Keene DJ1, Alsousou J2, Hulley P1, Harrison P3, Wagland S1, Thompson J1, O'Connor H1, Schlussel MM1, Dutton SJ1, Lamb SE1, Willett K1
1University of Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, United Kingdom, 2University of Liverpool, Institute of Translational Medicine, Liverpool, United Kingdom, 3University of Birmingham, Institute of Inflammation and Ageing, Birmingham, United Kingdom
Background: Slow recovery and disability after Achilles tendon rupture are major challenges. Platelet Rich Plasma (PRP) is an autologous supraphysiological concentration of platelets from whole blood that has demonstrated positive cellular and physiological effects on healing in the laboratory and is widely used in musculoskeletal treatments. However, evidence from adequately powered, robust clinical trials is lacking.
Purpose: We aimed to determine the clinical efficacy of PRP for treatment of acute Achilles tendon rupture.
Methods: Adults starting Achilles rupture non-surgical management within 12 days of injury were randomised to PRP injection or dry needle insertion to the rupture gap, under local anaesthetic. Injections were done by orthopaedic surgeons or advanced practice physiotherapists. Participants were blinded to study treatment and received standardised rehabilitation. Blinded outcome assessments were at 4, 7, 13, and 24 weeks. The primary outcome was muscle-tendon function assessed by work performed during the heel-rise endurance test (HRET), measured with the Limb Symmetry Index (LSI) (0-100%; 100% denotes full recovery) at 24 weeks. Secondary outcomes were the Achilles Tendon Rupture Score (ATRS), quality of life (SF-12), pain and goal attainment. The trial was prospectively registered.
Results: Of the 230 participants, 114 were allocated to PRP injection (103 received PRP), 116 were allocated to and received placebo. At 24 weeks, 201/230 (87%) completed the HRET and 214/230 (93%) completed patient reported outcomes. Participant characteristics between the groups were similar. There was no difference between groups at 24 weeks in LSI (mean difference = -4.373; 95% CI -11.217 to 2.471; p=0.195). There were no differences in the secondary outcomes and adverse event rates.
Conclusion(s): This trial design and standardised PRP preparation secure the first robust clinical trial evidence for PRP in managing Achilles tendon rupture, and suggest that PRP offers no patient benefit.
Implications: The use of PRP in soft tissue injuries must be questionable unless supported by equally robust evidence indicating positive outcomes.
Keywords: Achilles rupture, Platelet rich plasma, Randomised controlled trial
Funding acknowledgements: Funded by the Efficacy and Mechanism Evaluation (EME) Programme, a Medical Research Council and National Institute for Health Research partnership.
Purpose: We aimed to determine the clinical efficacy of PRP for treatment of acute Achilles tendon rupture.
Methods: Adults starting Achilles rupture non-surgical management within 12 days of injury were randomised to PRP injection or dry needle insertion to the rupture gap, under local anaesthetic. Injections were done by orthopaedic surgeons or advanced practice physiotherapists. Participants were blinded to study treatment and received standardised rehabilitation. Blinded outcome assessments were at 4, 7, 13, and 24 weeks. The primary outcome was muscle-tendon function assessed by work performed during the heel-rise endurance test (HRET), measured with the Limb Symmetry Index (LSI) (0-100%; 100% denotes full recovery) at 24 weeks. Secondary outcomes were the Achilles Tendon Rupture Score (ATRS), quality of life (SF-12), pain and goal attainment. The trial was prospectively registered.
Results: Of the 230 participants, 114 were allocated to PRP injection (103 received PRP), 116 were allocated to and received placebo. At 24 weeks, 201/230 (87%) completed the HRET and 214/230 (93%) completed patient reported outcomes. Participant characteristics between the groups were similar. There was no difference between groups at 24 weeks in LSI (mean difference = -4.373; 95% CI -11.217 to 2.471; p=0.195). There were no differences in the secondary outcomes and adverse event rates.
Conclusion(s): This trial design and standardised PRP preparation secure the first robust clinical trial evidence for PRP in managing Achilles tendon rupture, and suggest that PRP offers no patient benefit.
Implications: The use of PRP in soft tissue injuries must be questionable unless supported by equally robust evidence indicating positive outcomes.
Keywords: Achilles rupture, Platelet rich plasma, Randomised controlled trial
Funding acknowledgements: Funded by the Efficacy and Mechanism Evaluation (EME) Programme, a Medical Research Council and National Institute for Health Research partnership.
Topic: Musculoskeletal; Musculoskeletal: lower limb; Sport & sports injuries
Ethics approval required: Yes
Institution: National Research Ethics Service (UK)
Ethics committee: South Central - Oxford A Research Ethics Committee
Ethics number: 14/SC/1333
All authors, affiliations and abstracts have been published as submitted.
