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01.12.2018 | Update | Ausgabe 1/2018 Open Access

Trials 1/2018

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

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Michael M. Schlüssel, David J. Keene, Susan Wagland, Joseph Alsousou, Sarah E. Lamb, Keith Willett, Susan J. Dutton, on behalf of the PATH-2 Trial Study Group
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s13063-018-2840-z) contains supplementary material, which is available to authorized users.

Abstract

Background

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.

Methods

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 treatment. Secondary patient-reported outcome measures will be analysed using linear mixed effects models to allow all data collected at all follow-up points to be considered. Missing data will be summarised and reported by treatment arm. Missing data imputation will be performed, if appropriate.

Discussion

The PATH-2 trial will be reported in accordance with the CONSORT statement. This SAP publication will avoid bias arising from prior knowledge of the study results. Any changes or deviations from the current SAP will be described and justified in the final report.

Trial registration

ISRCTN registry: ISRCTN54992179, assigned 12 January 2015. ClinicalTrials.gov: NCT02302664, received 18 November 2014. UK Clinical Research Network Study Portfolio Database: ID 17850.
Zusatzmaterial
Additional file 1: Table S1. Baseline characteristics of participants according to intervention groups. Table S2. Stratification factors and sociodemographic characteristics of participants according to intervention groups. Table S3. Baseline patient reported outcomes by intervention groups. Table S4. Academic/employment-related characteristics of participants according to intervention groups. Table S5. Physical activity of participants before injury according to intervention groups. Table S6. Injury-related characteristics of participants by intervention groups. Table S7. Clinical characteristics of participants by intervention groups. Table S8. Medications that may influence platelet function taken by participants by intervention groups. Table S9. Complications reported by participants during the 24 weeks after injury and treatment. (PDF 1944 kb)
13063_2018_2840_MOESM1_ESM.pdf
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