1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [sundip.charmode@yahoo.com].
   


6. For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2027?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

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.