| CTRI Number |
CTRI/2025/09/094402 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prediction of Knee osteoarthritis using metabolic, mechanical, and X-ray markers |
|
Scientific Title of Study
|
Development and Validation of Knee Osteoarthritis Prediction Model Incorporating Metabolic, Mechanical and Radiographic Markers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sahil Kalra |
| Designation |
PhD Scholar |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Musculoskeletal Research Lab, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandehwar Deemed to be UNiversity,
Ambala
Ambala
HARYANA
133207
India |
| Phone |
7015426087 |
| Fax |
|
| Email |
sahilkalrask01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manu Goyal |
| Designation |
Professor and Principal |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Musculoskeletal Research Lab, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandehwar Deemed to be university,
Ambala
Ambala
HARYANA
133207
India |
| Phone |
8307715320 |
| Fax |
|
| Email |
manu.goyal@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manu Goyal |
| Designation |
Professor and Principal |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Musculoskeletal Research Lab, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandehwar Deemed to be UNiversity,
Ambala
Ambala
HARYANA
133207
India |
| Phone |
8307715320 |
| Fax |
|
| Email |
manu.goyal@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed To Be University, Mullana, Ambala,Haryana, 133207 |
|
|
Primary Sponsor
|
| Name |
Sahil Kalra |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed To Be University, Mullana, Ambala,Haryana, 133207 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Manu Goyal |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed To Be University, Mullana, Ambala,Haryana, 133207 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sahil Kalra |
Physiotherapy OPD, M.M. Superspeciality Hospital, Sadopur, Ambala |
Maharishi Markandeshwar College of Physiotherapy and Rehabilitation, M.M.University, Sadopur, Ambala
Ambala
HARYANA |
7015426087
sahilkalrask01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with symptomatic knee OA, confirmed by radiographic evidence (Kellgren-Lawrence classification)
Unilateral or Bilateral knee OA
|
|
| ExclusionCriteria |
| Details |
1. Osteoporosis
2. Any fixed deformity of lower limb and spine
3. Diagnosis of rheumatoid arthritis, gout, or other inflammatory or autoimmune joint disease.
4. History of TKR or knee surgery that may alter the natural progression of OA
5. Regular use of corticosteroids or other drugs significantly affecting joint metabolism.
6. Unwillingness to provide informed consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Metabolic marker - Lipid profile, HbA1c
Mechanical marker – Tibial Torsion, Q-angle
Radiological marker - X-ray
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="152"
Sample Size from India="152"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Osteoarthritis (OA) is a common chronic musculoskeletal disorder, often diagnosed using radiographic and clinical evaluations. However, early disease phases and molecular mechanisms may not be fully captured by these methods. Recent research suggests the role of metabolic, mechanical, and radiographic markers in OA diagnosis. A study will recruit patients with knee osteoarthritis, using x-rays, lipid profiles, HbA1c, and q-angle and tibial torsion as markers. The model aims to improve personalized treatment strategies and management of OA. |