| CTRI Number |
CTRI/2025/12/098947 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
10/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding How Foot Deformity Affects Knee Pain and Knee Load in People with Knee Arthritis |
|
Scientific Title of Study
|
Effect of Hallux Valgus on Knee Joint Loading in Patients With Knee Osteoarthritis: A Case-Control Study |
| Trial Acronym |
HAV-KOA Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANAGHA K |
| Designation |
PG STUDENT |
| Affiliation |
INSTITUTE OF PHYSIOTHERAPY, SRINIVAS UNIVERSITY |
| Address |
MUSCULOSKELETAL SCIENCES AND SPORTS PHYSIOTHERAPY DEPARTMENT,
INSTITUTE OF PHYSIOTHERAPY,
SRINIVAS UNIVERSITY,
PANDESHWAR,
DAKSHINA KANNADA
MANGALORE
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
6282207301 |
| Fax |
|
| Email |
anaghapramod2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MADHURIPU P |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Institute of physiotherapy, Srinivas University |
| Address |
MUSCULOSKELETAL SCIENCES AND SPORTS PHYSIOTHERAPY DEPARTMENT,
INSTITUTE OF PHYSIOTHERAPY,
SRINIVAS UNIVERSITY,
PANDESHWAR,
DAKSHINA KANNADA
MANGALORE
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9446292852 |
| Fax |
|
| Email |
madhuripu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANAGHA K |
| Designation |
PG STUDENT |
| Affiliation |
Institute of Physiotherapy, Srinivas university |
| Address |
MUSCULOSKELETAL SCIENCES AND SPORTS PHYSIOTHERAPY DEPARTMENT,
INSTITUTE OF PHYSIOTHERAPY,
SRINIVAS UNIVERSITY,
PANDESHWAR,
DAKSHINA KANNADA
MANGALORE
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
6282207301 |
| Fax |
|
| Email |
anaghapramod2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTE OF PHYSIOTHERAPY, SRINIVAS UNIVERSITY,
PANDESHWAR,
MANGALORE, DAKSHINA KANNADA,
KARNATAKA, INDIA
575001 |
|
|
Primary Sponsor
|
| Name |
ANAGHA K |
| Address |
INSTITUTE OF PHYSIOTHERAPY, SRINIVAS UNIVERSITY,
PANDESHWAR
MANGALORE |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| ANAGHA K |
MUSCULOSKELETAL SCIENCES AND SPORTS PHYSIOTHERAPY OPD |
Musculoskeletal sciences and sports physiotherapy department,
Institute of Physiotherapy,
Srinivas University,
City campus- ground floor,
Pandeshwar,
Dakshina Kannada,
Mangalore
Dakshina Kannada
KARNATAKA |
6282207301
anaghapramod2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD AND ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Bilateral or unilateral OA knee
2. Individuals who fulfilled American College of Rheumatology criteria for knee osteoarthritis using history and physical examination
1a. Pain in the knee and any 3 of the following
2b. more than 50years of age
2c. less than 30 mins of morning stiffness
2d. Crepitus on active motion
2e. Bony tenderness
2f. Bony enlargement
2g. No warmth on palpation
3. Manchester self-assessment scale for HV score 2/3/4 as cases and score of 1 as controls.
|
|
| ExclusionCriteria |
| Details |
1. History of lower extremity trauma or surgery
2. Neurologic problems affecting balance
3. Knee pain associated with other conditions, including hip joint disorders, fibromyalgia, and radiculopathies
4. Diabetes mellitus (DM) for more than 15years
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| KNEE JOINT LOADING PATTERN |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VAS |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
01/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Primary Purpose: The primary purpose of this protocol is to evaluate the effect of hallux valgus (HV) on knee joint loading (KJL) patterns in patients with knee osteoarthritis (KOA). By comparing KOA patients with and without HV, the study aims to understand the biomechanical interplay between foot deformities and knee loading, which may inform targeted rehabilitation strategies.
Study Hypothesis: KOA patients with HV will exhibit altered knee joint loading patterns, specifically changes in knee adduction and flexion moments, compared to KOA patients without HV.
|