| CTRI Number |
CTRI/2026/02/103670 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
12/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Multidirectional Locked Tibia Nailing and Anterolateral Locked Tibia Plating in Managing Extraarticular Distal Tibial Fractures |
|
Scientific Title of Study
|
Comparative Analysis of Multidirectional Locked Tibia Nailing Versus Aanterolateral Locked Tibia Plating in the Management of Extraarticular Distal Tibia Fractures: A Randomised Control Trial |
| 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 Sandeep Kumar Singh |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Uttar Pradesh University of Medical Sciences |
| Address |
Department of Orthopaedics, UPUMS, Saifai, Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7905995309 |
| Fax |
|
| Email |
sandysandeepsingh65@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Kumar Singh |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Uttar Pradesh University of Medical Sciences |
| Address |
Department of Orthopaedics, UPUMS, Saifai, Etawah
UTTAR PRADESH
206130
India |
| Phone |
7905995309 |
| Fax |
|
| Email |
sandysandeepsingh65@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Kumar Singh |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Uttar Pradesh University of Medical Sciences |
| Address |
Department of Orthopaedics, UPUMS, Saifai, Etawah
UTTAR PRADESH
206130
India |
| Phone |
7905995309 |
| Fax |
|
| Email |
sandysandeepsingh65@gmail.com |
|
|
Source of Monetary or Material Support
|
| NIL |
| Uttar Pradesh University of Medical Sciences, Saifai, Etawah. 206130 |
|
|
Primary Sponsor
|
| Name |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES |
| Address |
UPUMS, Saifai, Etawah |
| 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 Kumar Singh |
Uttar Pradesh University of Medical Sciences |
UPUMS, Saifai, Etawah
Etawah
UTTAR PRADESH |
7905995309
sandysandeepsingh65@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Uttar Pradesh University of Medical Sciences, Saifai, Etawah |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S823||Fracture of lower end of tibia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Anterolateral Locked Tibia Plating |
Standard care |
| Intervention |
Multidirectional Locked Tibia Nailing |
Locked Nailing of tibia in multidirection |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patient more than 18 years of age and less than 70 years of age.
2. Closed fractures and grade I compound fractures of distal tibial fractures without intra articular extension.
|
|
| ExclusionCriteria |
| Details |
1 Intraarticular tibial fracture, pathological fracture
2 Fractures with suspected neurovascular complications
3 Comorbidities |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fracture fixation |
Fracture fixation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to radiological union |
|
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
26/02/2026 |
| 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="0"
Months="8"
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
|
This randomized controlled trial compares multidirectional locked intramedullary tibial nailing with anterolateral locked distal tibial plating in adults with extra-articular distal tibial fractures. Forty-six patients will be randomly allocated into two equal groups and followed for one year. Outcomes assessed include fracture union, complications, and functional outcome using the Olerud–Molander Ankle Score. The study aims to identify the more effective surgical modality for optimal healing and functional recovery. |