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BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2018

Open Access 01-12-2018 | Study protocol

Nonoperative, open reduction and internal fixation or primary arthrodesis in the treatment of Lisfranc injuries: a prospective, randomized, multicenter trial – study protocol

Authors: Ville T. Ponkilainen, Ville M. Mattila, Heikki-Jussi Laine, Antti Paakkala, Heikki M. Mäenpää, Heidi H. Haapasalo

Published in: BMC Musculoskeletal Disorders | Issue 1/2018

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Abstract

Background

Lisfranc injuries are known to be rare and often overlooked injuries that can cause long-term disability and pain when missed or treated incorrectly. The wide variety of Lisfranc injuries ranges from subtle ligament distensions to open fracture dislocations. The treatment of Lisfranc joint injuries is still controversial and very little is known about what types of injury can be treated nonoperatively. The current literature provides only two randomized studies on dislocated Lisfranc injuries. These studies have shown that primary arthrodesis (PA) leads to a similar or better outcome and results in fewer secondary operations when compared with open reduction and internal fixation (ORIF) in ligamentous injuries. There have been no previous randomized studies of the nonoperative versus operative treatment of Lisfranc injuries. Therefore, the purpose of this study is to compare the operative and nonoperative treatment of non-dislocated Lisfranc injuries and to compare the ORIF and PA treatment of dislocated Lisfranc injuries.

Methods

This study is a prospective, randomized, national multi-center trial. The trial comprises two strata: Stratum I compares cast-immobilization versus open reduction and internal fixation (ORIF) treatment of non-dislocated Lisfranc joint injuries. Stratum II compares PA versus ORIF in the treatment of dislocated injuries of the Lisfranc joint. The main hypothesis of stratum I is that the nonoperative treatment of non-dislocated Lisfranc injuries achieves a similar outcome compared with operative treatment (ORIF). The hypothesis of stratum II is that PA of dislocated Lisfranc injuries yields a similar functional outcome compared with ORIF, but that PA results in fewer secondary operations than ORIF. The main outcome measure is the American Orthopaedic Foot and Ankle Society (AOFAS) Midfoot score and the secondary outcome measures are Visual-Analogue-Scale Foot and Ankle (VAS-FA), Visual-Analogue-Scale (VAS), rate of secondary operations and other treatment-related complications. The results will be analyzed after the 2-year follow-up period.

Discussion

This publication presents a prospective, randomized, national multi-center trial study protocol. It provides details of patient flow, randomization, aftercare and methods of analysis of the material and ways to present and publish the results.

Trial registration

ClinicalTrials.gov identifier: NCT02953067 24.10.2016.
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Metadata
Title
Nonoperative, open reduction and internal fixation or primary arthrodesis in the treatment of Lisfranc injuries: a prospective, randomized, multicenter trial – study protocol
Authors
Ville T. Ponkilainen
Ville M. Mattila
Heikki-Jussi Laine
Antti Paakkala
Heikki M. Mäenpää
Heidi H. Haapasalo
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2018
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/s12891-018-2222-4

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