Platelet-rich plasma in Achilles tendon healing 2 (PATH-2) trial: statistical analysis plan for a multicentre, double-blinded, parallel-group, placebo-controlled randomised clinical trial

Trials
Michael Maia SchlüsselPATH-2 Trial Study Group

Abstract

There has been a recent steep growth in platelet-rich plasma (PRP) use for musculoskeletal conditions, but findings from high quality clinical trial data are lacking in the literature. Here, we describe the statistical analysis plan (SAP) for the Platelet-rich plasma in Achilles Tendon Healing 2 (PATH-2) trial. PATH-2 is a pragmatic, parallel-group, multi-centre, double-blinded, randomised, placebo-controlled, superiority trial. The study aims to evaluate the clinical efficacy of PRP in acute Achilles tendon rupture in terms of muscle-tendon function. Patients are identified in the orthopaedic/trauma outpatient clinic. The primary outcome is muscle-tendon work capacity from the Heel Rise Endurance Test result, expressed as the Limb Symmetry Index (work, in joules), at 24 weeks post randomisation. Multivariate linear regression adjusting for the stratification factors (centre and age) and additional prognostic factors will be used to investigate the adjusted effect of the intervention. The analysis will be by modified intention-to-treat. Sensitivity analysis will assess the internal validity of the trial results by performing a per-protocol analysis. Safety will be summarised by treatment arm for all patients who started treatme...Continue Reading

Associated Clinical Trials

References

Mar 17, 2004·Controlled Clinical Trials·Heejung BangClarence E Davis
Dec 13, 2006·The American Journal of Sports Medicine·Katarina Nilsson-HelanderJon Karlsson
Feb 20, 2008·Annals of Internal Medicine·Isabelle BoutronUNKNOWN CONSORT Group
Nov 13, 2008·BMJ : British Medical Journal·Merrick ZwarensteinUNKNOWN Pragmatic Trials in Healthcare (Practihc) group
Mar 25, 2010·BMJ : British Medical Journal·Kenneth F SchulzUNKNOWN CONSORT Group
Jan 13, 2011·Statistics in Medicine·Ian R WhiteAngela M Wood
Oct 28, 2011·The Journal of Orthopaedic and Sports Physical Therapy·Katyana Kowalchuk HornJ Haxby Abbott
Jan 14, 2012·The Journal of Bone and Joint Surgery. American Volume·Ujash ShethMohit Bhandari

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Citations

Nov 22, 2019·BMJ : British Medical Journal·David J KeeneUNKNOWN PATH-2 trial group

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Methods Mentioned

BETA
HRET
biopsy

Software Mentioned

SPLUS
OpenClinica
SAS
MuscleLab
SAP
R
CONSORT
STATA
Ergotest

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