scholarly journals Cast versus functional brace in the rehabilitation of patients treated non-operatively for a rupture of the Achilles tendon: protocol for the UK study of tendo achilles rehabilitation (UK STAR) multi-centre randomised trial

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e019628 ◽  
Author(s):  
Juul Achten ◽  
Nick R Parsons ◽  
Rebecca L Kearney ◽  
Michael Maia Schlüssel ◽  
Anna S Liew ◽  
...  
Keyword(s):  
Achilles Tendon ◽  
Tendon Rupture ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Achilles Tendon Rupture ◽  
Plaster Cast ◽  
Quality Adjusted Life Year ◽  
Eligibility Criteria ◽  
Usual Practice ◽  
The Uk

IntroductionAchilles tendon rupture affects over 11 000 people yearly in the UK, and the incidence is increasing. Controversy remains with regard to the best rehabilitation strategy for these patients. In operatively treated patients, functional bracing provides better outcomes compared with plaster casts. However, the role of functional bracing in non-operatively managed patients is unclear. This is the protocol for a multicentre randomised trial of plaster cast immobilisation versus functional bracing for patients with a non-operatively managed Achilles tendon rupture.Methods and analysisAll adults presenting with a primary rupture of the Achilles tendon will be screened. Non-operatively treated patients will be eligible to take part in the trial. Broad eligibility criteria will ensure that the results of the study can be generalised to the wider patient population. Randomisation will be on a 1:1 basis. Both rehabilitation strategies are widely used within the National Health Service. Standardised protocols will be followed, and details of plaster material and brace will be as per the site’s usual practice.A minimum of 330 patients will be randomised to obtain 90% power to detect a difference of 8 points in Achilles Tendon Total Rupture Score at 9 months. Quality of life and resource use will be collected at 3, 6 and 9 months. The differences between treatment groups will be assessed on an intention-to-treat basis. The results of the trial-based economic evaluation will be expressed in terms of incremental cost per quality-adjusted life-year gained.Ethics and disseminationThe National Research Ethic Committee approved this study on 18 March 2016 (16/SC/0109).The National Institute for Health Research Health Technology Assessment monograph and a manuscript to a peer-reviewed journal will be submitted on completion of the trial (summer 2019). The results of this trial will substantially inform clinical practice on the clinical and cost-effectiveness of the treatment of this injury. This study has been registered on the International Standard Randomised Controlled Trial Number registry with reference noISRCTN62639639.

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 Bearing Weight at the Same Day in Conservatively Treated Acute Achilles Tendon Rupture Patients

2014 ◽  
Vol 2 (11_suppl3) ◽  
pp. 2325967114S0020
Author(s):  
Murat Korkmaz ◽  
Sadiye Yolcu ◽  
Özlem Balbaloğlu ◽  
Zekeriya Öztemur ◽  
Fatih Karaarslan
Keyword(s):  
Surgical Treatment ◽  
Achilles Tendon ◽  
Tendon Rupture ◽  
Achilles Tendon Rupture ◽  
Treatment Protocol ◽  
Early Mobilization ◽  
Treated Group ◽  
Plaster Cast ◽  
Wound Complications ◽  
American Orthopaedic

Objectives: Achilles tendon rupture (ATR) often occurs in 40- to 50-year-old men.. At treating there has been considerable research interest in attempting to identify the optimal treatment strategy, surgical or non-surgical, combined with functional early mobilisation or plaster cast immobilisation. Our aimed to compare the outcomes of bearing weight at the same day in conservatively treated and surgically treated groups of ATR patients. Methods: Thirty-two conservatively treated ATR patients and twenty nine surgically treated ATR patients were included to our study. Patients were over 18 years old who had been followed for 12 months by our clinic. All patients underwent knee supporting cast at four week and both group was asked for walking with bearing weight (%30-40) at same day. Results: In all groups 2nd and 12th months’ AOFAS (American Orthopaedic Foot and Ankle Society) scorings of the patients had significant differences (p<0.001). Return to work time results were significantly different and shorter in conservatively treated group (p= 0.035). This study founded a relatively high complication percentage of (6 patients) 20.6% in the surgically treated group. On the contrary the wound complications non-surgical group has not been be observed. Conclusion: In conclusion, this study adds to evidence that a well conducted non-surgical treatment protocol (early mobilization treatment regimen) gives a good clinical outcome and complication rate is not higher than after surgical treatment.

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 Individualized treatment for acute Achilles tendon rupture based on the Copenhagen Achilles Rupture Treatment Algorithm (CARTA): a study protocol for a multicenter randomized controlled trial

2020 ◽  
Author(s):  
Maria Swennergren Hansen ◽  
Marianne Toft Vestermark ◽  
Per Hölmich ◽  
Morten Tange Kristensen ◽  
Kristoffer Weisskirchner Barfod
Keyword(s):  
Randomized Controlled Trial ◽  
Achilles Tendon ◽  
Tendon Rupture ◽  
Controlled Trial ◽  
Achilles Tendon Rupture ◽  
Treatment Algorithm ◽  
Intervention Group ◽  
Individualized Treatment ◽  
Control Group ◽  
Randomized Controlled

Abstract Background: An individualized treatment algorithm (Copenhagen Achilles Rupture Treatment Algorithm - CARTA) based on the ultrasonographic appearance of an acute Achilles tendon rupture has been developed aiming to select the correct patients for operative and non-operative treatment. The objective of this study is to investigate if this individualized treatment algorithm gives a better functional outcome than treating all patients either operatively or non-operatively per default. Methods: This study is conducted as a multicenter three-armed randomized controlled trial. Participants are included from four hospitals in Denmark and randomized 1:1:1 to one of three parallel groups: 1) Intervention group: Participants are treated according to an individualized treatment algorithm, 2) Control group A: Participants are treated non-operative, 3) Control group B: Participants are treated operative. The individualized treatment algorithm for the intervention group is based on an ultrasonographic examination; tendon overlap and elongation below 7% is to be treated non-operative, while no tendon overlap and and/or elongation above 7% will be treated operative. 300 participants will be included over a period of 3 years. The primary outcome is the heel-rise work test at 12 months post-injury. Secondary outcomes are tendon elongation, the Achilles tendon Total Rupture Score (ATRS), the rate of re-ruptures and other complications. The primary analysis will be conducted as intention-to-treat analysis.Discussion: This trial will indicate if treatment of acute Achilles tendon rupture can be individualized based on the elongation and tendon overlap. It is hypothesized that different patients will benefit from different treatment instead of offering all the same treatment. Trial registration: ClinicalTrials.gov Identifier: NCT03525964. Registered 16 May 2018.

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