PATH2: Platelet rich plasma in Achilles tendon healing
| ISRCTN | ISRCTN54992179 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54992179 |
| IRAS number | 146684 |
| ClinicalTrials.gov number | NCT02302664 |
| Secondary identifying numbers | 17850, IRAS 146684 |
- Submission date
- 08/01/2015
- Registration date
- 12/01/2015
- Last edited
- 11/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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?
Oxford Trauma and Emergency Care research group, oxfordtrauma@ndorms.ox.ac.uk
Contact information
Scientific
Critical Care, Trauma and Rehabilitation (CCTR) Trials Group
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences
University of Oxford
Oxford
OX3 7LD
United Kingdom
| Phone | +44 (0)1865 223115 |
|---|---|
| oxfordtrauma@ndorms.ox.ac.uk |
Study information
| Study design | Randomized; Interventional |
|---|---|
| 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 to request a patient information sheet |
| 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. |
| Study acronym | PATH2 |
| Study objectives | 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(s) | NRES Committee South Central - Oxford A, 11/11/2014, ref: 14/SC/1333 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/04/2015 |
| Completion date | 21/11/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 230; UK Sample Size: 230; Description: 20% loss to follow up incorporated in Sample size |
| Total final enrolment | 230 |
| Key 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) |
| Key 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) |
| Date of first enrolment | 20/07/2015 |
| Date of final enrolment | 18/09/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Sponsor information
University/education
Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
England
United Kingdom
"ROR" |
https://ror.org/052gg0110 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 30/06/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Current publication and dissemination plan as of 16/06/2022: MRC/NIHR EME report – December 2019 Published in peer review journal – November 2019 A summary of the trial outcome was disseminated to trial participants on relevant websites, and by email, where an email address was provided. In addition to the NIHR monograph report, the results were published in peer-reviewed medical literature, and were presented at relevant national and international conferences. The work may also contribute to any refresh of NICE guidance. Results of an extended 2-year follow-up will be published by December 2022. Previous publication and dissemination plan from 11/12/2020 to 16/06/2022: MRC/NIHR EME report – December 2019 Published in peer review journal – November 2019 A summary of the trial outcome was disseminated to trial participants on relevant websites, and by email, where an email address was provided. In addition to the NIHR monograph report, the results were published in peer-reviewed medical literature, and were presented at relevant national and international conferences. The work may also contribute to any refresh of NICE guidance. Results of an extended 2-year follow-up will be published by June 2021 Original 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. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 16/11/2017 | Yes | No | |
| Statistical Analysis Plan | statistical analysis plan | 29/08/2018 | No | No | |
| Results article | results | 20/11/2019 | 09/12/2020 | Yes | No |
| Results article | funder report | 01/11/2020 | 11/12/2020 | Yes | No |
| Results article | results of substudy analysis | 26/11/2020 | 11/12/2020 | Yes | No |
| Plain English results | 14/06/2022 | 14/06/2022 | No | Yes | |
| Results article | 20/11/2019 | 14/06/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 2-year follow-up | 01/11/2022 | 11/06/2025 | Yes | No |
Additional files
Editorial Notes
11/06/2025: Publication reference added.
07/11/2023: Contact details updated. IRAS number added.
16/06/2022: The publication and dissemination plan was updated.
14/06/2022: Publication reference added. Results in plain English uploaded as an additional file.
11/12/2020: The following changes were made to the trial record:
1. Publication references added.
2. The publication and dissemination plan was changed.
09/12/2020: Publication reference added.
04/11/2020: The following changes were made to the trial record:
1. The overall end date was changed from 30/11/2020 to 21/11/2019.
2. The total final enrolment was added.
3. The trial website was added.
24/09/2019: The following changes have been made:
1. The description of the primary outcome measure has been expanded to clarify and ensure consistency with the protocol.
2. The secondary outcome measures descriptions have been amended to add clarity and to ensure the list is comprehensive and consistent with the protocol.
3. The scientific contact has been changed.
31/08/2018: Publication reference added.
20/11/2017: Publication reference added.
19/09/2017: Recruitment end date has been updated from 30/09/2017 to 18/09/2017.
08/09/2017: The recruitment end date has been updated from 31/07/2017 to 30/09/2017. The target number of participants has been updated from 214 to 230.
20/03/2017: The overall trial end date has been updated from 30/05/2018 to 30/11/2020. In addition, Kadoorie Centre Trauma Research Charitable Fund has been added as a funder, as they are funding the extended follow up for this study.
20/03/2017: The overall trial end date has been updated from 30/11/2016 to 30/05/2018
16/03/2017: The following changed have been made to the record:
1. In the inclusion criteria, the upper age limit of 70 has been removed, the time from injury has been extended from 7 to 12 days and a further inclusion criteria has been added
2. A further exclusion criteria has been added
3. The recruitment dates have been updated from 01/04/2015 - 30/11/2016 to 20/07/2015 - 31/07/2017
18/12/2015: The sponsor details for this study was changed from the Department of of Psychiatry (Oxford) to Clinical Trials and Research Governance (John Radcliffe Hospital)
