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CTRI Number  CTRI/2025/10/095546 [Registered on: 01/10/2025] Trial Registered Prospectively
Last Modified On: 30/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   A study on recovery in patients aged 16 to 70 years with upper or lower shin bone fractures treated using expert tibial nailing 
Scientific Title of Study   Functional Outcomes of Expert Tibial Nailing for Proximal and Distal Tibial Fractures - A Prospective Observational Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SIDDARTH 
Designation  POST GRADUATE RESIDENT 
Affiliation  Sri Venkateshwaraa Medical College Hospital and Research Centre 
Address  DEPARTMENT OF ORTHOPAEDICS, SRI VENKATESHWARAA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, ARIYUR, PUDUCHERRY

Pondicherry
PONDICHERRY
605102
India 
Phone  7708049700  
Fax    
Email  siddarthezhil@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  MANIKANDAN.A 
Designation  PROFESSOR 
Affiliation  Sri Venkateshwaraa Medical College Hospital and Research Centre 
Address  DEPARTMENT OF ORTHOPAEDICS, SRI VENKATESHWARAA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, ARIYUR, PUDUCHERRY

Pondicherry
PONDICHERRY
605102
India 
Phone  7904532243  
Fax    
Email  drmanikandanadimoolam@gmail.com  
 
Details of Contact Person
Public Query  
Name  SIDDARTH 
Designation  POST GRADUATE RESIDENT 
Affiliation  Sri Venkateshwaraa Medical College Hospital and Research Centre 
Address  DEPARTMENT OF ORTHOPAEDICS, SRI VENKATESHWARAA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, ARIYUR, PUDUCHERRY

Pondicherry
PONDICHERRY
605102
India 
Phone  7708049700  
Fax    
Email  siddarthezhil@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Sri Venkateshwaraa Medical College Hospital and Research Centre 
Address  Department of Orthopaedics, Sri Venkateshwaraa Medical College Hospital and Research Centre, Ariyur, Puducherry - 605102 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
siddarth  Sri Venkateshwaraa Medical College Hospital and Research Centre  Department of Orthopaedics, Sri Venkateshwaraa Medical College Hospital and Research Centre, Ariyur, Puducherry - 605102
Pondicherry
PONDICHERRY 		 7708049700

siddarthezhil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE(HUMAN STUDIES), SRI VENKATESHWARAA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S823||Fracture of lower end of tibia, (2) ICD-10 Condition: S821||Fracture of upper end of tibia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients with closed or type I open proximal/distal tibial fractures
2.Aged 18 to 70 years 
 
ExclusionCriteria 
Details  1.Pathological fractures
2.Previous surgery to the same limb
3.Associated neurovascular injury
4.Polytrauma or life threatening injuries
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Functional outcome after Expert Tibial Nailing for proximal/distal tibial fractures, assessed using Klemm & Borner functional score and AO radiological criteria  At baseline (pre-operative),3 weeks,6 weeks,3 months and 6 months post-operatively
 
 
Secondary Outcome  
Outcome  TimePoints 
Time to Union (radiological)  3 weeks, 6 weeks, 3 months, 6 months 
Complications(infection,malalignment,implant failure,delayed/non union  3 weeks, 6 weeks, 3 months, 6 months 
Pain(VAS)  3 weeks, 6 weeks, 3 months, 6 months 
Knee and Ankle ROM  3 weeks, 6 weeks, 3 months, 6 months 
Demographics and distribution  baseline/throughout follow up 
 
Target Sample Size   Total Sample Size="33"
Sample Size from India="33" 
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)   11/10/2025 
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="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   This is a prospective observational study conducted in the Department of Orthopaedics at Sri Venkateshwaraa Medical College Hospital and Research Centre, Puducherry. The study aims to evaluate the functional outcome of Expert Tibial Nailing in patients with proximal and distal tibial fractures. Adult patients aged 18 years and above with proximal or distal tibial fractures requiring surgical fixation will be included. Functional outcome will be assessed using Klemm and Borner functional score and AO radiological criteria at regular follow-up intervals. Secondary outcomes will include radiological union, complications, range of motion, and pain scores. The estimated sample size is 33 patients, and the duration of study will be approximately 18 months. 
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