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

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/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 Aparticipants 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 heelrise 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.

Effect of the Copenhagen Achilles Rupture Treatment Algorithm (CARTA) on Calf Muscle Volume and Tendon Elongation After Acute Achilles Tendon Rupture: A Predefined Secondary Analysis of the First 60 Patients in a Randomized Controlled Trial

“…This satellite study is briefly described in the protocol paper for the main trial. 8 No changes were made to the study design in the period between the study design and the completion of data collection. After data collection, it was realized that the amount of data was too vast to publish in a single article.…”

“…2,6,9,18,19 The Copenhagen Achilles Rupture Treatment Algorithm (CARTA) was developed to provide individualized treatment selection based on ultrasonographic evaluation of the rupture. 1,8 The protocol for the randomized controlled trial is available via open access in our previous study. 8 The aim of the present study was, in a randomized setup, to investigate whether treatment selection according to the CARTA influences muscle volume of the triceps surae and the deep calf flexors and reduces elongation of the Achilles tendon 1 year after rupture in comparison with (1) patients treated surgically and (2) patients treated nonsurgically.…”

“…1,8 The protocol for the randomized controlled trial is available via open access in our previous study. 8 The aim of the present study was, in a randomized setup, to investigate whether treatment selection according to the CARTA influences muscle volume of the triceps surae and the deep calf flexors and reduces elongation of the Achilles tendon 1 year after rupture in comparison with (1) patients treated surgically and (2) patients treated nonsurgically. We hypothesized that treatment selection according to the CARTA would reduce atrophy of the triceps surae muscle, reduce hypertrophy of the deep calf flexors, and reduce elongation of the Achilles tendon when compared with patients treated nonsurgically per default and result in equal muscle volume and tendon length as in patients treated surgically per default.…”

Achilles Tendon Tissue Turnover Before and Immediately After an Acute Rupture

“…Open surgery was performed through a 5-to 8-cm incision as previously described. 16 Each patient had 2 tendon biopsy specimens taken (~5 mm long, ~2 mm wide, and ~2 mm deep): 1 biopsy specimen from one of the stump ends of the ruptured part of the Achilles tendon (rupture) and one biopsy specimen 3 to 5 cm proximal to the rupture site where the Achilles tendon appeared macroscopically healthy (control). The biopsy specimens were snap-frozen in liquid nitrogen and stored for later analysis of 14 C, 2 H-alanine (from 2 H 2 O), and 15 N-proline to investigate tendon turnover in the years before the rupture, in the days from the rupture to surgery, and in the hours leading up to surgery, respectively.…”

What Is the Best Evidence to Guide Management of Acute Achilles Tendon Ruptures? A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials

“…However, the question of rerupture risk remains unsettled. To further inform treatment decision-making, future research, both randomized and observational, should examine rerupture risk between treatments in populations that may be at higher risk for poor outcomes and rerupture such as those with increased tendon diastasis or more proximal ruptures [26,92], and older patients or those with higher BMI [7,50,67,82,93]. Rerupture risk between treatments should also be investigated in high-demand groups such as younger patients and those engaged in athletics [38].…”