| CTRI Number |
CTRI/2025/10/095511 [Registered on: 01/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Different Coronal plane knee alignments after HTO using different planning methods |
|
Scientific Title of Study
|
COMPARISON OF PREOPERATIVE PLANNING METHODS FOR OPEN WEDGE HIGH TIBIAL OSTEOTOMY IN PATIENTS WITH GENU VARUM DEFORMITY |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SANDEEP PADHY |
| Designation |
Postgraduate resident |
| Affiliation |
Maulana Azad Medical College, Delhi |
| Address |
A3/153-D, Pocket A3, DDA LIG Flats, Mayur Vihar Phase-3, Delhi-110096
Room no 610, Old resident Doctor hostel, Lok Nayak hospital, Delhi
Central
DELHI
110096
India |
| Phone |
8076809236 |
| Fax |
|
| Email |
padhysandeep856@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUMIT ARORA |
| Designation |
PROFESSOR |
| Affiliation |
Maulana Azad Medical College, Delhi |
| Address |
Lok Nayak Hospital, Orthopedics block, Room Number 608
Central
DELHI
110002
India |
| Phone |
8076809236 |
| Fax |
|
| Email |
sumitaroraortho@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SANDEEP PADHY |
| Designation |
Postgraduate resident |
| Affiliation |
Maulana Azad Medical College, Delhi |
| Address |
A3/153-D, Pocket A3, DDA LIG Flats, Mayur Vihar Phase-3, Delhi-110096
Room no 610, Old resident Doctor hostel, Lok Nayak hospital, Delhi
Central
DELHI
110096
India |
| Phone |
8076809236 |
| Fax |
|
| Email |
padhysandeep856@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical college, Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical college Delhi |
| Address |
Bahadur Shah Zafar Marg, New Delhi, India,110002 |
| 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 SANDEEP PADHY |
Maulana Azad Medical college |
Orthopaedics block, Room no 608, Delhi-110002
Central
DELHI |
8076809236
padhysandeep856@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, MAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M211||Varus deformity, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Deformity of tibial origin |
|
| ExclusionCriteria |
| Details |
Flexion deformity more than 15 degrees
Varus deformity more than 20 degrees
Joint line congruence angle more than 3 degrees
Pan-compartmental arthritis (Kellgren-Lawrence grade 4)
Diaphyseal femoral/ tibial deformity
Bone dysplasias
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correction angle |
Correction angle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Femorotibial angle
MPTA
Mikulicz line deviation |
|
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
20/10/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
We measure the correction angle calculated using Miniaci, Dugdale and paley methods and compare them against the angle required for physiological correction of varus deformity |