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Randomized controlled trial

Alejandro Gabriel G Gonzalez Garay, Daniel Molano Franco, Víctor H Nieto Estrada, Arturo J Martí-Carvajal, Ingrid Arevalo-Rodriguez
BACKGROUND: High altitude illness (HAI) is a term used to describe a group of mainly cerebral and pulmonary syndromes that can occur during travel to elevations above 2500 metres (˜ 8200 feet). Acute mountain sickness (AMS), high altitude cerebral oedema (HACE) and high altitude pulmonary oedema (HAPE) are reported as potential medical problems associated with high altitude ascent. In this second review, in a series of three about preventive strategies for HAI, we assessed the effectiveness of five of the less commonly used classes of pharmacological interventions...
March 12, 2018: Cochrane Database of Systematic Reviews
Robert H Hopper, Henry Ho, Supatra Sritulanondha, Ann C Williams, Charles A Engh
BACKGROUND: Crosslinked polyethylene (XLPE) liners used for primary THA have demonstrated lower wear rates than noncrosslinked, conventional polyethylene (CPE) liners through the first decade of clinical service. However, little high-quality evidence is currently available regarding the second decade performance of these implants and it remains uncertain whether the onset of osteolysis has simply been delayed or if the wear associated with XLPE liners will remain low enough that osteolysis will not occur...
February 2018: Clinical Orthopaedics and related Research
Matthieu Ollivier, Sébastien Parratte, Ludovic Lino, Xavier Flecher, Sébastien Pesenti, Jean-Noël Argenson
BACKGROUND: Previously published studies reported benefits of computer-assisted surgery (CAS) in terms of radiographic implant position in TKA, but whether these improvements result in clinically important survival differences or functional differences that a patient might perceive at a minimum 10-year followup remains largely unknown. QUESTIONS/PURPOSES: We performed a prospective randomized trial and asked whether CAS (1) improved survival free from aseptic loosening; and (2) demonstrated any clear difference in patient-reported outcomes at latest followup using validated outcome measures at minimum 10-year followup...
January 2018: Clinical Orthopaedics and related Research
Anders Odgaard, Frank Madsen, Per Wagner Kristensen, Andreas Kappel, Jesper Fabrin
BACKGROUND: Controversy exists over the surgical treatment for severe patellofemoral osteoarthritis. We therefore wished to compare the outcome of patellofemoral arthroplasty (PFA) with TKA in a blinded randomized controlled trial. QUESTIONS/PURPOSES: In the first 2 years after surgery: (1) Does the overall gain in quality of life differ between the implants based on the area under the curve of patient-reported outcomes (PROs) versus time? (2) Do patients obtain a better quality of life at specific points in time after PFA than after TKA? (3) Do patients get a better range of movement after PFA than after TKA? (4) Does PFA result in more complications than TKA? METHODS: Patients were eligible if they had debilitating symptoms and isolated patellofemoral disease...
January 2018: Clinical Orthopaedics and related Research
Sharon E Culliton, Dianne M Bryant, Steven J MacDonald, Kathryn M Hibbert, Bert M Chesworth
BACKGROUND: In 2012, a new Knee Society Knee Scoring System (KSS) was developed and validated to address the needs for a scoring system that better encompasses the expectations, satisfaction, and physical involvement of a younger, more active population of patients undergoing TKA. Revalidating this tool in a separate population by individuals other than the developers of the scoring system seems important, because such replication would tend to confirm the generalizability of this tool...
January 2018: Clinical Orthopaedics and related Research
Matthew J Dietz
No abstract text is available yet for this article.
January 2018: Clinical Orthopaedics and related Research
Simon W Young, Mei Zhang, Grant A Moore, Rocco P Pitto, Henry D Clarke, Mark J Spangehl
BACKGROUND: In primary TKA, prophylaxis with low-dose vancomycin through intraosseous regional administration (IORA) achieves tissue concentrations six to 10 times higher than systemic administration and was shown to provide more effective prophylaxis in an animal model. However, in revision TKA, the presence of a tibial implant may compromise IORA injection, and tourniquet deflation during a prolonged procedure may lower tissue concentrations. QUESTIONS/PURPOSES: (1) Does low-dose IORA reliably provide equal or higher tissue concentrations of vancomycin compared with systemic IV administration in revision TKA? (2) Are tissue concentrations of vancomycin after IORA maintained for the duration of the revision TKA despite a period of tourniquet deflation? (3) Is there any difference in early postoperative (< 6 weeks) complications between IORA and systemic IV administration in revision TKA? METHODS: Twenty patients undergoing aseptic revision TKA were randomized to two groups...
