TY - JOUR

T1 - Individualized treatment for acute Achilles tendon rupture based on the Copenhagen Achilles Rupture Treatment Algorithm (CARTA)

T2 - a study protocol for a multicenter randomized controlled trial

AU - Hansen, Maria Swennergren

AU - Vestermark, Marianne Toft

AU - Hölmich, Per

AU - Kristensen, Morten Tange

AU - Barfod, Kristoffer Weisskirchner

PY - 2020

Y1 - 2020

N2 - 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.

AB - 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.

KW - Achilles Tendon/diagnostic imaging

KW - Acute Disease

KW - Adult

KW - Aged

KW - Algorithms

KW - Case-Control Studies

KW - Conservative Treatment

KW - Denmark/epidemiology

KW - Gait Analysis/methods

KW - Heel/physiopathology

KW - Humans

KW - Intention to Treat Analysis

KW - Lysholm Knee Score

KW - Magnetic Resonance Imaging/methods

KW - Middle Aged

KW - Recovery of Function

KW - Rupture/diagnostic imaging

KW - Tendon Injuries/physiopathology

KW - Treatment Outcome

KW - Ultrasonography/methods

U2 - 10.1186/s13063-020-04332-z

DO - 10.1186/s13063-020-04332-z

M3 - Journal article

C2 - 32398120

VL - 21

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 399

ER -