NDLI: Study protocol for the DEFENDD trial: an RCT on the Dynamic Locking Blade Plate (DLBP) versus the Dynamic Hip Screw (DHS) for displaced femoral neck fractures in patients 65 years and younger

Content Provider	Springer Nature : BioMed Central
Author	Kalsbeek, J. H. Roerdink, W. H. Krijnen, P. van den Akker-van Marle, M. E. Schipper, I. B.
Abstract	Background The Dynamic Locking Blade Plate (DLBP) was recently introduced for fixation of displaced femoral neck fractures (FNF) and has been well received. Although the results of this implant in young patients are promising, the DLBP has not yet been compared to a standard device such as the Dynamic Hip Screw (DHS). The aim of this study is to compare the clinical outcome and costs of displaced FNF treated with internal fixation by means of either the DLBP or the DHS in patients up to 65 years of age. We hypothesize that the DLBP is superior compared to the DHS in terms of revision surgery rate, union rate, incidence of avascular necrosis and implant related failure. Methods The DEFENDD (DisplacEd Femoral Neck fractures Dlbp versus Dhs) trial is a multicentre randomized controlled trial that will include 266 patients of 18–65 years with a displaced FNF. Patients will be randomized to receive either a DLBP or a DHS with a 1:1 allocation using a random block size, stratified for centre. Clinical follow up will last 1 year and questionnaires will be obtained up to 2 years. The main outcome parameter is the incidence of revision surgery within 1 year, due to either non-union, avascular necrosis (AVN) or cut out of the implant. Secondary study parameters are the incidence of avascular necrosis, non-union, (implant related) complications, functional outcome, elective removal of the implant and health-related quality of life and costs. Discussion The outcome of the DEFENDD trial will provide high-level evidence of which implant is favourable for the treatment of femoral neck fractures in young patients (≤65 years). Trial registration Netherlands Trial Register, NL7300 Registration date 25-09-2018.
Related Links	https://bmcmusculoskeletdisord.biomedcentral.com/counter/pdf/10.1186/s12891-020-3131-x.pdf
Ending Page	6
Page Count	6
Starting Page	1
File Format	HTM / HTML
ISSN	14712474
DOI	10.1186/s12891-020-3131-x
Journal	BMC Musculoskeletal Disorders
Issue Number	1
Volume Number	21
Language	English
Publisher	BioMed Central
Publisher Date	2020-03-03
Access Restriction	Open
Subject Keyword	Orthopedics Rehabilitation Rheumatology Sports Medicine Internal Medicine Epidemiology Hip fractures Dynamic locking blade plate Dynamic hip screw Femoral neck fractures Internal fixation Gannet Displaced DHS DLBP
Content Type	Text
Resource Type	Article
Subject	Orthopedics and Sports Medicine Rheumatology
Journal Impact Factor	2.2/2023
5-Year Journal Impact Factor	2.6/2023

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