January 2018: Clinical Orthopaedics and related Research
Rupali Soeters, Peter B White, Mary Murray-Weir, Jayme C B Koltsov, Michael M Alexiades, Amar S Ranawat
BACKGROUND: As length of stay decreases for total joint arthroplasty, much of the patient preparation and teaching previously done in the hospital must be performed before surgery. However, the most effective form of preparation is unknown. This randomized trial evaluated the effect of a one-time, one-on-one preoperative physical therapy education session coupled with a web-based microsite (preopPTEd) on patients' readiness to discharge from physical therapy (PT), length of hospital stay, and patient-reported functional outcomes after total joint arthroplasty...
January 2018: Clinical Orthopaedics and related Research
Mustafa Kir, Gulay Kir
OBJECTIVE: Postoperative pain is a frequently problem after orthopedic procedures like hallux valgus surgery. The aim of this study was to evaluate whether ankle block improves early and mid-term functional outcomes and postoperative pain management after hallux valgus surgery in patients receiving general anesthesia. SUBJECTS AND METHODS: This randomized controlled trial investigated 60 patients who underwent hallux valgus surgery under general anesthesia. Patients were prospectively randomized into two groups; general anesthesia only (Group A) and ankle block added to general anesthesia (Group B)...
March 12, 2018: Medical Principles and Practice: International Journal of the Kuwait University, Health Science Centre
Ruben Barakat, Evelia Franco, María Perales, Carmina López, Michelle F Mottola
OBJECTIVE: to examine the influence of an exercise program throughout pregnancy on the duration of labor in healthy pregnant women. STUDY DESIGN: A randomized clinical trial was used (Identifier: NCT02109588). In all, 508 healthy pregnant women were randomly assigned between 9 and 11 weeks of gestation to either a Control Group (CG, N = 253) or an Exercise Group (EG, N = 255). A moderate aerobic exercise program throughout pregnancy (three weekly sessions) was used as the intervention...
March 6, 2018: European Journal of Obstetrics, Gynecology, and Reproductive Biology
Chunqing Lin, Chiao-Wen Lan, Li Li, Keming Rou
BACKGROUND: Methadone maintenance treatment (MMT) programs have expanded rapidly in China during the last decade. However, variance in service providers' practice may have an impact on the quality of care received by the patients. This study examined Chinese service providers' adherence to the MMT protocol and its associated factors. METHODS: The study used baseline data from a randomized intervention trial implemented in MMT clinics in five provinces of China. The data were collected from January 2012 to August 2013...
March 9, 2018: International Journal on Drug Policy
Nikos C Apostolopoulos, Ian M Lahart, Michael J Plyley, Jack Taunton, Alan M Nevill, Yiannis Koutedakis, Matthew Wyon, George S Metsios
Effects of passive static stretching intensity on recovery from unaccustomed eccentric exercise of right knee extensors was investigated in 30 recreationally active males randomly allocated into three groups: high-intensity (70-80% maximum perceived stretch), low-intensity (30-40% maximum perceived stretch), and control. Both stretching groups performed 3 sets of passive static stretching exercises of 60s each for hamstrings, hip flexors, and quadriceps, over 3 consecutive days, post-unaccustomed eccentric exercise...
March 12, 2018: Applied Physiology, Nutrition, and Metabolism, Physiologie Appliquée, Nutrition et Métabolisme
Stephan Reichenbach, Sabine Adler, Harald Bonel, Jennifer L Cullmann, Stefan Kuchen, Lukas Bütikofer, Michael Seitz, Peter M Villiger
Objective: To analyse magnetic resonance angiographic (MRA) vessel wall signals from a randomized controlled trial of tocilizumab (TCZ) to treat GCA. Methods: Participants were assigned in a 2:1 ratio to receive either TCZ + glucocorticoids (GCs) or placebo + GC infusions at 4-week intervals for 52 weeks. GCs were started at 1 mg/kg/day, then tapered to 0.1 mg/kg/day at week 12 and thereafter down to zero. Patients with initial positive MRA findings underwent control MRA at weeks 12 and 52...
