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.

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.