Efficacy of early controlled motion of the ankle compared with no motion after non-operative treatment of an acute Achilles tendon rupture: study protocol for a randomized controlled trial

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).

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Acute Achilles Tendon Rupture: Minimally Invasive Surgery Versus Nonoperative Treatment With Immediate Full Weightbearing – A Randomized Controlled Trial

Yearbook of Orthopedics ◽

10.1016/s0276-1092(09)79425-8 ◽

2009 ◽

Vol 2009 ◽

pp. 138-139

Author(s):

B.F. Morrey

Keyword(s):

Randomized Controlled Trial ◽

Minimally Invasive Surgery ◽

Minimally Invasive ◽

Achilles Tendon ◽

Invasive Surgery ◽

Tendon Rupture ◽

Controlled Trial ◽

Achilles Tendon Rupture ◽

Nonoperative Treatment ◽

Randomized Controlled

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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

10.21203/rs.3.rs-19305/v2 ◽

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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Functional weight-bearing mobilization after Achilles tendon rupture enhances early healing response: a single-blinded randomized controlled trial

Knee Surgery Sports Traumatology Arthroscopy ◽

10.1007/s00167-016-4270-3 ◽

2016 ◽

Vol 25 (6) ◽

pp. 1807-1816 ◽

Cited By ~ 34

Author(s):

Kars P. Valkering ◽

Susanna Aufwerber ◽

Francesco Ranuccio ◽

Enricomaria Lunini ◽

Gunnar Edman ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Achilles Tendon ◽

Tendon Rupture ◽

Controlled Trial ◽

Weight Bearing ◽

Achilles Tendon Rupture ◽

Randomized Controlled ◽

Healing Response ◽

Early Healing

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Efficacy of early controlled motion of the ankle compared with immobilisation in non-operative treatment of patients with an acute Achilles tendon rupture: an assessor-blinded, randomised controlled trial

British Journal of Sports Medicine ◽

10.1136/bjsports-2019-100709 ◽

2019 ◽

Vol 54 (12) ◽

pp. 719-724 ◽

Cited By ~ 8

Author(s):

Kristoffer Weisskirchner Barfod ◽

Maria Swennergren Hansen ◽

Per Hölmich ◽

Morten Tange Kristensen ◽

Anders Troelsen

Keyword(s):

Randomised Controlled Trial ◽

Achilles Tendon ◽

Operative Treatment ◽

Tendon Rupture ◽

Controlled Trial ◽

Achilles Tendon Rupture ◽

Control Group ◽

Intention To Treat ◽

Controlled Motion ◽

Randomised Controlled

BackgroundEarly controlled motion (ECM) of the ankle is widely used in the non-operative treatment of acute Achilles tendon rupture, although its safety and efficacy have not been investigated properly in a randomised set-up.Purpose/Aim of the studyTo investigate if ECM of the ankle was superior to immobilisation in the treatment of acute Achilles tendon rupture.Materials and methodsThis was an assessor-blinded, randomised controlled trial with patients allocated in a 1:1 ratio to one of two parallel groups. Patients aged 18–70 years were eligible for inclusion. The ECM group performed movements of the ankle five times a day from week 3 to week 8 after rupture. The control group was immobilised for 8 weeks. The primary outcome was the Achilles tendon Total Rupture Score (ATRS) evaluated at 1-year postinjury. The secondary outcomes were heel-rise work test (HRW), Achilles tendon elongation and rate of rerupture. Analysis was conducted as intention-to-treat using inverse probability weighting.Findings/Results189 patients were assessed for eligibility and 130 were included from February 2014 to December 2016. There were 64 patients in the ECM group and 58 in the immobilisation group. There were no statistically significant differences (p>0.3) between the ECM and the immobilisation groups at 1 year: mean (SD) ATRS was 74 (18) and 75 (18), respectively. HRW was 60% (21) and 60% (21) of the uninjured limb, and elongation was 18 mm (13) and 16 mm (11), respectively. Correspondingly, there were six and seven reruptures.ConclusionsECM revealed no benefit compared with immobilisation in any of the investigated outcomes.Trial registration numberNCT02015364

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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

10.21203/rs.3.rs-19305/v1 ◽

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. Keywords: Achilles tendon, Achilles tendon rupture, individualized treatment, ultrasound.

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