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Platelet-Rich plasma Injection Management for Ankle osteoarthritis study (PRIMA): protocol of a Dutch multicentre, stratified, block-randomised, double-blind, placebo-controlled trial.
- Source :
-
BMJ open [BMJ Open] 2019 Oct 07; Vol. 9 (10), pp. e030961. Date of Electronic Publication: 2019 Oct 07. - Publication Year :
- 2019
-
Abstract
- 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.<br />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.<br />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.<br />Trial Registration Number: NTR7261.<br />Competing Interests: Competing interests: None declared.<br /> (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)
- Subjects :
- 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
Ankle Joint pathology
Ankle Joint physiopathology
Osteoarthritis physiopathology
Osteoarthritis psychology
Osteoarthritis therapy
Platelet-Rich Plasma
Quality of Life
Subjects
Details
- Language :
- English
- ISSN :
- 2044-6055
- Volume :
- 9
- Issue :
- 10
- Database :
- MEDLINE
- Journal :
- BMJ open
- Publication Type :
- Academic Journal
- Accession number :
- 31594891
- Full Text :
- https://doi.org/10.1136/bmjopen-2019-030961