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 Platelet rich plasma injection for acute Achilles tendon rupture: PATH-2 randomised, placebo controlled, superiority trial

BMJ ◽  
2019 ◽  
pp. l6132 ◽  
Author(s):  
David J Keene ◽  
Joseph Alsousou ◽  
Paul Harrison ◽  
Philippa Hulley ◽  
Susan Wagland ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Achilles Tendon ◽  
Tendon Rupture ◽  
Platelet Rich Plasma ◽  
Achilles Tendon Rupture ◽  
Endurance Test ◽  
Patient Reported ◽  
Superiority Trial ◽  
Secondary Outcomes

Abstract Objective To determine whether an injection of platelet rich plasma improves outcomes after acute Achilles tendon rupture. Design Randomised, placebo controlled, two arm, parallel group, participant and assessor masked, superiority trial. Setting Secondary care trauma units across 19 hospitals in the United Kingdom’s health service. Participants Recruitment commenced in July 2015 and follow-up was completed in March 2018. 230 adults aged 18 years and over were included, with acute Achilles tendon rupture presenting within 12 days of injury and managed with non-surgical treatment. Exclusions were injury at the insertion or musculotendinous junction, major leg injury or deformity, diabetes mellitus, platelet or haematological disorder, systemic corticosteroids, anticoagulation treatment, and other contraindicating conditions. Interventions Participants were randomised 1:1 to platelet rich plasma (n=114) or placebo (dry needle; n=116) injection. All participants received standard rehabilitation care (ankle immobilisation followed by physiotherapy). Main outcomes and measures Primary outcome was muscle tendon function at 24 weeks, measured objectively with the limb symmetry index (injured/uninjured×100) in maximal work done during the heel rise endurance test (an instrumented measure of repeated single leg heel rises until fatigue). Secondary outcomes included patient reported function (Achilles tendon rupture score), quality of life (short form 12 version 2®), pain (visual analogue scale), goal attainment (patient specific functional scale), and adverse events. A central laboratory analysed the quality and content of platelet rich plasma. Analyses were by modified intention to treat. Results Participants were 46 years old on average, and 57 (25%) of 230 were female. At 24 weeks, 202 (88%) participants completed the heel rise endurance test and 216 (94%) the patient reported outcomes. The platelet rich plasma was of good quality, with expected growth factor content. No difference was detected in muscle tendon function between participants receiving platelet rich plasma injections and those receiving placebo injections (limb symmetry index, mean 34.7% (standard deviation 17.7%) v 38.5% (22.8%); adjusted mean difference −3.9% (95% confidence interval −10.5% to 2.7%)) or in any secondary outcomes or adverse event rates. Complier average causal effect analyses gave similar findings. Conclusions There is no evidence to indicate that injections of platelet rich plasma can improve objective muscle tendon function, patient reported function, or quality of life after acute Achilles tendon rupture compared with placebo, or that they offer any patient benefit. Trial registration ISRCTN54992179.

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 Does Early Functional Mobilization Affect Long-Term Outcomes After an Achilles Tendon Rupture? A Randomized Clinical Trial

2020 ◽  
Vol 8 (3) ◽  
pp. 232596712090652 ◽  
Author(s):  
Susanna Aufwerber ◽  
Annette Heijne ◽  
Gunnar Edman ◽  
Karin Grävare Silbernagel ◽  
Paul W. Ackermann
Keyword(s):  
Achilles Tendon ◽  
General Health ◽  
Tendon Rupture ◽  
Standard Treatment ◽  
Negative Impact ◽  
Controlled Trial ◽  
Achilles Tendon Rupture ◽  
Control Group ◽  
Ankle Motion ◽  
Patient Reported

Background: Functional deficits and health-related impairments are common after an Achilles tendon rupture (ATR). Rehabilitation protocols vary greatly, and few studies have allowed loading in combination with ankle motion immediately after surgery (ie, early functional mobilization [EFM]). It is unclear whether EFM may counteract the negative impact of ankle immobilization after an ATR. Purpose: The primary aim of this study was to assess the efficacy of EFM compared with standard treatment (ie, 2 weeks of unloading in a plaster cast followed by 4 weeks of weightbearing in an orthosis) regarding patient-reported and functional outcomes in patients with an ATR after acute operative repair. The secondary aim was to explore whether the occurrence of deep venous thrombosis (DVT) during the 2 postoperative treatments affected outcomes. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 135 patients who underwent ATR repair, randomized to either EFM, including immediate postoperative loading and ankle motion, or standard treatment, were evaluated with functional tests and 5 self-administered outcome questionnaires at 6 and 12 months postoperatively. Results: At 6 months, the EFM group scored higher on the RAND 36-Item Health Survey (RAND-36) questionnaire subscales of general health and vitality ( P < .05) compared with the control group. No significant differences between the groups were found on disease-specific questionnaires (Achilles tendon Total Rupture Score [ATRS] and Foot and Ankle Outcome Score [FAOS]). At 12 months, no significant differences on any of the patient-reported outcome measures or the functional heel-rise test were seen between the groups. The RAND-36 subscale of general health, however, exhibited higher values in the EFM group (82.6 ± 16.9) than the control group (77.1 ± 17.0) ( P = .051) at 12 months after the injury. Patients sustaining DVT postoperatively had lower self-reported outcomes on the ATRS, FAOS, and RAND-36 questionnaires at 6 and 12 months compared with patients not having sustained DVT (all P < .05). Conclusion: This study demonstrated that an accelerated postoperative protocol with immediate loading and ankle motion resulted in better general health and vitality at 6 months. However, there were no differences between the groups in the recovery of heel-rise function. Future studies should focus on the means to reduce the risk of DVT to improve patient outcomes after ATR. Registration: NCT02318472 (ClinicalTrials.gov identifier).

