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Trial record 1 of 2 for:    path-2
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PATH-2: Platelet Rich Plasma in Achilles Tendon Healing (PATH-2)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by University of Oxford
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT02302664
First received: November 18, 2014
Last updated: June 19, 2017
Last verified: June 2017
  Purpose

Platelet Rich Plasma in Achilles Tendon Healing

Does using a Platelet Rich Plasma (PRP) injection immediately before standard casting benefit patients aged 18 or over who are suitable for nonsurgical treatment of the Achilles tendon rupture (ATR)? This is a multicentre, blinded, randomised, placebo controlled trial with two sub studies: (1) blood sample analysis and (2) needle biopsy in 16 participants.

ATR is the most common tendon injury and leads to months of incapacity. With an average work absence of 63108 days there are significant societal and National Health Service (NHS) costs. PRP potential benefit is to improve recovery and return to normal activities earlier, and reduce the NHS and societal impact. The investigators will investigate the efficacy of PRP using disease specific and patient important outcomes to improve the evidence for this treatment of ATR.

A minimum of 15 United Kingdom (UK) NHS hospitals will be included to recruit 214 participants. Patients will be identified in the orthopaedic outpatient clinic, usually following an emergency hospital attendance for ATR. After checking eligibility and the informed consent process, baseline data is collected and participants randomised to either 'PRP injection' or 'Imitation (placebo) injection'. A participant's own blood sample is taken and prepared according to allocation. The injection is delivered by a trained surgeon in clinic who will be aware of allocation while the participant remains blind.

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 pre-set questions.

The results may be applicable to the many other tendon and ligament injuries. The National Institute for Health Research (NIHR)/Medical Research Council (MRC) Efficacy and Mechanism Evaluation Programme provides funding and University of Oxford is Sponsor.


Condition Intervention
Achilles Tendon Rupture Procedure: PRP Injection into Achilles tendon rupture gap Procedure: Imitation Injection into Achilles tendon rupture gap

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Health Services Research
Official Title: A Pragmatic Multi-centre Blinded Randomised Placebo-controlled Trial Comparing Platelet Rich Plasma Injection (PRP) to Placebo (Imitation) Injection in Adults With Achilles Tendon Rupture

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Heel-Rise Endurance Test (HRET) [ Time Frame: 24 weeks following study treatment ]
    The HRET is a validated objective measure of calf-muscle Achilles tendon capacity to work which is measured in the unit joules (J). The HRET involves the participant standing on one leg and raising and lowering the heel repeatedly until fatigued. The work during the HRET for each lower limb is measured. The performance of each limb is then converted into a limb symmetry index, which is the primary outcome metric from the HRET.


Secondary Outcome Measures:
  • Achilles Tendon Rupture Score (ATRS) [ Time Frame: 4, 7, 13 and 24 weeks and 24 months following study treatment ]
    Patient-report outcome measure (via questionnaire)

  • Patient Specific Functional Scale (PSFS) [ Time Frame: 4, 7, 13, and 24 weeks and 24 months following study treatment ]
    Patient-report outcome measure (via questionnaire)

  • Short Form (SF-12 acute version) [ Time Frame: 4, 7, 13, and 24 weeks and 24 months following study treatment ]
    Patient-report outcome measure (via questionnaire)

  • Pain diary - Visual analogue score (VAS) [ Time Frame: 0-2 weeks following study treatment ]
    Daily pain diary


