Dataset Information

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.

ABSTRACT: INTRODUCTION:Intertrochanteric 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 ANALYSIS:A 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 DISSEMINATION:The 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 NUMBER:ACTRN12618001431213.

SUBMITTER: Sivakumar A

PROVIDER: S-EPMC7044810 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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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.

Sivakumar Arjun A Thewlis Dominic D Ladurner Andreas A Edwards Suzanne S Rickman Mark M

BMJ open 20200210 2

<h4>Introduction</h4>Intertrochanteric 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 dynam ...[more]

PMID: 32047013

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Project description:BackgroundThe aim of this meta-analysis was to evaluate the advantages and disadvantages of proximal femoral nail anti-rotation (PFNA) versus dynamic hip screw (DHS) for the treatment of unstable intertrochanteric fractures, including the available evidence drawn from the literature.MethodsA systematic search was conducted to identify available and relevant randomized controlled trials and retrospective comparative observational studies regarding PFNA compared against DHS in treating unstable femoral intertrochanteric fractures in Embase, PubMed, Cochrane Library, Web of Science, and Scopus Online up to February 12, 2022. Data from the included studies were extracted independently by 2 reviewers and analyzed using RevMan 5.3, and the quality of the studies was assessed.ResultsFive randomized controlled trials and 12 observational studies were recruited and met the inclusion criteria, which consisted of 1332 patients with PFNA and 1271 patients with DHS. The results of the meta-analysis showed that, compared with the DHS, PFNA exhibited a beneficial role in postoperative Harris Hip Scores, operation time, intraoperative blood loss, length of hospital stay, fracture healing time and full weight-bearing time, limb shortening, cutout, reoperation, union problems, the varus collapse of the femoral head/neck, and infection; however, DHS was superior to PFNA in hidden blood loss (relative risk [RR] = 139.81, 95% confidence interval [CI] [136.18, 143.43], P < .00001), postoperation drainage (RR = -17.85, 95% CI [-30.10, -5.60], P = .004), total blood loss (RR = 50.34, 95% CI [42.99, 57.69], P < .00001), and femoral shaft fracture (RR = 4.72, 95% CI [1.15, 19.32], P = .03) treated by DHS were significantly decreased, compared with those by PFNA; however, no significant differences were observed in tip-apex distance, fixation failures, screw migration, or other complicants between the 2 surgical methods.ConclusionAnalysis of a large number of relevant clinical indicators available shows that PFNA has better clinical manifestation than DHS in treating unstable femoral intertrochanteric fractures.

Project description:Background:Proximal femoral nail antirotation-2 (PFNA-2) has been widely used to treat intertrochanteric fractures with varied outcomes in the previous studies. The entry point of the nail plays an important role in achieving acceptable reduction, stable fixation, and avoiding implant related complications. This study was proposed to determine the optimal greater trochanteric entry point for PFNA-2 in unstable intertrochanteric femur fractures. Methods:We conducted an observational study on 40 patients with unstable intertrochanteric fracture treated with PFNA-2 implant in a tertiary care hospital. The patients were grouped into two based on the entry point: group L for lateral and group M for medial entry. Randomization was carried out by assigning the patients to the group by alternate allocation. The quality of reduction, tip apex distance, Cleveland index, and all the complications were noted. The final follow-up was conducted at six months. The functional outcome was evaluated using modified Harris hip score. The data analysis was performed using Student's t-test, chi square test, and Mann-Whitney test. A P value below 0.05 was considered significant. Results:Forty patients with 20 patients treated with medial entry point were included in group M and 20 patients in group L with lateral entry point. The group L had an average tip apex distance of 20.53 and group M had 20.02 (P=0.8). The complication of screw back out was seen in 3 out of 4 patients with poor reduction in group L. As per the Cleveland index, 6 patients in each group had suboptimal position and 4 out of 6 patients in group L with suboptimal position had screw back out. The lateral cortex impingement was seen in 14 patients of group L and 6 patients in group M with significant comparison (P=0.01). Three patients in group L had varus collapse with screw back out. Also, none in group M (0.05). The average modified Harris hip score in group L at six months follow-up was 71.94 and 76.8 in group M (P=0.84). Conclusion:Overall, to achieve good quality of fixation and reducing damage to gluteus medius entry point for PFNA-2 should be 5?mm medial to the greater trochanter tip.

