دورية أكاديمية
Platelet-Rich plasma Injection Management for Ankle osteoarthritis study (PRIMA): protocol of a Dutch multicentre, stratified, block-randomised, double-blind, placebo-controlled trial.
| العنوان: | Platelet-Rich plasma Injection Management for Ankle osteoarthritis study (PRIMA): protocol of a Dutch multicentre, stratified, block-randomised, double-blind, placebo-controlled trial. |
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| المؤلفون: | Paget L; Orthopaedic Surgery, Amsterdam UMC-Location AMC, Amsterdam, The Netherlands l.d.paget@amsterdamumc.nl.; Amsterdam Collaboration for Health and Safety in Sports (ACHSS), AMC/VUMC IOC Research Center, Amsterdam, The Netherlands., Bierma-Zeinstra S; Department of General Practice, Erasmus University Medical Centre, Rotterdam, The Netherlands.; Orthopaedic Surgery, Erasmus Medical Center, Rotterdam, The Netherlands., Goedegebuure S; Sports Medicine, OLVG, The Sport Physician Group, Amsterdam, The Netherlands.; Academic Center for Evidence-based Sports medicine (ACES), Amsterdam UMC, Amsterdam, The Netherlands., Kerkhoffs G; Orthopaedic Surgery, Amsterdam UMC-Location AMC, Amsterdam, The Netherlands.; Amsterdam Collaboration for Health and Safety in Sports (ACHSS), AMC/VUMC IOC Research Center, Amsterdam, The Netherlands., Krips R; Orthopaedic Surgery, Flevoziekenhuis, Almere, The Netherlands., Maas M; Academic Center for Evidence-based Sports medicine (ACES), Amsterdam UMC, Amsterdam, The Netherlands.; Radiology, Amsterdam UMC-Location AMC, Amsterdam, The Netherlands., Moen MH; Sports Medicine, Bergman Clinics, Naarden, The Netherlands.; OLVG, The Sport Physician Group, Amsterdam, The Netherlands., Reurink G; Sports Medicine, OLVG, The Sport Physician Group, Amsterdam, The Netherlands.; Academic Center for Evidence-based Sports medicine (ACES), Amsterdam UMC, Amsterdam, The Netherlands., Stufkens S; Orthopaedic Surgery, Amsterdam UMC-Location AMC, Amsterdam, The Netherlands.; Amsterdam Collaboration for Health and Safety in Sports (ACHSS), AMC/VUMC IOC Research Center, Amsterdam, The Netherlands., de Vos RJ; Orthopaedics and Sports Medicine, Erasmus University Medical Centre, Rotterdam, The Netherlands., Weir A; Orthopaedics and Sports Medicine, Erasmus University Medical Centre, Rotterdam, The Netherlands.; Sports Medicine and Exercise Clinic Haarlem (SBK), Haarlem, The Netherlands., Tol JL; Academic Center for Evidence-based Sports medicine (ACES), Amsterdam UMC, Amsterdam, The Netherlands.; Aspetar Orthopaedic and Sports Medicine Hospital, Doha, Qatar. |
| المصدر: | BMJ open [BMJ Open] 2019 Oct 07; Vol. 9 (10), pp. e030961. Date of Electronic Publication: 2019 Oct 07. |
| نوع المنشور: | Clinical Trial Protocol; Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: [London] : BMJ Publishing Group Ltd, 2011- |
| مواضيع طبية MeSH: | Ankle Joint*/pathology , Ankle Joint*/physiopathology , Osteoarthritis*/physiopathology , Osteoarthritis*/psychology , Osteoarthritis*/therapy , Platelet-Rich Plasma* , Quality of Life*, Adult ; Double-Blind Method ; Female ; Humans ; Immunologic Factors/administration & dosage ; Injections, Intra-Articular/methods ; Male ; Netherlands ; Pain Measurement/methods ; Randomized Controlled Trials as Topic ; Regeneration ; Sports Medicine/methods |
| مستخلص: | Introduction: Platelet-rich plasma (PRP) is a potentially efficacious treatment for ankle osteoarthritis (OA), but its use has not been examined in high-quality studies. Systematic reviews show that PRP injections significantly decrease pain and improve function in patients with knee OA. Ankle OA is more common than hip or knee OA in the young active population; with a prevalence of 3.4%.PRP injections in ankle OA are shown to be safe and improve quality of life over time, but no randomised controlled trial has been conducted. Our randomised controlled trial will evaluate the efficacy of PRP injections for symptom reduction and functional improvement, compared with placebo, in the treatment of ankle (talocrural) OA. Methods and Analysis: We will conduct the Platelet-Rich plasma Injection Management for Ankle OA study: a multicentre, randomised, placebo-controlled trial. One hundred patients suffering from ankle OA will be randomised into two treatment groups: PRP injection or placebo (saline) injection. Both groups will receive two injections of PRP or placebo at an interval of 6 weeks. Primary outcome is the American Orthopaedic Foot and Ankle Society score at 26 weeks. Secondary outcomes determined at several follow-up moments up to 5 years, include Ankle Osteoarthritis Score, Foot and Ankle Outcome Score, pain subscale of (0-40), Visual Analogue Scale score (0-100), Ankle Activity Score (0-10), subjective patient satisfaction Short Form Health Survey-36, Global Attainment Scaling and the EuroQol-5 dimensions-3 levels utility score. A cost-effectiveness analysis will be performed at 1 year. Ethics and Dissemination: The study is approved by the Medical Ethics Review Committee Amsterdam Medical Center, the Netherlands (ABR 2018-042, approved 23 July 2018) and registered in the Netherlands trial register (NTR7261). Results and new knowledge will be disseminated through the Dutch Arthritis Association (ReumaNederland), Dutch patient federation, conferences and published in a scientific peer-reviewed journal. Trial Registration Number: NTR7261. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.) |
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| فهرسة مساهمة: | Keywords: Platelet-rich Plasma; ankle osteoarthritis; foot & ankle; orthopaedic & trauma surgery; osteoarthritis; sports medicine |
| سلسلة جزيئية: | NTR NTR7261 |
| المشرفين على المادة: | 0 (Immunologic Factors) |
| تواريخ الأحداث: | Date Created: 20191010 Date Completed: 20201023 Latest Revision: 20201023 |
| رمز التحديث: | 20231215 |
| مُعرف محوري في PubMed: | PMC6797250 |
| DOI: | 10.1136/bmjopen-2019-030961 |
| PMID: | 31594891 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 2044-6055 |
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| DOI: | 10.1136/bmjopen-2019-030961 |