跳至主要内容
临床试验/NCT04851509
NCT04851509招募中不适用

Static Helical Screw Locking of Pertrochanteric Femur Fractures Using the TFN-Advanced Proximal Femoral Nailing System - a Randomized Trial

Fraser Orthopaedic Research Society2 个研究点 分布在 1 个国家目标入组 218 人开始时间: 2021年5月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
218
试验地点
2
主要终点
Radiographic Assessment

研究概览

简要总结

The study will investigate the shortening and collapse of pertrochanteric fractures following surgical management with the TFN-Advanced nailing system. The focus will be on comparing radiographic assessments of nails which have been statically locked versus dynamically locked. This is a randomized control study with the initial invention being randomized to either statically locking or dynamically locking. For a two-month period, all eligible patients will receive the randomized allocated treatment, then treatment will switch to the alternate treatment for the next two months and will continue to alternate treatments for two-month periods until study enrollment has completed.

详细描述

Hip fractures are common injuries in the elderly population that result in significant morbidity and mortality and a significant burden on health care systems. Hip fractures can be treated with arthroplasty or with internal fixation, depending on the fracture pattern. Cephalomedullary nailing (CMN) has become one of the established treatments for intertrochanteric hip fractures with a wide variety of implant designs from many different companies. The TFN-ADVANCED™ Proximal femoral nailing system (TFN-A) is a novel implant for treating intertrochanteric and subtrochanteric proximal femur fractures with a paucity of published literature on the performance of this implant.

A method to decrease the amount of fracture compression is to use the set screw to lock the screw "statically" so it does not slide to the same degree as if the screw is placed in the "dynamic" or sliding position. To the knowledge of the investigators, the role of statically locking the screw to prevent fracture collapse has not been studied. Statically locking CMN to treat hip fractures has become standard of care at the Royal Columbian Hospital with all the investigating surgeons having adopted this practice in an attempt to prevent significant fracture collapse and neck shortening. Anecdotally, the investigators have not seen significant rates of cephalic screw cut-out over the past five years, and believe the investigators' screw cut-out rates are lower than what is reported in the literature. The investigators have been using the Gamma Nail (Stryker) to statically lock the screw as the previous TFN lacked the ability for static locking. However, with the advent of the TFN-A, the investigators have adopted this implant as their long cephalomedullary nail of choice for fixation of pertrochanteric femur fractures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Surgeons cannot be blinded to the treatment allocation of the surgical intervention due to having to perform the static or dynamic rotational lock. Participants will be blinded to the form of locking they receive. Research personnel completing the outcome measures will be blinded. Data analyst(s) and the radiographic reviewer(s) will be blinded to the treatment arm.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients >18 years of age
  • AO/OTA 31-A fractures who the surgeon deems eligible for treatment with a cephalomedullary nail
  • Open and closed fractures
  • Ambulatory prior to injury (with or without walking aides)
  • Native (non-fractured, no implant) contralateral hip
  • Willing and able to sign consent (substitute decision maker)

排除标准

  • Contralateral hip fracture or hip arthroplasty
  • Fracture not amenable to treatment with a cephalomedullary nail
  • Non-ambulatory patient
  • Fractures >14 days (time of injury to OR)
  • Bilateral pertrochanteric hip fractures
  • Non-unions
  • Pathologic fractures
  • Periprosthetic fractures
  • Patients with spinal injury
  • Incarceration
  • Pregnancy
  • Limited life expectancy due to significant medical co-morbidities or medical contra-indications to surgery
  • Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e., patients with no fixed address, report a plan to move out of town, or intellectually challenged patients without adequate family support).

结局指标

主要结局

Radiographic Assessment

时间窗: 12 months post treatment

The primary objective of this study will be to investigate how statically locking the TFN-A influences shortening or collapse of pertrochanteric fractures by measuring radiographic shortening or collapse of pertrochanteric fractures treated with the TFN-A implant.

次要结局

  • Fracture Reduction Quality(Intra-operatively)
  • Femoral Offset(1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months)
  • Tip-Apex distance(1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months)
  • Complications(intra-operatively, 1 day post-op, 6 weeks, 12 weeks, 6 months, and 12 months)

研究者

发起方
Fraser Orthopaedic Research Society
申办方类型
Network
责任方
Sponsor

研究点 (2)

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