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Table 1 Study objectives and endpoints

From: 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

Objectives Endpoints
Primary: • Evaluate the clinical efficacy of platelet-rich plasma (PRP) in acute Achilles tendon rupture (ATR) recovery in terms of muscle-tendon function At 24 weeks post treatment: • Limb Symmetry Index of work capacity during heel-rise endurance test (HRET); maximum heel-rise height and repetitions during HRET will be reported as secondary outcomes
Secondary: • Evaluate the clinical efficacy of PRP in acute ATR in terms of participant-reported functional recovery, pain and quality of life During the first 2 weeks post treatment: • Visual analogue scale pain daily diary [15] At 4, 7, 13 and 24 weeks post treatment: • Achilles Tendon Rupture Score [16] • Patient-Specific Functional Scale [17, 18] • SF-12 (acute) [19]
Exploratory (sub-studies): • Determine the key components of PRP that contribute to its mechanism of action • Further understand, in an immunohistochemical sub-study, the mechanisms of PRP that may account for its clinical efficacy • Identify the histological pathways that PRP may alter to exert its effects; using these results and those from the PRP biological component sub-study, inform future targeted manipulation of PRP properties to maximise its efficacy in tendon healing At baseline (sub-study 1) • Blood sample for PRP component analysis (cell count, relevant tendon active growth factors, concentrations and platelet activation); all PRP group participants • Whole blood analysis for cell count and concentrations; all participants. At 6 weeks post treatment (sub-study 2): • A needle biopsy of the healing Achilles tendon under ultrasound guidance during an outpatient visit for immunohistochemistry analysis (n = 16)