Is arthropla S ty b E tter than inter N al fixation for undi S placed femoral n E ck fracture? A national pragmatic RCT: the SENSE trial

Bjarke Viberg, Søren Kold, Ole Brink, Morten Schultz Larsen, Kristoffer Borbjerg Hare, Henrik Palm, SENSE collaborators, Thomas Giver Jensen, Mikael Skov Nielsen, Rikke Thorninger, Thomas Egendal, Morten Homilius, Peter Ivan Andersen, Jesper Schønnemann, Michael Krasheninnikoff, Hans-Ulrik Ahler-Toftehøj, Peter Toquer, Tobias Aasvang, Jens Peter Alva-Jørgensen, Michael Mølmer, Sead Hasific, Thomas Brandi Bloch, Lasse Pedersen, Peter Szephalmi, Mohammed Adel Al-Bayati, Frithjof Peitz, Steffan Tábori Jensen, Annie Primdahl, Bjarke Viberg, Søren Kold, Ole Brink, Morten Schultz Larsen, Kristoffer Borbjerg Hare, Henrik Palm, SENSE collaborators, Thomas Giver Jensen, Mikael Skov Nielsen, Rikke Thorninger, Thomas Egendal, Morten Homilius, Peter Ivan Andersen, Jesper Schønnemann, Michael Krasheninnikoff, Hans-Ulrik Ahler-Toftehøj, Peter Toquer, Tobias Aasvang, Jens Peter Alva-Jørgensen, Michael Mølmer, Sead Hasific, Thomas Brandi Bloch, Lasse Pedersen, Peter Szephalmi, Mohammed Adel Al-Bayati, Frithjof Peitz, Steffan Tábori Jensen, Annie Primdahl

Abstract

Introduction: Undisplaced femoral neck fractures (FNFs) are usually treated by internal fixation (IF) but two randomised controlled trials (RCTs) have demonstrated advantages of treatment with arthroplasty. The complication rate was lowered but there were no clinically improved patient-reported outcome measures (PROM), which could be due to underpowering or choice of selected PROM as the studies do appear to report a better functional outcome. We will conduct an RCT comparing IF with arthroplasties in patients aged over 65 years with an undisplaced FNF.

Methods and analysis: All hospitals in Denmark treating patients with hip fracture can provide patients for this study; therefore, the study can be considered a national RCT. Patients over 65 years old with an undisplaced FNF will be screened for eligibility and patients will only be excluded if they are unable to understand the study information (due to dementia or language), if they have a posterior tilt >20°, a pathological fracture or they cannot walk. Participants will be electronically randomised (in alternating blocks of 4 or 6) into either IF or arthroplasty. Postoperative care will follow the department standards.Primary and secondary outcomes and measuring points have been established in collaboration with patients with hip fracture by focus group interviews. The primary outcome measure is the New Mobility Score assessed after 1 year. Secondary outcomes are the Oxford Hip Score, EuroQol 5 domain (EQ-5D-5L), degree of posterior tilt, pain Verbal Rating Scale, reoperation and mortality.

Ethics and dissemination: The study is approved by the Danish Data Protection Agency (19/7429) and the scientific ethics committee (S-20180036). All participants will sign an informed consent before entering the trial. Because this is a national trial, all relevant healthcare professionals in Denmark will automatically receive the trial results that will be published in international peer-reviewed journals.

Trial registration number: ClinicalTrials.gov Registry (NCT04075461).

Keywords: adult orthopaedics; geriatric medicine; hip; rehabilitation medicine; trauma management.

Conflict of interest statement

Competing interests: Outside the study, BV has received payment for lectures held for Zimmer Biomet and Osmedic Swemac.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Assessment of pragmatic design using the PRagmatic Explanatory Continuum Indicator Summary-2 wheel.

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