scholarly journals Knee Fix or Replace Trial (KFORT): a randomized controlled feasibility study

2019 ◽  
Vol 101-B (11) ◽  
pp. 1408-1415 ◽  
Author(s):  
Peter D. Hull ◽  
Daud T. S. Chou ◽  
Sophie Lewis ◽  
Andrew D. Carrothers ◽  
Joseph M. Queally ◽  
...  
Keyword(s):  
Sample Size ◽  
Controlled Trial ◽  
Sample Size Calculation ◽  
Femoral Fractures ◽  
Full Scale ◽  
Willingness To Participate ◽  
Randomized Controlled ◽  
The Mean ◽  
Mean Cost

Aims The aim of this study was to assess the feasibility of conducting a full-scale, appropriately powered, randomized controlled trial (RCT) comparing internal fracture fixation and distal femoral replacement (DFR) for distal femoral fractures in older patients. Patients and Methods Seven centres recruited patients into the study. Patients were eligible if they were greater than 65 years of age with a distal femoral fracture, and if the surgeon felt that they were suitable for either form of treatment. Outcome measures included the patients’ willingness to participate, clinicians’ willingness to recruit, rates of loss to follow-up, the ability to capture data, estimates of standard deviation to inform the sample size calculation, and the main determinants of cost. The primary clinical outcome measure was the EuroQol five-dimensional index (EQ-5D) at six months following injury. Results Of 36 patients who met the inclusion criteria, five declined to participate and eight were not recruited, leaving 23 patients to be randomized. One patient withdrew before surgery. Of the remaining patients, five (23%) withdrew during the follow-up period and six (26%) died. A 100% response rate was achieved for the EQ-5D at each follow-up point, excluding one missing datapoint at baseline. In the DFR group, the mean cost of the implant outweighed the mean cost of many other items, including theatre time, length of stay, and readmissions. For a powered RCT, a total sample size of 1400 would be required with 234 centres recruiting over three years. At six months, the EQ-5D utility index was lower in the DFR group. Conclusion This study found that running a full-scale trial in this country would not be feasible. However, it may be feasible to undertake an international multicentre trial, and our findings provide some guidance about the power of such a study, the numbers required, and some challenges that should be anticipated and addressed. Cite this article: Bone Joint J 2019;101-B:1408–1415.

scholarly journals Results Are Similar Two Years After Acute or Delayed Anterior Cruciate Ligament Reconstruction. A Randomized Controlled Trial

2017 ◽  
Vol 5 (5_suppl5) ◽  
pp. 2325967117S0017
Author(s):  
Karl Eriksson ◽  
Christoffer von Essen ◽  
Björn Barenius
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Endpoint ◽  
Pivot Shift ◽  
Controlled Trial ◽  
Acl Injury ◽  
Activity Level ◽  
Randomized Controlled ◽  
Delayed Group ◽  
The Mean

Objectives: Acute ACLR has been avoided since the 1990’s due to reports of postoperative stiffness. But are these risks still valid with modern arthroscopic techniques? The aim of this randomized controlled trial was to assess the impact of the time between injury and reconstruction on the outcome after ACLR. Our hypothesis was that acute ACLR with semitendinosus graft can be performed safely. Methods: The primary endpoint was ROM at three months after surgery. A power calculation revealed the need for 64 patients to detect a ROM difference of 5 degrees between the groups (5% significance level). 70 patients with a high recreational activity level (Tegner ≥6) who presented with an acute ACL injury were randomized to an acute reconstruction within 8 days from the injury or delayed reconstruction (after normalized ROM) 6-10 weeks after the injury. Fixation was with Endobutton in femur and a metallic interference screw in tibia. The rehabilitation was performed at the same physiotherapy center for all patients. Follow up assessment was performed by a physiotherapist not involved with the rehabilitation. The follow up at 24 months included ROM, Lachman, instrumented laxity with Rolimeter, pivot shift, one leg hop index, Biodex, IKDC, KOOS, Lysholm and Tegner Activity level, and a VAS question regarding knee function and the knee function’s effect on activity level. Results: Seventy percent of the patients were males, mean age at the time of surgery was 27 years (18 -41) and the median pre-injury Tegner level was 9 (6-10) with no differences between the groups. 64 (91%) patients were assessed at three months with no difference according to the primary endpoint. Median Tegner level was restored to pre-injury levels in both groups after one year, and did not change between one and two years. 63 (90%) patients were available for the 2-year follow up. There was one graft rupture and one contralateral ACL injury in both groups. There was additional surgery in 15% of the acute patients and in 31% in the delayed (n.s.). The mean instrumented laxity was 1.8 mm in the acute and 2.0 in the delayed group. There were no positive pivot shift in the acute group and 6 patients with grade 1 or not possible to perform in the delayed group (p=0.039). IKDC revealed no significant differences between the groups. Lysholm score was 87 in both groups. KOOS values showed no significant difference between the groups. VAS response to the question “How is your knee working on a scale from 0-100? (100 = best)” was 81 in the acute and 71 in the delayed group (p=0.1) and “How does your knee affect your activity level? (100 = no affection)” the mean score was 75 in the acute and 67 in the delayed group (p=0.3). Functional strength (one leg hop index >90%) was 85% in the acute and 67% in the delayed group (n.s). Conclusion: We found no increased risk of arthrofibrosis after acute ACLR. Good results can be achieved at two years regardless of ROM and swelling in the acute stage.