scholarly journals Platelet-rich plasma injection for adults with acute Achilles tendon rupture: the PATH-2 RCT

2019 ◽  
Vol 6 (12) ◽  
pp. 1-98 ◽  
Author(s):  
Joseph Alsousou ◽  
David J Keene ◽  
Paul Harrison ◽  
Philippa Hulley ◽  
Susan Wagland ◽  
...  
Keyword(s):  
Placebo Group ◽  
Achilles Tendon ◽  
Cell Count ◽  
Platelet Activation ◽  
Whole Blood ◽  
Goal Attainment ◽  
Primary Outcome ◽  
Tendon Rupture ◽  
Platelet Rich Plasma ◽  
Achilles Tendon Rupture

Background Achilles tendon rupture (ATR) has a long healing period, which is challenging for patients and clinicians. Platelet-rich plasma (PRP) is an autologous concentration of platelets thought to improve tendon function recovery. Although preliminary research has indicated positive effects, there is, as yet, no evidence of clinical efficacy from adequately powered robust clinical trials. Objectives The objectives were to determine the clinical efficacy of PRP in patients with acute ATR using an objective mechanical muscle–tendon function measure and patient-reported outcome measures (PROMs), and to determine which PRP components contribute to its mechanism. Design This was a multicentre, parallel-group, participant- and outcome assessor-blinded randomised controlled trial (RCT) comparing PRP with placebo. Two embedded substudies investigated the PRP’s quality and composition and its effects on healing tendon tissues. Setting This trial was set in trauma and orthopaedic surgery departments in 19 NHS hospitals in England and Wales. Participants Adults with acute ATR presenting within 12 days of injury to be treated non-surgically were eligible. Patients with platelet dysfunction or leg functional deficiency were excluded. Interventions Participants were randomised 1 : 1 to the PRP injection group or the placebo group (dry needle in the rupture gap) by central computer-based randomisation using minimisation, stratified by centre and age. Main outcome measures The primary outcome measure was the Limb Symmetry Index (LSI) of work during the heel-rise endurance test at 24 weeks. Secondary outcomes measures, collected at 4, 7, 13 and 24 weeks, were repetitions, maximum heel-rise height, Achilles tendon Total Rupture Score (ATRS), quality of life (as measured using the Short Form questionnaire-12 items version 2), pain and participant goal attainment. Needle biopsies of the affected tendon zone were taken under ultrasound guidance at 6 weeks from 16 participants from one centre. Whole blood was analysed for cell count. PRP was analysed for cell count, platelet activation and growth factor concentration. The primary analysis was intention to treat. Results A total of 230 participants were randomised: 114 to the PRP group (103 treated) and 116 to the placebo group (all treated). One participant withdrew after randomisation but before the intervention. At 24 weeks, 201 out of 230 participants (87.4%) completed the primary outcome and 216 out of 230 participants (93.9%) completed the PROMs. The treatment groups had similar participant characteristics. At 24 weeks, there was no difference in work LSI (mean difference –3.872; 95% confidence interval –10.454 to 2.710; p = 0.231), ATRS, pain or goal attainment between PRP- and placebo-injected participants. There were no differences between the groups in any PROM at any time point or in complication rates, including re-rupture and deep-vein thrombosis. There was no correlation between work LSI and platelet activation in PRP, or erythrocyte, leucocyte or platelet counts in whole blood or PRP. Biopsies showed similar cellularity and vascularity between groups. Conclusions This trial design and standardised PRP preparation gives the first robust RCT evidence about PRP’s role in managing ATR, which suggests that PRP offers no patient benefit. Equally robust evidence to investigate PRP application in tendon and soft tissue injuries is required. The 24-month follow-up will be completed in April 2020. Trial registration Current Controlled Trials ISRCTN54992179. Funding This project was funded by the Efficacy and Mechanism Evaluation programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership. The trial was supported by the NIHR Biomedical Research Centre, Oxford, and the NIHR Fellowship programme.

