Is It Necessary to Repair Stable Ramp Lesions of the Medial Meniscus During Anterior Cruciate Ligament Reconstruction? A Prospective Randomized Controlled Trial

2017 ◽  
Vol 45 (5) ◽  
pp. 1004-1011 ◽  
Author(s):  
Xin Liu ◽  
Hui Zhang ◽  
Hua Feng ◽  
Lei Hong ◽  
Xue-song Wang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Clinical Outcomes ◽  
Acl Reconstruction ◽  
Medial Meniscus ◽  
Controlled Trial ◽  
Control Group ◽  
Study Group ◽  
Randomized Controlled ◽  
Kt 1000

Background: A special type of meniscal lesion involving the peripheral attachment of the posterior horn of the medial meniscus (PHMM), termed a “ramp lesion,” is commonly associated with an anterior cruciate ligament (ACL) injury. However, its treatment is still controversial. Recently, stable ramp lesions treated with abrasion and trephination alone have been shown to have good clinical outcomes after ACL reconstruction. Hypothesis: Stable ramp lesions treated with abrasion and trephination alone during ACL reconstruction will result in similar clinical outcomes compared with those treated with surgical repair. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: A prospective randomized controlled study was performed in 91 consecutive patients who had complete ACL injuries and concomitant stable ramp lesions of the medial meniscus. All patients were randomly allocated to 1 of 2 groups based on whether the stable ramp lesions were surgically repaired (study group; n = 50) or only abraded and trephined (control group; n = 41) during ACL reconstruction. All surgical procedures were performed by a single surgeon who was blinded to the functional assessment findings of the patients. The Lysholm score, subjective International Knee Documentation Committee (IKDC) score, and stability assessments (pivot-shift test, Lachman test, KT-1000 arthrometer side-to-side difference, and KT-1000 arthrometer differences of <3, 3-5, and >5 mm) were evaluated preoperatively and at the last follow-up. Moreover, magnetic resonance imaging (MRI) was used to evaluate the healing status of the ramp lesions. Results: All consecutive patients who were screened for eligibility from August 2008 to April 2012 were enrolled and observed clinically. There were 40 patients in the study group and 33 patients in the control group who were observed for at least 2 years. At the final follow-up, there were no significant differences between the study group and the control group in terms of the mean Lysholm score (88.7 ± 4.8 vs 90.4 ± 5.8, respectively; P = .528), mean subjective IKDC score (83.6 ± 3.7 vs 82.2 ± 4.5, respectively; P = .594), pivot-shift test results ( P = .658), Lachman test results ( P = .525), KT-1000 arthrometer side-to-side difference (1.6 ± 1.2 vs 1.5 ± 1.1, respectively; P = .853), or KT-1000 arthrometer grading ( P = .738). Overall, for both groups (n = 73), 67 patients showed completely healed (38 study, 29 control), 3 showed partially healed (1 study, 2 control), and 3 showed nonhealed (1 study, 2 control) signals on follow-up MRI when evaluating the healing status of the ramp lesions. There was no significant difference regarding the healing status of the ramp lesions between the 2 groups ( P = .543). Conclusion: This prospective randomized controlled trial showed that, in terms of subjective scores, knee stability, and meniscal healing status, concomitant stable ramp lesions of the medial meniscus treated with abrasion and trephination alone during ACL reconstruction resulted in similar clinical outcomes compared with those treated with surgical repair.

Effectiveness and safety of a mixture of diosmin, coumarin and arbutin (Linfadren®) in addition to conventional treatment in the management of patients with post-trauma/surgery persistent hand edema: a randomized controlled trial

2019 ◽  
Vol 33 (5) ◽  
pp. 904-912 ◽  
Author(s):  
Angelo Cacchio ◽  
Giancarlo Di Carlo ◽  
Cofini Vincenza ◽  
De Blasis Elisabetta
Keyword(s):  
Randomized Controlled Trial ◽  
Conventional Treatment ◽  
Rescue Medication ◽  
Controlled Trial ◽  
Trauma Surgery ◽  
Control Group ◽  
Study Group ◽  
Randomized Controlled ◽  
End Of Treatment

