Fixation Using Alternative Implants for the Treatment of Hip Fractures

التفاصيل البيبلوغرافية
العنوان: Fixation Using Alternative Implants for the Treatment of Hip Fractures
المؤلفون: Lauren C. Hill, Krista M. Brown, Robert V O'Toole, Mohit Bhandari, Sofia Bzovsky, Sheila Sprague, Greg E. Gaski, Gregory J. Della Rocca, Lehana Thabane, Andrea Howe, Mauri Zomar, Taryn Scott, Gerard P. Slobogean, Darius Viskontas, Diane Heels-Ansdell
المصدر: OTA International
بيانات النشر: Wolters Kluwer Health, 2020.
سنة النشر: 2020
مصطلحات موضوعية: medicine.medical_specialty, Randomization, Nutritional Supplementation, Population, vitamin D, Placebo, Femoral Neck Fractures, femoral neck fractures, law.invention, Clinical/Basic Science Research Article, Randomized controlled trial, law, Fracture fixation, medicine, clinical protocols, education, Femoral neck, education.field_of_study, business.industry, General Medicine, medicine.anatomical_structure, internal, randomized controlled trial, Physical therapy, fracture fixation, business
الوصف: Objectives: To conduct a pilot trial for the Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2) protocol to assess feasibility of a definitive trial. Design: Pilot trial. Setting: Twenty-five clinical sites across North America and Australia were initiated, but enrolment occurred in only 15 North American sites. Patients/Participants: Ninety-one randomized adults aged 18 to 60 years with a femoral neck fracture requiring surgical fixation. Intervention: Eligible patients were randomized to receive surgical treatment (sliding hip screw or cancellous screws) AND nutritional supplementation (4000 IU of vitamin D or placebo) for 6 months postfracture. Main Outcome Measurements: Feasibility outcomes included: clinical site initiation, participant enrolment rate, proportion of participants with complete 12-month follow-up, level of data quality, and rate of protocol adherence (number of randomization errors, crossovers between treatment groups, and daily supplementation adherence). Results: Eighty-six of 91 participants randomized into the pilot trial from 15 North American hospitals were deemed eligible. Four of five primary feasibility criteria were not achieved as we were unable to initiate clinical sites outside of North America and Australia due to feasibility constraints, slow participant enrolment (60 participants recruited over 36 mo), low adherence with daily nutritional supplementation at the 6-week (72.1%), 3-month (60.5%), and 6-month (54.7%) follow-up visits, and a high loss to follow-up rate of 22.1% at 12 months. Conclusions: Despite not meeting key feasibility criteria, we increased our knowledge on the logistics and anticipated barriers when conducting vitamin D supplementation trials in this trauma population, which can be used to inform the design and conduct of future trials on this topic.
اللغة: English
تدمد: 2574-2167
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::df8383cf4e5482e54251d25a57cefbe2
http://europepmc.org/articles/PMC8022909
Rights: OPEN
رقم الانضمام: edsair.doi.dedup.....df8383cf4e5482e54251d25a57cefbe2
قاعدة البيانات: OpenAIRE