FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/092867 [Registered on: 12/08/2025] Trial Registered Prospectively
Last Modified On: 12/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To Determine Rotational malalingnemt of tibia following intramedullary nail fixation after surgical fixation of midshaft tibia fracture 
Scientific Title of Study   Rotational malalignment of tibia following intramedullary nail fixation 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aditya Dalvi 
Designation  Junior resident 
Affiliation  Datta Meghe Institute Of Medical Sciences Wardha 
Address  Datta Meghe Institute of medical sciences Sawangi Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9930341159  
Fax    
Email  adityadalvi1404@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nitin Samal 
Designation  Professor 
Affiliation  Datta Meghe Institute Of Medical Sciences Wardha 
Address  Department of Orthopaedics Datta Meghe Institute of Medical Sciences Sawangi Meghe Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  8888244448  
Fax    
Email  nitinsamal2486@gmail.com  
 
Details of Contact Person
Public Query  
Name  Aditya Dalvi 
Designation  Junior resident 
Affiliation  Datta Meghe Institute Of Medical Sciences Wardha 
Address  Department of Orthopaedics Datta Meghe Institute Of Medical Sciences Sawangi Meghe Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9930341159  
Fax    
Email  adityadalvi1404@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Medical Sciences Wardha  
 
Primary Sponsor  
Name  Aditya Dalvi 
Address  Datta Meghe Institute Of Medical Sciences Sawangi Meghe Wardha 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
Datta Meghe Institute Of Medical Sciences   Datta Meghe Institute Of Medical Sciences Sawangi Meghe Wardha 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Aditya Dalvi  Department of Orthopaedics Datta meghe intstitute of medical sciences Wardha  Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education & Research, Sawangi, Meghe, Wardha 442001
Wardha
MAHARASHTRA 		 9930341159

adityadalvi1404@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute Of Higher Education And Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: X58||Exposure to other specified factors,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients aged 18 to 65 years and
Undergoing intramedullary nail fixation for tibial fractures
 
 
ExclusionCriteria 
Details  Pre existing tibial malrotation
Open fractures
Conditions affecting rotational alignment
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Patient Satisfaction Gait Analysis Range of Motion  Patient Satisfaction Gait Analysis Range of Motion 
 
Secondary Outcome  
Outcome  TimePoints 
To identify and analyze potential preoperative and intraoperative risk factors associated with the occurrence and severity of tibial malrotation  To identify and analyze potential preoperative and intraoperative risk factors associated with the occurrence and severity of tibial malrotation 
 
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)   23/08/2025 
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)   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  

The study seeks to address critical questions regarding the incidence of rotational malalignment, the identification of potential risk factors contributing to malalignment, and the assessment of its impact on functional outcomes and patient satisfaction.

Despite the clinical significance of rotational malalignment, there is a noticeable gap in the literature regarding its prevalence and implications in the context of tibial fracture management. By shedding light on this aspect, our study aims to contribute valuable insights that could influence surgical decision-making and postoperative care. Understanding the factors that may contribute to rotational malalignment and its consequences is essential for optimizing surgical techniques, refining rehabilitation protocols, and ultimately improving patient outcomes.

This study adopts a prospective observational cohort design to systematically capture data from a diverse patient population undergoing either intramedullary nail fixation. By following patients longitudinally, we aim to delineate the trajectory of rotational malalignment postoperatively, identify potential risk factors, and assess the functional repercussions over time. 
Close