Objective: To evaluate the effectiveness and safety of oral administration of Linfadren® in addition to conventional treatment in patients with post-trauma/surgery persistent hand edema. Design: Parallel-group randomized controlled trial. Setting: Outpatient rehabilitation center. Subjects: A total of 60 outpatients (mean age 48.5 (standard deviation (SD) = 12.3) years) with post-trauma/surgery persistent hand edema. Interventions: Patients were randomized to either receive six-week conventional treatment plus Linfadren® (Study Group) or conventional treatment (Control Group). Main Measures: Primary outcome was hand edema as measured by figure-of-eight method. Secondary outcomes were hand function, patient’s overall perceived treatment effectiveness and rescue medication request. Tolerability of Linfadren® was also evaluated. Assessments were performed at baseline, at the end of treatment and three months after the end of treatment. Results: All patients completed the six-week program and 57 patients (95%) completed the three-month follow-up. At six weeks, the Study Group had significantly greater improvement in hand edema (423.3 (SD = 23.8) mm vs 439.4 (SD = 22.6) mm; P = 0.009) and upper limb function ( Quick Disabilities of Arm, Shoulder and Hand questionnaire: 23.6 (SD = 13.6) vs 37.7 (SD = 15.9); P = 0.005) compared to the Control Group. Moreover, the percentage of patients who perceived treatment as effective was significantly higher in the Study Group than in the Control Group both after treatment (70% vs 37%, P = 0.002) and at follow-up (77% vs 30%, P < 0.0001). The rescue medication request was not different between groups. No adverse events were recorded. Conclusion: Linfadren® in addition to conventional treatment was safe and more effective than conventional treatment alone in patients with post-trauma/surgery persistent hand edema.

scholarly journals Effect of physician prescribed information on hospital readmission and death after discharge among patients with health failure: A randomized controlled trial

2021 ◽  
Vol 27 (1) ◽  
pp. 146045822199640
Author(s):  
Faranak Kazemi Majd ◽  
Vahideh Zarea Gavgani ◽  
Ali Golmohammadi ◽  
Ali Jafari-Khounigh
Keyword(s):  
Randomized Controlled Trial ◽  
Hospital Readmission ◽  
Medical Information ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Long Term Follow Up ◽  
Oral Information

In order to understand if a physician prescribed medical information changes, the number of hospital readmission, and death among the heart failure patients. A 12-month randomized controlled trial was conducted (December 2013–2014). Totally, 120 patients were randomly allocated into two groups of intervention ( n = 60) and control ( n = 60). Accordingly, the control group was given the routine oral information by the nurse or physician, and the intervention group received the Information Prescription (IP) prescribed by the physician as well as the routine oral information. The data was collected via telephone interviews with the follow-up intervals of 6 and 12 months, and also for 1 year after the discharge. The patients with the median age of (IQR) 69.5 years old (19.8) death upon adjusting a Cox survival model, [RR = 0.67, 95%CI: 0.46–0.97]. Few patients died during 1 year in the intervention group compared to the controls (7 vs 15) [RR = 0.47, 95%CI: 0.20–1.06]. During a period of 6-month follow-up there was not statistically significant on death and readmission between two groups. Physician prescribed information was clinically and statistically effective on the reduction of death and hospital readmission rates among the HF patients in long term follow-up.

scholarly journals Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

scholarly journals Effectiveness of Antipyretic with Tepid Sponging Versus Antipyretic Alone in Febrile Children: A Randomized Controlled Trial

2018 ◽  
Vol 37 (2) ◽  
pp. 129-133
Author(s):  
Chetak Kadbasal Basavaraj ◽  
Shyamala Gowri Pocha ◽  
Ravi Mandyam Dhati
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Study Group ◽  
Axillary Temperature ◽  
Medical College ◽  
Randomized Controlled ◽  
Significant Difference

