| CTRI Number |
CTRI/2019/09/021355 [Registered on: 20/09/2019] Trial Registered Prospectively |
| Last Modified On: |
08/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relation of flattening of foot with osteoarthritis of knee in adults |
|
Scientific Title of Study
|
Relation of flat foot with knee osteoarthritis in adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhvani Pankajkumar Naik |
| Designation |
Post Graduate Student |
| Affiliation |
Sumandeep Vidyapeeth an Institution Deemed to be University |
| Address |
PG Classroom, On Ground Floor, College of Physiotherapy, Sumandeep Vidyapeeth an Institution Deemed to be University, At and Post Piparia, Taluka Waghodia, District Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8690764875 |
| Fax |
|
| Email |
dhavaninaik23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neha Mukkamala |
| Designation |
Assistant Professor and Guide |
| Affiliation |
Sumandeep Vidyapeeth an Institution Deemed to be University |
| Address |
PG Classroom, On Ground Floor, College of Physiotherapy, Sumandeep Vidyapeeth an Institution Deemed to be University, At and Post Piparia, Taluka Waghodia, District Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9898216184 |
| Fax |
|
| Email |
neha.cop@sumandeepvidyapeethdu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Neha Mukkamala |
| Designation |
Assistant Professor |
| Affiliation |
Sumandeep Vidyapeeth an Institution Deemed to be University |
| Address |
PG Classroom, On Ground Floor, College of Physiotherapy, Sumandeep Vidyapeeth an Institution Deemed to be University, At and Post Piparia, Taluka Waghodia, District Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9898216184 |
| Fax |
|
| Email |
neha.cop@sumandeepvidyapeethdu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dhiraj General Hospital Affiliated to Sumandeep Vidyapeeth an Institution Deemed to be University. At and Post Piparia, Taluka Waghodia, District Vadodara 391760 |
|
|
Primary Sponsor
|
| Name |
Dhvani Pankajkumar Naik |
| Address |
College of Physiotherapy, Sumandeep Vidyapeeth an Institution Deemed to be University, At and Post Piparia, Taluka Waghodia, District Vadodara |
| 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 |
| Neha Mukkamala |
OPD 9, Physiotherapy OPD, Dhiraj General Hospital affiliated to Sumandeep Vidyapeeth |
OPD 9, Physiotherapy OPD, Dhiraj General Hospital, Sumandeep Vidyapeeth an Institution Deemed to be University, At and Post Piparia, Taluka Waghodia, District Vadodara
Vadodara
GUJARAT |
9898216184
neha.cop@sumandeepvidyapeethdu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee (SVIEC) |
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
|
|
|
Inclusion Criteria
|
| Age From |
38.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Male and female subjects diagnosed with knee Osteoarthritis. |
|
| ExclusionCriteria |
| Details |
History of knee surgery.
Inflammatory arthritis in lower limb joints.
Presence of neurological problems.
Any recent trauma or fractures in lower limb.
Any congenital deformity in lower limb.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Staheli Arch Index |
1 time in the Research study of 1 year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Staheli Arch Index |
1 time in the Research Study Of 1 year. |
|
|
Target Sample Size
|
Total Sample Size="73"
Sample Size from India="73"
Final Enrollment numbers achieved (Total)= "73"
Final Enrollment numbers achieved (India)="73" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/09/2019 |
| Date of Study Completion (India) |
20/01/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
A cross sectional study was conducted which aimed to find out the relation between flat foot and knee osteoarthritis in adults in 73 patients with knee osteoarthritis that was conducted in Dhiraj General hospital, Vadodara in India. In adult patients with knee osteoarthritis, outcome measure of Staheli Arch Index was taken only at the time of enrollment of the patient. Total 73 Osteoarthritis knee patients participated in the study (26 Males, 47 Females) with mean age of 54.66+8.48 years. Compared with all other feet, flat foot had 1.08 and 1.26 times the odds of Osteoarthritis of knee on left and right side respectively. There was no statistically significant correlation between SAI and WOMAC (r: - 0.08, p:-0.49 on right side and r:-0.08, p:0.50 on left side) and KL and flat foot (p = 0.65on left and p = 0.93on right side). There was positive correlation found between BMI and SAI (r: - 0.24, p:-0.041on right side and r:-0.27, p:0.022 on left side). Knee osteoarthritis patients are more prone to have flat foot but, knee OA severity and disability caused by knee osteoarthritis is not related to flat foot |