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 01-01-2028 and end date provided 31-12-2029?
   Response - Immediately following publication. No end date.
   


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

Knee joint osteoarthritis is the second most common rheumatologic problem in Indian with a prevalence of 28.7 percent. There is no effective treatment to reverse the degenerative process, so the patient chooses to undergo surgical intervention as a management approach, which has its own disadvantages. Advancements in digital medicine and computing have enhanced finite element analysis (FEA), enabling non-invasive, cost-effective simulations of tissue mechanics through which stress and strains, deformations at tissue level can be observed in various structures of the body. In recent years, many researchers across the world have used FEA to visualize the tissue level and biomechanical changes occurring in osteoarthritic knee joints. In India, only couple of studies exist who have use FEA to study the underlying patho-physiology. The present prospective study aims to used FEA to prepare subject-specific 3D joint models of osteoarthritic knee joints before and after correction of its mechanical axis. Thus, FEA and modelling shall be used in facilitating the orthotics management, and shall observe the tissue level and biomechanical changes, along with contact pressures analyzing how the correcting the mechanical axis impacts the degenerative process in the osteoarthritic knee joints in Indian population despite their variable sitting postures.

This prospective study will be conducted in collaboration with the Department of Physics of Saurashtra university. The patients with knee osteoarthritis will be selected using the eligibility criteria and the radiological data (like MRI and X ray) will be collected after taking informed consent. Patient   demographics will be collected using a case record form. In case of any additional radiological investigations is required for the study purpose, it shall be conducted, and the soft copies of the data will be processed in RadiANT DICOM software and the measurements of knee condyles, cartilage, meniscus and joint spaces conducted. The entire data shall be provided to the department of physics for processing into Mimics (or equivalent software) for data segmentation and conversion into 3D models. Later, finite element software’s namely Abacus, ANSYS or any other equivalent software will be used to assign material properties and to calculate the stress, strain, density distribution and various other physical parameters when it is subjected to static load using the software. The FEA results will be shared to AIIMS Rajkot and based on them orthotic management will be provided to the patient. The patients will be followed up prospectively at regular periods and the FEA and joint modelling will be done to observe the tissue level and biomechanical changes along with contact pressures in the said joint, thereby observing the progression of the degenerative process in osteoarthritic knee joints.