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Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

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

Authors: Kristoffer Weisskirchner Barfod, Maria Swennergren Hansen, Per Holmich, Anders Troelsen, Morten Tange Kristensen

Published in: Trials | Issue 1/2016

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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.
Appendix
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Literature
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.CrossRefPubMed
2.
Hansen MS, Christensen M, Budolfsen T, Østergaard TF, Kallemose T, Troelsen A, Barfod KW. Achilles tendon Total Rupture Score at 3 months can predict patients’ ability to return to sport 1 year after injury. Knee Surg Sport Traumatol Arthrosc. 2016;24:1365–71.CrossRef
3.
Ganestam A, Kallemose T, Troelsen A, Barfod KW: Increasing incidence of acute Achilles tendon rupture and a noticeable decline in surgical treatment from 1994 to 2013. A nationwide registry study of 33,160 patients. Knee Surg Sport Traumatol Arthrosc. 2015. doi:10.1007/s00167-015-3544-5
4.
Huttunen TT, Kannus P, Rolf C, Felländer-Tsai L, Mattila VM. Acute Achilles tendon ruptures: incidence of injury and surgery in Sweden between 2001 and 2012. Am J Sports Med. 2014;2014(42):2419–23.CrossRef
5.
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.CrossRefPubMed
6.
Jones MP, Khan RJK, Smith RLC. Surgical interventions for treating acute Achilles tendon rupture: key findings from a recent Cochrane review. J Bone Joint Surg Am. 2012;88:1–6.
7.
8.
Barfod KW, Nielsen F, Helander KN, Mattila VM, Tingby O, Boesen A, Troelsen A. Treatment of acute Achilles tendon rupture in Scandinavia does not adhere to evidence-based guidelines: a cross-sectional questionnaire-based study of 138 departments. J Foot Ankle Surg. 2013;52:629–33.CrossRefPubMed
9.
Kearney RS, Costa ML. Current concepts in the rehabilitation of an acute rupture of the tendo Achillis. J Bone Joint Surg Br. 2012;94:28–31.CrossRefPubMed
10.
Kearney RS, McGuinness KR, Achten J, Costa ML. A systematic review of early rehabilitation methods following a rupture of the Achilles tendon. Physiotherapy. 2012;98:24–32.CrossRefPubMed
11.
Saleh M, Marshall PD, Senior R. The Sheffield splint for controlled early mobilisation after rupture of the calcaneal tendon. A prospective, randomised comparison with plaster treatment. J Bone Joint Surg. 1992;74:206–9.
12.
Mortensen NHM, Skov O, Jensen PE. Early motion of the ankle after operative treatment of a rupture of the Achilles tendon. J Bone Joint Surg. 1999;81:983–90.CrossRefPubMed
13.
Costa ML, MacMillan K, Halliday D, Chester R, Shepstone L, Robinson AH, Donell ST. Randomised controlled trials of immediate weight-bearing mobilisation for rupture of the tendo Achillis. J Bone Joint Surg Br. 2006;88:69–77.CrossRefPubMed
14.
15.
Gelberman RH, Woo SL-Y. The physiological basis for application of controlled stress in the rehabilitation of flexor tendon injuries. J Hand Ther. 1989;2:66–70.CrossRef
16.
Strickland JW. The scientific basis for advances in flexor tendon surgery. J Hand Ther. 2005;18:94–110.CrossRefPubMed
17.
Matsumoto F, Trudel G, Uhthoff HK, Backman DS. Mechanical effects of immobilization on the Achilles[apos] tendon. Arch Phys Med Rehabil. 2003;84:662–7.PubMed
18.
Twaddle BC, Poon P. Early motion for Achilles tendon ruptures: is surgery important? A randomized, prospective study. Am J Sports Med. 2007;35:2033–8.CrossRefPubMed
19.
Nilsson-Helander K, Silbernagel KG, Thomeé R, Faxén E, Olsson N, Eriksson BI, Karlsson J. Acute Achilles tendon rupture: a randomized, controlled study comparing surgical and nonsurgical treatments using validated outcome measures. Am J Sports Med. 2010;38:2186–93.CrossRefPubMed
