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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.

230 patients were 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 participant received the study treatment or placebo treatment and then participated 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. In a 2-year follow-up, the participant will complete a questionnaire either by post or by telephone.

 

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

Patients were identified in the outpatient trauma/orthopaedic clinic in 18 hospitals across the UK. Recruitment began in July 2015 and finished when the target was reached in September 2017. The study is now in follow-up.

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