Condition category
Injury, Occupational Diseases, Poisoning
Date applied
10/11/2009
Date assigned
18/01/2010
Last edited
18/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.ox.ac.uk/

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

Results - basic reporting

Publication summary

2009 literature review performed as part of the study at http://www.ncbi.nlm.nih.gov/pubmed/19651823

Publication citations

  1. 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.

Additional files

Editorial Notes