Platelet rich plasma in Accelerated Tendo-achilles Healing
| ISRCTN | ISRCTN93608625 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93608625 |
| Protocol serial number | PATH v2.0 |
| Sponsor | University of Oxford (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) - Oxford Biomedical Research Centre (OxBRC) |
- 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
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 |
|---|---|
| josephalsousou@doctors.org.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Parallel double arm double blinded individually randomised controlled efficacy trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Platelet rich plasma |
| Primary outcome measure(s) |
Achilles tendon Total Rupture Score (ATRS), measured at 1, 3, 6, 8, 12 weeks |
| Key secondary outcome measure(s) |
1. Functional ultrasound elastography scan, measured at 3 and 6 months |
| Completion date | 01/11/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Nuffield Department of Orthopaedic Rheumatology and Musculoskeletal Science
Oxford
OX3 9DU
United Kingdom
OX3 9DU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
