scholarly journals 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 ◽  
Vol 7 (11) ◽  
pp. e018135 ◽  
Author(s):  
Joseph Alsousou ◽  
David J Keene ◽  
Philippa A Hulley ◽  
Paul Harrison ◽  
Susan Wagland ◽  
...  
Keyword(s):  
Achilles Tendon ◽  
Research Ethics ◽  
Tendon Rupture ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Achilles Tendon Rupture ◽  
Treatment Strategies ◽  
Ethics Committee ◽  
Research Network ◽  
Research Ethics Committee

BackgroundAchilles tendon injuries give rise to substantial long-lasting morbidity and pose considerable challenges for clinicians and patients during the lengthy healing period. Current treatment strategies struggle to curb the burden of this injury on health systems and society due to lengthy rehabilitation, work absence and reinjury risk. Platelet-rich plasma (PRP) is an autologous preparation that has been shown to improve the mechanobiological properties of tendons in laboratory and animal studies. The use of PRP in musculoskeletal injuries is on the increase despite the lack of adequately powered clinical studies.Methods and designThis is a multicentre randomised controlled trial to evaluate the efficacy and mechanism of PRP in patients with acute Achilles tendon rupture (ATR). All adults with acute ATR presenting within 12 days of the injury who are to be treated non-operatively are eligible. A total of 230 consenting patients will be randomly allocated via a remote web-based service to receive PRP injection or placebo injection to the site of the injury. All participants will be blinded to the intervention and will receive standardised rehabilitation to reduce efficacy interference.Participants will be followed up with blinded assessments of muscle–tendon function, quality of life, pain and overall patient’s functional goals at 4, 7, 13, 24 weeks and 24 months post-treatment. The primary outcome is the heel-rise endurance test (HRET), which will be supervised by a blinded assessor at 24 weeks. A subgroup of 16 participants in one centre will have needle biopsy under ultrasound guidance at 6 weeks. Blood and PRP will be analysed for cell count, platelet activation and growth factor concentrations.Ethics and disseminationThe protocol has been approved by the Oxfordshire Research Ethics Committee (Oxfordshire Research Ethics Committee A, reference no 14/SC/1333). The trial will be reported in accordance with the CONSORT statement and published in peer-reviewed scientific journals.Trial registration numberISRCTN: 54992179, assigned 12 January 2015. ClinicalTrials.gov:NCT02302664, received 18 November 2014. UK Clinical Research Network Study Portfolio Database: ID 17850.

scholarly journals 3 Platelet rich plasma for acute achilles tendon rupture: a double-blind, multicentre, randomised, placebo-controlled trial

2019 ◽  
Vol 53 (13) ◽  
pp. 843.3-844
Author(s):  
DJ Keene ◽  
J Alsousou ◽  
P Harrison ◽  
P Hulley ◽  
S Wagland ◽  
...  
Keyword(s):  
Achilles Tendon ◽  
Goal Attainment ◽  
Tendon Rupture ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Achilles Tendon Rupture ◽  
Soft Tissue Injuries ◽  
Double Blind ◽  
Patient Reported ◽  
Secondary Outcomes

AimSlow 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. We aimed to determine the clinical efficacy of PRP for treatment of acute Achilles tendon rupture.Methods230 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. 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.ResultsOf 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.ConclusionThis 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. The use of PRP in soft tissue injuries must be questionable unless supported by equally robust evidence indicating positive outcomes.

scholarly journals A Prospective Study of Platelet-Rich Plasma as Biological Augmentation for Acute Achilles Tendon Rupture Repair

2016 ◽  
Vol 2016 ◽  
pp. 1-8 ◽  
Author(s):  
Jian Zou ◽  
Xiaolian Mo ◽  
Zhongmin Shi ◽  
Tanzhu Li ◽  
Jianfeng Xue ◽  
...  
Keyword(s):  
Achilles Tendon ◽  
Tendon Rupture ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Achilles Tendon Rupture ◽  
Control Group ◽  
Sf 36 ◽  
Study Results ◽  
A Prospective Study ◽  
Biological Augmentation

Acute Achilles tendon rupture is one of the most common tendon injuries in adults. We hypothesized that Platelet-Rich Plasma (PRP) can be used as biological augmentation for surgical treatment of acute Achilles tendon rupture. Our study is a prospective randomized controlled trial. Patients with acute Achilles tendon rupture undergoing surgical repair were randomly assigned into either control group or PRP group. End-to-end modified Krackow suture was performed in both groups. In the PRP group, PRP was injected into the paratenon sheath and around the ruptured tissue after the tendon was repaired. Postoperatively we evaluated isokinetic muscle strength at 3, 6, 12, and 24 months. In addition, ankle ROM, calf circumference, Leppilahti score, and the SF-36 score were evaluated at 6, 12, and 24 months after operation. At 3 months, the PRP group had better isokinetic muscle. The PRP group also achieved higher SF-36 and Leppilahti scores at 6 and 12 months. At 24 months, the PRP group had an improved ankle range of motion compared to the control group. Our study results suggest that PRP can serve as a biological augmentation to acute Achilles tendon rupture repair and improves both short and midterm functional outcomes.

scholarly journals Interest of platelet rich plasma in Achilles tendon rupture management: a systematic review