A randomized controlled trial with 4-month follow-up of adjunctive repetitive transcranial magnetic stimulation of the left prefrontal cortex for depression

2007 ◽  
Vol 38 (3) ◽  
pp. 323-333 ◽  
Author(s):  
A. Mogg ◽  
G. Pluck ◽  
S. V. Eranti ◽  
S. Landau ◽  
R. Purvis ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Magnetic Stimulation ◽  
Sham Group ◽  
Rating Scale ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Real Group ◽  
The Mean

BackgroundEffectiveness of repetitive transcranial magnetic stimulation (rTMS) for major depression is unclear. The authors performed a randomized controlled trial comparing real and sham adjunctive rTMS with 4-month follow-up.MethodFifty-nine patients with major depression were randomly assigned to a 10-day course of either real (n=29) or sham (n=30) rTMS of the left dorsolateral prefrontal cortex (DLPFC). Primary outcome measures were the 17-item Hamilton Depression Rating Scale (HAMD) and proportions of patients meeting criteria for response (⩾50% reduction in HAMD) and remission (HAMD⩽8) after treatment. Secondary outcomes included mood self-ratings on Beck Depression Inventory-II and visual analogue mood scales, Brief Psychiatric Rating Scale (BPRS) score, and both self-reported and observer-rated cognitive changes. Patients had 6-week and 4-month follow-ups.ResultsOverall, Hamilton Depression Rating Scale (HAMD) scores were modestly reduced in both groups but with no significant group×time interaction (p=0.09) or group main effect (p=0.85); the mean difference in HAMD change scores was −0.3 (95% CI −3.4 to 2.8). At end-of-treatment time-point, 32% of the real group were responders compared with 10% of the sham group (p=0.06); 25% of the real group met the remission criterion compared with 10% of the sham group (p=0.2); the mean difference in HAMD change scores was 2.9 (95% CI −0.7 to 6.5). There were no significant differences between the two groups on any secondary outcome measures. Blinding was difficult to maintain for both patients and raters.ConclusionsAdjunctive rTMS of the left DLPFC could not be shown to be more effective than sham rTMS for treating depression.

scholarly journals How should a clinician interpret results of randomized controlled trials?

2010 ◽  
Vol 17 (1-2) ◽  
pp. 30-34
Author(s):  
Virginijus ŠAPOKA ◽  
Vytautas KASIULEVIČIUS ◽  
Janina DIDŽIAPETRIENĖ
Keyword(s):  
Randomized Controlled Trials ◽  
Sample Size ◽  
Controlled Trial ◽  
Sample Size Calculation ◽  
Study Groups ◽  
Controlled Trials ◽  
Random Allocation ◽  
Equivalence Testing ◽  
Randomized Controlled ◽  
Selection Of

Randomized controlled trials (RCTs) and systematic reviews are the most reliable methods of determining the effects of treatment. The randomization procedure gives a randomized controlled trial its strength. Random allocation means that all participants have the same chance of being assigned to each of the study groups. The choice of which end point(s) to select is critical to any study design. Intention-to-treat is the preferred approach to the analysis of clinical trials. Sample size calculations and data analyses have an important impact on the planning, interpretation, and conclusions of randomized trials. In this article, we discuss the problematic areas that can affect the outcome of a trial, such as blinding, sample size calculation, randomization; concealment allocation; intention of treating the analysis; selection of end points; selection of traditional versus equivalence testing, early stopped trials, selective publications. Keywords: randomized controlled trials, sample size, outcomes, type of analyses

scholarly journals Effects of a novel dye containing toothpaste versus regular fluoridated toothpaste for supragingival biofilm reduction in patients with chronic gingivitis: A Randomized Controlled Trial

