scholarly journals Prospective randomised controlled trial of an intramedullary nail versus a sliding hip screw for intertrochanteric fractures of the femur

2013 ◽  
Vol 38 (1) ◽  
pp. 155-161 ◽  
Author(s):  
Ioannis Aktselis ◽  
Constantine Kokoroghiannis ◽  
Evaggelos Fragkomichalos ◽  
Georgios Koundis ◽  
Anastasios Deligeorgis ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Intramedullary Nail ◽  
Controlled Trial ◽  
Intertrochanteric Fractures ◽  
Sliding Hip Screw ◽  
Hip Screw ◽  
Randomised Controlled ◽  
Fractures Of The Femur

scholarly journals Proximal Femoral Nail Unlocked versus Locked (ProFNUL): a protocol for a multicentre, parallel-armed randomised controlled trial for the effect of femoral nail mode of lag screw locking and screw configuration in the treatment of intertrochanteric femur fractures

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e032640 ◽  
Author(s):  
Arjun Sivakumar ◽  
Dominic Thewlis ◽  
Andreas Ladurner ◽  
Suzanne Edwards ◽  
Mark Rickman
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Functional Independence ◽  
Local Health ◽  
Intertrochanteric Fractures ◽  
Management Options ◽  
Lag Screw ◽  
Femoral Nail ◽  
Surgical Data ◽  
Randomised Controlled

IntroductionIntertrochanteric fractures are common fragility injuries in the elderly. Surgical fixation using intramedullary devices are one of the widely used management options. To date, evidence demonstrating the effects of lag screw configuration and the mode of lag screw locking in these devices is lacking. The purpose of this study is to investigate whether the lag screw configuration (single vs integrated dual interlocking screw) and the mode of lag screw locking (static vs dynamic) of a femoral nail device result in differences in clinical and functional outcomes.Methods and analysisA multicentre, pragmatic, single-blinded randomised controlled trial (RCT) with a three-arm parallel group design is proposed. Nine-hundred patients with intertrochanteric fractures (A1 and A2 AO/OTA) will be randomised to fracture treatment using a Gamma3 nail (Stryker; proximally dynamic) or a Trigen Intertan nail (Smith & Nephew) in a dynamic or static lag screw configuration. The primary outcome measure consists of radiological evidence of construct failure within 6 months following surgery, with failure being defined as breakage of the femoral nail or distal locking screw, a change in tip-apex distance of more than 10 mm or lag screw cut-out through the femoral head. Secondary outcomes include surgical data (operation time, fluoroscopy time), complications (surgical site infection, reoperation, patient death), return to mobility and home circumstances, functional independence, function and pain. Patients who are able to walk independently with or without a mobility aid and are able to answer simple questions and follow instructions will be asked to participate in three dimensional gait analysis at 6 weeks and 6 months to assess hip biomechanics from this cohort. Additional secondary measures of gait speed, hip range of motion, joint contact and muscle forces and gross activity monitoring patterns will be obtained in this subgroup.Ethics and disseminationThe Central Adelaide Local Health Network Human Research Ethics Committee has approved the protocol for this RCT (HREC/17/RAH/433). The results will be disseminated via peer-reviewed publications and presentations at relevant conferences.Trial registration numberACTRN12618001431213.

Treatment of OTA type A2 Intertrochanteric Fractures of the Femur Using Sliding Hip Screw: An Analysis of Risk Factors

2006 ◽  
Vol 18 (5) ◽  
pp. 479 ◽  
Author(s):  
Sang Hoon Lee ◽  
Jong Deuk Rha ◽  
Hyun Soo Park ◽  
Young Soo Jang ◽  
Tae Won Chung ◽  
...  
Keyword(s):  
Risk Factors ◽  
Intertrochanteric Fractures ◽  
Sliding Hip Screw ◽  
Hip Screw ◽  
Fractures Of The Femur

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.

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