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 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.

Conflict of interest statement

DJO Global has made a significant contribution to the trial. The company has not at any time shown a special interest in the trial design or any other vital part of the project. The authors do not recognize that one outcome would be more beneficial than the other for DJO. Based on this, DJO’s incentives to influence the study is believed to be non-existent. None of the authors have other competing interests in relation to the study.

Figures

Fig. 1

SPIRIT table of enrolment and assessments. CALM Copenhagen Achilles Length Measure, ATRS Achilles tendon Total Rupture Score, ATRA Achilles Tendon Resting Angle, MRI magnetic resonance imaging

Fig. 2

Copenhagen Achilles Length Measure (CALM): an ultrasonographic measurement of tendon elongation. CALM comprises two measurements: the total length of the Achilles tendon (distance 1) and the free length of the Achilles tendon (distance 2)

Fig. 3

The Copenhagen Achilles Rupture Treatment Algorithm (CARTA) based on two ultrasonographic (US) examinations

Fig. 4

Illustration of the peritendium sparring surgical technique. a An incision of approximately 5 cm is placed over the rupture site. The peritendium is reached by careful stump dissection and is kept intact. b A transverse incision is made at the rupture site to expose the rupture. c The tendon stumps are drawn into the transverse incision and two modified Kessler sutures (Fiber-wire®, Arthrex size 2) are used to fix the tendon approximately 4 cm proximal and distal to the transverse incision. d The peritendium is closed with Vicryl, Ethicon 2–0 and the ankle is placed in maximal, unforced plantar flexion before the sutures are tightened maximally, bringing the tendon stumps together inside the peritendium. e A schematic drawing of the double Fiber-wire®, Arthrex size 2 a.m. Kessler with modification in terms of knots proximally on the sides