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Avita Rath ◽  
Chong Junning ◽  
Priyadarshini HR ◽  
Brandon Nicholas Teo ◽  
Naik Hsian Zhen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Image Analysis ◽  
Controlled Trial ◽  
Control Group ◽  
Dental Biofilm ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Tooth Surfaces ◽  
The Mean

AIM:To compare the effects of a plaque disclosing toothpaste with a regular fluoridated toothpaste for supragingival biofilm reduction in patients with chronic gingivitis.MATERIALS AND METHODS:This study was a randomized controlled trial with a parallel design. Forty patients, both males and females aged 18-25 years with chronic generalized gingivitis (N=40) were randomly allocated to two groups of twenty each (n=20), using lottery method. Participants in the experimental group brushed with a plaque disclosing toothpaste, while participants in the control group brushed with regular fluoridated toothpaste. Clinically, biofilm was measured using Silness & Loe Plaque Index, both at baseline and at follow up visits by two assessors who were blinded to group allocation. Adjunctly, intraoral photographs were taken for Digital Plaque Image Analysis of the remaining dental biofilm in the upper and lower anterior labial tooth surfaces, and calculated based on the area of stained pixels. Data was analyzed using SPSS version 22. Mean plaque scores between the groups were compared using independent sample t-test and p<0.05 was considered significant.RESULTS:Data of all the 40 participants were analyzed as they were no drop outs. No significant differences were found in the mean plaque scores between the two groups (p=0.059) at the end of the study. Similarly, Digital Plaque Image Analysis showed no significant difference in the mean plaque scores between the groups (p= 0.93).CONCLUSION:This study showed that there are no additional benefits of using a plaque disclosing toothpaste, in enhancing the removal of the supragingival dental biofilm during routine oral hygiene maintenance.   

scholarly journals Electromagnetic stimulation as coadjuvant in the healing of diaphyseal femoral fractures: a randomized controlled trial

2014 ◽  
pp. 67-71 ◽  
Author(s):  
Alfredo Martinez Rondanelli ◽  
Juan Pablo Martinez ◽  
María Elena Moncada ◽  
Eliana Manzi ◽  
Carlos Rafael Pinedo ◽  
...  
Keyword(s):  
Electromagnetic Field ◽  
Bone Healing ◽  
Controlled Trial ◽  
Weight Bearing ◽  
Femoral Fractures ◽  
Femoral Diaphysis ◽  
Randomized Controlled ◽  
Electromagnetic Stimulation ◽  
Diaphyseal Fractures ◽  
The Mean

Introduction: There is controversy in medical literature regarding the use of electromagnetic fields to promote bone healing. Methods: After designing and building devices capable of generating an electromagnetic field for this study, their safety was confirmed and the electromagnetic therapy was randomly allocated and compared to placebo in patients with fracture of the femoral diaphysis. Treatment began six weeks after the fracture and it was administered once a day, during 1 h, for eight consecutive weeks. Twenty devices were built, 10 of which were placebo-devices. Between June 2008 and October 2009, 64 patients were randomized in two different hospitals and were followed for 24 weeks. The mean age was 30 years (18-59) and 81% were males. Results: Healing observed at week 12 was 75% vs. 58% (p= 0.1); at week 18, it was 94% vs. 80% (p= 0.15); and at week 24, it was 94% vs. 87% (p= 0.43) for the device group and the placebo group, respectively. Discussion: This study suggests that an electromagnetic field stimulus can promote earlier bone healing compared to placebo in femoral diaphyseal fractures. Faster bone healing translates into sooner weight bearing, which – in turn – permits quicker return to normal daily activities.

scholarly journals Intradermal mesotherapy versus intravenous dexketoprofen for the treatment of migraine headache without aura: a randomized controlled trial

2021 ◽  
Vol 41 (3) ◽  
pp. 127-134
Author(s):  
Ilker Akbas ◽  
Meryem Betos Kocak ◽  
Abdullah Osman Kocak ◽  
Sultan Tuna Akgol Gur ◽  
Sinem Dogruyol ◽  
...  
Keyword(s):  
Adverse Effect ◽  
Randomized Controlled Trial ◽  
Pain Intensity ◽  
Sample Size ◽  
Systemic Therapy ◽  
Migraine Without Aura ◽  
Therapy Group ◽  
Controlled Trial ◽  
Randomized Controlled

