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 aged 18 and over 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 2020
Who is funding the study?
1. NIHR/MRC Efficacy and Mechanism Evaluation Programme (UK)
2. Kadoorie Centre Trauma Research Charitable Fund (UK)
Who is the main contact?
Dr Susan Wagland, path-2.study@ndorms.ox.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Susan Wagland
ORCID ID
Contact details
Oxford Trauma Research group
Critical Care
Trauma and Rehabilitation (CCTR) Trials Group
Nuffield Department of Orthopaedics
Rheumatology and Musculoskeletal Sciences
University of Oxford
Oxford
OX3 7LD
United Kingdom
+44 (0)1865 223123
susan.wagland@ndorms.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT02302664
Protocol/serial number
17850
Study information
Scientific title
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.
Acronym
PATH2
Study hypothesis
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?
Ethics approval
NRES Committee South Central - Oxford A, 11/11/2014, ref: 14/SC/1333
Study design
Randomised; Interventional
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Injuries and emergencies, Musculoskeletal disorders; Subtopic: Injuries and Emergencies (all Subtopics), Musculoskeletal (all Subtopics); Disease: Injuries and Emergencies, Musculoskeletal
Intervention
1. Imitation injection (placebo): needle insertion into tendon rupture gap
2. Platelet Rich Plasma injection: Platelet Rich Plasma injected into Achilles tendon rupture gap
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Current primary outcome measure as of 24/09/2019:
Muscle-tendon function, measured objectively with the limb symmetry index (LSI) in maximal work during the heel-rise endurance test (HRET) at 24 weeks post-treatment
Previous primary outcome measure:
Heel-raise Endurance Test; Timepoint(s): 24 weeks post treatment
Secondary outcome measures
Current secondary outcome measures as of 24/09/2019:
1. Number of heel rise repetitions and maximum heel rise height (cm) during the Heel-rise Endurance Test at 24 weeks
2. Achilles Tendon Rupture Score at 4, 7, 13 and 24 weeks and 24 months
3. Patient Specific Function Scale at 4, 7, 13 and 24 weeks and 24 months
4. Health-related quality of life assessed using the SF-12 (Acute version) at 4, 7, 13 and 24 weeks and 24 months
5. Pain diary assessed using a Visual Analogue Score daily during the first 2 weeks following treatment
Previous secondary outcome measures:
1. Achilles Tendon Rupture Score; Timepoint(s): 4, 7, 13 and 24 weeks and 24 months
2. Patient Specific Function Scale; Timepoint(s): 4, 7, 13 and 24 weeks and 24 months
3. SF-12 (Acute version); Timepoint(s): 4, 7, 13 and 24 weeks and 24 months
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
01/04/2015
Overall trial end date
30/11/2020
Reason abandoned (if study stopped)
Eligibility
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 years and over
2. Diagnosed with acute Achilles tendon rupture
3. Presenting within and receiving study treatment within 12 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
7. Patient must be Ambulatory prior to injury without the use of walking aids or assistance of another person (added 16/03/2017)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 230; UK Sample Size: 230; 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
11. Achilles tendon injuries at the insertion to the calcaneum or at the musculotendinous junction (added 16/030/2017)
Recruitment start date
20/07/2015
Recruitment end date
18/09/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
John Radcliffe Hospital
Oxford Centre
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Funder name
Kadoorie Centre Trauma Research Charitable Fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Internal MRC/NIHR EME report – June 2021
Publish in peer review journal – April 2021
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
30/06/2021
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29150470
2018 statistical analysis plan in: https://www.ncbi.nlm.nih.gov/pubmed/30157940