Introduction: Fever is the most common presenting complain for which children are brought to the paediatrician.Physical methods are widely used in treating febrile children, tepid sponging being commonly practiced in hospitals along with antipyretics. The objectives of this study were to compare the effectiveness of tepid sponging and antipyretic drug versus antipyretic drug alone in febrile children.Material and Methods: This was a Randomized controlled trial done in JSS Medical College and Hospital. All children under the age of 6 months to 12 years, admitted with axillary temperature of >99oF were included in the study. A total of 500 children were included over two years study period. Children with recorded axillary temperature of >990F were randomized into control and study group by computer generated randomisation. Children in the control group received only paracetamol (15mg/kg) at 5 minutes and combined group received paracetamol and tepid sponging at five minutes. Axillary temperature was monitored every 15 minutes for a period of 2 hours in both the groups.Results: There is no significant difference in reduction of temperature between the two groups by the end of two hours. Children in combined group had a higher level of discomfort than those in only antipyretic group.Conclusion: Tepid sponging does not add to the efficacy of paracetamol in antipyresis and that addition of tepid sponging to antipyretic, results in additional discomfort for the child. This study, therefore, endorses the view that antipyretic alone without tepid sponging should be the modality of therapy in children with fever.  

scholarly journals A Randomized, Controlled Trial Comparing Autologous Matrix-Induced Chondrogenesis (AMIC®) to Microfracture: Analysis of 1- and 2-Year Follow-Up Data of 2 Centers

2013 ◽  
Vol 7 (1) ◽  
pp. 133-143 ◽  
Author(s):  
Sven Anders ◽  
Martin Volz ◽  
Hubert Frick ◽  
Jörg Gellissen
Keyword(s):  
Randomized Controlled Trial ◽  
Clinical Outcomes ◽  
Controlled Trial ◽  
Collagen Type I ◽  
Cartilage Defects ◽  
Type I ◽  
Randomized Controlled ◽  
First Results ◽  
Post Operation

Microfracture (MFx) is currently the recommended option for the treatment of small cartilage defects but is not regarded as suitable for the treatment of defects larger than 2.5 cm2. To extent its applicability to medium-sized defects MFx has been combined with a collagen type I/III matrix (Chondro-Gide®). This technique is called Autologous Matrix-Induced Chondrogenesis (AMIC®) and meanwhile a clinically established treatment option for localized full-thickness small- to medium-sized cartilage defects. Despite its more spreading clinical use, clinical data published so far are limited to mainly case report series.In this study, we report the first results of a randomized, controlled trial assessing the efficacy and safety of AMIC®versus MFx. Patients enrolled in 2 centers were included in this analysis. 38 patients (aged 21-50 years, mean defect size 3.4 cm2) were randomized and treated either with MFx, with sutured AMIC®or glued AMIC®. Clinical outcomes (modified Cincinnati and ICRS score) could be assessed in 30 patients at 1-year and 27 patients at 2-years post-operation. Improvements in both scores were seen at 1-and 2-years post-operation, irrespective of the technique used. MRI assessment revealed a satisfactory and homogenous defect filling in the majority of patients. No treatment-related adverse events were reported.This interim analysis confirms the mid-term results for AMIC®reported in literature. It demonstrates clearly that clinical outcomes at 1-year post-operation are maintained at 2-years. Therefore we consider enhancing MFx with Chondro-Gide®is a valid and safe cartilage repair option for small- to medium-sized cartilage defects of the knee.

Challenges of Increasing Childcare Center Compliance With Nutrition Guidelines: A Randomized Controlled Trial of an Intervention Providing Training, Written Menu Feedback, and Printed Resources

2018 ◽  
Vol 33 (3) ◽  
pp. 399-411 ◽  
Author(s):  
Meghan Finch ◽  
Kirsty Seward ◽  
Taya Wedesweiler ◽  
Fiona Stacey ◽  
Alice Grady ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Group Intervention ◽  
Controlled Trial ◽  
Theoretical Domains Framework ◽  
Practice Change ◽  
Control Group ◽  
Food Groups ◽  
Randomized Controlled ◽  
Nutrition Guidelines