BACKGROUND: Migraine is a prevalent disabling primary headache disorder that is classified into two major types: migraine without aura and migraine with aura. New therapeutic methods to reduce migraine headaches in the emergency department (ED) include intradermal mesotherapy. OBJECTIVE: Compare the efficacy of intradermal mesotherapy versus a systemic therapy in pain control in patients with headache related to migraine without aura. DESIGN: Prospective parallel-group randomized controlled trial. SETTING: University hospital in Turkey. PATIENTS AND METHODS: Patients 18 years of age and older who were admitted to the ED over a 15-month period with headache related to migraine without aura were eligible for inclusion if they had a VAS score of 4 or above. Patients were randomly allocated to one session of mesotherapy or intravenous dexketoprofen. Changes in pain intensity were measured by the score on a visual analog scale (VAS) at 30, 60, and 120 minutes and 24 hours after treatment. Efficacy was also assessed by the need for use of an analgesic drug within 24 hours, by readmission with the same complaint to the ED within 72 hours, and by adverse effect rates. MAIN OUTCOME MEASURE: Pain intensity on the VAS scale. SAMPLE SIZE: 148 patients (154 enrolled and treated; 1 patient in the mesotherapy and 5 patients in the systemic therapy group lost to follow up). RESULTS: Pain intensity on the VAS scale decreased from a median score of 8 to 4 in the mesotherapy group and from 8 to 5 in the systemic therapy group. These differences were statistically significant from baseline for all time intervals ( P =.001 to 30 minutes, P =.004 to 60 minutes, P =.005 to 120 minutes, and P =.002 to 24 hours). The need to use analgesics and the rate of readmission to the ED were higher in the systemic therapy group ( P =.013 and P =.030, respectively). Adverse effect rates were minimal and similar in the study groups during the one-week follow-up period. CONCLUSIONS: Mesotherapy is more efficacious than intravenous dexketoprofen in the management of acute attack of migraine without aura in the ED. LIMITATIONS: Unblinded. Valid for assessing short-term pain relief, but not sufficient to predict long-term efficacy. Not generalizable because single center and small sample size. CONFLICT OF INTEREST: None. REGISTRATION: ClinicalTrials.gov (NCT04519346)

Rotator Cuff Calcific Tendinitis: Ultrasound-Guided Needling and Lavage Versus Subacromial Corticosteroids: Five-Year Outcomes of a Randomized Controlled Trial

2017 ◽  
Vol 45 (14) ◽  
pp. 3305-3314 ◽  
Author(s):  
Pieter Bas de Witte ◽  
Arjen Kolk ◽  
Ferdinand Overes ◽  
Rob G.H.H. Nelissen ◽  
Monique Reijnierse
Keyword(s):  
Randomized Controlled Trial ◽  
Rotator Cuff ◽  
Repeated Measures ◽  
Mixed Model ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
The Mean ◽  
Group 2 ◽  
Group 1

Background: Barbotage (needling and lavage) is often applied in the treatment of calcific tendinitis of the rotator cuff (RCCT). In a previously published randomized controlled trial, we reported superior clinical and radiological 1-year outcomes for barbotage combined with a corticosteroid injection in the subacromial bursa (SAIC) compared with an isolated SAIC. There are no trials with a midterm or long-term follow-up of barbotage available. Purpose: To compare the 5-year results of 2 regularly applied treatments of RCCT: ultrasound (US)–guided barbotage combined with a SAIC (group 1) versus an isolated US-guided SAIC (group 2). Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients were randomly assigned to group 1 or 2 and evaluated before and after treatment at regular time points until 12 months and also at 5 years using the Constant score (CS), the Western Ontario Rotator Cuff Index (WORC), and the Disabilities of the Arm, Shoulder and Hand (DASH). The calcification location and size and Gärtner classification were assessed on radiographs. The rotator cuff condition was evaluated with US. Results were analyzed using t tests, linear regression, and a mixed model for repeated measures. Results: Forty-eight patients were included (mean age, 52.0 ± 7.3 years; 25 [52%] female) with a mean baseline CS of 68.7 ± 11.9. After a mean follow-up of 5.1 ± 0.5 years, the mean CS was 90 (95% CI, 83.0-95.9) in group 1 versus 87 (95% CI, 80.5-93.5) in group 2 ( P = .58). The mean improvement in the CS in group 1 was 18 (95% CI, 12.3-23.0) versus 21 (95% CI, 16.2-26.2) in group 2 ( P = .32). There was total resorption in 62% of group 1 and 73% of group 2 ( P = .45). The US evaluation of the rotator cuff condition showed no significant differences between the groups. With the mixed model for repeated measures, taking into account the baseline CS and Gärtner classification, the mean treatment effect for barbotage was 6 (95% CI, –8.9 to 21.5), but without statistical significance. Follow-up scores were significantly associated with baseline scores and the duration of follow-up. Results for the DASH and WORC were similar. There were no significant complications, but 4 patients in group 1 and 16 in group 2 underwent additional treatment during the follow-up period ( P < .001). Conclusion: No more significant differences were found in the clinical and radiological outcomes between barbotage combined with a SAIC versus an isolated SAIC after 5 years of follow-up. Registration: NTR2282 (Dutch Trial Registry).

