跳至主要内容
临床试验/CTRI/2025/02/080391
CTRI/2025/02/080391招募中不适用

Fracture patterns in different anatomical locations and age demographics: A Cross-sectional Analysis of Microscopic Anatomy.

Dr Sundip Charmode1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年3月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
The primary outcome of the study is to study the fracture patterns in different anatomical locations at microscopic level in patients reporting to orthopedic OPD.

研究概览

简要总结

Till now it was thought that the bone repair and regeneration is controlled by the bone turnover process which is an interplay of bone cells (osteoblasts, osteoclasts and osteocytes), and osteo-inductive growth factors, but recently published review articles observed a major role of immune cells and pro-inflammatory cytokines behind it. These articles also say that the presence of an appropriate immune microenvironment is very important to create an acute inflammatory response which is essential for onset of bone repair and also for late bone remodeling. The bone callus is known to be histologically compatible and non-immunogenic and has osteogenic potential to be used as a graft, but very few studies have practically proven this in humans. These review articles have found that the reason behind slow bone repair and regeneration in elderly is the secretion of senescent markers by the older osteoblasts and osteoclasts, but human studies are required to prove their underlying mechanism. Thus, there is an urgent need to do human research studies to see the structure and function of bone callus with respect to its cellular composition, presence of osteo-inductive growth factors, and the existence of immune micro-environment using histological, immunohistochemistry analyses. No studies have examined the bone callus structure in different age groups, fracture locations and post-fracture times, creating to the need of our study.

The patients with fractures coming to orthopedic OPD, who will fulfil the eligibility criteria will be selected if they give written consent to participate in this project. General information of the patient and the medical/surgical history will be taken using a case record form. The bone callus samples will be collected from the patient during the operation by the orthopedic surgeon who is the co-investigator. The specimen shall be sent to histology laboratory of anatomy department to the principal investigator for staining using the standard histological methods. The stained specimens will be photographed using the trinocular microscope with attached camera and recorded by the principal investigator.      The quantitative data will be compiled in a master chart, tabulated and graphically represented. Later statistical analysis of the data will be done based on the various age groups, fracture sites and fracture period times and conclusions will be derived.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 18 years and above.
  • Any bone fractures treated with any modality of open reduction and internal fixation with any type of fixation device.
  • Secondary surgeries for internal fixation failures or hypertrophic nonunion.

排除标准

  • Patients under 18 years.
  • Fractures with infection, brain injury, bone tumors, systemic diseases, or those treated with hormones, steroids, vitamin D, or calcium.

结局指标

主要结局

The primary outcome of the study is to study the fracture patterns in different anatomical locations at microscopic level in patients reporting to orthopedic OPD.

时间窗: This is a cross-sectional study, so all the 50 study participants/patients and their respective callus samples shall be assessed for all the variables/parameters [Anthropometric and Microscopic] only at the time of their reporting to the OPD/IPD i.e. at the baseline. | No follow-up is going to be done in this study.

次要结局

  • The secondary outcomes of this project study is as follows:(1. To study the fractures patterns in patients reporting at varying periods of time to the orthopedic OPD.)

研究者

发起方
Dr Sundip Charmode
申办方类型
Other [All the expenses arising from this project study will be paid from my Learning resource allowance. ]
责任方
Principal Investigator
主要研究者

Dr Sundip Charmode

All-India Institute of Medical Sciences Rajkot

研究点 (1)

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