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Randomised controlled trial of the sliding hip screw versus X-Bolt Dynamic Hip Plating System for the fixation of trochanteric fractures of the hip in adults: a protocol study for WHiTE 4 (WHiTE4).

ABSTRACT: INTRODUCTION:Sliding hip screw fixation is well established in the treatment of trochanteric fractures of the hip. The X-Bolt Dynamic Hip Plating System builds on the successful design features of the sliding hip screw but differs in the nature of the fixation in the femoral head. A randomised pilot study suggested that the X-bolt Dynamic Hip Plating System might provide similar health-related quality of life while reducing the risk of revision surgery when compared with the sliding hip screw. This is the protocol for a multicentre randomised trial of sliding hip screw versus X-Bolt Dynamic Hip Plating System for patients 60 years and over treated for a trochanteric fracture of the hip. METHODS AND ANALYSIS:Multicentre, multisurgeon, parallel, two-arm, randomised controlled trial. Patients aged 60 years and older with a trochanteric hip fracture are potentially eligible. Participants will be randomly allocated on a 1:1 basis to either sliding hip screw or X-Bolt Dynamic Hip Plating System. Otherwise, all care will be in accordance with National Institute for Health and Care Excellence guidance. A minimum of 1128 patients will be recruited to obtain 90% power to detect a 0.075-point difference in EuroQol-5D health-related quality of life at 4 months postrandomisation. Secondary outcomes include mortality, residential status, revision surgery and radiographic measures. The treatment effect will be estimated using a two-sided t-test adjusted for age, gender and cognitive impairment based on an intention-to-treat analysis. ETHICS AND DISSEMINATION:National Research Ethics Committee approved this study on 5 February 2016 (16/WM/0001). The study is sponsored by the University of Oxford and funded through an investigator initiated grant by X-Bolt Orthopaedics. A manuscript for a high-impact peer-reviewed journal will be prepared, and the results will be disseminated to patients through local mechanisms at participating centres. TRIAL REGISTRATION NUMBER:ISRCTN92825709.

SUBMITTER: Griffin XL

PROVIDER: S-EPMC5879871 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Randomised controlled trial of the sliding hip screw versus X-Bolt Dynamic Hip Plating System for the fixation of trochanteric fractures of the hip in adults: a protocol study for WHiTE 4 (WHiTE4).

Griffin Xavier L XL Achten Juul J Sones William W Cook Jonathan J Costa Matthew L ML

BMJ open 20180126 1

<h4>Introduction</h4>Sliding hip screw fixation is well established in the treatment of trochanteric fractures of the hip. The X-Bolt Dynamic Hip Plating System builds on the successful design features of the sliding hip screw but differs in the nature of the fixation in the femoral head. A randomised pilot study suggested that the X-bolt Dynamic Hip Plating System might provide similar health-related quality of life while reducing the risk of revision surgery when compared with the sliding hip ...[more]

