Platelet rich plasma in Accelerated Tendo-achilles Healing

ISRCTN	ISRCTN93608625
DOI	https://doi.org/10.1186/ISRCTN93608625
Secondary identifying numbers	PATH v2.0

Submission date: 10/11/2009
Registration date: 18/01/2010
Last edited: 18/01/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Joseph Alsousou
Scientific

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

Phone	+44 (0)1865 851021
Email	josephalsousou@doctors.org.uk

Study information

Study design	Parallel double arm double blinded individually randomised controlled efficacy trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	PATH
Study objectives	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(s)	Oxfordshire Ethics Committee B approved on the 21st July 2009 (ref: 09/H0605/78)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	01/11/2009
Completion date	01/11/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	360
Key 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
Key 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
Date of first enrolment	01/11/2009
Date of final enrolment	01/11/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Nuffield Department of Orthopaedic Rheumatology and Musculoskeletal Science

Oxford
OX3 9DU
United Kingdom

Sponsor information

University of Oxford (UK)
University/education

Clinical Trials and Research Governance (CRTG) Office
John Radcliffe Hospital
Oxford
OX3 9DU
England
United Kingdom

Phone	+44 (0)1865 743005
Email	heather.house@admin.ox.ac.uk
Website	http://www.ox.ac.uk/
"ROR"	https://ror.org/052gg0110

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Oxford Biomedical Research Centre (OxBRC)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other publications	literature review performed as part of the study at	01/08/2009		Yes	No