2021 ◽  
Author(s):  
Pauline Daley ◽  
Pierre Menu ◽  
Bastien Louguet ◽  
Vincent Crenn ◽  
Marc Dauty ◽  
...  
Keyword(s):  
Systematic Review ◽  
Achilles Tendon ◽  
Tendon Rupture ◽  
Platelet Rich Plasma ◽  
Achilles Tendon Rupture

scholarly journals Risk of Deep Vein Thrombosis After Acute Achilles Tendon Rupture: A Secondary Analysis of a Randomized Controlled Trial Comparing Early Controlled Motion of the Ankle Versus Immobilization

2020 ◽  
Vol 8 (4) ◽  
pp. 232596712091590 ◽  
Author(s):  
Kristoffer Weisskirchner Barfod ◽  
Emil Graakjær Nielsen ◽  
Beth Hærsted Olsen ◽  
Pablo Gustavo Vinicoff ◽  
Anders Troelsen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Achilles Tendon ◽  
Tendon Rupture ◽  
Controlled Trial ◽  
Achilles Tendon Rupture ◽  
Vein Thrombosis ◽  
Randomized Controlled ◽  
Deep Vein ◽  
D Dimer

Background: Immobilization of the ankle joint has been suggested as a key element in the pathogenesis leading to deep vein thrombosis (DVT). Purpose: To investigate whether early controlled ankle motion (ECM) could reduce the incidence of DVT compared with immobilization (IM) in the treatment of acute Achilles tendon rupture. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: Patients aged 18 to 70 years were eligible for inclusion, and treatment was nonoperative. The ECM group performed movements of the ankle 5 times a day from weeks 3 to 8 after rupture. The control group was immobilized for 8 weeks. The outcome measure was DVT diagnosed with color Doppler ultrasound for above- and below-knee DVT at 2 and 8 weeks. The Achilles tendon Total Rupture Score, the heel-rise work test, and the Copenhagen Achilles ultrasonographic Length Measurement were performed at 4-, 6-, and 12-month follow-up. Results: A total of 189 patients were assessed for eligibility from February 2014 to December 2016. Of these, 130 were randomized: 68 patients were allocated to the ECM group and 62 to the IM group. All patients participated in follow-up at 8 weeks assessing for DVT. In total, 62 (47.7%) patients were diagnosed with DVT: 33 of 68 (48.5%) in the ECM group and 28 of 61 (46.8%) in the IM group ( P = .84). DVT did not affect treatment outcomes at 4, 6, and 12 months. D-dimer had low sensitivity (71%) for detecting DVT. Conclusion: We found that 1 in 2 patients presented with DVT in nonoperative treatment of acute Achilles tendon rupture. The ECM protocol revealed no benefit versus IM in reducing the incidence of DVT. DVT did not influence functional and patient-reported outcomes the first year after rupture. D-dimer seems an inappropriate test for detection of DVT in patients with acute Achilles tendon rupture. Registration: NCT02015364 ( ClinicalTrials.gov identifier).

scholarly journals Methotrexate and prednisolone study in erythema nodosum leprosum (MaPs in ENL) protocol: a double-blind randomised clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e037700
Author(s):  
Barbara de Barros ◽  
Saba M Lambert ◽  
Mahesh Shah ◽  
Vivek V Pai ◽  
Joydeepa Darlong ◽  
...  
Keyword(s):  
Research Ethics ◽  
Erythema Nodosum ◽  
Controlled Trial ◽  
Ethics Committee ◽  
Primary Objective ◽  
Ethical Review ◽  
London School ◽  
Double Blind ◽  
Research Ethics Committee ◽  
Erythema Nodosum Leprosum

IntroductionErythema nodosum leprosum (ENL) is an immunological complication of leprosy. ENL results in morbidity and disability and if it is not treated can lead to death. The current treatment consists of thalidomide or high doses of oral corticosteroids for prolonged periods. Thalidomide is not available in many leprosy endemic countries. The use of corticosteroids is associated with morbidity and mortality. Identifying treatment regimens that reduce the use of corticosteroids in ENL is essential. Methotrexate (MTX) is used to treat many inflammatory diseases and has been used successfully to treat patients with ENL not controlled by other drugs, including prednisolone and thalidomide. We present the protocol of the ‘MTX and prednisolone study in ENL’ (MaPs in ENL) a randomised controlled trial (RCT) designed to test the efficacy of MTX in the management of ENL.Methods and analysisMaPs in ENL is an international multicentre RCT, which will be conducted in leprosy referral centres in Bangladesh, Brazil, Ethiopia, India, Indonesia and Nepal. Patients diagnosed with ENL who consent to participate will be randomly allocated to receive 48 weeks of weekly oral MTX plus 20 weeks of prednisolone or 48 weeks of placebo plus 20 weeks of prednisolone. Participants will be stratified by type of ENL into those with acute ENL and those with chronic and recurrent ENL. The primary objective is to determine whether MTX reduces the requirement for additional prednisolone. Patients’ reported outcome measures will be used to assess the efficacy of MTX. Participants will be closely monitored for adverse events.Ethics and disseminationResults will be submitted for publication in peer-reviewed journals. Ethical approval was obtained from the Observational/Interventions Research Ethics Committee of the London School of Hygiene & Tropical Medicine (15762); The Leprosy Mission International Bangladesh Institutional Research Board (in process); AHRI-ALERT Ethical Review Committee, Ethiopia; Ethics Committee of the Managing Committee of the Bombay Leprosy Project; and The Leprosy Mission Trust India Ethics Committee; the Nepal Health and Research Council and Health Research Ethics Committee Dr. Soetomo, Indonesia. This study is registered at www.clinicaltrials.gov. This is the first RCT of MTX for ENL and will contribute to the evidence for the management of ENL.Trial registration numberNCT 03775460.

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