PATH-2: Platelet Rich Plasma in Achilles Tendon Healing

NCT02302664 | Completed DMC

• 1 other identifier: 14/SC/1333
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

Achilles Tendon Rupture

Keywords

Achilles; Platelet Rich Plasma; Patient reported outcome measure; Orthopaedic trauma; Musculoskeletal; Tendon; Sports Injury; Heel-Rise Endurance Test

Outcome Measures

Primary Outcomes (1)

• Heel-Rise Endurance Test (HRET)

  Muscle-tendon function, measured objectively with the limb symmetry index (LSI) in maximal work during the heel-rise endurance test (HRET) \[ Time Frame: 24 weeks following study treatment \] The HRET is a validated objective performant test 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.

  24 weeks following study treatment

Secondary Outcomes (6)

• Number of heel rise repetitions

  24 weeks following study treatment

• Maximum heel rise height

  24 weeks following study treatment

• Achilles Tendon Rupture Score (ATRS)

  4, 7, 13 and 24 weeks and 24 months following study treatment

• Patient Specific Functional Scale (PSFS)

  4, 7, 13, and 24 weeks and 24 months following study treatment

• Short Form (SF-12 acute version)

  4, 7, 13, and 24 weeks and 24 months following study treatment

Study Arms (2)

PRP Injection

ACTIVE COMPARATOR

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

Imitation Injection

SHAM COMPARATOR

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

Interventions

PRP Injection into Achilles tendon rupture gap PROCEDURE

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.

PRP Injection

Imitation Injection into Achilles tendon rupture gap PROCEDURE

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.

Imitation Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Oxford: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (18)

John Radcliffe Hospital, Oxford

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Basildon University Hospital

Basildon, SS16 5NL, United Kingdom

Location

Southmead Hospital

Bristol, BS10 5NB, United Kingdom

Location

University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

Location

University Hospital Coventry

Coventry, CV3 2DX, United Kingdom

Location

Leighton Hospital

Crewe, United Kingdom

Location

Royal Devon & Exeter Hospital

Exeter, United Kingdom

Location

Royal Surrey Hospital

Guildford, United Kingdom

Location

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, L7 8XP, United Kingdom

Location

Aintree Hospital

Liverpool, United Kingdom

Location

Royal London Hospital

London, E1 1BB, United Kingdom

Location

University Hospital South Manchester

Manchester, United Kingdom

Location

Peterborough City Hospital

Peterborough, PE3 9GZ, United Kingdom

Location

Northern General Hospital

Sheffield, United Kingdom

Location

Morriston Hospital

Swansea, United Kingdom

Location

Musgrove Park Hospital

Taunton, TA1 5DA, United Kingdom

Location

Warrington & Halton Hospitals Trust

Warrington, WA5 1QG, United Kingdom

Location

Related Publications (3)

• Keene DJ, Alsousou J, Willett K. How effective are platelet rich plasma injections in treating musculoskeletal soft tissue injuries? BMJ. 2016 Feb 17;352:i517. doi: 10.1136/bmj.i517. No abstract available.

  PMID: 26888826 BACKGROUND

• Schlussel MM, Keene DJ, Wagland S, Alsousou J, Lamb SE, Willett K, Dutton SJ; PATH-2 Trial Study Group. Platelet-rich plasma in Achilles tendon healing 2 (PATH-2) trial: statistical analysis plan for a multicentre, double-blinded, parallel-group, placebo-controlled randomised clinical trial. Trials. 2018 Aug 29;19(1):464. doi: 10.1186/s13063-018-2840-z.

  PMID: 30157940 DERIVED

• Alsousou J, Keene DJ, Hulley PA, Harrison P, Wagland S, Byrne C, Schlussel MM, Dutton SJ, Lamb SE, Willett K. Platelet rich Plasma in Achilles Tendon Healing 2 (PATH-2) trial: protocol for a multicentre, participant and assessor-blinded, parallel-group randomised clinical trial comparing platelet-rich plasma (PRP) injection versus placebo injection for Achilles tendon rupture. BMJ Open. 2017 Nov 16;7(11):e018135. doi: 10.1136/bmjopen-2017-018135.

  PMID: 29150470 DERIVED

MeSH Terms

Conditions

Athletic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Keith Willett, Professor

  Professor of Orthopaedic Surgery University of Oxford

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: November 27, 2014
• Study Start: July 1, 2015
• Primary Completion: September 18, 2017
• Study Completion: March 8, 2018
• Last Updated: May 5, 2021

Record last verified: 2017-06

Locations

GB (18)