跳至主要内容
临床试验/CTRI/2025/02/081105
CTRI/2025/02/081105招募中不适用

Assessing the progression of Knee Joint Osteoarthritis using Arthro-kinematic and Finite Element Analysis: A Prospective Cohort study

All India Institute of Medical Sciences AIIMS Rajkot1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2025年3月15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
55
试验地点
1
主要终点
The patients will be selected using eligibility criteria and provide written consent. Demographics and medical history will be recorded via a patient information sheet. They will be divided into two groups: the study group, receiving customized orthotics after correction of the knee joint mechanical axis, and the control group, receiving conventional management (e.g., physiotherapy, knee belt). Both groups will be followed up at 3-month intervals.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • Age 35 years and above.
  • Patient with degenerative changes in knee with any deviation from the normal mechanical axis.

排除标准

  • Patients under 35 years.
  • Patients with any contraindication for MRI like electronic device, metallic implants, etc.
  • Patients with claustrophobia.
  • Neurological disorders, systemic disorders, muscular dystrophy, metabolic bone diseases affecting bone metabolism.
  • Soft tissue, or bone swelling causing knee misalignment.
  • Axial skeleton deformities.
  • Conditions requiring surgery.
  • Already operated cases for knee joint osteoarthritis.
  • Gross deformity in proximal (hip) and distal (ankle joint and foot) segments.
  • BMI above morbid obesity.

结局指标

主要结局

The patients will be selected using eligibility criteria and provide written consent. Demographics and medical history will be recorded via a patient information sheet. They will be divided into two groups: the study group, receiving customized orthotics after correction of the knee joint mechanical axis, and the control group, receiving conventional management (e.g., physiotherapy, knee belt). Both groups will be followed up at 3-month intervals.

时间窗: Both groups will be followed up at 3-month intervals. MRI will be performed at the baseline and will be done at 9 and 18 months, whereas arthro-kinematic analysis shall be done at 3, 6, 9, 12, 15 and 18 months.

At baselines:

时间窗: Both groups will be followed up at 3-month intervals. MRI will be performed at the baseline and will be done at 9 and 18 months, whereas arthro-kinematic analysis shall be done at 3, 6, 9, 12, 15 and 18 months.

A.MRI will be done of the knee joint affected side.

时间窗: Both groups will be followed up at 3-month intervals. MRI will be performed at the baseline and will be done at 9 and 18 months, whereas arthro-kinematic analysis shall be done at 3, 6, 9, 12, 15 and 18 months.

B. Anthropometric analysis of knee joint variables will be conducted as follows using ‘RadiANT DICOM Viewer’ software:

时间窗: Both groups will be followed up at 3-month intervals. MRI will be performed at the baseline and will be done at 9 and 18 months, whereas arthro-kinematic analysis shall be done at 3, 6, 9, 12, 15 and 18 months.

C. Knee joint biomechanical findings (Range of motion)

时间窗: Both groups will be followed up at 3-month intervals. MRI will be performed at the baseline and will be done at 9 and 18 months, whereas arthro-kinematic analysis shall be done at 3, 6, 9, 12, 15 and 18 months.

1. Flexion at knee joint (Active/passive)

时间窗: Both groups will be followed up at 3-month intervals. MRI will be performed at the baseline and will be done at 9 and 18 months, whereas arthro-kinematic analysis shall be done at 3, 6, 9, 12, 15 and 18 months.

2. Extension at knee joint (Active/passive)

时间窗: Both groups will be followed up at 3-month intervals. MRI will be performed at the baseline and will be done at 9 and 18 months, whereas arthro-kinematic analysis shall be done at 3, 6, 9, 12, 15 and 18 months.

3. Internal rotation (active/passive)

时间窗: Both groups will be followed up at 3-month intervals. MRI will be performed at the baseline and will be done at 9 and 18 months, whereas arthro-kinematic analysis shall be done at 3, 6, 9, 12, 15 and 18 months.

4. External rotation (active/passive)

时间窗: Both groups will be followed up at 3-month intervals. MRI will be performed at the baseline and will be done at 9 and 18 months, whereas arthro-kinematic analysis shall be done at 3, 6, 9, 12, 15 and 18 months.

次要结局

  • Finite element analysis of the knee joint (side) will be done using the sift copies of the MRI scans using the following parameters:(1 Contact area (mm3))

研究者

发起方
All India Institute of Medical Sciences AIIMS Rajkot
申办方类型
Government medical college
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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