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临床试验/NCT05363943
NCT05363943已完成不适用

Double Plating (DP) Fixation vs Distal Femoral Replacement (DFR) in the Management of Distal Femoral Fractures in Geriatric Patients.

Amr Gamaleldin Mahmoud Khalil Gendya2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年8月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
change in Knee Society Score

研究概览

简要总结

The aim of this study was to compare the functional and radiological outcomes of fixation by using double plating technique versus replacement using distal femur tumor prothesis as a primary management for the distal femoral fractures in geriatric patients. The hypothesis was that the distal femoral replacement will yield better functional outcome and earlier rehabilitation and return to pre-injury level of activity.

详细描述

Geriatric distal femoral fractures represent a major challenge for the orthopedic surgeons, to the present days still there is no definite algorithm or specific guidelines that can be used accurately in the management of these fractures. Unlike hip fractures however, there is no widely accepted treatment algorithm or standard of care.

The surgical treatment of distal femoral fractures depends on both patient and fracture characteristics. Options include conservative treatment, open reduction internal fixation, intramedullary nails, or recently distal femoral replacement.

There is currently a move towards distal femoral replacement (DFR) for these complex fractures which has the potential benefit of allowing early weight bearing, and therefore aiming to prevent complications associated with immobility and non-union.

Using distal femoral replacement had yield good results in small case series, as it allows immediate full weightbearing, eliminate the risk of nonunion and may provide greater satisfaction scores. However, DFR has its own risks, most notably deep infection, and loosening. While a DFR is more costly compared with fixation plates and nails, the initial increased cost may be outweighed by faster rehabilitation and return to the patient's usual place of residence.

In the study, the investigators are aiming to compare the functional and radiological outcomes of fixation by using double plating technique versus replacement as a primary management for the geriatric distal femoral 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 (Care Provider, Investigator)

入排标准

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

入选标准

  • AO 33 A3 and 33 C fractures
  • Age group ≥ 60 years
  • Closed fractures
  • Neurovascular intact

排除标准

  • Open fractures
  • Non ambulant patients
  • Patients with peripheral neurovascular diseases
  • Peri-prosthetic fractures
  • Associated other orthopedic injuries
  • Poly-traumatized patients
  • Pathological fractures

结局指标

主要结局

change in Knee Society Score

时间窗: 1 month, 6 month and 12 month

the score has two-part, knee and function parts. The score is graded from 0 to 100 in each domain with 100 is the best outcome and 0 is the worst. The knee part assesses the range of motion, pain, and alignment of the joint while the function part assesses walking, stairs and usage of walking aids.

次要结局

  • Postoperative complications(form first day to 12 month)
  • Operative time(At the operation)
  • Reoperation rate(form first day to 12 month)
  • change in Knee range of motion(1 month and 12 month)

研究者

发起方
Amr Gamaleldin Mahmoud Khalil Gendya
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Amr Gamaleldin Mahmoud Khalil Gendya

Assistant Lecturer , Ain Shams University.

Ain Shams University

研究点 (2)

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