Contact information
Type
Scientific
Primary contact
Mr Joseph Alsousou
ORCID ID
Contact details
Nuffield Department of Orthopaedic Rheumatology and Musculoskeletal Science
University of Oxford
Kadoorie Trauma Research Unit
The John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 851021
josephalsousou@doctors.org.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PATH v2.0
Study information
Scientific title
PATH: a prospective, randomised, controlled trial to investigate the clinical efficacy of platelet rich plasma in accelerating acute achilles tendon rupture healing and comparing it to traditional cast immobilisation treatment or operative treatment
Acronym
PATH
Study hypothesis
Null hypothesis: Platelet rich plasma or concentrates do not accelerate the rate of acute achilles tendon rupture healing and do not reduce the risk of re-rupture following non-operative or operative treatment.
Ethics approval
Oxfordshire Ethics Committee B approved on the 21st July 2009 (ref: 09/H0605/78)
Study design
Parallel double arm double blinded individually randomised controlled efficacy trial
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 below to request a patient information sheet
Condition
Acute achilles tendon rupture
Intervention
Patients will follow a conservative or operative pathway according to the established protocol, which is determined depending on the tendo-achilles (TA) rupture gap size measured by ultrasound scan (USS). Patients in each arm of the trial will be randomised into one of two groups using sequentially numbered opaque envelopes or computer generated randomisation:
Conservative treatment arm (rupture gap less than 5 mm):
1. Standard cast immobilisation group
2. Platelet rich plasma (PRP) and standard cast immobilisation group
Operative treatment arm (rupture gap greater than 5 mm):
3. Standard surgical repair group
4. Platelet rich plasma (PRP) and standard surgical repair group
PRP is applied once only and total follow-up time is 1 year. Patients in all groups will be asked to complete Achilles Tendon Rupture Score (ATRS) questionnaire and other outcome measures questionnaire in the follow up outpatient clinic. The change in the ATRS is the clinical outcome measures. In addition, Functional UltraSound Elastography Scan will be performed to determine the stiffness of the healing tendon in all groups at each visit. Objective assessment of the range of motion (ROM), maximum tip toeing and muscle strength will be measured at 3 and 6 months.
Intervention type
Drug
Phase
Not Applicable
Drug names
Platelet rich plasma
Primary outcome measure
Achilles tendon Total Rupture Score (ATRS), measured at 1, 3, 6, 8, 12 weeks
Secondary outcome measures
1. Functional ultrasound elastography scan, measured at 3 and 6 months
2. Foot and Ankle Outcome Score (FAOS), measured at 1, 3, 6, 8, 12 weeks
3. Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A), measured at 1, 3, 6, 8, 12 weeks
4. Range of movement, measured at 3 and 6 months
5. Maximum tip-toeing, measured at 3 and 6 months
6. 36-item short form health survey (SF-36), measured at 3 and 6 months
7. Re-rupture rate, measured at 3 and 6 months
Overall trial start date
01/11/2009
Overall trial end date
01/11/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Participant is willing and able to give informed consent for participation in the study
2. Male or female, aged 18 - 55 years
3. Diagnosed with acute achilles tendon rupture
4. Presenting within 72 hours post-injury, due to sport activity or low energy hyper-dorsal flexion of the foot
5. Able (in the Investigators opinion) and willing to comply with all study requirements
6. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
360
Participant exclusion criteria
1. Previous tendon injury
2. History of diabetes mellitus (DM)
3. Platelet abnormality or platelets count less than 100 x 10^9 /l
4. Haematological disorder
5. Serum haemoglobin less than 11 g/dl
6. Use of systemic cortisone
7. Use of any anticoagulant
8. Evidence of gangrene/ulcers or peripheral vascular disease
9. History of hepatic or renal impairment or dialysis
10. Patient is known to have a psychological, developmental, physical, emotional or social disorder that may interfere with compliance with study requirements
11. History of alcohol or drug abuse
12. Patient has a religious or cultural conflict with the use of platelet gel treatment or blood products
13. Patient has inadequate venous access for blood draw
14. Patient is currently receiving or has received radiation or chemotherapy within the last 3 months prior to the study
15. Patient has evidence of Charcot foot/ankle joint
16. Female participants who are pregnant, lactating or planning pregnancy during the course of the study
17. 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 participant's ability to participate in the study
Recruitment start date
01/11/2009
Recruitment end date
01/11/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Nuffield Department of Orthopaedic Rheumatology and Musculoskeletal Science
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
Clinical Trials and Research Governance (CRTG) Office
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 743005
heather.house@admin.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Oxford Biomedical Research Centre (OxBRC)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 literature review performed as part of the study at http://www.ncbi.nlm.nih.gov/pubmed/19651823
Publication citations
-
Literature review performed as part of the study at
Alsousou J, Thompson M, Hulley P, Noble A, Willett K, The biology of platelet-rich plasma and its application in trauma and orthopaedic surgery: a review of the literature., J Bone Joint Surg Br, 2009, 91, 8, 987-996, doi: 10.1302/0301-620X.91B8.22546.