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Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Vascular Impulse Technology versus elevation in the treatment of posttraumatic swelling of extremity fractures: study protocol for a randomized controlled trial

Authors: Marc Schnetzke, Benedict Swartman, Isabel Bonnen, Holger Keil, Svenja Schüler, Paul A. Grützner, Jochen Franke

Published in: Trials | Issue 1/2017

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Abstract

Background

Fractures of the extremities are often complicated by a variable degree of swelling secondary to hemorrhage and soft tissue injury. Patients typically require up to 7 days of inpatient bed rest and elevation to reduce swelling to an acceptable level for operative treatment with internal fixation. Alternatively, an intermittent pneumatic compression device, such as the Vascular Impulse Technology (VIT) system, can be used at the injured extremity to reduce the posttraumatic swelling. The VIT system consists of a pneumatic compressor that intermittently rapidly inflates a bladder positioned under the arch of the hand or the foot, which results in compression of the venous hand or foot plexus. That intermittent compression induces an increased venous velocity and aims to reduce the soft tissue swelling of the affected extremity.

Methods/design

The VIT study is a prospective, monocenter, randomized controlled trial to compare the VIT system with elevation in the treatment of posttraumatic swelling in the case of a fracture of the upper and lower extremity. This study will include 280 patients with fractures of the upper and the lower extremity with nine different injury types. For each of the nine injury types a separate randomization to the two intervention groups (VIT group or control group) will be performed. The primary outcome parameter is the time taken for the swelling to resolve sufficiently to permit surgery. A separate analysis for each of the nine injury types will be performed.

Discussion

In the proposed study, the effectiveness of the VIT system in the treatment of posttraumatic swelling of upper and lower extremity fractures will be evaluated.

Trial registration

German Clinical Trial Register, No. DRKS00010510. Registered on 17 July 2016.
Appendix
Available only for authorised users
Literature
1.
2.
Wang D, Xiang JP, Chen XH, Zhu QT. A meta-analysis for postoperative complications in tibial plafond fracture: open reduction and internal fixation versus limited internal fixation combined with external fixator. J Foot Ankle Surg. 2015;54(4):646–51. doi:10.​1053/​j.​jfas.​2014.​06.​007.CrossRefPubMed
3.
4.
Musahl V, Tarkin I, Kobbe P, Tzioupis C, Siska PA, Pape HC. New trends and techniques in open reduction and internal fixation of fractures of the tibial plateau. J Bone Joint Surg (Br). 2009;91(4):426–33. doi:10.​1302/​0301-620x.​91b4.​20966.CrossRef
5.
6.
Leyes M, Torres R, Guillen P. Complications of open reduction and internal fixation of ankle fractures. Foot Ankle Clin. 2003;8(1):131–47. ix.CrossRefPubMed
7.
Sanders R. Intra-articular fractures of the calcaneus: present state of the art. J Orthop Trauma. 1992;6(2):252–65.CrossRefPubMed
8.
Thordarson DB, Krieger LE. Operative vs. nonoperative treatment of intra-articular fractures of the calcaneus: a prospective randomized trial. Foot Ankle Int. 1996;17(1):2–9.CrossRefPubMed
9.
Konrath G, Karges D, Watson JT, Moed BR, Cramer K. Early versus delayed treatment of severe ankle fractures: a comparison of results. J Orthop Trauma. 1995;9(5):377–80.CrossRefPubMed
10.
11.
12.
Mora S, Zalavras CG, Wang L, Thordarson DB. The role of pulsatile cold compression in edema resolution following ankle fractures: a randomized clinical trial. Foot Ankle Int. 2002;23(11):999–1002.CrossRefPubMed
13.
Stockle U, Hoffmann R, Schutz M, von Fournier C, Sudkamp NP, Haas N. Fastest reduction of posttraumatic edema: continuous cryotherapy or intermittent impulse compression? Foot Ankle Int. 1997;18(7):432–8.CrossRefPubMed
14.
Thordarson DB, Ghalambor N, Perlman M. Intermittent pneumatic pedal compression and edema resolution after acute ankle fracture: a prospective, randomized study. Foot Ankle Int. 1997;18(6):347–50.CrossRefPubMed
15.
Matsen FA 3rd, Questad K, Matsen AL. The effect of local cooling on postfracture swelling. A controlled study. Clinical orthopaedics and related research. 1975(109):201–6.
16.
Fordyce MJ, Ling RS. A venous foot pump reduces thrombosis after total hip replacement. J Bone Joint Surg. 1992;74(1):45–9.
17.
Warwick D, Harrison J, Glew D, Mitchelmore A, Peters TJ, Donovan J. Comparison of the use of a foot pump with the use of low-molecular-weight heparin for the prevention of deep-vein thrombosis after total hip replacement. A prospective, randomized trial. J Bone Joint Surg Am. 1998;80(8):1158–66.CrossRefPubMed
18.
Asano H, Matsubara M, Suzuki K, Morita S, Shinomiya K. Prevention of pulmonary embolism by a foot sole pump. J Bone Joint Surg. 2001;83(8):1130–2.CrossRef
19.
Santori FS, Vitullo A, Stopponi M, Santori N, Ghera S. Prophylaxis against deep-vein thrombosis in total hip replacement. Comparison of heparin and foot impulse pump. J Bone Joint Surg. 1994;76(4):579–83.CrossRef
20.
Caschman J, Blagg S, Bishay M. The efficacy of the A-V Impulse system in the treatment of posttraumatic swelling following ankle fracture: a prospective randomized controlled study. J Orthop Trauma. 2004;18(9):596–601.CrossRefPubMed
21.
Myerson MS, Henderson MR. Clinical applications of a pneumatic intermittent impulse compression device after trauma and major surgery to the foot and ankle. Foot Ankle. 1993;14(4):198–203.CrossRefPubMed
22.
Myerson MS, Juliano PJ, Koman JD. The use of a pneumatic intermittent impulse compression device in the treatment of calcaneus fractures. Mil Med. 2000;165(10):721–5.PubMed
23.
24.
Marsh JL, Slongo TF, Agel J, Broderick JS, Creevey W, DeCoster TA, et al. Fracture and dislocation classification compendium – 2007: Orthopaedic Trauma Association classification, database and outcomes committee. J Orthop Trauma. 2007;21(10 Suppl):S1–S133.CrossRefPubMed
25.
Metadata
Title
Vascular Impulse Technology versus elevation in the treatment of posttraumatic swelling of extremity fractures: study protocol for a randomized controlled trial
Authors
Marc Schnetzke
Benedict Swartman
Isabel Bonnen
Holger Keil
Svenja Schüler
Paul A. Grützner
Jochen Franke
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1824-8

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Commentary

Clinical trial registries: more international, converging efforts are needed