scholarly journals The effects of the online gatekeeping using search-based advertising on users’ suicidal ideation

2021 ◽  
Author(s):  
Hajime Sueki ◽  
Asumi Takahashi ◽  
Jiro Ito
Keyword(s):  
Suicidal Ideation ◽  
Suicide Prevention ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Control Group ◽  
Consultation Service ◽  
Randomized Controlled ◽  
Internet Users ◽  
The Mean

Background: Recently, the practice of “online gatekeeping” related to suicide prevention—placing online advertisements directed at users who search the web for suicide-related terms and leading them to email-based consultations—has been implemented. However, the effectiveness of this practice has not been examined. Aim: To quantitatively examine the effectiveness of suicide-related online gatekeeping. Methods: This was a non-randomized, single-arm study of online gatekeeping among Japanese Internet users. Outcomes were measured at the beginning of the use of the consultation service (T1) and approximately four weeks later (T2). The primary outcome measured was suicidal ideation. Results: In total, 167 participants completed two assessment surveys; approximately 80% were women, and 59.3% were young people (in their twenties or younger). Data analysis of 167 online gatekeeping service users showed that the mean suicidal ideation at T2 was statistically significantly lower than that at T1, and its effect size was small to medium (d = 0.38). Limitations: This study used a single-arm design with no control group. Additionally, the study did not include a second follow-up period. Conclusions: Online gatekeeping is a promising suicide-prevention tool, although further research is warranted to examine its effectiveness using a randomized controlled trial.

scholarly journals Effectiveness of a Web-Based Menu-Planning Intervention to Improve Childcare Service Compliance With Dietary Guidelines: Randomized Controlled Trial

10.2196/13401 ◽  
2020 ◽  
Vol 22 (2) ◽  
pp. e13401 ◽  
Author(s):  
Alice Grady ◽  
Luke Wolfenden ◽  
John Wiggers ◽  
Chris Rissel ◽  
Meghan Finch ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Dietary Guidelines ◽  
Food Groups ◽  
Web Based ◽  
Randomized Controlled ◽  
Menu Planning ◽  
The Mean ◽  
The Web ◽  
Planning Intervention

Background Foods provided in childcare services are not consistent with dietary guideline recommendations. Web-based systems offer unique opportunities to support the implementation of such guidelines. Objective This study aimed to assess the effectiveness of a Web-based menu planning intervention in increasing the mean number of food groups on childcare service menus that comply with dietary guidelines. Secondary aims were to assess the impact of the intervention on the proportion of service menus compliant with recommendations for (1) all food groups; (2) individual food groups; and (3) mean servings of individual food groups. Childcare service use and acceptability of the Web-based program were also assessed. Methods A single-blind, parallel-group randomized controlled trial was undertaken with 54 childcare services in New South Wales, Australia. Services were randomized to a 12-month intervention or usual care control. Intervention services received access to a Web-based menu planning program linked to their usual childcare management software system. Childcare service compliance with dietary guidelines and servings of food groups were assessed at baseline, 3-month follow-up, and 12-month follow-up. Results No significant differences in the mean number of food groups compliant with dietary guidelines and the proportion of service menus compliant with recommendations for all food groups, or for individual food groups, were found at 3- or 12-month follow-up between the intervention and control groups. Intervention service menus provided significantly more servings of fruit (P<.001), vegetables (P=.03), dairy (P=.03), and meat (P=.003), and reduced their servings of discretionary foods (P=.02) compared with control group at 3 months. This difference was maintained for fruit (P=.03) and discretionary foods (P=.003) at 12 months. Intervention childcare service staff logged into the Web-based program an average of 40.4 (SD 31.8) times and rated the program as highly acceptable. Conclusions Although improvements in childcare service overall menu and individual food group compliance with dietary guidelines were not statistically significant, findings indicate that a Web-based menu planning intervention can improve the servings for some healthy food groups and reduce the provision of discretionary foods. Future research exploring the effectiveness of differing strategies in improving the implementation of dietary guidelines in childcare services is warranted. Trial Registration Australian New Zealand Clinical Trial Registry (ANZCTR): 16000974404; http://www.anzctr.org.au/ACTRN12616000974404.aspx

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