scholarly journals Effect on Health-related Quality of Life of the X-Bolt Dynamic Plating System versus the Sliding Hip Screw for the Fixation of Trochanteric Fractures of the Hip in Adults: The WHiTE Four Randomized Clinical Trial

OrthoMedia ◽  
2021 ◽  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Health Related Quality ◽  
Trochanteric Fractures ◽  
Sliding Hip Screw ◽  
System Versus ◽  
Related Quality ◽  
Health Related ◽  
Hip Screw

scholarly journals 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)

BMJ Open ◽  
2018 ◽  
Vol 8 (1) ◽  
pp. e019944 ◽  
Author(s):  
Xavier L Griffin ◽  
Juul Achten ◽  
William Sones ◽  
Jonathan Cook ◽  
Matthew L Costa
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Health Related Quality ◽  
Trochanteric Fractures ◽  
Sliding Hip Screw ◽  
Related Quality ◽  
Health Related ◽  
Hip Screw ◽  
Randomised Controlled

IntroductionSliding 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 analysisMulticentre, 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 disseminationNational 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 numberISRCTN92825709.

scholarly journals Effect on health-related quality of life of the X-Bolt dynamic plating system versus the sliding hip screw for the fixation of trochanteric fractures of the hip in adults: the WHiTE Four randomized clinical trial

2021 ◽  
pp. 1-8
Author(s):  
Xavier L. Griffin ◽  
Juul Achten ◽  
Heather Marie O'Connor ◽  
Jonathan A. Cook ◽  
Matt L. Costa ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Hip Fracture ◽  
Health Related Quality ◽  
Sliding Hip Screw ◽  
Treatment Groups ◽  
Related Quality ◽  
Health Related ◽  
Hip Screw ◽  
Secondary Outcomes

Aims Surgical treatment of hip fracture is challenging; the bone is porotic and fixation failure can be catastrophic. Novel implants are available which may yield superior clinical outcomes. This study compared the clinical effectiveness of the novel X-Bolt Hip System (XHS) with the sliding hip screw (SHS) for the treatment of fragility hip fractures. Methods We conducted a multicentre, superiority, randomized controlled trial. Patients aged 60 years and older with a trochanteric hip fracture were recruited in ten acute UK NHS hospitals. Participants were randomly allocated to fixation of their fracture with XHS or SHS. A total of 1,128 participants were randomized with 564 participants allocated to each group. Participants and outcome assessors were blind to treatment allocation. The primary outcome was the EuroQol five-dimension five-level health status (EQ-5D-5L) utility at four months. The minimum clinically important difference in utility was pre-specified at 0.075. Secondary outcomes were EQ-5D-5L utility at 12 months, mortality, residential status, mobility, revision surgery, and radiological measures. Results Overall, 437 and 443 participants were analyzed in the primary intention-to-treat analysis in XHS and SHS treatment groups respectively. There was a mean difference of 0.029 in adjusted utility index in favour of XHS with no evidence of a difference between treatment groups (95% confidence interval -0.013 to 0.070; p = 0.175). There was no evidence of any differences between treatment groups in any of the secondary outcomes. The pattern and overall risk of adverse events associated with both treatments was similar. Conclusion Any difference in four-month health-related quality of life between the XHS and SHS is small and not clinically important. There was no evidence of a difference in the safety profile of the two treatments; both were associated with lower risks of revision surgery than previously reported.

The Impact of Prior Use of Corticosteroid to Dental Extraction on Oral Health-Related Quality-of-Life and Clinical Outcomes: A Randomized Clinical Trial

2020 ◽  
Vol 78 (12) ◽  
pp. 2153.e1-2153.e9
Author(s):  
Heitor B. Pansard ◽  
Mayara C. Prado ◽  
Gabriel F. Marchi ◽  
Camila S. Sfreddo ◽  
Jovito A. Skupien
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Oral Health ◽  
Randomized Clinical Trial ◽  
Health Related Quality ◽  
Prior Use ◽  
Related Quality ◽  
Health Related ◽  
The Impact

scholarly journals Impact of TG4010 Vaccine on Health-Related Quality of Life in Advanced Non-Small-Cell Lung Cancer: Results of a Phase IIB Clinical Trial

PLoS ONE ◽  
2015 ◽  
Vol 10 (7) ◽  
pp. e0132568 ◽  
Author(s):  
Christine Rotonda ◽  
Amélie Anota ◽  
Mariette Mercier ◽  
Bérangère Bastien ◽  
Gisèle Lacoste ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Clinical Trial ◽  
Small Cell Lung Cancer ◽  
Small Cell ◽  
Health Related Quality ◽  
Small Cell Lung ◽  
Related Quality ◽  
Health Related

scholarly journals Hip function and health-related quality of life in intramedullary and extramedullary internal fixation of trochanteric fractures