scholarly journals Early mobilization does not reduce the risk of deep venous thrombosis after Achilles tendon rupture: a randomized controlled trial

2019 ◽  
Vol 28 (1) ◽  
pp. 312-319 ◽  
Author(s):  
Susanna Aufwerber ◽  
Annette Heijne ◽  
Gunnar Edman ◽  
Karin Grävare Silbernagel ◽  
Paul W. Ackermann
Keyword(s):  
Venous Thrombosis ◽  
Deep Venous Thrombosis ◽  
Achilles Tendon ◽  
Tendon Rupture ◽  
Controlled Trial ◽  
Achilles Tendon Rupture ◽  
Control Group ◽  
Level Of Evidence ◽  
Treatment As Usual ◽  
Patient Reported

Abstract Purpose The hypothesis was that early functional mobilization would reduce the incidence of deep venous thrombosis (DVT) during leg immobilization after Achilles tendon rupture surgery. A secondary aim was to evaluate if the amount of weightbearing and daily steps influenced the risk of sustaining a DVT. Methods One-hundred and fifty patients with Achilles tendon rupture repair were randomized to treatment with early functional mobilization, encouraging full weightbearing and ankle motion in orthosis, or treatment-as-usual, i.e., 2 weeks of unloading in plaster cast followed by 4 weeks weightbearing in orthosis. At 2 and 6 weeks postoperatively, all patients were screened for DVT using compression duplex ultrasound. During the first 2 weeks postoperatively, patient-reported loading, pain and step counts were assessed. Results At 2 weeks, 28/96 (29%) of the patients in early functional mobilization group and 15/49 (31%) in the control group (n.s) had sustained a DVT. At 6 weeks, the DVT rate was 35/94 (37%) in the early functional mobilization and 14/49 (29%) in the control group (n.s). During the first postoperative week, the early functional mobilization group reported low loading and higher experience of pain vs. the control group (p = 0.001). Low patient-reported loading ≤ 50% (OR = 4.3; 95% CI 1.28–14.3) was found to be an independent risk factor for DVT, in addition to high BMI and higher age. Conclusions Early functional mobilization does not prevent the high incidence of DVT during leg immobilization in patients with Achilles tendon rupture as compared to treatment-as-usual. The low efficacy of early functional mobilization is mainly explained by postoperative pain and subsequent low weightbearing. To minimize the risk of DVT, patients should be encouraged to load at least 50% of body weight on the injured leg 1 week after surgery. Level of evidence Therapeutic, level 1

scholarly journals The Ruptured Achilles Tendon Elongates for 6 Months After Surgical Repair Regardless of Early or Late Weightbearing in Combination With Ankle Mobilization: A Randomized Clinical Trial

2018 ◽  
Vol 46 (10) ◽  
pp. 2492-2502 ◽  
Author(s):  
Pernilla Eliasson ◽  
Anne-Sofie Agergaard ◽  
Christian Couppé ◽  
René Svensson ◽  
Rikke Hoeffner ◽  
...  
Keyword(s):  
Achilles Tendon ◽  
Tendon Rupture ◽  
Surgical Repair ◽  
Controlled Trial ◽  
Achilles Tendon Rupture ◽  
Home Exercise ◽  
Full Weightbearing ◽  
Tendon Elongation ◽  
Patient Reported ◽  
Functional Scores

Background: Treatment strategies for Achilles tendon rupture vary considerably, and clinical outcome may depend on the magnitude of tendon elongation after surgical repair. The aim of this project was to examine whether tendon elongation, mechanical properties, and functional outcomes during rehabilitation of surgically repaired acute Achilles tendon ruptures were influenced by different rehabilitation regimens during the early postsurgical period. Hypothesis: Restricted early weightbearing that permits only limited motion about the ankle in the early phase of tendon healing limits tendon elongation and improves functional outcome. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: 75 consecutive patients with an acute Achilles tendon rupture were included. They underwent surgical repair, and tantalum beads were placed in the distal and proximal parts of the tendon; thereafter, the patients were randomized into 3 groups. The first group was completely restricted from weightbearing until week 7. The second group was completely restricted from weightbearing until week 7 but performed ankle joint mobilization exercises. The first and second groups were allowed full weightbearing after week 8. The third group was allowed partial weightbearing from day 1 and full weightbearing from week 5. All patients received the same instructions in home exercise guidelines starting from week 9. Results: The rehabilitation regimen in the initial 8 weeks did not significantly influence any of the measured outcomes including tendon elongation. Achilles tendon elongation and tendon compliance continued for up to 6 months after surgery, and muscle strength, muscle endurance, and patient-reported functional scores did not reach normal values at 12 months. Conclusion: Differences in rehabilitation loading pattern in the initial 8 weeks after the repair of an Achilles tendon rupture did not measurably alter the outcome. The time to recover full function after an Achilles tendon rupture is at least 12 months. Registration: NCT02422004 ( ClinicalTrials.gov identifier).

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.

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