This is a plain-English translation of the academic paper above, prepared for patients, referring clinicians, and other non-specialist readers. It preserves the structure of the original paper while removing technical jargon. For the full clinical paper, follow the PubMed or DOI links.
Background
The pre-agreed statistical plan for the PATH-2 trial — a multi-centre, double-blinded, randomised study testing whether platelet-rich plasma (PRP) injections help acute Achilles tendon ruptures heal better than placebo.
Rationale
PRP has become widely used for tendon and muscle injuries, but it has been adopted faster than the high-quality trial evidence to support it. Publishing a statistical analysis plan before the results are known is good scientific practice: it locks in how the data will be analysed, so the team cannot be accused of choosing the analysis after seeing the answer they want.
Results
The plan describes how the main outcome — calf-muscle work measured by a heel-rise endurance test at 24 weeks — will be compared between the PRP and placebo groups. It defines secondary patient-reported outcomes, how missing data will be handled, and how safety will be reported. Crucially, this paper does not report any results: it is published before the data are unblinded.
Implications
Patients can have more confidence in trial findings when the analysis was pre-specified. The PATH-2 trial itself, when reported, will give a clearer answer on whether PRP genuinely helps Achilles ruptures recover — an answer that has been overdue for the orthopaedic community.
Source: Schlüssel MM, Keene DJ, Wagland S, Alsousou J, Lamb SE, Willett K, et al.. 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 2018;19(1):464. doi:10.1186/s13063-018-2840-z
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