| CTRI Number |
CTRI/2020/05/025225 [Registered on: 18/05/2020] Trial Registered Prospectively |
| Last Modified On: |
31/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To correlate knee and ankle alignment in osteoarthritis knee |
|
Scientific Title of Study
|
Correlation of knee alignment with ankle and hindfoot alignment and clinical severity in grade 4 osteoarthritis knee |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Navin Sagar |
| Designation |
Post graduate first year |
| Affiliation |
VMMC AND SAFDARJUNG HOSPITAL |
| Address |
Room No- 33,Ground Floor, PMR OPD, Safdarjung Hospital, New Delhi
South
DELHI
110029
India |
| Phone |
7982218232 |
| Fax |
|
| Email |
dr.navinsagarsjh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Diganta Borah |
| Designation |
Professor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Room No-173,First Foor, PMR department, OPD building, Safdarjung Hospital,New Delhi
South
DELHI
110029
India |
| Phone |
7503005456 |
| Fax |
|
| Email |
diganta29@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Navin Sagar |
| Designation |
Post graduate first year |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Room No- 33,Ground Foor, PMR department,OPD building, Safdarjung Hospital, New Delhi
South
DELHI
110029
India |
| Phone |
7982218232 |
| Fax |
|
| Email |
dr.navinsagarsjh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Safdarjung Hospital Ansari Nagar East, New Delhi-110029 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Navin Sagar |
Safdarjung Hospital |
Room No- 33,Ground Floor,PMR department, OPD building
New Delhi
DELHI |
7982218232
dr.navinsagarsjh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients diagnosed with primary knee osteoarthritis according to ACR criteria
2. Kellgren- Lawrence grade IV |
|
| ExclusionCriteria |
| Details |
1. Previous surgery involving knee and/ or
ankle.
2. Secondary Osteoarthritis.
3. History of injury of foot and/ or knee that
may compromise knee function.
4. Nerve related symptoms ( radiculopathy)
5. Patients with complex regional pain syndrome.
6. Rheumatoid and other inflammatory arthritis,
diabetes mellitus, local or systemic
infection.
7. Peripheral vascular disease, metabolic
disease such as gout, malignency
8. Presence of other cause of knee pain.
9. Pregnency
10.Other deformity of lower limb except varus-
valgus knee. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Correlation of knee alignment with Ankle and hindfoot alignment in terms of
a. Angle between mid diaphyseal line of tibia and mid diaphyseal line of calcaneus.
b. Tibiotalar angle.
c. Tibial anterior surface angle.
d. Talar tilt angle.
e. Angle between ground surface and distal tibial plafold. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Disease severity in terms of
a. Western Ontario and McMaster Universities Osteoarthritis Index.
b. Health Assessment Questionnaire.
c. Visual Analogue Scale. |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "77"
Final Enrollment numbers achieved (India)="77" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/05/2020 |
| Date of Study Completion (India) |
24/09/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Purpose of the study is to correlate the knee alignment with ankle and hindfoot alignment and clinical severity in grade iv osteoarthritis knee using antero-posterior full lower limb radiograph and ankle long axial view radiograph by measuring various angles. |