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Open Access 01-12-2018 | Study protocol

Nordic Innovative Trial to Evaluate OsteoPorotic Fractures (NITEP-group): non-operative treatment versus surgery with volar locking plate in the treatment of distal radius fracture in patients aged 65 and over – a study protocol for a prospective, randomized controlled trial

Authors: Teemu P. Hevonkorpi, Antti P. Launonen, Lauri Raittio, Toni Luokkala, Juha Kukkonen, Aleksi Reito, Bakir O. Sumrein, Minna K. Laitinen, Ville M. Mattila, on behalf of the NITEP-group

Published in: BMC Musculoskeletal Disorders | Issue 1/2018

Abstract

Background

In the literature, there are numerous studies that compare different surgical procedures in the treatment of distal radius fractures (DRF). It is, however, unknown whether operative treatment and better restoration of anatomy with volar locking plate yields a better functional outcome in the elderly population when compared with non-operative treatment.

Methods and design

This study is a prospective, randomized, controlled, multi-center trial. The purpose will be to compare the non-operative and operative treatment of initially or early malaligned distal radius fractures in patients aged 65 and older. The primary outcome in this study will be the patient rated wrist evaluation (PRWE) score measured after 1 and 2 years.

Discussion

We expect that initial operative treatment of a DRF with volar locking plate will not yield superior results when compared with non-operative treatment with cast immobilization in terms of functional outcome, pain, disability, quality of life, grip strength, and number of complications.

Trial registration

This trial is registered on clinicaltrials.gov, identifier NCT02879656, registration date 08/17/2016.

Available only for authorised users

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Title: Nordic Innovative Trial to Evaluate OsteoPorotic Fractures (NITEP-group): non-operative treatment versus surgery with volar locking plate in the treatment of distal radius fracture in patients aged 65 and over – a study protocol for a prospective, randomized controlled trial
Authors: Teemu P. Hevonkorpi
Antti P. Launonen
Lauri Raittio
Toni Luokkala
Juha Kukkonen
Aleksi Reito
Bakir O. Sumrein
Minna K. Laitinen
Ville M. Mattila
on behalf of the NITEP-group
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/s12891-018-2019-5

At a glance: The STEP trials

Springer Medicine

Nordic Innovative Trial to Evaluate OsteoPorotic Fractures (NITEP-group): non-operative treatment versus surgery with volar locking plate in the treatment of distal radius fracture in patients aged 65 and over – a study protocol for a prospective, randomized controlled trial

Abstract

Background

Methods and design

Discussion

Trial registration

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods and design

Discussion

Trial registration

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