Purpose: To assess the effectiveness of an intervention including training, provision of written menu feedback, and printed resources on increasing childcare compliance with nutrition guidelines. Design: Parallel group randomized controlled trial. Setting: Hunter New England region, New South Wales, Australia. Participants: Forty-four childcare centers that prepare and provide food on-site to children while in care. Intervention: The intervention was designed using the Theoretical Domains Framework, targeted managers, and cooks and included implementation strategies that addressed identified barriers. Measures: Outcomes included the proportion of menus providing food servings (per child) compliant with overall nutrition guideline recommendations and each individual food group assessed via menu assessments. Cook knowledge of recommendations, intervention acceptability, adverse events, and barriers were also assessed via questionnaires with cooks and managers. Analysis: Logistic regression models, adjusted for baseline values of the outcome. Results: At baseline and follow-up, zero centers in the intervention and control groups were compliant with the overall menu guidelines or for the vegetable and meat food groups. Follow-up between-group differences in compliance for discretionary (33.3 vs 5, P = .18), dairy (41.7 vs 15, P = .16), breads and cereals (8.3 vs 10 P = 1.00), and fruit (16.7 vs 10, P = .48) were all nonsignificant. Relative to the control group, intervention centers showed a significantly greater increase in percentage of cooks with correct knowledge for vegetable servings (93.3 vs 36.4, P = .008). Conclusion: Although the application of the theoretical framework produced a broader understanding of the determinants of menu compliance, due to the complexity of guidelines, limited follow-up support, lower training uptake, and low intervention dose, the intervention was not effective in supporting the practice change required.

Citation Advantage of Promoted Articles in a Cross-Publisher Distribution Platform: 36-month Follow-up to a Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Paul Kudlow ◽  
Tashauna Brown
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Digital Tool ◽  
Randomized Controlled ◽  
Subject Areas ◽  
The Subject ◽  
The Difference ◽  
Citation Advantage

BACKGROUND There are limited evidence-based strategies that have been shown to increase the rate at which peer-reviewed articles are cited. In a previously reported randomized controlled trial we demonstrated that promotion of article links in an online cross-publisher distribution platform (TrendMD) persistently augments citation rates after 12 months, leading to a statistically significant, 50% increase in citations relative to control. OBJECTIVE To investigate if the citation advantage of promoted articles upholds after 36-months. METHODS Three thousand two hundred articles published in 64 peer-reviewed journals across eight subject areas were block randomized at the subject level to either the TrendMD group (n=1600) or the control group (n=1600) of the study. Articles were promoted in the TrendMD Network for 6 months. We compared the citation rates in both groups after 36 months. RESULTS At 36 months, we found the citation advantage endured; articles randomized to TrendMD showed a 28% increase in mean citations relative to control. The difference in mean citations at 36 months for articles randomized to TrendMD versus control was 10.52, 95% CI [3.79, 17.25] and was statistically significant (p=0.001). CONCLUSIONS To our knowledge, this is the first randomized controlled trial to demonstrate how a post-publication article promotion intervention can be used to persistently augment citations of peer-reviewed articles. TrendMD is an efficient digital tool for knowledge translation and dissemination to targeted audiences to facilitate uptake of research.

Manganese and Lipoflavonoid Plus® to Treat Tinnitus: A Randomized Controlled Trial

2016 ◽  
Vol 27 (08) ◽  
pp. 661-668 ◽  
Author(s):  
Eveling Rojas-Roncancio ◽  
Richard Tyler ◽  
Hyung-Jin Jun ◽  
Tang-Chuan Wang ◽  
Haihong Ji ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Data Collection And Analysis ◽  
Loudness Match ◽  
Minimal Masking Level ◽  
Lost To Follow Up ◽  
To Receive

Background: Several tinnitus sufferers suggest that manganese has been helpful with their tinnitus. Purpose: We tested this in a controlled experiment where participants were committed to taking manganese and Lipoflavonoid Plus® to treat their tinnitus. Research Design: Randomized controlled trial. Study Sample: 40 participants were randomized to receive both manganese and Lipoflavonoid Plus® for 6 months, or Lipoflavonoid Plus® only (as the control). Data Collection and Analysis: Pre- and postmeasures were obtained with the Tinnitus Handicap Questionnaire, Tinnitus Primary Functions Questionnaire, and tinnitus loudness and annoyance ratings. An audiologist performed the audiogram, the tinnitus loudness match, and minimal masking level. Results: Twelve participants were dropped out of the study because of the side effects or were lost to follow-up. In the manganese group, 1 participant (out of 12) showed a decrease in the questionnaires, and another showed a decrease in the loudness and annoyance ratings. No participants from the control group (total 16) showed a decrease in the questionnaires ratings. Two participants in the control group reported a loudness decrement and one reported an annoyance decrement. Conclusions: We were not able to conclude that either manganese or Lipoflavonoid Plus® is an effective treatment for tinnitus.

Sign in / Sign up

Export Citation Format

Share Document