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临床试验/NCT07542249
NCT07542249进行中(未招募)不适用

Retrograde Nail Versus Double Plating for Distal Femoral Extra-articular and Simple Articular Fractures With Metaphyseal Comminution

Benha University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年9月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
The Oxford Knee Score

研究概览

简要总结

The objective of this study is to compare the short term functional clinical and radiological outcomes of retrograde nail versus double plating for distal femoral extra-articular and simple articular fractures with metaphyseal comminution.

详细描述

Fractures of the distal femur are complex injuries that constitute a challenge to the orthopedic surgeon. It represents about 7% of all the femoral fractures. It usually occurs during high energy trauma in younger patients and frequently is associated with concomitant injuries. In elderly patients with severe osteopenia might sustain solitary distal femoral fractures from minor trauma such as simple fall.

The challenge for the surgeons remains in the balance of providing stable fixation to support physiological loading until union while allowing necessary micro motion for callus formation. So, significant advances have been made in treatment of these fractures in the past few decades. It is recognized that operative fixation with the ability to maintain anatomical reduction of the joint surface, restoring axial ligament and early range of motion presents clear advantages over closed means of treatment.

There are principles that have been proposed for the treatment of these fractures which include anatomical reduction of distal femoral articular surface, stable internal fixation, minimal soft tissue stripping and early active mobilization.

Comminuted distal femur fractures are associated with extensive soft tissue injuries like injuries to Ligaments of the knee, injuries to the surrounding muscles additional challenges like extensive bone loss, loss of soft tissue coating and these fractures produce very unfavorable conditions for fracture union. As the long list of challenges a surgeon has to face while treating such injuries, the functional outcomes are usually not satisfactory. These fractures are associated with high rates of malunion, nonunion and infection.

Intramedullary (IM) nail offers a potential biomechanical advantage over side plates and screws because the Intramedullary location results in less stress over the implant and better stress distribution than with eccentric side plate and screws. They have the potential for load shearing. Their use involves minimal soft tissue injury, short operative time, limited perioperative blood loss, and ability to mobilize patients early.

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
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male patients aged more than 18 years old and females more than 16 years old.
  • Both genders
  • Extra-articular fracture with metaphyseal comminution
  • Simple articular fractures with metaphyseal comminution

排除标准

  • Skeletally immature patients
  • Pathological fractures
  • Open fractures
  • Periprosthetic fractures
  • Medically unfit patients
  • Patients with pre-existing knee pathology
  • Neuro-vascular ipsilateral lower limb injuries

研究组 & 干预措施

Group A: will be treated by retrograde nail

Experimental

干预措施: Retrograde nail (Procedure)

Group B :will be treated by double plating

Experimental

干预措施: Double plating (Procedure)

结局指标

主要结局

The Oxford Knee Score

时间窗: 6 months

The Oxford Knee Score (OKS) is a 12-item patient-reported specifically designed and developed to assess function and pain after around knee surgeries. It is short, reproducible, valid and sensitive to clinically important changes. Scores range from 0 to 48, with lower scores indicating severe arthritis (0-19) and higher scores representing better joint function (40-48).

次要结局

  • Radiographic evaluation: The standard antero-anterior and the lateral radiograph views and oblique views will be evaluated both pre- and post-operatively for assessment of union and alignment and/or CT when necessary(before surgery and 6 months postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Elsayed Abdellah Elwarwary

Resident at Orthopedic surgery Ain Shams University

Benha University

研究点 (1)

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