2020 ◽  
Vol 148 (7-8) ◽  
pp. 451-454
Author(s):  
Milan Mitkovic ◽  
Sasa Milenkovic ◽  
Ivan Micic ◽  
Igor Kostic ◽  
Predrag Stojiljkovic ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Internal Fixation ◽  
Harris Hip Score ◽  
Health Related Quality ◽  
Trochanteric Fractures ◽  
Component Score ◽  
Related Quality ◽  
Health Related ◽  
Hip Function

Introduction/Objective. There are extramedullary and intramedullary methods of trochanteric fractures? internal fixation with implants having a lag screw. The objective of this study was to examine the difference in impact of these fixation types on final hip function and health-related quality of life. Method. There were 75 patients treated for a trochanteric fracture, using self-dynamisable internal fixator (SIF group), as an extramedullary method, or gamma nail (GN group), as an intramedullary method. These patients were called for the evaluation of Harris Hip Score (HHS) and SF-12 questionnaire at least two years after surgery. The SF-12 questionnaire has dual expression ? physical component score (PCS) and mental component score (MCS). Results. There were no significant differences between the SIF group and the GN group regarding HHS, PCS, and MCS. Positive correlation was confirmed between HHS, PCS, and MCS, with the strongest relation between HHS and PCS. Negative correlation was confirmed between age and HHS. Conclusion. There was no difference in final hip function and health-related quality of life between SIF and GN methods in trochanteric fractures treatment (p > 0.05). These parameters of outcome were confirmed to have positive interrelation (p < 0.05). Both submuscular presence of extramedullary implant with dimensions of SIF and the need for bone reaming in cephalomedullary fixation were considered not to have significant impact in HHS and SF-12 scores after trochanteric fractures treatment by internal fixation.

scholarly journals A.01 The relationship between fatigue and health-related quality of life in a clinical trial population of Duchenne muscular dystrophy patients

2017 ◽  
Vol 44 (S2) ◽  
pp. S8-S8
Author(s):  
Y Wei ◽  
B El-Aloul ◽  
C Nguyen ◽  
E Zapata-Aldana ◽  
C Campbell
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Duchenne Muscular Dystrophy ◽  
Muscular Dystrophy ◽  
Parent Report ◽  
Health Related Quality ◽  
Patient Report ◽  
Related Quality ◽  
Health Related

Background: Fatigue was recently reported to be the largest contributor to poor health-related quality of life (HRQOL) in paediatric Duchenne muscular dystrophy (DMD). Additional studies are necessary to confirm the generalizability of this finding. Our objective was to explore the longitudinal relationship between fatigue and HRQOL in an additional cohort of DMD patients. Methods: We performed a secondary analysis of data from a clinical trial (NCT00592553), which enrolled patients with nonsense mutation DMD, aged 5–20 years, from 37 sites in 11 countries (N=174). Fatigue and HRQOL were assessed using the PedsQLTM Multidimensional Fatigue Scale and Generic Core Scales, respectively, by patient- and parent-report at baseline and over 48 weeks. Results: Patients reported greater fatigue than healthy controls from published data. There was no significant difference between patient- and parent-reported fatigue. Fatigue was significantly correlated with worse HRQOL at baseline, by patient-report (r=0.70, P<0.001) and parent-report (r=0.70, P<0.001); and at 48 weeks, by patient-report (r=0.79, P<0.001) and parent-report (r=0.74, P<0.001). Change in fatigue was significantly correlated with change in HRQOL over 48 weeks, by patient-report (r=0.64, P<0.001) and parent-report (r=0.67, P<0.001). Conclusions: Fatigue is a major contributor to HRQOL in DMD. The strong association between fatigue and HRQOL corroborates previous studies, and suggests that reducing fatigue may improve HRQOL.

Chewing ability and oral health‐related quality of life in frail elders after new complete dentures insertion: A paired controlled clinical trial

2020 ◽  
Vol 40 (2) ◽  
pp. 168-174 ◽  
Author(s):  
Olívia Maria Costa Figueredo ◽  
Mariana Barbosa Câmara‐Souza ◽  
Talita Malini Carletti ◽  
Renata Cunha Matheus Rodrigues Garcia
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Controlled Clinical Trial ◽  
Complete Dentures ◽  
Health Related Quality ◽  
Frail Elders ◽  
Chewing Ability ◽  
Related Quality ◽  
Health Related
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