February 23, 2018: Rheumatology
Isabel Lane, Ashley Bryce, Suzanne M Ingle, Alastair D Hay
Purpose: Antimicrobial resistance is a significant threat to public health. Diagnostic uncertainty is a key driver of antimicrobial prescribing. We sought to determine whether locally relevant, real-time syndromic or microbiological infection epidemiology can improve prescribing by reducing diagnostic uncertainty. Methods: Eligible studies investigated effects on primary care prescribing for common infections in Organisation For Economic Co-Operation And Development countries...
February 26, 2018: Family Practice
Anussara Prayongrat, Kikuo Umegaki, Arjen van der Schaaf, Albert C Koong, Steven H Lin, Thomas Whitaker, Todd McNutt, Naruhiro Matsufuji, Edward Graves, Masahiko Mizuta, Kazuhiko Ogawa, Hiroyuki Date, Kensuke Moriwaki, Yoichi M Ito, Keiji Kobashi, Yasuhiro Dekura, Shinichi Shimizu, Hiroki Shirato
Particle beam therapy (PBT), including proton and carbon ion therapy, is an emerging innovative treatment for cancer patients. Due to the high cost of and limited access to treatment, meticulous selection of patients who would benefit most from PBT, when compared with standard X-ray therapy (XRT), is necessary. Due to the cost and labor involved in randomized controlled trials, the model-based approach (MBA) is used as an alternative means of establishing scientific evidence in medicine, and it can be improved continuously...
February 24, 2018: Journal of Radiation Research
Sara J White, Emma L Carran, Andrew N Reynolds, Jillian J Haszard, Bernard J Venn
Background: The consumption of large amounts of fructose from added sugars results in the hepatic production and export of uric acid into the circulation. Objective: Our aim was to test whether fructose present in fruit is of sufficient quantity or in a form that will increase uric acid concentration. Design: Seventy-three participants were randomly assigned to 1 of 3 groups to ingest small (205 g) and large (410 g) servings of apple segments, small (170 mL) and large (340 mL) servings of apple juice, or a glucose and a fructose control beverage...
February 1, 2018: American Journal of Clinical Nutrition
Bernardette Cichon, Christian Fabiansen, Ann-Sophie Iuel-Brockdorf, Charles W Yaméogo, Christian Ritz, Vibeke B Christensen, Suzanne Filteau, André Briend, Kim F Michaelsen, Henrik Friis
Background: Children with moderate acute malnutrition (MAM) are treated with lipid-based nutrient supplements (LNSs) or corn-soy blends (CSBs) but little is known about the impact of these supplements on hemoglobin, iron status, and inflammation. Objective: The objective of this study was to investigate the impact of supplementary foods for treatment of MAM on hemoglobin, iron status, inflammation, and malaria. Design: A randomized 2 × 2 × 3 factorial trial was conducted in Burkina Faso...
February 1, 2018: American Journal of Clinical Nutrition
Natalie Teasdale, Ahmed Elhussein, Frances Butcher, Carmen Piernas, Gill Cowburn, Jamie Hartmann-Boyce, Rhea Saksena, Peter Scarborough
Background: Self-monitoring (SM) of diet and tailored feedback (TF) have been suggested as tools for changing dietary behavior. New technologies allow users to monitor behavior remotely, potentially improving reach, adherence, and outcomes. Objective: We conducted a systematic literature review and meta-analysis to address the following question: are remotely delivered standalone (i.e., no human contact) interventions that use SM or TF effective in changing eating behaviors? Design: Five databases were searched in October 2016 (updated in September 2017)...
February 1, 2018: American Journal of Clinical Nutrition
Suzanne Phelan, Rena R Wing, Anna Brannen, Angelica McHugh, Todd A Hagobian, Andrew Schaffner, Elissa Jelalian, Chantelle N Hart, Theresa O Scholl, Karen Munoz-Christian, Elaine Yin, Maureen G Phipps, Sarah Keadle, Barbara Abrams
Background: Behavioral lifestyle interventions during pregnancy can prevent excessive gestational weight gain (GWG) in women with normal weight; however, effective interventions to reduce GWG in ethnically diverse women with obesity are lacking. Objective: A randomized controlled trial was conducted to test whether a behavioral lifestyle intervention with partial meal replacement reduces GWG rate in Hispanic and non-Hispanic women with overweight or obesity relative to enhanced usual care...
February 1, 2018: American Journal of Clinical Nutrition
David R Merkle
No abstract text is available yet for this article.
February 1, 2018: American Journal of Clinical Nutrition
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