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Randomized Controlled Trial
. 2016 Nov 29;17(1):564.
doi: 10.1186/s13063-016-1697-2.

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

Kristoffer Weisskirchner Barfod  1 , Maria Swennergren Hansen  2 , Per Holmich  3 , Anders Troelsen  4 , Morten Tange Kristensen  2
Affiliations
Randomized Controlled Trial

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

Kristoffer Weisskirchner Barfod et al. Trials. .

Abstract

Background: Early controlled ankle motion is widely used in the non-operative treatment of acute Achilles tendon rupture, though its safety and efficacy have never been investigated in a randomized setup. The objectives of this study are to investigate if early controlled motion of the ankle affects functional and patient-reported outcomes.

Methods/design: The study is performed as a blinded, randomized, controlled trial with patients allocated in a 1:1 ratio to one of two parallel groups. Patients aged from 18 to 70 years are eligible for inclusion. The intervention group performs early controlled motion of the ankle in weeks 3-8 after rupture. The control group is immobilized. In total, 130 patients will be included from one big orthopedic center over a period of 2½ years. The primary outcome is the patient-reported Achilles tendon Total Rupture Score evaluated at 12 months post-injury. Secondary outcome measures are the heel-rise work test, Achilles tendon elongation, and the rate of re-rupture. The primary analysis will be conducted as intention-to-treat analyses.

Discussion: This trial is the first to investigate the safety and efficacy of early controlled motion in the treatment of acute Achilles tendon rupture in a randomized setup. The study uses the patient-reported outcome measure, the Achilles tendon Total Rupture Score, as the primary endpoint, as it is believed to be the best surrogate measure for the tendon's actual capability to function in everyday life.

Trial registration: ClinicalTrials.gov: NCT02015364 . Registered on 13 December 2013.

Keywords: Achilles tendon; Achilles tendon rupture; Dynamic mobilization; Early controlled motion; Non-operative treatment.

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Figures

Fig. 1
Fig. 1
Study design
Fig. 2
Fig. 2
The intervention: early controlled motion of the ankle joint. The orthosis is removed with the patient sitting on the edge of a table with both legs hanging. Gravity bends the foot downward, whereupon the patient must actively flex the foot upwards to a horizontal position. This is done at least five times a day in series of 25 repetitions
Fig. 3
Fig. 3
SPIRIT table of enrollment, interventions, and assessments
See this image and copyright information in PMC

References

    1. Barfod KW, Bencke J, Lauridsen HB, Ban I, Ebskov L, Troelsen A. Nonoperative dynamic treatment of acute Achilles tendon rupture: the influence of early weight-bearing on clinical outcome: a blinded, randomized controlled trial. J Bone Joint Surg Am. 2014;96:1497–503. doi: 10.2106/JBJS.M.01273. - DOI - PubMed
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    1. Jiang N, Wang B, Chen A, Dong F, Yu B. Operative versus nonoperative treatment for acute Achilles tendon rupture: a meta-analysis based on current evidence. Int Orthop. 2012;36:765–73. doi: 10.1007/s00264-011-1431-3. - DOI - PMC - PubMed

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