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A pragmatic multi-centre, blinded, randomised placebo-controlled trial comparing Platelet Rich Plasma injection (PRP) to placebo (imitation) injection in adults with Achilles tendon rupture. Two sub-studies are embedded within the main study to contribute to the understanding of the PRP mechanism in tendon healing.

The PATH-2 Study is a pragmatic multi-centre, blinded, randomised placebo-controlled trial comparing Platelet Rich Plasma injection (PRP) to placebo (imitation) injection in adults with Achilles tendon rupture (ATR).  Two sub-studies are embedded within the main study to contribute to the understanding of the PRP mechanism in tendon healing.

The study has been designed to evaluate the clinical efficacy of PRP in acute ATR in terms of mechanical muscle-tendon function.

214 patients will be recruited to be randomly allocated to receive either:

PRP injection into the ATR gap

or

An imitation (placebo) injection

A cast, splint or boot is the current standard treatment.

The patient will receive the study/placebo treatment and will then participate in telephone follow-ups at weeks 4, 7 and 13 and attend for a 24 week follow-up in clinic, arranged by the recruiting site.

The primary outcome is a Heel-rise Endurance Test at the 24 week follow-up appointment in clinic.

Patients will be identified in the outpatient trauma/orthopaedic clinic in a minimum of 15 hospitals across the UK. Recruitment will start in spring 2015 and will recruit for 20 months (or until recruitment target is met). It is anticipated that each site will recruit a minimum of 1 patient per month.

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