跳至主要内容
临床试验/CTRI/2025/03/083182
CTRI/2025/03/083182尚未招募Phase 3 4

Comparison of Surgical, Functional and Radiological Outcomes following Integrated Screw and Nail System (ISNS)Versus Helical-Blade Anti- rotation Proximal Femoral Nail (PFNA2) in Trochantreic fractures - a Randomised Control Trial.

Pondicherry Institute of Medical science1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2025年4月4日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
入组人数
38
试验地点
1
主要终点
Operative time in minutes ,

研究概览

简要总结

Hip fractures are one of the most prevalent orthopaedic injuries as more than a million human subjects are prone for the same. Nearly half of all hip fractures are intertrochanteric femur fractures (IFFs), which are more common among the elderly and are often as a result of low-energy traumas. In order to achieve a satisfactory early recovery of the injured patients, surgical treatment is mandatory to manage these fractures. The gold standard therapy for stable intertrochanteric fractures, was earlier the dynamic hip screw (DHS) implant. However, they were found inadequate for the stabilizing fractures of the unstable kind. Contrarily, as opposed to extramedullary devices such as DHS, proximal femoral nails (PFN) have a biomechanical advantage because of their closer location to the vector of force as opposed to extramedullary devices, and shorter moment arm. Moreover, based on the results of several earlier reports, intramedullary fixation may be preferable to extramedullary fixation for hip fracture patients as the functional scores are higher and there is a lower risk of implant failure and reoperation. Further, only a minimally invasive procedure is required to implant a PFN. Therefore, a closed reduction of the fracture, aids to maintain the haematoma, and the surgeon can perform a minimally invasive procedure with least possible soft-tissue dissection, thereby lowering surgical trauma, blood loss, infection, and wound complications.

Healing of the bones is significantly managed by the interfragmentary linear compression provided by the lag screw in majority of the PFNs. One or two lag screws, integrated or locked lag screws, and a wedge block that offers rotational stability are some of the PFN designs available in the market. Clinical and radiological evaluations of only two distinct PFNs have been studied extensively. However, only few studies have compared the differences between ISNS and PFNA2 with respect to its surgical outcome, and radiological outcome in patients treated with closed reduction and internal fixation for IFFs and this study aims to bring in more light in this area.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All cases of isolated unilateral intertrochanteric femur fractures
  • Age more than18 years,
  • Patients consented to participate are included in the study.

排除标准

  • All open injuries and Pathological fractures
  • Patients refused to participate in this program,
  • Patients with associated injuries (such as head injury, abdominal injury, or other bone injuries),
  • Patients with a subtrochanteric femur fracture,
  • Patients with a intra-capsular femur fracture.

结局指标

主要结局

Operative time in minutes ,

时间窗: base line - during the day of surgery

Blood loss (ml) ,

时间窗: base line - during the day of surgery

Number of C-Arm shots

时间窗: base line - during the day of surgery

次要结局

  • Cut through, DVT, embolism , femoral neck angle, Hip apex angle, neck shaft angle, ROM, knee pain/ stiffness, Weight bearing, Modified harris hip score, Katz index(2 weeks, 6 weeks, 12 weeks, 18 weeks & 24 weeks after surgery)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Samuel Kirubakaran

Pondicherry Institute of Medical Sciences

研究点 (1)

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