Efficacy of intra-articular injections of platelet-rich plasma as a symptom- and disease-modifying treatment for knee osteoarthritis - the RESTORE trial protocol
Abstract Background Knee osteoarthritis (OA) causes substantial pain, physical dysfunction and impaired quality of life. There is no cure for knee OA, and for some people, the disease may involve progressive symptomatic and structural deterioration over time. Platelet-rich plasma (PRP) is a therapeu...
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2018-07-01
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Series: | BMC Musculoskeletal Disorders |
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Online Access: | http://link.springer.com/article/10.1186/s12891-018-2205-5 |
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doaj-36aeb86da7a7489fb4499dc5a58c5735 |
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record_format |
Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Kade L. Paterson David J. Hunter Ben R. Metcalf Jillian Eyles Vicky Duong Jessica Kazsa Yuanyuan Wang Rachelle Buchbinder Flavia Cicuttini Andrew Forbes Anthony Harris Shirley P. Yu Bing Hui Wang David Connell James Linklater Kim L. Bennell |
spellingShingle |
Kade L. Paterson David J. Hunter Ben R. Metcalf Jillian Eyles Vicky Duong Jessica Kazsa Yuanyuan Wang Rachelle Buchbinder Flavia Cicuttini Andrew Forbes Anthony Harris Shirley P. Yu Bing Hui Wang David Connell James Linklater Kim L. Bennell Efficacy of intra-articular injections of platelet-rich plasma as a symptom- and disease-modifying treatment for knee osteoarthritis - the RESTORE trial protocol BMC Musculoskeletal Disorders Osteoarthritis Knee Cartilage Pain Platelet-rich plasma Saline |
author_facet |
Kade L. Paterson David J. Hunter Ben R. Metcalf Jillian Eyles Vicky Duong Jessica Kazsa Yuanyuan Wang Rachelle Buchbinder Flavia Cicuttini Andrew Forbes Anthony Harris Shirley P. Yu Bing Hui Wang David Connell James Linklater Kim L. Bennell |
author_sort |
Kade L. Paterson |
title |
Efficacy of intra-articular injections of platelet-rich plasma as a symptom- and disease-modifying treatment for knee osteoarthritis - the RESTORE trial protocol |
title_short |
Efficacy of intra-articular injections of platelet-rich plasma as a symptom- and disease-modifying treatment for knee osteoarthritis - the RESTORE trial protocol |
title_full |
Efficacy of intra-articular injections of platelet-rich plasma as a symptom- and disease-modifying treatment for knee osteoarthritis - the RESTORE trial protocol |
title_fullStr |
Efficacy of intra-articular injections of platelet-rich plasma as a symptom- and disease-modifying treatment for knee osteoarthritis - the RESTORE trial protocol |
title_full_unstemmed |
Efficacy of intra-articular injections of platelet-rich plasma as a symptom- and disease-modifying treatment for knee osteoarthritis - the RESTORE trial protocol |
title_sort |
efficacy of intra-articular injections of platelet-rich plasma as a symptom- and disease-modifying treatment for knee osteoarthritis - the restore trial protocol |
publisher |
BMC |
series |
BMC Musculoskeletal Disorders |
issn |
1471-2474 |
publishDate |
2018-07-01 |
description |
Abstract Background Knee osteoarthritis (OA) causes substantial pain, physical dysfunction and impaired quality of life. There is no cure for knee OA, and for some people, the disease may involve progressive symptomatic and structural deterioration over time. Platelet-rich plasma (PRP) is a therapeutic agent that aims to address underlying biological processes responsible for OA pathogenesis. As such, it has the potential to improve both symptoms and joint structure. The aim of this clinical trial is to determine whether a series of injections of PRP into the knee joint will lead to a significantly greater reduction in knee pain, and less loss of medial tibial cartilage volume over 12 months when compared to a series of placebo saline injections in people with knee OA. Methods This will be a two-group, superiority, randomised, participant-, interventionist- and assessor-blinded, placebo-controlled trial. Two hundred and eighty-eight participants aged over 50 years with painful knee OA and mild to moderate structural change on x-ray (Kellgren and Lawrence grade 2 and 3) will be randomly allocated to receive either three PRP injections or three normal saline injections into the knee joint at weekly intervals. The primary outcomes will be 12-month change in average overall knee pain severity (numeric rating scale) and medial tibial cartilage volume (magnetic resonance imaging (MRI)). Secondary outcomes include additional measures of knee pain and other symptoms, function in daily living and sport and recreation, quality of life, participant-perceived global ratings of change, and other MRI structural outcomes including meniscal and cartilage morphology, synovitis, effusion, bone marrow lesions and cartilage defects. A range of additional measures will be recorded, and a separate health economic evaluation will be performed. Discussion The findings from this study will help determine whether PRP improves both clinical and structural knee OA outcomes over 12 months when compared to a series of placebo saline injections. Trial registration Australian New Zealand Clinical Trials Registry reference: ACTRN12617000853347. Prospectively registered 9th of June 2017. |
