| CTRI Number |
CTRI/2026/01/101355 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
15/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Outcome of Dual Plate Surgery on Knee Function and Bone Healing in Patients with Upper Tibia Joint Fractures |
|
Scientific Title of Study
|
RADIOLOGICAL AND FUNCTION OUTCOME OF PROXIMAL TIBIA INTRA-ARTICULAR FRACTURE TREATED WITH DUAL PLATING |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harsh Chandak |
| Designation |
POSTGRADUATE |
| Affiliation |
Vinayaka Missions Kirupanand variyar medical college and hospital |
| Address |
Pg room f7,Vinayaka Mission Kirupananda Variyar Medical college and hospital chinnaseeragapadi salem
Salem
TAMIL NADU
636308
India |
| Phone |
8200353483 |
| Fax |
|
| Email |
harshdchandak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harsh Chandak |
| Designation |
professor |
| Affiliation |
Vinayaka Missions Kirupanand variyar medical college and hospital |
| Address |
DEPARTMENT OF ORTHOPAEDICS
vinayaka mission kirupananda variyar medical college and hospital chinnaseeragapadi salom tamil nadu
TAMIL NADU
636308
India |
| Phone |
9790449375 |
| Fax |
|
| Email |
sivadr1983@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harsh Chandak |
| Designation |
POSTGRADUATE |
| Affiliation |
Vinayaka Missions Kirupanand variyar medical college and hospital |
| Address |
Pg room f7,Vinayaka Mission Kirupananda Variyar Medical college and hospital chinnaseeragapadi salem
TAMIL NADU
636308
India |
| Phone |
8200353483 |
| Fax |
|
| Email |
harshdchandak@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR HARSH CHANDAK |
| Address |
Vinayaka Mission Kirupananda Variyar Medical college and hospital chinnaseeragapadi salem |
| 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 |
| DR HARSH CHANDAK |
VINAYAKA MISSIONS KIRIPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITAL |
Department of Orthopaedics VMKVMCH CHINNASEERAGAPADI SALEM
Salem
TAMIL NADU |
8200353483
harshdchandak@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: S821||Fracture of upper end of tibia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged more than 18 years with closed, displaced intra-articular proximal tibial fractures classified as Schatzker types IV to VI, who undergo treatment with dual plating within two weeks of injury and provide informed consent, will be included in the study. |
|
| ExclusionCriteria |
| Details |
Patients younger than 18 years, those with open fractures classified as Gustilo–Anderson grade II or III, pathological or periprosthetic fractures, polytrauma patients in whom early fixation is not feasible, and patients with pre-existing ipsilateral knee pathology or prior knee surgery will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Radiological union of the fracture and functional knee outcome assessed using the Knee Society Score following dual plating of proximal tibia intra-articular fractures. |
evaluate knee function using the Knee Society Score and radiology union at 3, 6, and 12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
27/01/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Proximal tibia intra-articular fractures are complex knee injuries that require stable fixation to restore joint anatomy and function. Dual plating provides strong fixation for such fractures, especially unstable patterns. This study assesses radiological healing and functional recovery of the knee following dual plate fixation to evaluate its effectiveness. |