20.
Willits K, Amendola A, Bryant D, Mohtadi NG, Giffin JR, Fowler P, Kean CO, Kirkley A. Operative versus nonoperative treatment of acute Achilles tendon ruptures: a multicenter randomized trial using accelerated functional rehabilitation. J Bone Joint Surg Am. 2010;92:2767–75.CrossRefPubMed
21.
Cetti R, Henriksen LO, Jacobsen KS. A new treatment of ruptured Achilles tendons. A prospective randomized study. Clin Orthop Relat Res. 1994;308(Nov):155–65.
22.
Kangas J, Pajala A, Siira P, Hämäläinen M, Leppilahti J. Early functional treatment versus early immobilization in tension of the musculotendinous unit after Achilles rupture repair: a prospective, randomized, clinical study. J Trauma. 2003;54:1171–80. discussion 1180–1.CrossRefPubMed
23.
Kangas J, Pajala A, Ohtonen P, Leppilahti J. Achilles tendon elongation after rupture repair: a randomized comparison of 2 postoperative regimens. Am J Sports Med. 2007;35:59–64.CrossRefPubMed
24.
Krapf D, Kaipel M, Majewski M. Structural and biomechanical characteristics after early mobilization in an Achilles tendon rupture model: operative versus nonoperative treatment. Orthopedics. 2012;35:e1383–8.CrossRefPubMed
25.
Silbernagel KG, Steele R, Manal K. Deficits in heel-rise height and Achilles tendon elongation occur in patients recovering from an Achilles tendon rupture. Am J Sports Med. 2012;40:1564–71.CrossRefPubMed
26.
Nilsson-Helander K, Thomeé R, Silbernagel KG, Grävare-Silbernagel K, Thomeé P, Faxén E, Eriksson BI, Karlsson J. The Achilles tendon Total Rupture Score (ATRS): development and validation. Am J Sports Med. 2007;35:421–6.CrossRefPubMed
27.
Olsson N, Karlsson J, Eriksson BI, Brorsson A, Lundberg M, Silbernagel KG. Ability to perform a single heel-rise is significantly related to patient-reported outcome after Achilles tendon rupture. Scand J Med Sci Sports. 2014;24:152–8.CrossRefPubMed
28.
Barfod KW, Riecke AF, Boesen A, Hansen P, Maier JF, Doessing S, Troelsen A. Validation of a novel ultrasound measurement of Achilles tendon length. Knee Surg Sport Traumatol Arthrosc. 2014;23:3398–406.CrossRef
29.
Carmont MR, Silbernagel KG, Mathy A, Mulji Y, Karlsson J, Maffulli N. Reliability of Achilles tendon resting angle and calf circumference measurement techniques. Foot Ankle Surg. 2013;19:245–9.CrossRefPubMed
30.
Thompson TC, Doherty JH. Spontaneous rupture of tendon of Achilles: a new clinical diagnostic test. J Trauma. 1962;2:126–9.CrossRefPubMed
31.
Amlang MH, Zwipp H, Friedrich A, Peaden A, Bunk A, Rammelt S. Ultrasonographic classification of Achilles tendon ruptures as a rationale for individual treatment selection. ISRN Orthop. 2011;2011:1–10.CrossRef
32.
Barfod KW. Achilles tendon rupture. Assessment of non- operative treatment. Dan Med J. 2014;61:B4837.PubMed
33.
Ganestam A, Barfod K, Klit J, Troelsen A. Validity and reliability of the Achilles tendon total rupture score. J Foot Ankle Surg. 2013;52:736–9.CrossRefPubMed
34.
Olsson N, Silbernagel KG, Eriksson BI, Sansone M, Brorsson A, Nilsson-Helander K, Karlsson J. Stable surgical repair with accelerated rehabilitation versus nonsurgical treatment for acute Achilles tendon ruptures: a randomized controlled study. Am J Sports Med. 2013;41:2867–76.CrossRefPubMed
35.
Silbernagel KG, Nilsson-Helander K, Thomeé R, Eriksson BI, Karlsson J. A new measurement of heel-rise endurance with the ability to detect functional deficits in patients with Achilles tendon rupture. Knee Surg Sports Traumatol Arthrosc. 2010;18:258–64.CrossRefPubMed
Metadata
Title
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
Authors
Kristoffer Weisskirchner Barfod
Maria Swennergren Hansen
Per Holmich
Anders Troelsen
Morten Tange Kristensen
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1697-2

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