Platelet rich plasma injection for acute Achilles tendon rupture: PATH-2 randomised, placebo controlled, superiority trial

被引:55
作者
Keene, David J. [1 ]
Alsousou, Joseph [2 ,16 ,19 ]
Harrison, Paul [3 ]
Hulley, Philippa Anne [4 ]
Wagland, Susan [1 ]
Parsons, Scott R. [1 ]
Thompson, Jacqueline [1 ]
O'Connor, Heather M. [5 ]
Schlussel, Michael Maia [5 ]
Dutton, Susan J. [5 ]
Lamb, Sarah E. [1 ,5 ]
Willett, Keith [1 ]
Handley, Robert [6 ]
Lewis, Kathryn [6 ]
Spoors, Louise [6 ]
Zhang, Yuhan [6 ]
Mestre, Maria [6 ]
Muller, Doreeen [6 ]
Prasath, Sangeetha [6 ]
Austin, Martin [6 ]
Bhatia, Maneesh [7 ]
Attwal, Manjit [7 ]
Christie, Carla [7 ]
Brear, Tracy [7 ]
Kelly, Andrew [8 ]
Beacham, Keira [8 ]
Brown, Sarah [8 ]
Allen, James [8 ]
Whitcher, Alison [8 ]
James, Kate [8 ]
Foster, Eliza [8 ]
Hepple, Steve [9 ]
Barnfield, Steven [9 ]
Coates, Katherine [9 ]
Halliday, Ruth [9 ]
Hooper, Lucille [9 ]
Hodgson, Paul [10 ]
Hodgson, Helen [10 ]
Cleary, Cheryl [10 ]
Nott, Claire [10 ]
Whiteman, Jessica [10 ]
Carmont, Michael [11 ]
Tonics, Louise [11 ]
Heidari, Nima [12 ]
Kassam, Jamila [12 ]
Hilton, Catherine [12 ]
Ahmad, Shanaz [12 ]
Young, Sophie [12 ]
Young, Jonathan [13 ]
Clarkson, Louise [13 ]
机构
[1] Univ Oxford, Kaoorie Res Ctr, Nuffield Dept Orthopaed Rheumatol & Musculoskelet, Oxford, England
[2] Univ Liverpool, Inst Translat Med, Liverpool, Merseyside, England
[3] Univ Birmingham, Inst Inflammat & Ageing, Birmingham, W Midlands, England
[4] Univ Oxford, Botnar Res Ctr, Nuffield Dept Orthopaed Rheumatol & Musculoskelet, Oxford, England
[5] Univ Oxford, Ctr Stat Med, Nuffield Dept Orthopaed Rheumatol & Musculoskelet, Oxford Clin Trials Res Unit, Oxford, England
[6] Oxford Univ Hosp NHS Trust, Oxford, England
[7] Univ Hosp Leicester NHS Trust, Leicester, Leics, England
[8] Taunton & Somerset NHS Fdn Trust, Taunton, Somerset, England
[9] North Bristol NHS Trust, Bristol, Avon, England
[10] Cardiff & Vale Univ Hlth Board, Cardiff, S Glam, Wales
[11] Shrewsbury & Telford Hosp NHS Trust, Shrewsbury, Salop, England
[12] Barts Hlth NHS Trust, London, England
[13] Univ Hosp Coventry & Warwickshire NHS Trust, Coventry, W Midlands, England
[14] Warrington & Halton Hosp NHS Fdn Trust, Warrington, Cheshire, England
[15] Basildon & Thurrock Univ Hosp NHS Fdn Trust, Basildon, England
[16] Royal Liverpool & Broadgreen Univ Hosp NHS Trust, Liverpool, Merseyside, England
[17] Peterborough & Stamford Hosp NHS Fdn Trust, Peterborough, Cambs, England
[18] Abertawe Bro Morgannwg Univ Hlth Board, Port Talbot, Wales
[19] Univ Hosp Aintree NHS Fdn Trust, Liverpool, Merseyside, England
[20] Univ Hosp South Manchester NHS Fdn Trust, Manchester, Lancs, England
[21] Sheffield Teaching Hosp NHS Fdn Trust, Sheffield, S Yorkshire, England
[22] Royal Devon & Exeter NHS Fdn Trust, Exeter, Devon, England
[23] Mid Cheshire Hosp NHS Fdn Trust, Crewe, Cheshire, England
[24] Royal Surrey Cty Hosp NHS Fdn Trust, Guildford, Surrey, England
来源
BMJ-BRITISH MEDICAL JOURNAL | 2019年 / 367卷
基金
美国国家卫生研究院; 英国医学研究理事会;
关键词
GROWTH-FACTOR; EPIDEMIOLOGY; METAANALYSIS; MANAGEMENT; SCALE;
D O I
10.1136/bmj.l6132
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
OBJECTIVE To determine whether an injection of platelet rich plasma improves outcomes after acute Achilles tendon rupture. DESIGN Randomised, placebo controlled, two arm, parallel group, participant and assessor masked, superiority trial. SETTING Secondary care trauma units across 19 hospitals in the United Kingdom's health service. PARTICIPANTS Recruitment commenced in July 2015 and follow-up was completed in March 2018. 230 adults aged 18 years and over were included, with acute Achilles tendon rupture presenting within 12 days of injury and managed with non-surgical treatment. Exclusions were injury at the insertion or musculotendinous junction, major leg injury or deformity, diabetes mellitus, platelet or haematological disorder, systemic corticosteroids, anticoagulation treatment, and other contraindicating conditions. INTERVENTIONS Participants were randomised 1:1 to platelet rich plasma (n=114) or placebo (dry needle; n=116) injection. All participants received standard rehabilitation care (ankle immobilisation followed by physiotherapy). MAIN OUTCOMES AND MEASURES Primary outcome was muscle tendon function at 24 weeks, measured objectively with the limb symmetry index (injured/uninjuredx100) in maximal work done during the heel rise endurance test (an instrumented measure of repeated single leg heel rises until fatigue). Secondary outcomes included patient reported function (Achilles tendon rupture score), quality of life (short form 12 version 2 (R)), pain (visual analogue scale), goal attainment (patient specific functional scale), and adverse events. A central laboratory analysed the quality and content of platelet rich plasma. Analyses were by modified intention to treat. RESULTS Participants were 46 years old on average, and 57 (25%) of 230 were female. At 24 weeks, 202 (88%) participants completed the heel rise endurance test and 216 (94%) the patient reported outcomes. The platelet rich plasma was of good quality, with expected growth factor content. No difference was detected in muscle tendon function between participants receiving platelet rich plasma injections and those receiving placebo injections (limb symmetry index, mean 34.7% (standard deviation 17.7%) v 38.5% (22.8%); adjusted mean difference -3.9% (95% confidence interval -10.5% to 2.7%)) or in any secondary outcomes or adverse event rates. Complier average causal effect analyses gave similar findings. CONCLUSIONS There is no evidence to indicate that injections of platelet rich plasma can improve objective muscle tendon function, patient reported function, or quality of life after acute Achilles tendon rupture compared with placebo, or that they offer any patient benefit.
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页数:11
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