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Trials
Published in: Trials 1/2011

Open Access 01-12-2011 | Study protocol

Rationale and design of the plate or pin (pop) study for dislocated midshaft clavicular fractures: study protocol for a randomised controlled trial

Authors: Frans JG Wijdicks, R Marijn Houwert, Marcel GW Dijkgraaf, Diederik H De Lange, Sven AG Meylaerts, Michiel HJ Verhofstad, Egbert JJM Verleisdonk

Published in: Trials | Issue 1/2011

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Abstract

Background

To describe the rationale and design of a future study comparing results of plate fixation and Elastic Stable Intramedullary Nailing (ESIN) with a Titanium Elastic Nail (TEN) for adults with a dislocated midshaft clavicular fracture.

Methods/Design

Prospective randomized multicenter clinical trial in two level 1 and one level 2 trauma centers. 120 patients between 18 and 65 years of age will be included. They are randomized to either plate fixation or ESIN with a TEN with a one year follow-up. Sixty patients will be treated with plate fixation and 60 patients will be treated with ESIN. Primary outcome parameter is the Disabilities of the Arm, Shoulder and Hand score after 6 months. Secondary outcome parameters are Constant Shoulder Score, complications, experienced pain, radiologic consolidation and cosmetics after both procedures.

Discussion

Prospective randomized studies comparing operative techniques for treatment of dislocated midshaft clavicular fracture are lacking. By studying shoulder function, complications, quality of life, radiographic union, cosmetics as well as experienced pain, a complete efficacy assessment of both procedures will be performed.

Trial registration

The POP study is registered in the Dutch Trial Register (NTR NTR2438).
Appendix
Available only for authorised users
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Metadata
Title
Rationale and design of the plate or pin (pop) study for dislocated midshaft clavicular fractures: study protocol for a randomised controlled trial
Authors
Frans JG Wijdicks
R Marijn Houwert
Marcel GW Dijkgraaf
Diederik H De Lange
Sven AG Meylaerts
Michiel HJ Verhofstad
Egbert JJM Verleisdonk
Publication date
01-12-2011
Publisher
BioMed Central
Published in
Trials / Issue 1/2011
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-12-177

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