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

Teemu P Hevonkorpi, Antti P Launonen, Lauri Raittio, Toni Luokkala, Juha Kukkonen, Aleksi Reito, Bakir O Sumrein, Minna K Laitinen, Ville M Mattila, NITEP-group, Teemu P Hevonkorpi, Antti P Launonen, Lauri Raittio, Toni Luokkala, Juha Kukkonen, Aleksi Reito, Bakir O Sumrein, Minna K Laitinen, Ville M Mattila, NITEP-group

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.

Keywords: Distal radius; Forearm fractures; Non-operative treatment; Operative treatment; RCT; Randomized controlled trial; Volar plating.

Conflict of interest statement

Ethics approval and consent to participate

This study has been approved by the local medical ethics committee (Regional Ethics Committee of Tampere University Hospital, ETL-code R16105). Each participating patient will receive written and spoken information about the trial and a consent form from the clinical investigator. Participation is voluntary. All data are handled anonymously.

Consent for publication

Not applicable.

Competing interests

No competing interests declared.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Patient flow chart of the trial

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