt exercise testing, a 30 s sit-to-stand test, a bilateral arm curl test, and a final survey on a seven-point Likert scale. A statistically significant difference in the increase of moderate PA time (Δ 244.7 (95% CI 189.1, 300.4) minutes, p < 0.001) and in the reduction of sedentary behavior time (Δ −77.5 (95% CI 104.9, −50.1) minutes, p = 0.004) was shown when the IG was compared with the CG. This was associated with an improvement in heart rate, blood pressure, and patients’ Borg rating on the category ratio scale 10 (CR10) in iso-watt exercise testing (all p < 0.05). Furthermore, only the IG did not show a worsening of the strength parameters in the follow-up leading to a change of the 30 s sit-to-stand test with a difference of +2.2 (95% CI 1.23, 3.17) repetitions compared to CG (p = 0.03). The telemedical intervention has been appreciated by the IG, whose willingness to continue with regular PA emerged to be superior compared to the CG. Text messages are an effective and inexpensive adjuvant after phase 2 CR that improves adherence to regular PA. Further studies are needed to confirm these results in a larger patient population and in the long term.

scholarly journals A randomized controlled clinical trial of the effect of supportive counseling on mental health in Iranian mothers of premature infants

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Leila Seiiedi-Biarag ◽  
Mojgan Mirghafourvand ◽  
Khalil Esmaeilpour ◽  
Shirin Hasanpour
Keyword(s):  
Mental Health ◽  
Clinical Trial ◽  
Premature Infants ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Postpartum Bonding ◽  
Supportive Counseling

Abstract Background Premature birth can affect maternal mental health. Considering that the mental health disorder in mothers may play a vital role in the growth and development of their children, therefore, this study was conducted to determine the effect of supportive counseling on mental health (primary outcome), mother-child bonding and infant anthropometric indices (secondary outcomes) in mothers of premature infants. Methods This randomized controlled clinical trial was carried out on 66 mothers with hospitalized neonates in the NICU of Alzahra hospital in Tabriz- Iran. Participants were randomly allocated into two groups of intervention (n = 34) and control (n = 32) through a block randomization method. The intervention group received 6 sessions of supportive counseling (45–60 minutes each session) by the researcher, and the control group received routine care. Questionnaires of Goldberg General Health and the postpartum bonding were completed before the intervention (first 72 hours postpartum) and 8 weeks postpartum. Also, the anthropometric index of newborns were measured at the same time. Results There was no statistically significant difference between the two groups in terms of socio-demographic characteristics. After the intervention, based on ANCOVA with adjusting the baseline score, mean score of mental health (AMD: -9.8; 95% Confident Interval (95% CI): -12.5 to -7.1; P < 0.001) and postpartum bonding (AMD: -10.0; 95% CI: -0.6 to 13.9; P < 0.001) in the counseling group was significantly lower than those of the control group; however, in terms of weight (P = 0.536), height (P = 0.429) and head circumference (P = 0.129), there was no significant difference between the two groups. Conclusions Supportive counseling may improve mental health and postpartum bonding in mothers of premature infants. Thus, it may be recommendable for health care providers to offer it to mothers. Trial registration Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N45. Date of registration: October 29, 2018.

A Prospective Comparison of 3 Hamstring ACL Fixation Devices - Rigidfix, BioScrew and Intrafix - Randomized Into 4 Groups with a Minimum Follow-Up of 5 Years.

2021 ◽  
Author(s):  
Leena Metso ◽  
Ville Bister ◽  
Arsi Harilainen ◽  
Jerker Sandelin
Keyword(s):  
Cruciate Ligament ◽  
Interference Screw ◽  
Controlled Clinical Trial ◽  
Level Of Evidence ◽  
Tibial Fixation ◽  
Fixation Group ◽  
Prospective Comparison ◽  
Group I ◽  
Significant Difference

Abstract Background: This is a five years follow-up report of some of the new devices for graft fixation. A two years follow-up data was published previously. As there were no statistically or clinically relevant differences in the results two years postoperatively, we hypothesize that after five years of follow-up there is no difference in the outcome after either cross-pin or absorbable interference screw fixation in ACL (anterior cruciate ligament) reconstruction with hamstring tendon autografts.Methods: 120 patients were randomized into four different groups (30 each) for ACL reconstruction with hamstring tendons: group I femoral Rigidfix cross-pin and Intrafix tibial extension sheath with a tapered expansion screw; group II Rigidfix femoral and BioScrew interference screw tibial fixation; group III BioScrew femoral and Intrafix tibial fixation; group IV BioScrew fixation into both tunnels. The evaluation methods were clinical examination, knee scores, and instrumented laxity measurements. Results: In this 5 years follow-up there were 102/120 (85%) patients available, but only 77 (64,2%) attended the clinical examinations. No significant difference between the groups in the clinical results was detected. There was a significant difference in additional procedures between the 2 and 5 years follow-up, group I had six additional procedures between the 2 and 5 years follow-up (P=.041). Conclusion: There was a statistically significant difference in the additional procedures, most in group I (six). None of these procedures found problems with the ACL graft. Other statistically or clinically significant differences in the 5 years follow-up results were not found. Study design: Randomized controlled clinical trial; Level of evidence, 1.Trial registration: ISRCTN registry with study ID ISRCTN34011837. Retrospectively registered 17.4.2020.

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