Plain English Summary
Background and study aims
Achilles tendon rupture (ATR) is when a person tears the tendon (the Achilles tendon) connecting the calf muscle and heal bone. It is the most common tendon injury and lead to months of incapacity. With an average work absence of 63-108 days there are significant costs to society and to the NHS. Platelet rich plasma (PRP) may improve recovery and return to normal activities earlier, and reduce the NHS and societal impact. This study investigates how good PRP is at treating ATR using disease-specific and patient important outcomes.
Who can participate?
Patients between the ages 18-70 years who are suitable for non-surgical treatment of the Achilles tendon rupture (ATR).
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are given a PRP injection. Those in group 2 are given an injection containing a placebo. Participants complete a pain diary and have four study assessments at 4,7,13 and 24 weeks, carried out by a member of the research team blind to allocation. Assessments take place over the telephone or during a hospital outpatient visit. The 24 week hospital visit includes an exercise test of ankle function. All assessments include collection of patient-reported responses to preset questions.The results may be applicable to the many other tendon and ligaments injuries.
What are the possible benefits and risks of participating?
Patients may benefit by taking part in the research as may be allocated to receive platelet rich plasma (PRP) into the Achilles tendon gap. This may increase healing. The intervention offered is an injection of the participants own platelet rich plasma and there are no known risk over receiving any injection
Where is the study run from?
John Radcliffe Hospital (UK)
When is the study starting and how long is it expected to run for?
April 2015 to November 2016
Who is funding the study?
NIHR/MRC Efficacy and Mechanism Evaluation Programme (UK)
Who is the main contact?
Ms Emma Roberts
A pragmatic multicentre, 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.
Does the strong PRP effect identified in basic science studies and pilot studies translate to improved tendon recovery in patients with Achilles tendon rupture when compared with control?
NRES Committee South Central - Oxford A, 11/11/2014, ref: 14/SC/1333
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Topic: Injuries and emergencies, Musculoskeletal disorders; Subtopic: Injuries and Emergencies (all Subtopics), Musculoskeletal (all Subtopics); Disease: Injuries and Emergencies, Musculoskeletal
1. Imitation Injection (Placebo): Needle insertion into tendon rupture gap
2. Platelet Rich Plasma Injection: Platelet Rich Plasma injected into Achilles tendon rupture gap
Primary outcome measures
Heel-raise Endurance Test; Timepoint(s): 24 weeks post treatment
Secondary outcome measures
1. Achilles Tendon Rupture Score; Timepoint(s): 4, 7, 13 and 24 weeks
2. Patient Specific Function Scale; Timepoint(s): 4, 7, 13 and 24 weeks
3. SF-12 (Acute version); Timepoint(s): 4, 7, 13 and 24 weeks
4. Visual Analogue Score; Timepoint(s): First 2 weeks following treatment, daily
5. Pain diary: Timepoint(s): 0-2 weeks self completion at home by patient
Overall trial start date
Overall trial end date
Participant inclusion criteria
All patients with acute Achilles tendon rupture attending outpatient trauma/orthopaedic clinic within 7 days of sustaining the injury will be eligible for inclusion in the trial. Patient is willing and able to give informed consent for participation in the study
1. Aged 18 – 70 years
2. Diagnosed with acute Achilles tendon rupture
3. Presenting within and receiving study treatment within 7 days post injury
4. Patients in whom the decision has been made for nonoperative treatment
5. Able (in the Investigators opinion) and willing to comply with all study requirements
6. Able to attend a PATH2 study hospital site for the 24 week follow-up
Target number of participants
Planned Sample Size: 214; UK Sample Size: 214; Description: 20% loss to follow up incorporated in Sample size
Participant exclusion criteria
The patient may not enter the study if ANY of the following apply:
1. Previous major tendon or ankle injury or deformity to either lower leg
2. History of diabetes mellitus
3. Known platelet abnormality or haematological disorder
4. Current use of systemic cortisone or an anticoagulant
5. Evidence of lower limb gangrene/ulcers or peripheral vascular disease
6. History of hepatic or renal impairment or dialysis
7. Female patients who are pregnant or breast feeding
8. Is currently receiving or has received radiation or chemotherapy within the last 3 months
9. Has inadequate venous access for drawing blood
10. Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the patients ability to participate in the study
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
John Radcliffe Hospital
Oxford Centre Headley Way Headington
National Institute for Health Research
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Internal MRC/NIHR EME report – Sept 2017
Publish in peer review journal – Oct 2017
A summary of the trial outcome will be disseminated to trial participants on relevant websites, and by email, where an email address is provided.
In addition to the NIHR monograph report, the results will be published in peer-reviewed medical literature, and may be presented at relevant national and international conferences. The work may also contribute to any refresh of NICE guidance.
Intention to publish date
Participant level data
Not expected to be available
Results - basic reporting