PMID: 29374679

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Project description:ImportanceFractures of the hip have devastating effects on function and quality of life. Intramedullary nails (IMN) are the dominant implant choice for the treatment of trochanteric fractures of the hip. Higher costs of IMNs and inconclusive benefit in comparison with sliding hip screws (SHSs) convey the need for definitive evidence.ObjectiveTo compare 1-year outcomes of patients with trochanteric fractures treated with the IMN vs an SHS.Design, setting, and participantsThis randomized clinical trial was conducted at 25 international sites across 12 countries. Participants included ambulatory patients aged 18 years and older with low-energy trochanteric (AO Foundation and Orthopaedic Trauma Association [AO/OTA] type 31-A1 or 31-A2) fractures. Patient recruitment occurred between January 2012 and January 2016, and patients were followed up for 52 weeks (primary end point). Follow-up was completed in January 2017. The analysis was performed in July 2018 and confirmed in January 2022.InterventionsSurgical fixation with a Gamma3 IMN or an SHS.Main outcomes and measuresThe primary outcome was health-related quality of life (HRQOL), measured by the EuroQol-5 Dimension (EQ5D) at 1-year postsurgery. Secondary outcomes included revision surgical procedure, fracture healing, adverse events, patient mobility (measured by the Parker mobility score), and hip function (measured by the Harris hip score).ResultsIn this randomized clinical trial, 850 patients were randomized (mean [range] age, 78.5 [18-102] years; 549 [64.6% female) with trochanteric fractures to undergo fixation with either the IMN (n = 423) or an SHS (n = 427). A total of 621 patients completed follow-up at 1 year postsurgery (304 treated with the IMN [71.9%], 317 treated with an SHS [74.2%]). There were no significant differences between groups in EQ5D scores (mean difference, 0.02 points; 95% CI, -0.03 to 0.07 points; P = .42). Furthermore, after adjusting for relevant covariables, there were no between-group differences in EQ5D scores (regression coefficient, 0.00; 95% CI, -0.04 to 0.05; P = .81). There were no between-group differences for any secondary outcomes. There were also no significant interactions for fracture stability (β [SE] , 0.01 [0.05]; P = .82) or previous fracture (β [SE], 0.01 [0.10]; P = .88) and treatment group.Conclusions and relevanceThis randomized clinical trial found that IMNs for the treatment of trochanteric fractures had similar 1-year outcomes compared with SHSs. These results suggest that the SHS is an acceptable lower-cost alternative for trochanteric fractures of the hip.Trial registrationClinicalTrials.gov Identifier: NCT01380444.

Project description:BACKGROUND:It is still unknown whether bioabsorbable magnesium (Mg) screws provide an advantage over titanium screws in the treatment of medial malleolar (MM) fractures. The purpose of this retrospective study is to compare the clinical and radiological outcomes of MM fractures fixed with either bioabsorbable Mg screws or conventional titanium screws. MATERIALS AND METHODS:A cohort of 48 patients with MM fractures who underwent compression screw fixation was retrospectively reviewed. Twenty-three patients (16 male, 7 female; mean age: 37.9?±?17.7 years) were treated with bioabsorbable Mg screws, and 25 patients (14 male, 11 female; mean age: 45.0?±?15.7 years) were treated with conventional titanium screw fixation. All patients were followed up for at least 1 year, with a mean time of 24.6?±?10.5 months (12-53 months). The American Orthopedic Foot and Ankle Society (AOFAS) scale was used to evaluate the clinical results. The Kellgren-Lawrence (KL) osteoarthritis grading was used to evaluate posttraumatic osteoarthritis on final ankle radiographs. Fracture union, rate of implant removal, and complications were recorded. Comparative analysis of two independent groups was performed using the chi-squared test and the Mann-Whitney U-test. RESULTS:The two groups were comparable concerning demographic and clinical characteristics. Age (p?=?0.146), sex (p?=?0.252), side (p?=?0.190), MM fracture type (p?=?0.500), associated fractures (p?=?0.470), and follow-up period (p?=?0.903) were similar between the groups. At final follow-up examination, AOFAS score (p?=?0.191) was similar between groups. Fracture union was achieved in all cases. Grade of posttraumatic osteoarthritis, according to KL, was equally distributed in both groups (p?=?0.074). No deep infection or osteomyelitis was seen. Five patients in the titanium screw group underwent implant removal, due to pain in three of them and difficulty in wearing shoes in the other two (p?=?0.031). Implant removal was performed after a mean of 14.2?±?3.1 months (12-19 months). CONCLUSIONS:Bioabsorbable Mg and titanium screws had similar therapeutic efficacy in MM fracture fixation regarding functional and radiological outcomes. However, the rate of implant removal was higher with titanium screws. Bioabsorbable Mg screws may be a favorable fixation option since secondary implant removal procedures can be prevented. LEVEL OF EVIDENCE:Level IV, Retrospective case series.

Dataset Information

Randomised controlled trial of the sliding hip screw versus X-Bolt Dynamic Hip Plating System for the fixation of trochanteric fractures of the hip in adults: a protocol study for WHiTE 4 (WHiTE4).

Publications

Randomised controlled trial of the sliding hip screw versus X-Bolt Dynamic Hip Plating System for the fixation of trochanteric fractures of the hip in adults: a protocol study for WHiTE 4 (WHiTE4).

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