Estimated Enrollment: 214
Actual Study Start Date: July 2015
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PRP Injection
Intervention - PRP Injection: The injection is the intervention. A blood sample is withdrawn from patient. Away from patient part of sample is spun down in centrifuge to produce 'Platelet Rich Plasma' (PRP). Patient returns to treatment area and their own PRP is then injected into tendon rupture gap. This is carried out by a surgeon or extended scope physiotherapist, generally in the outpatient clinic, after a local anaesthetic has been applied. Patient is lying face down during procedure, unaware of treatment given to tendon at back of leg. Remaining blood sample sent for analysis.
Procedure: PRP Injection into Achilles tendon rupture gap
PRP injection delivered into the tendon rupture gap Intervention - PRP Injection: The injection is the intervention. A blood sample is withdrawn from patient. Away from patient part of sample is spun down in centrifuge to produce 'Platelet Rich Plasma' (PRP). Patient returns to treatment area and their own PRP is then injected into tendon rupture gap. This is carried out by a surgeon or extended scope physiotherapist, generally in the outpatient clinic, after a local anaesthetic has been applied. Patient is lying face down during procedure, unaware of treatment given to tendon at back of leg. Remaining blood sample sent for analysis.
Sham Comparator: Imitation Injection
Sham - Imitation Injection: The injection is the intervention. A blood sample is withdrawn from patient. Treatment is prepared. Patient returns to treatment area and a needle (no syringe) is inserted and held into tendon rupture gap to mimic injection (after local anaesthetic has been applied). No active ingredient given. Carried out by surgeon or extended scope physiotherapist, generally in the outpatient clinic. Patient is lying face down during procedure, unaware of treatment given to tendon at back of leg. Blood sample sent for analysis.
Procedure: Imitation Injection into Achilles tendon rupture gap
Imitation injection delivered into the tendon rupture gap Sham - Imitation Injection: The injection is the intervention. A blood sample is withdrawn from patient. Treatment is prepared. Patient returns to treatment area and a needle (no syringe) is inserted and held into tendon rupture gap to mimic injection (after local anaesthetic has been applied). No active ingredient given. Carried out by surgeon or extended scope physiotherapist, generally in the outpatient clinic. Patient is lying face down during procedure, unaware of treatment given to tendon at back of leg. Blood sample sent for analysis.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient is willing and able to give informed consent for participation in the study
  • Aged 18 years or over
  • Ambulatory prior to injury without the use of walking aids or assistance of another person
  • Diagnosed with an acute, complete, Achilles tendon rupture
  • Presenting within and receiving study treatment within 12 days post injury
  • Patients in whom the decision has been made for non-operative treatment
  • Able (in the Investigator's opinion) and willing to comply with all study requirements
  • Able to attend a PATH-2 study hospital site for the 24-week follow-up.

Exclusion Criteria:

The patient may not enter the study if any of the following apply:

  • Achilles tendon injuries at the insertion to the calcaneum or at the musculotendinous junction
  • Previous major tendon or ankle injury or deformity to either lower leg
  • History of diabetes mellitus
  • Known platelet abnormality or haematological disorder
  • Current use of systemic cortisone or a treatment dose of an anticoagulant (i.e. a prophylactic dose for preventing thrombosis would not be an exclusion)
  • Evidence of lower limb gangrene/ulcers or peripheral vascular disease
  • History of hepatic or renal impairment or dialysis
  • Female patients who are pregnant or breast feeding
  • Is currently receiving or has received radiation or chemotherapy within the last 3 months
  • Has inadequate venous access for drawing blood
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the patient's ability to participate in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02302664

Contacts
Contact: Susan Wagland, PhD 44(0)1865 223123 susan.wagland@ndorms.ox.ac.uk
Contact: Scott Parsons, PhD 44(0)1865 26540 path-2.study@ndorms.ox.ac.uk

Locations
United Kingdom
John Radcliffe Hospital, Oxford Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Basildon University Hospital Recruiting
Basildon, United Kingdom, SS16 5NL
Southmead Hospital Recruiting
Bristol, United Kingdom, BS10 5NB
University Hospital of Wales Recruiting
Cardiff, United Kingdom, CF14 4XW
University Hospital Coventry Recruiting
Coventry, United Kingdom, CV3 2DX
Leighton Hospital Recruiting
Crewe, United Kingdom
Royal Devon & Exeter Hospital Recruiting
Exeter, United Kingdom
Royal Surrey Hospital Recruiting
Guildford, United Kingdom
Leicester Royal Infirmary Recruiting
Leicester, United Kingdom, LE1 5WW
Royal Liverpool University Hospital Recruiting
Liverpool, United Kingdom, L7 8XP
Aintree Hospital Recruiting
Liverpool, United Kingdom
Royal London Hospital Recruiting
London, United Kingdom, E1 1BB
University Hospital South Manchester Recruiting
Manchester, United Kingdom
Peterborough City Hospital Recruiting
Peterborough, United Kingdom, PE3 9GZ
Northern General Hospital Recruiting
Sheffield, United Kingdom
Morriston Hospital Recruiting
Swansea, United Kingdom
Musgrove Park Hospital Recruiting
Taunton, United Kingdom, TA1 5DA
Warrington & Halton Hospitals Trust Recruiting
Warrington, United Kingdom, WA5 1QG
Sponsors and Collaborators
University of Oxford
National Institute for Health Research, United Kingdom
Investigators
Study Chair: Keith Willett, Professor Professor of Orthopaedic Surgery University of Oxford
  More Information

Additional Information:
Publications:
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02302664     History of Changes
Other Study ID Numbers: 14/SC/1333
Study First Received: November 18, 2014
Last Updated: June 19, 2017

Keywords provided by University of Oxford:
Achilles
Platelet Rich Plasma
Patient reported outcome measure
Orthopaedic trauma
Musculoskeletal
Tendon
Sports Injury
Heel-Rise Endurance Test

Additional relevant MeSH terms:
Rupture
Wounds and Injuries
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 22, 2017