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30 July 2010
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| [ Print-friendly version ] |
| Platelet rich plasma in Accelerated Tendo-achilles Healing |
| ISRCTN | ISRCTN93608625 |
| ClinicalTrials.gov identifier | |
| Public title | Platelet rich plasma in Accelerated Tendo-achilles Healing |
| 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 |
| Serial number at source | PATH v2.0 |
| 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 |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Acute achilles tendon rupture |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/11/2009 |
| Anticipated end date | 01/11/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 360 |
| Interventions |
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. |
| Primary outcome measure(s) | Achilles tendon Total Rupture Score (ATRS), measured at 1, 3, 6, 8, 12 weeks |
| Secondary outcome measure(s) |
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 |
| Sources of funding | National Institute for Health Research (NIHR) (UK) - Oxford Biomedical Research Centre (OxBRC) |
| Trial website | |
| Publications | 2009 literature review performed as part of the study at http://www.ncbi.nlm.nih.gov/pubmed/19651823 |
| Contact name | Mr Joseph Alsousou |
| Address |
Nuffield Department of Orthopaedic Rheumatology and Musculoskeletal Science
University of Oxford Kadoorie Trauma Research Unit The John Radcliffe Hospital Headley Way Headington |
| City/town | Oxford |
| Zip/Postcode | OX3 9DU |
| Country | United Kingdom |
| Tel | +44 (0)1865 851021 |
| Fax | +44 (0)1865 857611 |
| josephalsousou@doctors.org.uk | |
| Sponsor | University of Oxford (UK) |
| Address |
Clinical Trials and Research Governance (CRTG) Office
John Radcliffe Hospital |
| City/town | Oxford |
| Zip/Postcode | OX3 9DU |
| Country | United Kingdom |
| Tel | +44 (0)1865 743005 |
| heather.house@admin.ox.ac.uk | |
| Sponsor website: | http://www.ox.ac.uk/ |
| Date applied | 10/11/2009 |
| Last edited | 18/01/2010 |
| Date ISRCTN assigned | 18/01/2010 |
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| © 2010 ISRCTN unless otherwise stated. | |
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