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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

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Title: 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
Authors: Hansen, Maria Swennergren, Vestermark, Marianne Toft, Hölmich, Per, Kristensen, Morten Tange, Barfod, Kristoffer Weisskirchner
Source: Hansen , M S , Vestermark , M T , Hölmich , P , Kristensen , M T & Barfod , K W 2020 , ' 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 ' , Trials , vol. 21 , 399 . https://doi.org/10.1186/s13063-020-04332-z
Publication Year: 2020
Collection: University of Copenhagen: Research / Forskning ved Københavns Universitet
Subject Terms: Achilles Tendon/diagnostic imaging, Acute Disease, Adult, Aged, Algorithms, Case-Control Studies, Conservative Treatment, Denmark/epidemiology, Gait Analysis/methods, Heel/physiopathology, Humans, Intention to Treat Analysis, Lysholm Knee Score, Magnetic Resonance Imaging/methods, Middle Aged, Recovery of Function, Rupture/diagnostic imaging, Tendon Injuries/physiopathology, Treatment Outcome, Ultrasonography/methods
Description: 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/DESIGN: 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-operatively; 3) Control group B-participants are treated operatively. 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-operatively, while no tendon overlap and/or elongation above 7% will be treated operatively. Over a period of 3 years, 300 participants will be included. 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 an intention-to-treat analysis. DISCUSSION: This trial will indicate if treatment of acute Achilles tendon rupture can be individualized based on elongation and tendon overlap. It is hypothesized that different patients will benefit from different treatments instead of offering all the same treatment. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03525964. Registered 16 May 2018.
Document Type: article in journal/newspaper
File Description: application/pdf
Language: English
DOI: 10.1186/s13063-020-04332-z
Availability: https://researchprofiles.ku.dk/da/publications/7f79bdee-0837-4195-b22a-8382c7b4d460
https://doi.org/10.1186/s13063-020-04332-z
https://curis.ku.dk/ws/files/260055637/s13063_020_04332_z_1.pdf
Rights: info:eu-repo/semantics/openAccess
Accession Number: edsbas.BF7C7BDC
Database: BASE
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  Data: 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
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  Data: <searchLink fieldCode="AR" term="%22Hansen%2C+Maria+Swennergren%22">Hansen, Maria Swennergren</searchLink><br /><searchLink fieldCode="AR" term="%22Vestermark%2C+Marianne+Toft%22">Vestermark, Marianne Toft</searchLink><br /><searchLink fieldCode="AR" term="%22Hölmich%2C+Per%22">Hölmich, Per</searchLink><br /><searchLink fieldCode="AR" term="%22Kristensen%2C+Morten+Tange%22">Kristensen, Morten Tange</searchLink><br /><searchLink fieldCode="AR" term="%22Barfod%2C+Kristoffer+Weisskirchner%22">Barfod, Kristoffer Weisskirchner</searchLink>
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  Data: Hansen , M S , Vestermark , M T , Hölmich , P , Kristensen , M T & Barfod , K W 2020 , ' 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 ' , Trials , vol. 21 , 399 . https://doi.org/10.1186/s13063-020-04332-z
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  Data: University of Copenhagen: Research / Forskning ved Københavns Universitet
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  Data: <searchLink fieldCode="DE" term="%22Achilles+Tendon%2Fdiagnostic+imaging%22">Achilles Tendon/diagnostic imaging</searchLink><br /><searchLink fieldCode="DE" term="%22Acute+Disease%22">Acute Disease</searchLink><br /><searchLink fieldCode="DE" term="%22Adult%22">Adult</searchLink><br /><searchLink fieldCode="DE" term="%22Aged%22">Aged</searchLink><br /><searchLink fieldCode="DE" term="%22Algorithms%22">Algorithms</searchLink><br /><searchLink fieldCode="DE" term="%22Case-Control+Studies%22">Case-Control Studies</searchLink><br /><searchLink fieldCode="DE" term="%22Conservative+Treatment%22">Conservative Treatment</searchLink><br /><searchLink fieldCode="DE" term="%22Denmark%2Fepidemiology%22">Denmark/epidemiology</searchLink><br /><searchLink fieldCode="DE" term="%22Gait+Analysis%2Fmethods%22">Gait Analysis/methods</searchLink><br /><searchLink fieldCode="DE" term="%22Heel%2Fphysiopathology%22">Heel/physiopathology</searchLink><br /><searchLink fieldCode="DE" term="%22Humans%22">Humans</searchLink><br /><searchLink fieldCode="DE" term="%22Intention+to+Treat+Analysis%22">Intention to Treat Analysis</searchLink><br /><searchLink fieldCode="DE" term="%22Lysholm+Knee+Score%22">Lysholm Knee Score</searchLink><br /><searchLink fieldCode="DE" term="%22Magnetic+Resonance+Imaging%2Fmethods%22">Magnetic Resonance Imaging/methods</searchLink><br /><searchLink fieldCode="DE" term="%22Middle+Aged%22">Middle Aged</searchLink><br /><searchLink fieldCode="DE" term="%22Recovery+of+Function%22">Recovery of Function</searchLink><br /><searchLink fieldCode="DE" term="%22Rupture%2Fdiagnostic+imaging%22">Rupture/diagnostic imaging</searchLink><br /><searchLink fieldCode="DE" term="%22Tendon+Injuries%2Fphysiopathology%22">Tendon Injuries/physiopathology</searchLink><br /><searchLink fieldCode="DE" term="%22Treatment+Outcome%22">Treatment Outcome</searchLink><br /><searchLink fieldCode="DE" term="%22Ultrasonography%2Fmethods%22">Ultrasonography/methods</searchLink>
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  Data: 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/DESIGN: 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-operatively; 3) Control group B-participants are treated operatively. 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-operatively, while no tendon overlap and/or elongation above 7% will be treated operatively. Over a period of 3 years, 300 participants will be included. 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 an intention-to-treat analysis. DISCUSSION: This trial will indicate if treatment of acute Achilles tendon rupture can be individualized based on elongation and tendon overlap. It is hypothesized that different patients will benefit from different treatments instead of offering all the same treatment. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03525964. Registered 16 May 2018.
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        Value: 10.1186/s13063-020-04332-z
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      – SubjectFull: Acute Disease
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