Project description:BackgroundA meta-analysis to access the pros and cons of proximal femoral nail anti-rotation (PFNA) versus InterTAN nail for intertrochanteric femoral fractures including available evidence extracted from literature.MethodsAccording to the Cochrane systemic analysis method, randomized control trials (RCTs) and retrospective comparative observational studies which were related to the comparison of PFNA and InterTAN nail in the treatment of the elderly with intertrochanteric fractures were retrieved. Data were independently extracted from the included studies by two reviewers and analyzed using RevMan 5.3, and the quality of the studies was assessed.ResultsTwo RCTs and seven observational studies were recruited, which consisted of 681 patients with PFNA and 651 patients with InterTAN nail. The meta-analyses showed no significant differences between the two approaches on Harris Hip Score, operation time, blood loss, time to union, mean hospital stay, union problems, intraoperative complications, hematoma, infection, and other complications in both RCTs and observational studies. In terms of other outcomes, for the RCTs, results showed that there were shorter tip-apex distance and reduced pain at thigh or hip in InterTAN nail than in PFNA; however, InterTAN nail was not superior to PFNA in cutout, reoperation, and femoral shaft fracture; for observational studies, the risk of the screw migration (RR = 5.13, 95%CI [1.33,19.75], P = 0.02), cutout (RR = 3.26, 95%CI [1.64,6.47], P = 0.0008), the varus collapse of the femoral head (RR = 7.19, 95%CI [2.18,23.76], P = 0.001), femoral shaft fracture (RR = 5.73, 95%CI [2.24,14.65], P = 0.0003) treated by InterTAN nail were significantly decreased, compared with those by PFNA; however, no significant differences were observed in the aspects of tip-apex distance and pain at thigh or hip between these two groups.ConclusionAnalysis of a large number of relevant clinical indicators available shows that InterTAN nail has better clinical manifestation than PFNA in treating unstable femoral intertrochanteric fractures.

Project description:AbstractThe optimal surgical treatment of intertrochanteric femur fractures (ITF) to minimize the increased mortality in geriatric patients with high anesthetic risk was investigated by comparing closed external fixation (EF), a minimal invasive and biological osteosynthesis technique, proximal femoral nail (PFN) and hemiarthroplasty (HA) methods.Three different surgical methods were performed to 167 patients who were admitted to our clinic for ITF between 2014 and 2020 and considered at high risk (American Society of Anesthesiologists III - American Society of Anesthesiologists IV) by the Anesthesiology and Reanimation Department. Patients with multi-trauma, osteoarthritis, those with malignancies and developmental hip dysplasia were excluded from the study. Group I included patients who underwent closed reduction - external fixation (n = 46), Group II included patients who underwent partial arthroplasty (n = 77), and Group III included those who received PFN (n = 44). All fractures were classified according to the Modified Evans (Kyle) method and divided into 2 categories as type 1-2 (stable) and type 3-4 (unstable).The mean operation duration was 23 minutes and follow-up time was 14 months in Group 1, in which there was no in-hospital mortality. Five patients died due to non-operative reasons within 1 year. The mean operation duration and follow-up time in Group 2 were 40 minutes and 12 months, respectively. Six patients (7.8%) died during the operation or hospitalization, while 17 patients died due to comorbidities within 1 year. In Group 3, the mean operation duration and follow-up time were 40 minutes and 13 months, respectively. One patient died during the operation and 1 patient (n = 2, 4.5%), within 24 hours in the postoperative intensive care unit. Seven patients died due to comorbidities within 1 year. Statistical analysis revealed that the mean duration of operation, postoperative hospital stay, overall mortality and blood product transfusion amount were significantly lower in the EF group compared to other treatment methods.Closed EF is the most reliable surgical method that can minimize mortality in geriatric patients compared to other surgical options, due to the short duration of the operation, no evacuation of the fracture hematoma, early mobilization, lack of blood transfusion requirement, and early union.

Dataset Information

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.

Publications

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.

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