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临床试验/NCT05602155
NCT05602155已完成不适用

Comparison of Full-Weight and Partial-Weight-Bearing Patient Groups in Patients Over 65 Years of Age Who Underwent Proximal Femoral Nail Due to Intertrochanteric Fracture of the Femur

Kahramanmaras Sutcu Imam University1 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2018年8月1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
133
试验地点
1
主要终点
demographic datas

研究概览

简要总结

Femur intertrochanteric fractures (FITC) are one of the most common fractures of the lower extremity, caused by osteoporosis, caused by minor trauma in elderly patients. Today, it is successfully treated with proximal femoral nails (PFN) designed in different ways. After surgical fixation with PFN, patients are mobilized by placing full weight, but some complications can be seen due to the patients being osteoporotic. In this study, the investigators planned to investigate the effect of full weight bearing and partial weight bearing on complications, which were not previously described in the literature.

详细描述

Participants over the age of 60 who underwent PFN with the diagnosis of FITK were randomized (double-blinded consecutive full load on one patient and partial weight on one patient), and mobilized a group with full weight with the help of a walker after surgical fixation, and the other group with the help of a walker to give partial weight (balance). We planned to follow up his treatment prospectively. The compatibility of the groups will be evaluated by comparing the bone mineral density, calcium, alkaline phosphatase, phosphate, vitamin D levels and ages of the patients. Fracture types and post-treatment reduction quality of patients in both groups will be compared. We planned to compare the complication rates, Barthel Index and harris hip scores in the follow-up of the patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 95 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over 65 years of age with intertrochanteric femoral fractures
  • Patients treated with proximal femoral nail
  • Patients able to walk before treatment
  • Patients who can be contacted

排除标准

  • Patients without regular follow-up for 1 year
  • Patients who do not walk before or after fracture
  • who have a neurological disease
  • Patients with partial hip replacement after fracture
  • Patients who cannot be contacted after treatment
  • Patients who died within 1 year after treatment

结局指标

主要结局

demographic datas

时间窗: August 2018

Descriptive statistical data

comparison of groups

时间窗: patient's last control date, at least 1 year later

Following time (month): The time elapsed between the date the patient came for the last control and the first application

次要结局

未报告次要终点

研究者

发起方
Kahramanmaras Sutcu Imam University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Duran Topak

Orthopaedic Clinical Assoc. Prof.

Kahramanmaras Sutcu Imam University

研究点 (1)

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