topic |
Osteoarthritis Knee Cartilage Pain Platelet-rich plasma Saline |
url |
http://link.springer.com/article/10.1186/s12891-018-2205-5 |
work_keys_str_mv |
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doaj-36aeb86da7a7489fb4499dc5a58c57352020-11-24T21:17:10ZengBMCBMC Musculoskeletal Disorders1471-24742018-07-0119111110.1186/s12891-018-2205-5Efficacy of intra-articular injections of platelet-rich plasma as a symptom- and disease-modifying treatment for knee osteoarthritis - the RESTORE trial protocolKade L. Paterson0David J. Hunter1Ben R. Metcalf2Jillian Eyles3Vicky Duong4Jessica Kazsa5Yuanyuan Wang6Rachelle Buchbinder7Flavia Cicuttini8Andrew Forbes9Anthony Harris10Shirley P. Yu11Bing Hui Wang12David Connell13James Linklater14Kim L. Bennell15Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Faculty of Medicine Dentistry & Health Sciences, The University of MelbourneRheumatology Department, Royal North Shore Hospital Australia and Institute of Bone and Joint Research, Kolling Institute, University of SydneyCentre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Faculty of Medicine Dentistry & Health Sciences, The University of MelbourneRheumatology Department, Royal North Shore Hospital Australia and Institute of Bone and Joint Research, Kolling Institute, University of SydneyRheumatology Department, Royal North Shore Hospital Australia and Institute of Bone and Joint Research, Kolling Institute, University of SydneyDepartment of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash UniversityDepartment of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash UniversityMonash Department of Clinical Epidemiology, Cabrini InstituteMusculoskeletal Unit, Department of Epidemiology and Preventive Medicine, Monash University and Rheumatology Unit, Alfred HospitalDepartment of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash UniversityCentre for Health Economics, Monash UniversityRheumatology Department, Royal North Shore Hospital Australia and Institute of Bone and Joint Research, Kolling Institute, University of SydneyMonash Centre of Cardiovascular Research & Education in Therapeutics, Department of Epidemiology and Preventive Medicine, Monash UniversityImaging at Olympic ParkCastlereagh ImagingCentre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Faculty of Medicine Dentistry & Health Sciences, The University of MelbourneAbstract Background Knee osteoarthritis (OA) causes substantial pain, physical dysfunction and impaired quality of life. There is no cure for knee OA, and for some people, the disease may involve progressive symptomatic and structural deterioration over time. Platelet-rich plasma (PRP) is a therapeutic agent that aims to address underlying biological processes responsible for OA pathogenesis. As such, it has the potential to improve both symptoms and joint structure. The aim of this clinical trial is to determine whether a series of injections of PRP into the knee joint will lead to a significantly greater reduction in knee pain, and less loss of medial tibial cartilage volume over 12 months when compared to a series of placebo saline injections in people with knee OA. Methods This will be a two-group, superiority, randomised, participant-, interventionist- and assessor-blinded, placebo-controlled trial. Two hundred and eighty-eight participants aged over 50 years with painful knee OA and mild to moderate structural change on x-ray (Kellgren and Lawrence grade 2 and 3) will be randomly allocated to receive either three PRP injections or three normal saline injections into the knee joint at weekly intervals. The primary outcomes will be 12-month change in average overall knee pain severity (numeric rating scale) and medial tibial cartilage volume (magnetic resonance imaging (MRI)). Secondary outcomes include additional measures of knee pain and other symptoms, function in daily living and sport and recreation, quality of life, participant-perceived global ratings of change, and other MRI structural outcomes including meniscal and cartilage morphology, synovitis, effusion, bone marrow lesions and cartilage defects. A range of additional measures will be recorded, and a separate health economic evaluation will be performed. Discussion The findings from this study will help determine whether PRP improves both clinical and structural knee OA outcomes over 12 months when compared to a series of placebo saline injections. Trial registration Australian New Zealand Clinical Trials Registry reference: ACTRN12617000853347. Prospectively registered 9th of June 2017.http://link.springer.com/article/10.1186/s12891-018-2205-5OsteoarthritisKneeCartilagePainPlatelet-rich plasmaSaline |