Status:
COMPLETED
PATH-2: Platelet Rich Plasma in Achilles Tendon Healing
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Conditions:
Achilles Tendon Rupture
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Platelet Rich Plasma in Achilles Tendon Healing Does using a Platelet Rich Plasma (PRP) injection immediately before standard casting benefit patients aged 18 or over who are suitable for nonsurgical...
Detailed Description
PURPOSE The aim of this study is to evaluate the effectiveness of treating ruptured Achilles tendon with autologous platelet rich plasma. The investigators plan to compare the outcome of traditional m...
Eligibility Criteria
Inclusion
- Patient is willing and able to give informed consent for participation in the study
- Aged 18 years or over
- Ambulatory prior to injury without the use of walking aids or assistance of another person
- Diagnosed with an acute, complete, Achilles tendon rupture
- Presenting within and receiving study treatment within 12 days post injury
- Patients in whom the decision has been made for non-operative treatment
- Able (in the Investigator's opinion) and willing to comply with all study requirements
- Able to attend a PATH-2 study hospital site for the 24-week follow-up.
Exclusion
- The patient may not enter the study if any of the following apply:
- Achilles tendon injuries at the insertion to the calcaneum or at the musculotendinous junction
- Previous major tendon or ankle injury or deformity to either lower leg
- History of diabetes mellitus
- Known platelet abnormality or haematological disorder
- Current use of systemic cortisone or a treatment dose of an anticoagulant (i.e. a prophylactic dose for preventing thrombosis would not be an exclusion)
- Evidence of lower limb gangrene/ulcers or peripheral vascular disease
- History of hepatic or renal impairment or dialysis
- Female patients who are pregnant or breast feeding
- Is currently receiving or has received radiation or chemotherapy within the last 3 months
- Has inadequate venous access for drawing blood
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the patient's ability to participate in the study.
Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2018
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT02302664
Start Date
July 1 2015
End Date
March 8 2018
Last Update
May 5 2021
Active Locations (18)
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1
John Radcliffe Hospital, Oxford
Oxford, Oxfordshire, United Kingdom, OX3 9DU
2
Basildon University Hospital
Basildon, United Kingdom, SS16 5NL
3
Southmead Hospital
Bristol, United Kingdom, BS10 5NB
4
University Hospital of Wales
Cardiff, United Kingdom, CF14 4XW