Condition category
Musculoskeletal Diseases
Date applied
08/01/2015
Date assigned
12/01/2015
Last edited
04/01/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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 between the ages 18-70 years 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 2016

Who is funding the study?
NIHR/MRC Efficacy and Mechanism Evaluation Programme (UK)

Who is the main contact?
Ms Emma Roberts

Trial website

Contact information

Type

Scientific

Primary contact

Dr Scott Parsons

ORCID ID

Contact details

John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT02302664

Protocol/serial number

17850

Study information

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.

Acronym

PATH2

Study hypothesis

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

NRES Committee South Central - Oxford A, 11/11/2014, ref: 14/SC/1333

Study design

Randomised; Interventional

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

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

Phase

Drug names

Primary outcome measures

Heel-raise Endurance Test; Timepoint(s): 24 weeks post treatment

Secondary outcome measures

1. Achilles Tendon Rupture Score; Timepoint(s): 4, 7, 13 and 24 weeks
2. Patient Specific Function Scale; Timepoint(s): 4, 7, 13 and 24 weeks
3. SF-12 (Acute version); Timepoint(s): 4, 7, 13 and 24 weeks
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 trial start date

01/04/2015

Overall trial end date

30/11/2016

Reason abandoned

Eligibility

Participant 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 – 70 years
2. Diagnosed with acute Achilles tendon rupture
3. Presenting within and receiving study treatment within 7 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 214; UK Sample Size: 214; Description: 20% loss to follow up incorporated in Sample size

Participant 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

Recruitment start date

01/04/2015

Recruitment end date

30/11/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

John Radcliffe Hospital
Oxford Centre Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Internal MRC/NIHR EME report – Sept 2017
Publish in peer review journal – Oct 2017

Protocol indicates:
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.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

On 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).